Portable test device for analyzing biological samples

Abstract

A portable test device includes a housing having an integrated touch screen display and a container in which a sample reservoir containing a mixture of biological samples and reagents can be placed. The portable test device also includes an optical assembly disposed in the housing, an electronic assembly configured to receive data from the optical assembly and transmit it for display on the touch screen display, and a power source in the housing to power the portable test device. The optical assembly includes an excitation filter extending across the entire optical assembly and an emission filter extending across the entire optical assembly.

Description

[0001] This application is a divisional application of the patent application with international application number PCT / US2014 / 059487, international application date October 7, 2014, Chinese application number 201480064137.1, and invention name “Portable testing device for analyzing biological samples”. Technical Field

[0002] The present invention relates to devices capable of analyzing biological samples, and in particular to portable testing devices capable of being used in the field. Background Art

[0003] Typically, after a biological sample is collected on-site, it is tested in a laboratory. After the sample is collected, a number of steps are taken to prepare the sample, including mixing the sample with a reaction buffer, dye, and any other chemical solutions required for preparing the sample for testing. During or after sample preparation, the test equipment also needs to be prepared. This may include warming the equipment, calibrating the equipment for the specific test to be run, and any other initial procedures required for using the specific test equipment. After the sample and equipment are ready, the prepared sample can be placed in the equipment for testing.

[0004] The typical process for testing biological samples described above has significant disadvantages. One disadvantage is that the biological sample needs to be collected on site, brought to a laboratory, and then tested. This can present the following problems. First, the biological sample may become contaminated between the time it is collected and the time it is tested. Second, it may be discovered that not enough biological sample was collected on site, preventing the test from being completed. Third, it may be discovered later that the biological sample obtained is otherwise unsuitable for testing. When a biological sample is unsuitable for testing due to any of the above reasons, additional biological samples will need to be collected in order to complete the test. This requires additional time, money, and other resources to complete. Summary of the Invention

[0005] A portable testing device includes a housing having an integrated touchscreen display and a container in which a sample reservoir containing a mixture of a biological sample and a reagent can be placed. The portable testing device also includes an optical assembly disposed within the housing, an electronic assembly configured to receive data from the optical assembly and transmit it for display on the touchscreen display, and a power supply within the housing for powering the portable testing device. The optical assembly includes an excitation filter extending across the entire optical assembly and an emission filter extending across the entire optical assembly. BRIEF DESCRIPTION OF THE DRAWINGS

[0006] Figure 1 is a perspective view of a portable test device.

[0007] Figure 2A is a perspective view of the top side of the portable test device when the cover is placed over the display.

[0008] Figure 2B is a bottom plan view of the portable test device.

[0009] Figure 3A is a perspective view of the top side of an alternative design of the portable test device when the cover is placed over the display.

[0010] Figure 3B is a perspective view of the underside of an alternative design of the portable test device when the cover is stored in a recess on the underside of the portable test device.

[0011] Figure 4A is a perspective view of the portable testing device as sample receptacles in the form of a tube array are being placed in the portable testing device.

[0012] Figure 4B is a perspective view of the portable testing device as a sample receptacle in the form of a card is being placed in the portable testing device.

[0013] Figure 4C is a perspective view of the portable testing device when a card has been placed in the portable testing device.

[0014] Figure 5 is a block diagram of a portable test device.

[0015] Figure 6A is a perspective view of the optical components.

[0016] Figure 6B is a cross-sectional view of the optical component.

[0017] Figure 7 This is an exploded view of the heating section of the optical assembly.

[0018] Figure 8 This is an exploded view of the lens portion of the optical assembly.

[0019] Figure 9 This is an exploded view of the outer shell of the optical component.

[0020] Figure 10A is a partially exploded view of the first optical mounting portion of the optical assembly.

[0021] Figure 10B is a partially exploded view of the second optical mounting portion of the optical assembly.

[0022] Figure 10C is a partially exploded view of a first optical mounting portion and a second optical mounting portion of an optical assembly.

[0023] Figure 11A is a perspective view of the screen assembly.

[0024] Figure 11B This is a partially exploded view of the screen assembly.

[0025] Figure 11C is a partially exploded view of a machine-readable code reader attached to a screen assembly.

[0026] Figure 12 is an exploded view of the second housing portion and the cover of the portable testing device.

[0027] Figure 13A is an exploded view of the screen assembly and first housing portion of the portable testing device.

[0028] Figure 13B is a partially exploded view of a screen assembly, an optical assembly, a first housing portion, and a second housing portion of a portable testing device.

[0029] Figure 13C is a partially exploded view of the portable test device.

[0030] Figure 14 is a flow chart showing the steps for operating a portable testing device.

[0031] Figure 15A is a perspective view of a portable testing device with a tablet computer positioned on the portable testing device.

[0032] Figure 15B When the optical cover is opened Figure 15A A perspective view of the portable test device as seen in FIG.

[0033] Figure 16A is a perspective view of the upper optical assembly.

[0034] Figure 16B is Figure 16A Exploded view of the upper optical assembly as seen in .

[0035] Figure 17A is a perspective view of an optical assembly, the optical assembly being included in Figures 16A-16B The upper and lower optical components seen in .

[0036] Figure 17B is Figure 17A Exploded view of the optical components as seen in .

[0037] Figure 18A is a perspective view of the lower portion of the portable testing device, said lower portion comprising Figures 16A-16B The optical components and power supply components seen in the figure.

[0038] Figure 18B is Figure 18A Exploded view of the lower portion of the portable test device as seen in FIG.

[0039] Figure 19A is a perspective view of a portable test device.

[0040] Figure 19B is Figure 19A Exploded view of the portable test unit as seen in .

[0041] Figure 20A is a perspective view of the sample preparation area on the portable testing device.

[0042] Figure 20B is a perspective view of a membrane cover over a sample preparation area on a portable testing device.

[0043] Figure 20C is Figure 20A A perspective view of the sample preparation area as seen in FIG. 1 when a sample array has been placed in the sample preparation area.

[0044] Figure 20D is Figure 20A A perspective view of the sample preparation area as seen in FIG. 1 when the sample array has been placed in the portable testing device.

[0045] Figure 21 is a flow chart showing the steps for operating a portable testing device.

[0046] Figure 22A is a perspective view of the optical components.

[0047] Figure 22B is a top view of the optical assembly.

[0048] Figure 23 It is along Figure 22B A cross-sectional side view of the optical assembly taken along line 23-23.

[0049] Figure 24A is a perspective view of the optical assembly in a first position.

[0050] Figure 24B is a perspective view of the optical assembly in a second position.

[0051] Figure 24C is a perspective view of the optical assembly in a third position.

[0052] Figure 25 is a cross-sectional side view of the optical assembly.

[0053] Figure 26A is a side view of a first side of an optical assembly according to a first configuration.

[0054] Figure 26B is a side view of a second side of the optical assembly according to the first configuration.

[0055] Figure 27A is a side view of a first side of an optical assembly according to a second configuration.

[0056] Figure 27B is a side view of a second side of the optical assembly according to a second configuration.

[0057] Figure 28A is a perspective view of the optical components.

[0058] Figure 28B is a bottom view of the optical assembly.

[0059] Figure 29A is an exploded perspective view of a first side of the optical assembly.

[0060] Figure 29B is an exploded perspective view of the first side of the optical assembly.

[0061] Figure 29C is an exploded perspective view of the second side of the optical assembly.

[0062] Figure 29D is an exploded perspective view of the second side of the optical assembly.

[0063] Figure 30A It is a perspective view of the card.

[0064] Figure 30B is a side elevation view of the card.

[0065] Figure 30C This is a front elevation view of the card.

[0066] Figure 31A It is a front elevation view of the card showing slot variants AD.

[0067] Figure 31B It is a front elevation view of the card showing slot variant EH.

[0068] Figure 32A is a side elevation view of the card showing the seal on the card.

[0069] Figure 32B is a front elevational view of the card showing the first permanent seal and the removable seal.

[0070] Figure 32C is a front elevation view of the card after the removable seal has been removed.

[0071] Figure 32D is a front elevation view of the card after the second permanent seal has been applied.

[0072] Figure 33A is a perspective view of the top side of the card.

[0073] Figure 33B is a perspective view of the underside of the card.

[0074] Figure 34A is a perspective view of the card when the second body is turned down.

[0075] Figure 34B is a perspective view of a card with a first permanent seal.

[0076] Figure 34C is a perspective view of a card with a first removable seal.

[0077] Figure 34D is a perspective view of a card that can be placed in a freeze dryer.

[0078] Figure 34E is a perspective view of a card having a second removable seal over a first removable seal.

[0079] Figure 35A is a perspective view of a card having a first removable seal and a second removable seal.

[0080] Figure 35B is a perspective view of a card with the first and second removable seals removed to provide access to the slot.

[0081] Figure 35C is a perspective view of the card when the second body is folded over the slot, thereby sealing the slot with a permanent seal.

[0082] Figure 35D Here is a perspective view of the card ready for testing.

[0083] Figure 36A is a perspective view of the lid assembly.

[0084] Figure 36B is a top view of a seal that may be used with the lid assembly.

[0085] Figure 37A is a perspective view of a cap assembly attached to an array of sample tubes.

[0086] Figure 37B is a perspective view of a cap assembly with a seal applied to the cap assembly.

[0087] Figure 37C is a perspective view of the lid assembly in a closed position over the seal.

[0088] Figure 37Dis a perspective view of the open lid assembly and the gasket removed from the seal.

[0089] Figure 37E is a perspective view of the lid assembly in a closed position forming a seal with the permanent seal.

[0090] Figure 38A is a front view of a sample receptacle including a tube array and a cap array.

[0091] Figure 38B is a perspective view of the sample receptacles when the cap array has been placed on the tube array.

[0092] Figure 39A is a front view of a sample receptacle including a tube array and a cap array.

[0093] Figure 39B is a perspective view of the sample receptacles when the cap array has been placed on the tube array.

[0094] Figure 39C is a side view of the sample receptacle when the cap array has been placed on the tube array.

[0095] Figure 39D is a top view of the sample reservoir.

[0096] Figure 40A is a perspective view of the sample receptacles when the cap array has been placed on the tube array.

[0097] Figure 40B is a front view of the sample receptacles when the cap array has been placed on the tube array.

[0098] Figure 40C is a bottom view of the sample receptacle. DETAILED DESCRIPTION

[0099] Generally, the present invention is a portable testing device for analyzing biological samples. The portable testing device can be taken to the site to test biological samples as they are collected. This is advantageous relative to prior art systems because it allows the user to test biological samples while they are being collected. This can prevent the following problems: contamination and degradation of biological samples due to transportation to a laboratory for testing, finding that not enough samples have been obtained later, or finding that the collected biological samples are otherwise unsuitable for use later. Allowing users to test biological samples on site can save time, money, and resources. If the test results indicate a potentially harmful pathogen or toxin, testing on site also provides the ability to respond quickly and safely.

[0100] In the embodiment described below, the portable testing device can test biological samples with isothermal amplification methods (such as EnviroLogix's DNAble® chemistry or LAMP chemistry). This eliminates the need for thermal cycling as a means of amplifying nucleic acid products for endpoint detection. This allows the user to obtain data from the biological sample while running the test. The portable testing device displays these data on a screen on the portable testing device or on a tablet computer so that the user can watch the result of the field test. It is advantageous to allow the user to watch the result of the field test because the user can make the wise decision of whether to need additional testing subsequently. And if the test indicates that there are pathogens or toxins in the biological sample, the user can immediately start appropriate safety protocols to protect for pathogens or toxins. In an alternative embodiment, the portable testing device can also merge thermal cyclers to allow the use of non-isothermal polymerase chain reaction (PCR) chemistry and cause qPCR and endpoint analysis.

[0101] Portable test device 100 with optical assembly 156

[0102] Figure 1 1 is a perspective view of a portable test device 100. The portable test device 100 includes a housing 110 (including a first housing portion 112 and a second housing portion 114), a display 116, a handle 118, a lid 120, and a container 122 (shown in FIG. Figure 4A middle).

[0103] Portable test device 100 is used to analyze biological samples (also referred to as biological sample and reagent mixtures) that have been mixed with a reaction mixture. Housing 110 forms the body of portable test device 100. Housing 110 includes a first housing portion 112 and a second housing portion 114. First housing portion 112 forms the base portion of portable test device 100, and second housing portion 114 forms the top of portable test device 100. Positioned on the front top side of housing 110 is a display 116. Display 116 is a touch screen display in the embodiment shown, but can be any suitable display in an alternative embodiment. The user can use display 116 to select a test protocol and set parameters for the test to be run in portable test device 100. The user can also use display 116 to provide sample and measurement traceability information to portable test device 100. Display 116 will also be displayed on the data collected during the test.

[0104] The housing 110 also includes a handle 118. The handle 118 is located on the front side of the housing 110 in the illustrated embodiment, but may be located in any suitable location in alternative embodiments. The handle 118 is shown as being integral to the housing 110 in the illustrated embodiment, but may be attached to the portable testing device 100 in any suitable manner in alternative embodiments. Including the handle 118 on the portable testing device 100 allows the portable testing device 100 to be easily transported in the field.

[0105] The housing 110 also includes a lid 120. The lid 120 is located on the top side of the housing 110 in the embodiment shown, but may be located in any suitable location in alternative embodiments. The lid 120 is included on the portable testing device 100 to cover the container 122 (shown in FIG. Figure 4A ). The biological sample to be tested is loaded into a sample receptacle which can then be placed in container 122. Lid 120 covers container 122 to prevent contamination from entering container 122 when portable testing device 100 is used in the field. Lid 120 also prevents radiation from escaping the portable testing device 100 while the test is being completed, and prevents ambient light from entering the portable testing device 100. Lid 120 can be moved between open and closed positions and can be held in the closed position by any suitable means. In the illustrated embodiment, lid 120 is held in the closed position by a magnet. When lid 120 is in the closed position, it applies pressure to the sample receptacle placed in the heating stage within portable testing device 100. This improves the engagement and heat transfer between the sample receptacle and the heating stage within portable testing device 100.

[0106] The portable testing device 100 is designed for field use and provides many advantages for such use. Biological materials collected on site can be tested on site as they are collected. This alleviates concerns about contamination and degradation of biological samples because they do not need to be transported back to the laboratory for testing. Moreover, the portable testing device 100 allows the user to quickly react to the results of tests run on site. If the test is inconclusive, additional biological material can be collected and sampled immediately. Moreover, if the test indicates that there are pathogens or toxins in the sample, the user can immediately initiate an appropriate safety program to protect against the pathogens or toxins.

[0107] The portable test device 100 includes a number of features that make it suitable for field use. A handle 118 is included to easily transport the device. Integrating the display 116 into the portable test device 100 allows the portable test device 100 to function as an all-in-one system, as the portable test device 100 is capable of testing biological samples, processing the collected data, and displaying the data on the display 116. The display 116 eliminates the need to connect the portable test device 100 to other machines or computers to process and display test results. This allows users to avoid having to carry additional devices on site or having to wait until they return to the laboratory to read out the data. The portable test device 100 includes all the features necessary for testing, processing, and displaying test results in one compact, all-in-one device.

[0108] Figure 2A is a perspective view of the top side of the portable testing device 100 when the cover 124 is placed over the display 116 . Figure 2B 1 is a bottom plan view of the portable test device 100. The portable test device 100 includes a housing 110, a display 116 (not shown), and a display 116. Figures 2A-2B ), cover 124, power switch 126, power socket 128 and battery cover 130.

[0109] Housing 110 forms the body of portable test device 100. Display 116 is positioned on the top front portion of housing 110. Display 116 is a touchscreen display, and a user can use display 116 to select a test protocol and view data collected during testing. A cover 124 is provided to cover and protect display 116. Portable test device 100 is designed for field use, so there is a significant risk that display 116 could be damaged if exposed when transporting portable test device 100 in the field. Cover 124 forms an interference fit with housing 110 over display 116. Cover 124 can be positioned over display 116 and snapped into place, allowing it to remain in place during transport of portable test device 100. Cover 124 protects display 116 from damage during transport of portable test device 100. Cover 124 can be removed from display 116 using notches located along the perimeter of cover 124. The user may place a finger in the indentation and pull the cover 124 away from the display 116 .

[0110] The portable test device 100 also includes a power switch 126 and a power socket 128 located on the side of the housing 110. The user can turn the portable test device 100 on and off using the power switch 126. The power socket 128 is used to connect the portable test device 100 to a power source so that the battery in the portable test device 100 can be charged. A battery cover 130 holds the battery in the portable test device 100 and can be removed to access the battery.

[0111] Providing a cover 124 over display 116 is advantageous because display 116 can be easily damaged when portable test device 100 is used in the field. Display 116 is a touch screen display that serves as the primary user interface between the user and portable test device 100, so damage to display 116 can affect the overall operation of portable test device 100. Protecting display 116 with cover 124 prevents damage to display 116. Furthermore, powering portable test device 100 with a battery is advantageous because it allows portable test device 100 to be used in the field.

[0112] Figure 3A is a perspective view of the top side of an alternative design of the portable testing device 100 ′ when the cover 124 ′ is placed over the display 116 ′. Figure 3B 1 is a perspective view of the bottom side of an alternative design of the portable test device 100' when the cover 124' is stored in the recess 132' on the bottom side of the portable test device 100'. The portable test device 100' includes a housing 110', a display 116' (not shown), and a display 116'. Figures 3A-3B ), cover 124', power switch 126' and groove 132'.

[0113] The housing 110' forms the body of the portable test device 100'. The display 116' is positioned on the top front portion of the housing 110'. The cover 124' forms an interference fit with the housing 110' above the display 116'. The cover 124' can be positioned over the display 116' and snapped into place so that it remains in place during transportation of the portable test device 100'. The cover 124' protects the display 116' from damage during transportation of the portable test device 100'. The cover 124' can be removed from the display 116' using a notch located along the perimeter of the cover 124'. A user can place a finger in the notch and pull the cover 124' away from the display 116'.

[0114] When the portable test device 100' is in use, the cover 124' can be stored in the recess 132'. The recess 132' is built into the bottom side of the portable test device 100' and is shaped to fit the cover 124'. The cover 124' forms an interference fit with the recess 132' and can be snapped into place in the recess 132'. When the portable test device 100' is no longer in use, the cover 124' can be pulled out of the recess 132' using the notches located along the perimeter of the cover 124' and removed from the recess 132'. A power switch 126' is also positioned on the bottom side of the portable test device 100'. The power switch 126' can be used to turn the portable test device 100' on and off.

[0115] Providing a cover 124' over the display 116' is advantageous because the display 116' may be easily damaged when the portable test device 100' is used in the field. Protecting the display 116' with the cover 124' prevents the display 116' from being damaged. Moreover, providing a recess 132' to store the cover 124' is advantageous because this allows the user to easily store the cover 124' while using the portable test device 100'. This prevents the user from forgetting to put the cover 124' somewhere or deliberately removing the cover 124' so that the user does not have to keep track of the cover 124'. Providing an easy way to store the cover 124' in the recess 132' will ensure the proper use of the cover 124' and protect the display 116' from damage.

[0116] Figure 4A is a perspective view of the portable testing device 100 as a sample receptacle in the form of a tube array 140 is being placed in the portable testing device 100 . Figure 4B is a perspective view of the portable testing device 100 as a sample receptacle in the form of a card 142 is being placed in the portable testing device 100 . Figure 4C is a perspective view of the portable test device 100 when the card 142 has been placed in the portable test device 100. The portable test device 100 includes a housing 110, a display 116, a handle 118, and a cover 120. Figure 4A Also included are a container 122 and a tube array 140 . Figures 4B-4C A container 122' and a card 142 are also included.

[0117] As in Figure 4A As shown in FIG, the container 122 is located on the top side of the portable testing device 100 in the illustrated embodiment, but may be located in any suitable location in alternative embodiments. The container 122 is an opening in the housing 110 of the portable testing device 100. A sample receptacle containing a biological sample may be placed in the container 122 for testing. Figure 4AIn the embodiment, the container 122 is configured to receive the tube array 140. In alternative embodiments, the container 122 can be configured in any manner capable of receiving a sample receptacle.

[0118] As in Figures 4B-4C As shown in , the container 122' is located on the top side of the portable testing device 100 in the illustrated embodiment, but may be located in any suitable location in alternative embodiments. The container 122' is an opening in the housing 110 of the portable testing device 100. A sample receptacle containing a biological sample may be placed in the container 122' for testing. Figures 4B-4C In the embodiment, the container 122' is configured to receive the card 142. In alternative embodiments, the container 122' can be configured in any manner capable of receiving a sample receptacle.

[0119] When the sample receptacle is placed in the container 122 (or container 122') of the portable test device 100, it will be placed in the optical assembly retained in the portable test device 100. The optical assembly will be able to amplify, excite and detect the biological sample in the sample receptacle. The optical assembly includes a heating component for heating the biological sample to amplify it. The optical assembly will then use radiation to excite the biological sample, causing the biological sample to emit radiation. The lid 120 placed above the container 122 prevents radiation from leaking out of the housing 110 through the container 122. The lid 120 also prevents ambient light from entering the housing 110 through the container 122, which prevents ambient light from distorting or invalidating the results of the test being run in the portable test device 100. The lid 120 can be moved between an open and closed position. When the lid 120 is in the open position, the sample receptacle (including the tube array 140 or the card 142) can be inserted into or removed from the container 122. When the lid 120 is closed, the sample receptacle will remain in the container 122 and radiation in the portable testing device 100 will not escape from the housing 110 .

[0120] The container 122 can be shaped to receive any sample receptacle, allowing the portable test device 100 to be designed to accommodate a wide variety of standard and custom-designed sample receptacles. Tube array 140 and card 142 are respective examples. Tube array 140 is a standard sample receptacle that is widely available on the market. Card 142 is a custom-designed sample receptacle designed for use with the portable test device 100. The container 122 allows the portable test device 100 to be designed to accommodate a wide variety of sample receptacle shapes and sizes.

[0121] Figure 51 is a block diagram of the portable test device 100. The portable test device 100 includes a display 116, a power supply 150, an electronics assembly 152, a machine readable code reader 154, and an optical assembly 156. The optical assembly 156 includes a heating stage 160, a light emitting diode 162, and a light detector 164.

[0122] The portable test device 100 is used to analyze and obtain data from biological samples on site. To accomplish this, the portable test device 100 is equipped with a display 116, a power source 150, an electronic assembly 152, a machine-readable code reader 154, and an optical assembly 156. In the illustrated embodiment, the display 116 is a touch screen display that serves as the primary user interface between the user and the portable test device 100. The user can input information into the display 116 to indicate what tests should be run in the portable test device 100 for various biological samples. Furthermore, the user can monitor the results of the tests run in the portable test device 100 on the display 116.

[0123] The display 116 is connected to the electronics assembly 152 using an interface circuit. Information input into the display 116 is communicated to the electronics assembly 152 using the interface circuit. The electronics assembly 152 includes the hardware, firmware, and software that controls the operation of the portable test device 100, including a microprocessor. The electronics assembly 152 dictates what tests are to be run in the portable test device 100 and communicates this information throughout the device. Data collected in the portable test device 100 during testing is also communicated to the electronics assembly 152. The electronics assembly 152 can process this data and transmit it to the display 116 for display. The electronics assembly 152 also stores this data for later retrieval or transmission.

[0124] The electronic assembly 152 is connected to the power supply 150 using an interface circuit. The power supply 150 includes components capable of powering the portable test device 100, including a battery, a power distribution board, a power switch, and a power outlet that can be connected to a power supply for recharging. Power from the power supply 150 is sent to the electronic assembly 152 through the interface circuit, allowing the portable test device 100 to operate.

[0125] The portable test device 100 may also include a machine-readable code reader 154. When a sample receptacle containing a machine-readable code is placed in the portable test device 100, the machine-readable code reader 154 can read the machine-readable code on the sample receptacle. The machine-readable code may also be provided separately from the sample receptacle. The machine-readable code may contain all of the parameters for the test protocol and the assay traceability information for the test to be run. Alternatively, the machine-readable code may indicate what test to be run. This is advantageous because it allows the user to insert a sample into the portable test device 100 and the portable test device 100 will automatically select the test protocol and begin testing.

[0126] The electronic assembly 152 includes a microprocessor associated with a memory and interface circuitry for interacting with the display 116 and the optical assembly 156. Input received in the electronic assembly 152 from the display 116 can be processed in the electronic assembly 152. This information can be used to control the optical assembly 156. The optical assembly 156 performs a test on a biological sample placed in the portable testing device 100. When the test is being completed, the data collected in the optical assembly 156 can be communicated to the electronic assembly 152. The electronic assembly 152 processes this data and can transmit the data to the display 116 so that the user can monitor the test results. The electronic assembly 152 can also transmit the data to an external device using any suitable data transmission means, including wireless transmission or transmission via a USB port, a microUSB port, an SD card, or a microSD card.

[0127] The optical assembly 156 includes a heating stage 160, a light-emitting diode 162, and a photodetector 164 to perform testing on a biological sample placed in the portable testing device 100. The optical assembly 156 uses heat to amplify the biological sample and subsequently excites the sample with radiation to detect the presence of a specific fluorescent marker. The biological sample placed in the portable testing device 100 is mixed with a reaction mixture containing one or more fluorescent dyes. When the biological sample is placed in the portable testing device 100, the heating stage 160 amplifies the biological sample with heat. The heating stage 160 is positioned below the container 122 of the portable testing device 100 so that when a sample receptacle containing the biological sample is placed in the portable testing device 100, the sample receptacle is positioned within the heating stage 160. As the biological sample is amplified, it can be analyzed using the light-emitting diode 162 and photodetector 164. The light-emitting diode 162 emits radiation toward the biological sample to excite it. Multiple light-emitting diodes 162 can be used in the portable testing device 100 to excite the biological sample at a predetermined cycle rate. In the embodiment shown, a plurality of light emitting diodes 162 are cycled intermittently at 1.54 kHz. In an alternative embodiment, the light emitting diodes 162 can be cycled at any predetermined cycle rate. When the biological sample is excited at a predetermined cycle rate, it will emit radiation at the same predetermined cycle rate and the corresponding wavelength of the fluorescent dye added to the biological sample. This radiation can be received by a light detector 164. In the portable testing device 100, a plurality of light detectors 164 can be used to read out the radiation emitted from the biological sample at different radiation wavelengths. The signal generated by the light detector 164 can then be transmitted to the electronic assembly 152 for processing and analysis and displayed on the display 116 as data collected during the test.

[0128] The portable testing device 100 is advantageous because it is an all-in-one device. The portable testing device 100 includes an optical assembly 156 for performing testing of biological samples in the field. The portable testing device 100 also includes an electronic assembly 152 and a display 116 to specify what tests are to be run, as well as to process and display data collected during the tests. The portable testing device 100 also includes a power supply 150, which includes a battery, so that the portable testing device 100 can be used in the field. The portable testing device 100 includes every component necessary to perform testing of a biological sample and includes them in a compact device that can be easily used in the field. Using the portable testing device 100 in the field prevents concerns about contamination or degradation of the biological sample and allows the user to quickly react to the test results in the field.

[0129] Figure 6A is a perspective view of optical assembly 156 . Figure 6Bis a cross-sectional view of the optical assembly 156. The optical assembly 156 includes a heating portion 170 (not shown). Figure 6A ), lens portion 172 (not shown Figure 6A ), the housing portion 174, the first optical mounting portion 176 and the second optical mounting portion 178. Figure 6B Also shown is a tube array 140.

[0130] Optical assembly 156 includes a heating portion 170 for heating the biological sample and reagent mixture in tube array 140. Disposed within heating portion 170 is a lens portion 172 for directing radiation through optical assembly 156. A housing portion 174 is disposed around heating portion 170 and forms the main body of optical assembly 156. A first optical mount 176 is disposed on a first side of housing portion 174, and a second optical mount 178 is disposed on a second side of housing portion 174. Both first optical mount 176 and second optical mount 178 mount light emitting diodes to optical assembly 156 for exciting the biological sample and reagent mixture in tube array 140. Furthermore, both first optical mount 176 and second optical mount 178 mount light detectors to optical assembly 156 for detecting signals from the biological sample and reagent mixture in tube array 140.

[0131] Figure 7 is an exploded view of the heating portion 170 of the optical assembly 156. Figure 6B and 7 As shown in FIG, the heating portion 170 includes a sample stage 190, a heating member 192, a temperature sensor 194, a groove 196, a passage 198, a passage 200, a passage 202, and a passage 204.

[0132] The heating section 170 includes a sample stage 190, which forms the main body of the heating section 170. A heating element 192 is attached to a second side of the sample stage 190. In the illustrated embodiment, the heating element 192 is a flat polyimide heater, but in alternative embodiments, it can be any suitable heater. A temperature sensor 194 is placed on the bottom portion of the sample stage 190 to sense the temperature of the sample stage 190. Furthermore, in alternative embodiments, a thermal cutout, such as a PEPI switch, can be placed in series with the leads on the heating element 192.

[0133] The sample stage 190 includes slots 196 on the top side of the sample stage 190. Each slot 196 is sized to receive one of the tubes in the tube array 140. Figure 7In the embodiment shown in, heating block 192 is at each of constant temperature heating grooves 196, makes it possible to utilize isothermal amplification chemical use portable test device 100. In an alternative embodiment, heating block 192 can heat each groove 196 at different temperatures across a gradient, or a plurality of heating blocks can be arranged, so that each groove is heated to different temperatures with different heating blocks. This allows the user to carry out preliminary tests, to determine what temperature should be used for analyzing specific biological samples. In a further alternative embodiment, heating block 192 can comprise a thermal cycler that can circulate heating portion 170 through different temperatures, makes it possible to utilize non-isothermal polymerase chain reaction (PCR) chemical use portable test device 100.

[0134] The sample stage 190 also includes a passage 198, a passage 200, a passage 202, and a passage 204. Passage 198 extends from a first side of the sample stage 190 to the well 196. Passage 200 extends from a bottom side of the sample stage 190 to the well 196. Passage 202 extends from a second side of the sample stage 190 to the well 196. Passage 204 extends from a bottom side of the sample stage 190 to the well 196. Passages 198, 200, 202, and 204 extend through the sample stage 190 to direct radiation into and out of the biological sample and reagent mixture in the tube array 140 in the well 196.

[0135] Figure 8 is an exploded view of the lens portion 172 of the optical assembly 156. Figure 6B and 8 As shown in , the lens portion 172 includes a lens 210 and a lens positioner 212 .

[0136] The lens section 172 includes lenses 210 positioned in the sample stage 190 of the heating section 170. The passageways 198 in the sample stage 190 are sized to receive the lenses 210 on a first side of the sample stage 190. One lens 210 is positioned in each passageway 198 of the sample stage 190. The lenses 210 are held in the passageways 198 by lens retainers 212. The lens retainers 212 have a plurality of apertures that allow radiation to pass through the lens retainers 212 to pass through the lenses 210.

[0137] Figure 9 is an exploded view of the housing portion 174 of the optical assembly 156. Figures 6A-6B As shown in FIG. 9 , the housing portion 174 includes a first housing 220 , a second housing 222 , a heat shield 224 , a passage 226 , a passage 228 , a passage 230 , a passage 232 , and an aperture 234 .

[0138] The housing portion 174 includes a first housing 220 disposed on a first side of the heating portion 170 and a second housing 222 disposed on a second side of the heating portion 170. The first housing 220 and the second housing 222 form a main body of the housing portion 174. A heat shield 224 is disposed on the top side of the heating portion 170 between the first housing 220 and the second housing 222.

[0139] The first housing 220 includes a passageway 226 and a passageway 228. The passageway 226 extends from a first side of the first housing 220 to the inside of the first housing 220 adjacent to the sample stage 190. Each passageway 226 in the first housing 220 is aligned with one of the passageways 198 in the sample stage 190. The passageway 228 extends from the bottom side of the first housing 220 to the inside of the first housing 220 adjacent to the sample stage 190. Each passageway 228 in the first housing 220 is aligned with one of the passageways 200 in the sample stage 190. The passageways 226 and 228 extend through the first housing 220 to direct radiation into and out of the biological sample and reagent mixture in the tube array 140 in the slot 196 of the sample stage 190.

[0140] The second housing 222 includes a passage 230 and a passage 232. The passage 230 extends from a second side of the second housing 222 to the inside of the second housing 222 adjacent to the sample stage 190. Each passage 230 in the second housing 222 is aligned with one of the passages 202 in the sample stage 190. The passage 232 extends from the bottom side of the second housing 222 to the inside of the second housing 222 adjacent to the sample stage 190. Each passage 232 in the second housing 222 is aligned with one of the passages 204 in the sample stage 190. The passages 230 and 232 extend through the second housing 222 to direct radiation into and out of the biological sample and reagent mixture in the tube array 140 in the slot 196 of the sample stage 190.

[0141] A heat shield 224 is positioned above the sample stage 190 and held between the first housing 220 and the second housing 222. Holes 234 extend from the top side to the bottom side of the heat shield 224. Each hole 234 in the heat shield 224 aligns with a slot 196 in the sample stage 190. This allows the tube array 140 to be positioned within the slot 196 in the sample stage 190 through the hole 234 in the heat shield 224. The heat shield 224 is positioned above the sample stage 190 to prevent heat from escaping from the top side of the sample stage 190. The heat shield 224 also provides an insulating surface to protect the user from the top side of the sample stage 190 when the sample stage 190 is hot.

[0142] Figure 10A is a partially exploded view of the first optical mounting portion 176 of the optical assembly 156 . Figure 10B is a partially exploded view of the second optical mounting portion 178 of the optical assembly 156 . Figure 10C is a partially exploded view of the first optical mounting portion 176 and the second optical mounting portion 178 of the optical assembly 156. Figures 6A-6B , 10A and 10C, the first optical mount 176 includes a housing 240, a housing 242, an emission filter 244, a gasket 246, an excitation filter 248, a passage 250, a passage 252, a light detector mounting plate 254, a light detector 256, a gasket 258, a light emitting diode mounting plate 260, a light emitting diode 262 and a gasket 264. Figures 6A-6B As shown in 10B-10C, the second optical mounting portion 178 includes a housing 270, a housing 272, an emission filter 274, a gasket 276, an excitation filter 278, a passage 280, a passage 282, a light detector mounting plate 284, a light detector 286, a gasket 288, a light emitting diode mounting plate 290, a light emitting diode 292 and a gasket 294.

[0143] The first optical mount 176 is disposed on a first side of the housing portion 174. The first optical mount 176 includes a housing 240 and a housing 242 that form a main body of the first optical mount 176. The housing 240 is attached to a first side of the first housing 220 of the housing portion 174. An emission filter 244 is disposed in a groove on the first side of the first housing 220, between the housing 240 and the first housing 220. A gasket 246 is disposed between the emission filter 244 and the housing 240. The housing 242 is attached to the bottom side of the first housing 220 of the housing portion 174. An excitation filter 248 is disposed in a groove on the bottom side of the first housing 220, between the housing 242 and the first housing 220.

[0144] Housing 240 includes passages 250. Passages 250 extend from a first side of housing 240 to an inner side of housing 240 adjacent to first housing 220. Each passage 250 in housing 240 is aligned with one of passages 226 in first housing 220. Housing 242 includes passages 252. Passages 252 extend from a bottom side of housing 252 to an inner side of housing 242 adjacent to first housing 220. Each passage 252 in housing 242 is aligned with one of passages 228 in first housing 220.

[0145] A photodetector mounting board 254 is attached to a first side of the housing 240. The photodetector mounting board 254 is an electronic board that includes photodetectors 256. Each photodetector 256 on the photodetector mounting board 254 is positioned within one of the passages 250 in the housing 240. A gasket 258 is positioned between the photodetector mounting board 254 and the housing 240. An LED mounting board 260 is attached to the bottom side of the housing 242. The LED mounting board 260 is an electronic board that includes LEDs 262. Each LED 262 on the LED mounting board 260 is positioned within one of the passages 252 in the housing 242. A gasket 264 is positioned between the LED mounting board 260 and the housing 242.

[0146] The second optical mount 178 is disposed on a second side of the housing portion 174. The second optical mount 178 includes a housing 270 and a housing 272 that form a main body of the second optical mount 178. The housing 270 is attached to a second side of the second housing 222 of the housing portion 174. An emission filter 274 is disposed in a groove on the second side of the second housing 222, between the housing 270 and the second housing 222. A gasket 276 is disposed between the emission filter 274 and the housing 270. The housing 272 is attached to the bottom side of the second housing 222 of the housing portion 174. An excitation filter 278 is disposed in a groove on the bottom side of the second housing 222, between the housing 272 and the second housing 222.

[0147] Housing 270 includes passages 280. Passages 280 extend from a second side of housing 270 to an inner side of housing 270 adjacent to second housing 222. Each passage 280 in housing 270 is aligned with one of passages 230 in second housing 222. Housing 272 includes passages 282. Passages 282 extend from a bottom side of housing 282 to an inner side of housing 282 adjacent to second housing 222. Each passage 282 in housing 272 is aligned with one of passages 232 in second housing 222.

[0148] A photodetector mounting board 284 is attached to a first side of the housing 270. The photodetector mounting board 284 is an electronic board that includes photodetectors 286. Each photodetector 286 on the photodetector mounting board 284 is positioned within one of the passages 280 in the housing 270. A gasket 288 is positioned between the photodetector mounting board 284 and the housing 270. An LED mounting board 290 is attached to the bottom side of the housing 272. The LED mounting board 290 is an electronic board that includes LEDs 292. Each LED 292 on the LED mounting board 290 is positioned within one of the passages 282 in the housing 272. A gasket 294 is positioned between the LED mounting board 290 and the housing 272.

[0149] As in Figures 6A-10CAs shown in , optical assembly 156 can excite and detect emission from a biological sample and reagent mixture in tube array 140 disposed in optical assembly 156. Light emitting diode 262 is a dual-color light emitting diode that can emit radiation at two different wavelengths. In the embodiment shown, light emitting diode 262 is a dual-color light emitting diode of blue and yellow light to excite amidated fluorescein (FAM) fluorescent dye and 6-carboxy-X-rhodamine (ROX) fluorescent dye, respectively. Moreover, light emitting diode 262 emits radiation at a predetermined cycle rate of 1.54 kHz. The radiation from light emitting diode 262 can enter the biological sample and reagent mixture in tube array 140 held in groove 196 through passage 252, excitation filter 248, passage 228, and passage 200. Excitation filter 248 is a dual-bandpass excitation filter capable of passing any one of the two wavelengths emitted by light emitting diode 262. Excitation filter 248 is a single filter that extends across the entire length of tube array 140, and thus, excitation filter 248 extends between adjacent pathways 228 in first housing 220. Radiation from light emitting diode 262 can excite a fluorescent dye in the biological sample and reagent mixture. This excitation of the fluorescent dye will emit a signal from the biological sample and reagent mixture, and this emission can pass through pathway 198, pathway 226, emission filter 244, and pathway 250 to be detected by light detector 256. In the illustrated embodiment, emission filter 244 is a dual-bandpass emission filter. Emission filter 244 is a single filter that extends across the entire length of tube array 140, and thus, excitation filter 244 extends between adjacent pathways 226 in first housing 220.

[0150] Light emitting diode 292 is a light emitting diode that emits radiation at a single wavelength. In the embodiment shown, light emitting diode 292 is a green light emitting diode to excite 6-carboxy-X-hexachlorofluorescein (HEX) fluorescent dye. Moreover, light emitting diode 292 emits radiation at a predetermined cycle rate of 1.54 kHz. Radiation from light emitting diode 292 can enter the biological sample and reagent mixture in tube array 140 held in groove 196 through passage 282, excitation filter 278, passage 232, and passage 204. Excitation filter 278 is a single bandpass filter that can pass the wavelength emitted by light emitting diode 292. Excitation filter 278 is a single filter that extends across the entire length of tube array 140, so excitation filter 278 extends between adjacent passages 232 in second housing 222. Radiation from light emitting diode 292 can excite the fluorescent dye in the biological sample and reagent mixture. This excitation of the fluorescent dye will emit a signal from the biological sample and reagent mixture, and this emission can pass through passage 202, passage 230, emission filter 274, and passage 280 to be detected by light detector 286. In the embodiment shown, emission filter 274 is a single bandpass emission filter. Emission filter 274 is a single filter that extends across the entire length of tube array 140, so that excitation filter 274 extends between adjacent passages 230 in second housing 222.

[0151] In an alternative embodiment, the light emitting diode 292 can be a dual-color light emitting diode that can emit radiation at two different wavelengths. Furthermore, the excitation filter 278 is a dual-bandpass excitation filter that can pass both of the two wavelengths emitted by the light emitting diode 292, and the emission filter 274 can also be a dual-bandpass filter. This results in the portable testing device 100 being able to test four different fluorescent dyes that can be mixed into the biological sample and reagent mixture.

[0152] Light emitting diode 262 and light emitting diode 292 emit radiation in the form of light that circulates at a predetermined rate of 1.54 kHz. This results in emission from the biological sample and reagent mixture at the same predetermined rate. Light detector 256 and light detector 286 therefore receive emission from the biological sample and reagent mixture at the same rate of 1.54 kHz. The electronic circuitry connected to light detector 256 and light detector 286 is designed to electronically filter out all other frequencies except 1.54 kHz. This will exclude any ambient light or other radiation sources in the portable test device 100 that may interfere with the test accuracy.

[0153] Having a single filter for emission filter 244, excitation filter 248, emission filter 274, and excitation filter 278 simplifies the design of portable test device 100. This simplified design makes portable test device 100 more suitable for field use. If one of emission filter 244, excitation filter 248, emission filter 274, or excitation filter 278 must be replaced, it is easier to replace the entire filter rather than replacing a large number of different individual filters. Moreover, using one filter for each of emission filter 244, excitation filter 248, emission filter 274, or excitation filter 278 reduces the cost of portable test device 100.

[0154] Figure 11A is a perspective view of the screen assembly 300 . Figure 11B It is a partial exploded view of the screen assembly 300. Figure 11C 306. FIG. 307 is a partially exploded view of the machine-readable code reader 154 attached to the screen assembly 300. The screen assembly 300 includes a screen 302, a screen bracket 304, and a circuit board 306. The screen 302 includes the display 116. Figure 11A and 11C A machine readable code reader 154 is also shown.

[0155] The screen assembly 300 includes a screen 302 mounted to a screen bracket 304. The screen 302 includes the display 116 on a first side of the screen 302. A second side of the screen 302 is mounted to the first side of the screen bracket 304 using fasteners. In the illustrated embodiment, the screen 302 is mounted to the screen bracket 304 using adhesive fasteners, but in alternative embodiments, the screen 302 may be mounted to the screen bracket 304 using any suitable fasteners.

[0156] A circuit board 306 is attached to the second side of the screen bracket 304 using fasteners. In the illustrated embodiment, the circuit board 306 is attached to the screen bracket 304 using screw fasteners, but in alternative embodiments, the circuit board 306 may be mounted to the screen bracket 304 using any suitable fasteners. The circuit board 306 is part of the electronics assembly 152 that communicates with the screen 302 and contains the system computer for the portable test device 100. The circuit board 306 may also communicate with other electronic components of the electronics assembly 152 in the portable test device 100.

[0157] The machine-readable code reader 154 is also attached to the screen bracket 304 using fasteners. In the illustrated embodiment, the machine-readable code reader 154 is attached to the screen bracket 304 using screw fasteners, but in alternative embodiments, the machine-readable code reader 154 can be attached to the screen bracket 304 using any suitable fasteners. The machine-readable code reader 154 is connected to the electronics assembly 152 using interface circuitry. When a code is scanned using the machine-readable code reader 154, the code information can be communicated to the electronics assembly 152 to instruct the portable test device 100 what test protocol to run.

[0158] Figure 12 1 is an exploded view of the second housing portion 114 and the lid 120 of the portable testing device 100. The second housing portion 114 includes an opening 310, an opening 312, a gasket 314, a hinged insert 316, a magnet 318, and a window 320. The lid 120 includes a first lid portion 330, a second lid portion 332, and a magnet 334.

[0159] The second housing portion 114 includes an opening 310 and an opening 312. Opening 310 is an opening on the top side of the second housing portion 114 in which the screen 302 of the screen assembly 300 can be positioned. A gasket 314 is provided to form a seal between the opening 310 in the second housing portion 114 and the screen 302. Positioning the screen 302 of the screen assembly 300 in the opening 310 allows the display 116 of the screen 302 to be used through the opening 310. Opening 312 is an opening on the top side of the second housing portion 114 in which the optical assembly 156 can be positioned. Positioning the optical assembly 156 in the opening 312 allows a user to place and remove the tube array 140 from the optical assembly 156 for analysis. The lid 116 is positioned over the opening 312.

[0160] A hinged insert 316 is disposed on the second housing portion 114 to hingeably connect the lid 116 to the second housing portion 114. A magnet 318 is disposed on the second housing portion 114 to hold the lid 116 in place over the opening 312 when the lid is in the closed position. Both the hinged insert 316 and the magnet 318 are disposed adjacent to the opening 312 on the top side of the second housing portion 114. A window 320 is also provided on one side of the second housing portion 114. In the portable testing device 100, the machine-readable code reader 154 is disposed adjacent to the window 320 so that a code can be read by the machine-readable code reader 154 through the window 320.

[0161] The lid 116 is attached to the second housing portion 114 using a hinged insert 316. The lid 116 includes a first lid portion 330 and a second lid portion 332. The first lid portion 330 includes a hinge pin that mates with the hinged insert 316 to retain the lid 116 on the portable test device 100. The first lid portion 330 also includes a smooth surface on its inner surface to interface with the tube array 140 when the tube array 140 is placed in the portable test device 100. The smooth surface of the lid portion 330, which interfaces with the tube array 140, facilitates cleaning and decontamination after testing in the portable test device 100. A magnet 334 is positioned on the first lid portion 330 and aligns with the magnet 318 on the second housing portion 114. The magnet 334 and the magnet 318 retain the lid 116 on the second housing portion 114.

[0162] Second lid portion 332 is connected to the top of first lid portion 330, with a space provided therebetween. This space can be left open, or it can be filled with insulating material so that lid 116 can act as an insulator above container 122 of portable testing device 100. This will contain the heat emanating from heating element 192 in portable testing device 100. Furthermore, in an alternative embodiment, a heating element can be attached to lid 116 so as to contact the top of tube array 140. This can further heat the area surrounding tube array 140 and prevent condensation on the cap of tube array 140.

[0163] Figure 13A is an exploded view of the screen assembly 300 and the first housing portion 112 of the portable testing device 100 . Figure 13B is a partially exploded view of the screen assembly 300 , the optical assembly 156 , the first housing portion 112 , and the second housing portion 114 of the portable testing device 100 . Figure 13C 1 is a partially exploded view of portable test device 100. The portable test device includes first housing portion 112, second housing portion 114, power supply 150, electronics assembly 152, optical assembly 156, screen assembly 300, battery housing 340, gasket 350, and serial label 354. Power supply 150 includes power switch 126, power receptacle 128, power distribution board 342, and battery 352. Electronics assembly 152 includes electronics board 344, communication board 346, and USB port 348. Electronics board 344 is an input / output controller board.

[0164] As in Figure 13A As shown in FIG, the power supply 150, the electronic assembly 152, and the screen assembly 300 are disposed in the first housing portion 112. The battery housing 340 is also disposed in the first housing portion 112, above the battery 352.

[0165] The power supply 150 includes an electrical switch 126 and a power receptacle 128 that are attached to a power distribution board 342. The power distribution board 342 is positioned adjacent the back side of the first housing portion 112. The power distribution board 342 is also connected via interface circuitry to a battery 352 that is housed by the battery housing 340. The power supply 150 provides power to the portable testing device 100.

[0166] The electronics assembly 152 includes an electronics board 344, a communications board 346, and USB ports 348. The electronics board 344 is positioned in the center of the first housing portion 112. The screen assembly 300 is positioned adjacent to the front side of the first housing portion 112, partially positioned above the electronics board 344. An interface circuit can be used to connect the circuit board 306 of the screen assembly 300 to the circuit board 300. The communications board 346 is positioned adjacent to the back side of the first housing portion 112. Positioned on the communications board 346 are two USB ports 348. In an alternative embodiment, the USB ports 348 can be any port that allows the portable test device 100 to be connected to other electronic devices, including Bluetooth or wireless communication capabilities. The communications board 346 is connected to the electronics board 344 using an interface circuit. Global positioning functionality is also implemented in the communications board 346. This allows the portable test device 100 to log its location while running a test. This allows the user to track the location of detected pathogens when completing the test in the field.

[0167] As in Figure 13B , the optical assembly 156 is positioned above the power distribution board 342 and the communication board 346, adjacent to the back side of the portable test device 100. The second housing portion 114 can be positioned above the components held in the first housing portion 112 of the portable test device 100. The screen 302 of the screen assembly 300 extends through the opening 310 of the second housing portion 114 so that a user can access the display 116 of the screen 302. The optical assembly 156 is positioned adjacent to the opening 312 of the second housing portion 314 so that a sample receptacle can be placed in the optical assembly 156 through the opening 312. A gasket 350 is positioned between the perimeter of the opening 312 and the optical assembly 156 to form a seal between the second housing portion 114 and the optical assembly 156.

[0168] As in Figure 13C As shown in FIG, the battery 352 is inserted into the portable testing device 100 through the bottom side of the first housing portion 112. When the battery 352 is placed in the portable testing device 100, it will be seated in the battery housing 340 (as shown in FIG. Figure 13A). The battery cover 130 can then be placed over the battery 352 and secured to the first housing portion 112 to retain the battery 352 in the portable testing device 100. The cover 124 is also placed over the display 116 of the portable testing device 100 to protect the display 116 from damage. The serial label 354 can be affixed to the underside of the first housing portion 112 using any suitable securing means.

[0169] Figure 14 386. The process is shown as a flow chart of the steps for operating the portable test device 100. The flow chart includes steps 370-386. The process is started by step 370, which is a biological sample and a reagent mixture prepared for testing. The reagent mixture can contain a master mix (master mix) necessary for the desired mensuration, which includes a fluorescent dye or a label such as FAM or ROX necessary for detecting the desired analyte in the portable test device 100. After the user obtains the biological sample from the scene, the biological sample can be mixed with the reagent subsequently to form a biological sample and a reagent mixture. More specifically, the biological sample is first mixed with a reaction buffer. Then, a part for the biological sample and the reaction buffer mixture is transferred to a sample reservoir containing the dried master mix. This forms a biological sample and a reagent mixture for testing.

[0170] In step 372, use power switch 126 to open portable test device 100. In step 374, scan code with machine readable code reader 154. This code will contain information about what test program will be run and what parameter should be used. This information can be communicated by portable test device 100 so that heating element 170 can begin to be heated to the temperature required for the test program desired. In step 376, the user interface on display 116 will visually and audibly inform the user that portable test device 100 is ready for testing. The user opens lid 116 subsequently, and the sample receptacle with biological sample and reagent mixture is placed in the heating element 170 in the portable test device 100.

[0171] In step 378, the user uses the user interface on the display 116 to start the excitation and detection sequence for the desired assay. The optical assembly 156 starts the excitation and detection sequence. During the excitation and detection sequence, the portable test device 100 transmits the emission data to the electronic assembly 152 and the display 116. Step 380 includes displaying the real-time reaction data received from the portable test device 100 on the user interface on the display 116. During step 382, the electronic assembly 152 and the display 116 log the data received from the portable test device 100 and monitor the data for threshold activity. When the assay is complete, in step 384, the display 116 signals the user a positive, negative, or indeterminate result. Finally, in step 386, the electronic assembly 152 stores the resulting data for retrieval or transmission.

[0172] Generally, the present invention relates to a portable testing device for analyzing biological samples. The portable testing device can be taken to the site to test biological samples as they are collected. This is advantageous relative to prior art systems because it allows the user to test biological samples while they are being collected. This can prevent the problems associated with contamination and degradation of biological samples due to transportation to a laboratory for testing, discovering later that not enough samples have been obtained, or discovering later that the collected biological samples are otherwise unsuitable for use. Allowing users to test biological samples on site can save time, money, and resources. If the test results indicate a potentially harmful pathogen or toxin, testing on site also provides the ability to respond quickly and safely.

[0173] In the embodiment described below, the portable testing device can test biological samples with EnviroLogix's DNAble® chemistry using isothermal amplification. This eliminates the need for thermal cycling as a means of amplifying nucleic acid products for endpoint detection. This allows the user to obtain data from the sample while running the test. In an alternative embodiment, the portable testing device can be used to test biological samples with other isothermal amplification chemistry. The portable testing device displays this data so that the user can view the results of the field test. Allowing the user to view the results of the field test is advantageous because the user can then make an informed decision as to whether additional testing is needed. In an alternative embodiment, the portable testing device can also incorporate a thermal cycler to allow the use of non-isothermal polymerase chain reaction (PCR) chemistry and result in qPCR and endpoint analysis.

[0174] Portable test device 400 with optical assembly 418

[0175] Figure 15A is a perspective view of a portable testing device 400 with a tablet computer 404 positioned on the portable testing device 400 . Figure 15B When the optical cover 408 is opened, Figure 15A 4. Portable test device 400 includes a housing 402 and a tablet computer 404. Housing 402 includes a sample preparation area 406, an optical cover 408, a housing opening 410, a first housing portion 412, a second housing portion 414, and a bracket 416. Optical components and power supply components are also included in portable test device 400, but are not shown. Figures 15A-15B Shown in.

[0176] The portable testing device 400 is an integrated device for sampling and testing biological samples on site. The portable testing device 400 includes a housing 402 and a tablet computer 404. The housing 402 contains a Figures 15A-15B 10. The optical assembly and power supply assembly are shown in FIG. The power supply assembly provides power to the portable test device 400 and is capable of connecting to the tablet computer 102 to provide power to the tablet computer 102. The tablet computer 102 communicates with the portable test device 400 using Bluetooth technology or other suitable wireless technology. When a biological sample is placed in the portable test device 400, the optical assembly is used to heat the biological sample for isothermal nucleic acid amplification and to analyze the biological sample. The data collected during the test is transmitted to the tablet computer 404, where it is displayed in real time. In the embodiment shown, the data is transmitted wirelessly from the portable test device 400 to the tablet computer 404, but a direct connection may be used in an alternative embodiment.

[0177] The housing 402 includes a sample preparation area 406 where a biological sample can be prepared for testing. The sample preparation area 406 is positioned on the top surface of the housing 402 of the portable testing device 400. The sample preparation area 406 includes a plurality of apertures in the housing 402 that can be used to prepare a biological sample for testing in the portable testing device 400. The housing 402 also includes an optical cover 408 that covers an opening 410. The optical cover 408 can be opened so that a biological sample can be placed in the opening 410 of the housing 402 for testing. After the biological sample is placed in the portable testing device 400, the optical cover 408 is closed. The biological sample can then be tested using the optical assembly. The housing 402 also includes a tray 416 in which the tablet computer 102 can be positioned.

[0178] The portable testing device 400 is advantageous because it allows the user to collect biological samples on-site while testing them. This can prevent problems associated with contamination of biological samples because they are tested as they are collected. This can also prevent problems associated with biological samples that are collected and subsequently determined to be unsuitable for testing. Testing on-site allows the user to determine in real time whether a biological sample is suitable for testing and prevents the user from having to recollect the sample, saving time and money. Data collected on-site can be stored on the portable testing device 400 and downloaded or accessed at a later time. Furthermore, the data can be transmitted to a remote location via a telephone connection, an internet connection, or other suitable means. Cloud computing can also be used to transmit the data for later or immediate access by another person, allowing for rapid evaluation and closed-loop response when needed.

[0179] In addition, GPS functionality can be incorporated to allow the user to track specific sampling locations and verify that the test is completed at the correct location. The sampling locations can be specified and mapped using GPS mapping functionality. As an example, a map of a corn field can be displayed on a monitor, and predetermined sampling points (e.g., the locations of specific corn plants) can be displayed graphically or using GPS coordinates. The user can observe the monitor and use the GPS coordinates to reach the correct sampling point.

[0180] Figure 16A is a perspective view of the upper optical assembly 420. Figure 16B is in Figure 16A . Upper optical assembly 420 includes a heating member 422, a first set of light emitting diodes 424, a second set of light emitting diodes 426, a first structural member 428, a second structural member 430, a first optical filter 432, a second optical filter 434, a third optical filter 436, and a fourth optical filter 438.

[0181] Upper optical assembly 420 is one of two parts that form the optical system for portable testing device 400. Upper optical assembly 420 includes a first set of light-emitting diodes 424 and a second set of light-emitting diodes 426 for stimulating a biological sample for testing when placed in portable testing device 400. First set of light-emitting diodes 424 is located on a first side of upper optical assembly 420. In the embodiment shown, first set of light-emitting diodes 424 are blue light-emitting diodes to stimulate fluorescein amidate (FAM) fluorescent dye. Second set of light-emitting diodes 426 are located on a second side of upper optical assembly 420. In the embodiment shown, second set of light-emitting diodes 426 are yellow light-emitting diodes to stimulate 6-carboxy-X-rhodamine (ROX) fluorescent dye. In alternative embodiments, first set of light-emitting diodes 424 and second set of light-emitting diodes 426 can be any color light-emitting diode corresponding to the dye or marker used in testing the biological sample.

[0182] The upper optical assembly also includes a heating element 422. In the embodiment shown, the heating element 422 is a heating stage, but in alternative embodiments, it can be any suitable heating element. The heating element 422 is capable of heating from ambient temperature to a temperature of approximately 95 degrees Celsius. The heating element 422 has a plurality of holes extending from the top side of the heating element 422 to the bottom side of the heating element 422, wherein the array of tubes can be placed. The array of tubes will extend completely through and beyond the set of holes in the heating element 422. This allows the first set of light-emitting diodes 424 and the second set of light-emitting diodes 426 to pass light to the array of tubes to excite the biological sample in the array of tubes.

[0183] First structural member 428 and second structural member 430 form the structural foundation for upper optical assembly 420. First structural member 428 is positioned between first group of LEDs 424 and a first side of heating element 422. The first group of LEDs is positioned so that they extend into first structural member 428. Second structural member 430 is positioned between second group of LEDs 426 and a second side of heating element 422. The second group of LEDs is positioned so that they extend into second structural member 430. First structural member 428 and second structural member 430 also act as thermal insulators, preventing heat from escaping heating element 422. This improves the effectiveness and reliability of heating element 422. First structural member 428 and second structural member 430 provide a path through which light from first group of LEDs 424 and second group of LEDs 426 can travel. This prevents light loss and increases the effectiveness of first group of LEDs 424 and second group of LEDs 426 in stimulating a biological sample placed in heating element 422.

[0184] The first structural member 428 and the second structural member 430 also each include a cutout portion into which a first optical filter 432 and a second optical filter 434 can be placed. Both the first optical filter 432 and the second optical filter 434 are excitation filters that filter light from the light-emitting diodes as it passes to excite the biological sample. Light from the first set of light-emitting diodes 424 passes through the first optical filter 432 positioned in the first structural member 428 before entering the biological sample in the heating member 422. In the illustrated embodiment, the first optical filter 432 is a 490-nanometer filter to match FAM excitation. Light from the second set of light-emitting diodes 426 passes through the second optical filter 434 positioned in the second structural member 430 before entering the biological sample in the heating member 422. In the illustrated embodiment, the first optical filter 434 is a 580-nanometer filter to match ROX excitation. In alternative embodiments, the first optical filter 432 and the second optical filter 434 can be any filter compatible with different fluorescent dyes or markers.

[0185] The upper optical assembly 420 also includes a third filter 436 and a fourth filter 438. The third filter 436 and the fourth filter 438 are emission filters that are applied to the photodiodes 142 and 144 (at Figure 3B Photodiodes 142 and 144 are placed in the lower optical assembly, below the heating element 422, as shown in the following figure. Figures 3A-3B 4. A third optical filter 436 is positioned between the first set of photodiodes and the heating element 422. In the illustrated embodiment, the third optical filter 436 is a 610 nanometer filter to match ROX emission. A fourth optical filter 438 is positioned between the second set of photodiodes and the heating element 422. In the illustrated embodiment, the fourth optical filter 438 is a 520 nanometer filter to match FAM emission. In alternative embodiments, the third optical filter 436 and the fourth optical filter 438 can be any filters that match different fluorescent dyes or labels.

[0186] Upper optical assembly 420 is designed to excite a biological sample placed for testing in portable testing device 400. Upper optical assembly 420 is advantageous because it contains light emitted from first set of light emitting diodes 424 and second set of light emitting diodes 426. This prevents light from escaping and ensures accurate and reliable results each time a biological sample is analyzed using portable testing device 400.

[0187] Figure 17A is a perspective view of an optical assembly 418, which includes the optical assembly shown in FIG. Figures 16A-16B The upper optical assembly 420 and the lower optical assembly 440 are seen in FIG. Figure 17B It is as Figure 17AThe exploded view of the optical assembly 418 is shown in FIG. The upper optical assembly 420 has been referenced Figures 16A-16B As described above, lower optical assembly 440 includes a first set of photodiodes 442, a second set of photodiodes 444, spacers 446, spacers 448, an upper plate 450, and a lower plate 452. Lower optical assembly 440 also includes electronic components for controlling optical assembly 418, including electronic components for controlling the heating of heating element 422.

[0188] Lower optical assembly 440 is positioned below upper optical assembly 420 to form optical assembly 418. Lower optical assembly 440 includes a first group of photodiodes 442 and a second group of photodiodes 444. First group of photodiodes 442 are positioned in a first row on upper plate 450. Second group of photodiodes 444 are positioned in a second row on upper plate 450. Upper plate 450 is positioned below upper optical assembly 420 such that first group of photodiodes 442 and second group of photodiodes 444 are positioned below heating element 422 of upper optical assembly 420. This allows first group of photodiodes 442 and second group of photodiodes 444 to detect fluorescent emissions from biological samples placed in an array of tubes within heating element 422. In the illustrated embodiment, first group of photodiodes 442 are selected to align with ROX emission, and second group of photodiodes 444 are selected to align with FAM emission. In alternative embodiments, first group of photodiodes 442 and second group of photodiodes 444 can be selected to align with different fluorescent dyes or markers.

[0189] Lower optical assembly 440 also includes spacers 446 and gaskets 448. Spacers 446 extend between upper plate 450 and the bottom sides of first structural member 428 and second structural member 430 of upper optical assembly 420. Spacers 446 are positioned around first and second groups of photodiodes 442, 444. This contains light emitted from first and second groups of photodiodes 442, 444 and directs the light to the bottom of the array of tubes positioned in upper optical assembly 420. Gaskets 448 are positioned atop spacers 446 to form a seal between spacers 446 and upper optical assembly 420.

[0190] The first set of photodiodes 442, the second set of photodiodes 444, the spacers 446, and the spacers 448 are all placed on an upper plate 450. The upper plate 450 is then placed on a lower plate 452 to form the lower optical assembly 156. Electrical components are placed on the upper plate 450 and the lower plate 452 to operate the optical assembly 418, including heating of the heating element 422.

[0191] The optical assembly 418, which includes both the upper optical assembly 420 and the lower optical assembly 440, is capable of both excitation and detection of a biological sample placed in the portable testing device 400. The optical assembly 418 is designed to be compact to allow it to be used in the portable testing device 400. Being compact is advantageous because it allows excitation and detection of the biological sample to be performed on-site when the biological sample is collected. The optical assembly 418 can additionally include a light barrier around the optical assembly 418 to prevent light from escaping from the optical assembly 418. In a first embodiment, the light barrier can include surrounding the optical assembly 418 with light-proof tape. In an alternative embodiment, the light barrier can include a housing around the optical assembly 418 to prevent light from escaping.

[0192] exist Figures 17A-17B In the embodiment shown in FIG, the optical assembly 418 is designed to be compatible with EnviroLogix's DNAble® chemistry, which uses an isothermal amplification method. The reaction is performed at a single elevated temperature, typically 56 degrees Celsius. The DNAble® chemistry allows amplification to be completed in less than ten minutes. In alternative embodiments, the optical assembly 418 can be used for other chemistries, such as assays for Salmonella, soybean lectin, genetically modified organisms, E. coli, and influenza.

[0193] Figure 18A is a perspective view of the lower portion of the portable testing device 400, which includes Figures 17A-18B The optical component 418 and the power supply component 460 are seen in FIG. Figure 18B It is as Figure 18A . The lower portion of portable test device 400 includes first housing portion 412, optical assembly 418, and power assembly 460. Optical assembly 418 includes upper optical assembly 420 and lower optical assembly 440. Power assembly 460 includes battery 462, power receptacle 464, and power distribution board 466.

[0194] The portable testing device 400 includes a first housing portion 412 that serves as a base for the portable testing device 400. An optical assembly 418 and a power supply assembly 460 are placed in the first housing portion 412. The optical assembly 418 includes an upper optical assembly 420 for excitation attached to a lower optical assembly 440 for detection. The optical assembly 418 is positioned in the first housing portion 412 so that the heating component 422 of the upper optical assembly 420 is aligned with the opening in the portable device 100 for receiving a biological sample. The power supply assembly 460 is positioned in the first housing portion 112 around the optical assembly 418 to utilize the entire space in the first housing portion 412. This allows the portable testing device 400 to be as compact as possible for use as a handheld device.

[0195] The power supply assembly 460 includes a battery 462. The battery 462 provides power to the portable test device 400, allowing the portable test device 400 to be used in the field. The battery 462 can also power the tablet computer 404, as shown in FIG. Figures 15A-15B The tablet computer 404 can be connected to the power supply assembly 460 using a pigtail connection and powered by a battery 462 or an AC power source.

[0196] The power supply assembly 460 also includes a distribution board 466. The distribution board 466 combines and distributes electricity throughout the portable test device 400. Also included in the power supply assembly 460 is a power outlet 464 so that the power supply assembly 460 can be connected to a power source to recharge the battery 462 and the tablet computer 404. Including the power supply assembly 460 on the portable test device 400 is advantageous because it allows the portable test device to be used in the field. In alternative embodiments, the portable test device 400 can utilize solar cells, wind turbines, human-powered generators, or other suitable means of providing power to the unit. These alternative embodiments allow the portable test device 400 to be used in remote areas where electricity is not available or batteries are not available or unaffordable.

[0197] Figure 19A A perspective view of a portable testing device 400 . Figure 19B It is as Figure 19A . Portable testing device 400 includes housing 402, sample preparation area 406, optical cover 408, opening 410, bracket 416, optical assembly 418, power supply assembly 460, and power switch 468. Housing 402 includes first housing portion 412 and second housing portion 414.

[0198] The first housing portion 412 forms a base for the portable testing device 400, and the second housing portion 414 rests atop the first housing portion 412. In the illustrated embodiment, the first housing portion 412 and the second housing portion 414 are held together by fasteners, but in alternative embodiments they may be held together by any suitable means.

[0199] Housing 402 houses an optical assembly 418 and a power supply assembly 460. Optical assembly 418 tests a biological sample placed in portable testing device 400. Power supply assembly 460 provides power to the portable testing device and is capable of powering a tablet computer that can be placed on portable testing device 400. A power switch 468 extends between power supply assembly 460 and the outside of housing 402. Power switch 468 allows a user to easily turn portable testing device 400 on and off. Bracket 416 is a groove on the top side of housing 402 that extends from a first side to a second side of portable testing device 400. A tablet computer can be placed in bracket 416 when setting up an assay protocol, receiving data from portable testing device 400, and displaying test results in real time.

[0200] On the top side of housing 402 is a sample preparation area 406. Sample preparation area 406 is used to prepare biological samples for testing. On the top side of housing 402 is an opening 410. Opening 410 is positioned above optical assembly 418 so that an array of tubes containing biological samples can be placed through opening 410 and into optical assembly 418 for testing. An optical cover 408 is positioned above opening 410 and is connected to housing 402 along a hinge. Optical cover 408 can be opened so that a biological sample can be placed in opening 410 and then closed during testing.

[0201] Figure 20A is a perspective view of the sample preparation area 406 on the portable testing device 400 . Figure 20B is a perspective view of the membrane cover 476 over the sample preparation area 406 on the portable testing device 400. Figure 20C is Figure 20A A perspective view of the sample preparation area 406 as seen in FIG. 4 when a sample array has been positioned in the sample preparation area 406 . Figure 20D is Figure 20A 406 when the sample array has been placed in the portable testing device 400. The portable testing device 400 includes the sample preparation area 406, the optical cover 408, the opening 410 and the heating element 422. The sample preparation area 406 includes a tube container 470, a first group of tube containers 472 and a second group of tube containers 474. Figure 20B The membrane cover 476 is shown in FIG.

[0202] The sample preparation area 406 includes a tube container 470 located on a first side of the sample preparation area 406, a first set of tube containers 472 located in a row on the front side of the sample preparation area 406, and a second set of tube containers 474 located in a row on the back side of the sample preparation area 406. Figures 20A-20DIn the embodiment shown in FIG, a single tube containing a biological sample can be placed in a tube container 470, an array of tubes containing reaction buffer can be placed in a first group of tube containers 472, and an array of tubes containing a master mix can be placed in a second group of tube containers 474. In an alternative embodiment, the sample preparation area 406 can include multiple tube containers 170 to accommodate multiple biological samples. In a further alternative embodiment, the sample preparation area 406 can include one or more heating elements placed in the tube container 470, the first group of tube containers 472, or the second group of tube containers 474. Placing the heating element in the sample preparation area 406 allows heating of the biological sample, reaction buffer, and / or master mix during the preparation of the biological sample. Heating the biological sample, reaction buffer, and / or master mix while preparing the biological sample will help to lyse the biological sample collected on site to prepare the biological sample for testing. In an alternative embodiment, the sample preparation area 406 can be provided separately from the portable testing device 400 and can include additional containers and heating elements.

[0203] As in Figure 20B As shown in FIG, a membrane cover 476 can be placed above the sample preparation area 406. The membrane cover 476 is a pre-formed membrane structure having a flat portion that can be placed against the top surface of the sample preparation area 406 and a plurality of sleeves that can be placed in each of the tube container 470, the first group of tube containers 472, and the second group of tube containers 474. The membrane cover 476 can be placed on the sample preparation area 406 before each test and removed from the sample preparation area 406 after each test to prevent contamination between tests. In an alternative embodiment, the membrane cover 476 can be made of a high temperature film and can extend to the cover heating element 422.

[0204] As in Figure 20C As shown in , biological samples can be prepared for testing on the sample preparation area 406 by distributing the biological sample from a single tube in a tube container 470 to an array of tubes containing reaction buffer in a first set of tube containers 472. Subsequently, the mixture of reaction buffer and biological sample can be transferred from the array of tubes in the first set of tube containers 472 to the array of tubes in the second set of tube containers 474. This will mix the biological sample with the reaction buffer and a master mix containing the necessary reagents for performing the desired assay (including fluorescent dyes or labels, such as ROX or FAM). In alternative embodiments, the steps for preparing the sample can be varied, and different solutions can be used.

[0205] When the biological sample is ready for testing, the optical cover 408 can be opened to reveal the opening 410 and the heating element 422. The array of tubes in the second set of tube containers 474 can then be placed through the opening 410 into the wells of the heating element 422, as in Figure 20D This will place the array of tubes for testing together with the optical system in the portable testing device 400.

[0206] Preparing a biological sample on the sample preparation area 406 is advantageous because it allows the user to collect the sample, prepare the sample, and test the sample all in one handheld device. This allows the user to easily prepare and test the sample in the field without having to take the sample back to the laboratory to prepare it. It also allows the user to avoid having to carry multiple devices when the user is testing a sample in the field because a separate sample preparation device is not required.

[0207] Figure 21 4 is a flow chart showing the steps for operating the portable test device 400. The flow chart includes steps 500-522. The process begins with step 500, sample preparation. After the user obtains a sample from the field, they can insert it into the tube container 470 in the sample preparation area 406 of the portable test device 400. The field sample can be heated in the sample preparation area 406 to assist in releasing the biological sample from the field sample. In step 502, the portable test device 400 is turned on using the power switch 468. In step 504, the user then enters the desired assay and sample traceability information into the test setup menu on the tablet computer 404, which is located in the bracket 416 of the housing 402 of the portable test device 400. In step 506, the user then selects and starts the test protocol for the desired assay. When the test protocol is started, the heating element 422 begins heating to the temperature required for the desired assay.

[0208] When heating element 422 is heating, in step 508, in the array of the tubes in the first group of tube container 472, the user mixes the biological sample from tube container 470 with the reaction buffer necessary for the desired determination. In step 510, the user transfers the sample and reaction buffer mixture from the array of the tubes in the first group of tube container 472 to the array of the corresponding tubes in the second group of tube container 474. The array of the tubes in the second group of tube container 474 contains the master mix required for the desired determination, including the fluorescent dye or label necessary for detecting the analyte desired in the portable test device 400, such as FAM or ROX. The master mix can be liquid or lyophilized. The user mixes the sample with the buffer mixture and the master mix in the array of the tubes in the second group of tube container 474. In step 512, the user interface on tablet computer 404 will visually and audibly remind the user that portable test device 400 is ready for testing. The user then seals the array of tubes in the second set of tube containers 474 , opens the lid 108 and transfers the array of tubes through the opening 410 into the plurality of holes in the heating element 422 .

[0209] In step 514, the user initiates the excitation and detection sequence for the desired assay on the tablet computer 404. The optical system 118 initiates the excitation and detection sequence. During the excitation and detection sequence, the portable test device 400 transmits emission data to the tablet computer 404. Step 516 includes displaying real-time reaction data received from the portable test device 400 on a user interface on the tablet computer 404. During step 518, the tablet computer 404 logs the data received from the portable test device 400 and monitors the data for threshold activity. When the assay is complete, in step 520, the tablet computer 404 signals a positive or negative result to the user. Finally, in step 522, the tablet computer 404 can store the resulting data for retrieval or transmission.

[0210] Generally, the present invention relates to a portable testing device for analyzing biological samples. The portable testing device can be taken to the site to test biological samples as they are collected. This is advantageous relative to prior art systems because it allows the user to test biological samples while they are being collected. This can prevent the problems associated with contamination and degradation of biological samples due to transportation to a laboratory for testing, discovering later that not enough samples have been obtained, or discovering later that the collected biological samples are otherwise unsuitable for use. Allowing users to test biological samples on site can save time, money, and resources. If the test results indicate a potentially harmful pathogen or toxin, testing on site also provides the ability to respond quickly and safely.

[0211] In the embodiment described below, the portable testing device can be used to test biological samples using EnviroLogix's DNAble® chemical test using isothermal amplification. This eliminates the need for thermal cycling as a means of amplifying nucleic acid products for endpoint detection. This allows the user to obtain data from the sample while running the test. In an alternative embodiment, the portable testing device can be used to test biological samples using other isothermal amplification chemical tests. The portable testing device displays this data on a screen on the device so that the user can view the results of the field test. Allowing the user to view the results of the field test is advantageous because the user can then make an informed decision as to whether additional testing is needed. In an alternative embodiment, the portable testing device can also incorporate a thermal cycler to allow the use of non-isothermal polymerase chain reaction (PCR) chemistry and result in qPCR and endpoint analysis.

[0212] Optical components 600

[0213] Figure 22A is a perspective view of optical assembly 600 . Figure 22B6 is a top view of optical assembly 600. Optical assembly 600 includes tube array 602, sample stage 604, movable housing 606, and fixed housing 608. Sample stage 604 includes slot 620. Movable housing 606 includes body 610, detection portion 612, and excitation portion 614.

[0214] The sample stage 604, the movable housing 606, and the fixed housing 608 form the body of the optical assembly 600. The optical assembly 600 is also capable of receiving the tube array 602 in the sample stage 604. The sample stage 604 has a plurality of slots 620 located in the top side of the sample stage 604, which, in the embodiment shown, are configured to receive the tube array 602. In alternative embodiments, the slots 620 are configured to receive cards or any other suitable sample receptacles. The sample stage 604 contains a heating element to heat the biological material in the tube array 602.

[0215] The movable housing 606 includes a body 610, a detection portion 612, and an excitation portion 614. The body 610 has a rectangular shape. The sample stage 604 is disposed on a first side of the body 610. The first side of the detection portion 612 is attached to a second side of the body 610. The fixed housing 608 is disposed on a second side of the detection portion 612. The detection portion 612 can hold an emission filter. The fixed housing 608 can hold a light detector to detect color emission in a biological sample from the optical assembly 600. The excitation portion 614 is attached to the first side of the body 610 below the sample stage 604. The excitation portion 614 can hold a light emitting diode and an excitation filter to excite the biological sample in the optical assembly 600. The body 610, the detection portion 612, the fixed housing 608, and the excitation portion 614 all have multiple pathways therethrough, allowing radiation to travel through the movable housing 606 and into the biological sample in the sample stage 604.

[0216] The movable housing 606 includes multiple detection modules that can excite and detect biological materials at different radiation wavelengths. This allows the optical assembly 600 to be compatible with a wide variety of fluorescent dyes used during testing of biological samples. Each fluorescent dye is excited and detected at a different radiation wavelength. To ensure that each detection module reads each well 620 in the sample stage 604, the movable housing 606 is movable. In the illustrated embodiment, the movable housing 606 moves between a first position, a second position, and a third position, but in alternative embodiments, it can move between any number of positions. The sample stage 604 and the fixed housing 608 are fixed components, and the movable housing 606 slides between the sample stage 604 and the fixed housing 608. As the movable housing 606 moves, different detection modules align with different wells 620. This allows each well 620 to be read using a different detection module. The movable housing 606 can be moved using an actuator or other suitable means.

[0217] Providing a removable housing 606 in the optical assembly 600 is advantageous because the ability of the removable housing 606 to move allows the optical assembly 600 to test multiple radiation wavelengths. The optical assembly 600 is designed to be used in a portable testing device. The portable testing device needs to be designed to be as compact as possible so that it can be easily transported and used on site. Without moving the optical assembly 600, more space would be required to replace multiple detection modules that can be read at different radiation wavelengths. Because the removable housing 606 moves in the optical assembly 600, different detection modules can be easily relocated to read from each slot 620 in the sample stage 604. This saves significant space in the portable testing device because the number of detection modules required to test each slot 620 is greatly reduced.

[0218] Figure 23 It is along Figure 22B FIG2 is a cross-sectional side view of optical assembly 600 taken along line 23-23. Optical assembly 600 includes tube array 602, sample stage 604, movable housing 606, fixed housing 608, and detection modules 616. Sample stage 604 includes slot 620, aperture 622, and lens 624. Movable housing 606 includes body 610, detection section 612, and excitation section 614. Each detection module 616 includes a light emitting diode 632, a first path 634, a second path 636, an emission filter 638, and an excitation filter 640. Fixed housing 608 includes a light detector 630.

[0219] The sample stage 604 and the removable housing 606 form the body of the optical assembly 600. The sample stage 604 includes a plurality of slots 620 configured to receive the tube array 602. The tube array 602 includes a plurality of tubes, each of which contains a biological sample to be tested. The sample stage 604 also includes a plurality of holes 622 extending from a first side of the sample stage 604 to the slots 620. Each slot 620 will have a corresponding hole 622. A lens 624 can also be positioned in the hole 622 located between the first side of the sample stage 604 and the slot 620. The lens 624 can direct radiation in the optical assembly 600 into the slot 620 and the sample tube 202.

[0220] The movable housing 606 is movable and can be in three different positions relative to the sample stage 604. The movable housing 606 includes a plurality of detection modules 616 aligned with the wells 620 in the sample stage 604. Each detection module 616 is capable of exciting and detecting emission from a biological sample in one of the wells 620. Each detection module 616 includes a light emitting diode 632, a first path 634, a second path 636, an emission filter 638, and an excitation filter 640.

[0221] The fixed housing 608 is positioned on the second side of the movable housing 606. The fixed housing 608 includes a light detector 630. As the movable housing 606 moves between the three different positions, the fixed housing 608 remains stationary. This allows each of the different light detectors 630 in the fixed housing 608 to align with a different detection module 616.

[0222] The movable housing 606 includes a body 610 that forms the base of the movable housing 606. A detection portion 612 is attached to a first side of the body 610 of the movable housing 606, and an excitation portion 614 is attached to a second side of the body 610 of the movable housing 606. A first path 634 extends horizontally through the body 610 of the movable housing 606 from the detection portion 612 to the sample stage 604. A second path 636 extends at an angle through the body 610 of the movable housing 606 from the excitation portion 614 to the detection portion 612. The first path 634 and the second path 636 converge at the detection portion 612. Both the first path 634 and the second path 636 are capable of transmitting radiation through the movable housing 606. In the illustrated embodiment, the first path 634 and the second path 636 are shown as threaded paths, but may be smooth paths in alternative embodiments. Threading the first path 634 and the second path 636 may prevent stray radiation from traveling through the movable housing 606 because it will be reflected when it deviates from the main path.

[0223] The detection portion 612 of the movable housing 606 has a plurality of apertures capable of receiving emission filters 638. The emission filters 638 are positioned in the apertures in the detection portion 612 between a first side of the detection portion 612 and a second side of the detection portion 612.

[0224] The stationary housing 608 has a plurality of apertures capable of receiving the light detectors 630. The light detectors 630 are positioned on a second side of the stationary housing 608 and extend a distance into the stationary housing 608.

[0225] The excitation portion 614 of the removable housing 606 has a plurality of apertures capable of receiving light emitting diodes 632 and excitation filters 640. The light emitting diodes 632 are positioned on a first side of the excitation portion 614 and extend a distance into the excitation portion 614. The excitation filter 640 is positioned in the excitation portion 614 between the light emitting diodes 632 and a second side of the excitation portion 614.

[0226] Each detection module 616 operates as follows. To excite a biological sample placed in a tank 620, radiation is emitted from a light-emitting diode 632. The radiation emitted from the light-emitting diode 632 is filtered by an excitation filter 640. The filtered radiation then travels from a first end to a second end of a second path 636. At the second end of the second path 636, the radiation is reflected off an emission filter 638. The reflected radiation is directed into a first end of a first path 634. The radiation then travels from the first end to the second end of the first path 634. At the second end of the first path 634, the radiation passes through an aperture 622 and a lens 624 in the sample stage 604 and enters the tank 620. Once in the tank 620, the radiation can excite a biological sample in one of the tubes of the tube array 602.

[0227] After exciting the biological sample, it will emit radiation corresponding to the fluorescent tracer mixed with the biological sample. The radiation emitted from the biological sample can then travel from the slot 620 through the lens 624 and the aperture 622 into the second end of the first path 634. The radiation can then travel from the second end of the first path 634 to the first end. At the first end of the first path 634, the radiation will reach and pass through the emission filter 638. The radiation filtered by the emission filter 638 can then travel through the aperture in the detection portion 612 and into the aperture in the fixed housing 608. The light detector 630 disposed in the fixed housing 608 can then receive the radiation.

[0228] During nucleic acid amplification, different fluorescent dyes can be used to test the biological sample. To provide an instrument capable of reading different fluorescent dyes, the movable housing 606 can be moved relative to the sample stage 604 so that different detection modules 616 are aligned with each slot 620 depending on what fluorescent dye is added to the biological sample in each slot 620. If multiple fluorescent dyes are added to the biological sample in each slot 620, the movable housing 606 can be moved between multiple positions to ensure that different fluorescent dyes in each slot 620 are being read.

[0229] Optical assembly 600 is advantageous for use in portable testing devices because it can read fluorescence at multiple different radiation wavelengths with a compact design. A suitable portable testing device needs to be compact so that it can be easily transported and used in the field. In order to design a compact portable testing device, optical assembly 600 also needs to be compact. In previous optical assemblies, "compact" was equivalent to being able to test at only one or two different radiation wavelengths. Optical assembly 600 eliminates this problem because it can be moved to place different detection modules 616 together with different slots 620 in sample stage 604. This allows testing of more than two radiation wavelengths without sacrificing the compactness of optical assembly 600. For this reason, optical assembly 600 is advantageous and suitable for use in portable testing devices.

[0230] Figure 24A is a perspective view of the optical assembly 600 in a first position. Figure 24B is a perspective view of the optical assembly 600 in the second position. Figure 24C 6 is a perspective view of optical assembly 600 in a third position. Optical assembly 600 includes tube array 602, sample stage 604, movable housing 606, fixed housing 608, and detection modules 616 (including detection modules 616A, 616B, 616C, 616D, 616E, 616F, 616G, 616H, 616I, and 616J). Sample stage 604 includes slots 620 (including slots 620A, 620B, 620C, 620D, 620E, 620F, 620G, and 620H). The fixed housing 608 includes light detectors 630 (including light detector 630A, light detector 630B, light detector 630C, light detector 630D, light detector 630E, light detector 630F, light detector 630G, and light detector 630H).

[0231] Sample stage 604, movable housing 606, and fixed housing 608 form the body of optical assembly 600. Sample stage 604 is a fixed component having a plurality of slots 620. Tube array 602 can be placed in slots 620. Tube array 602 includes a plurality of individual tubes, each containing a biological sample and a reaction mixture with a fluorescent dye. Each tube in tube array 602 is placed in a slot 620. Fixed housing 608 is also a fixed component and has a plurality of light detectors 630. One light detector 630 in fixed housing 608 is aligned with one slot 620 in sample stage 604. Photodetector 630A is aligned with slot 620A; photodetector 630B is aligned with slot 620B; photodetector 630C is aligned with slot 620C; photodetector 630D is aligned with slot 620D; photodetector 630E is aligned with slot 620E; photodetector 630F is aligned with slot 620F; photodetector 630G is aligned with slot 620G; and photodetector 630H is aligned with slot 620H.

[0232] In the illustrated embodiment, the movable housing 606 is a movable part that can be moved between a first position, a second position, and a third position relative to the sample stage 604 and the fixed housing 608. In an alternative embodiment, the movable housing 606 can be moved between any number of positions. The movable housing 606 includes a plurality of detection modules 616. When the movable housing 606 moves, each detection module 616 will be aligned with a slot 620 and a light detector 630. Each detection module 616 includes a light emitting diode to excite the biological sample. In order to detect multiple different fluorescent dyes, the light emitting diodes placed in each detection module can be changed. Figures 24A-24C The embodiment shown in FIG includes eight wells 620, eight light detectors 630, and ten detection modules 616. This allows for testing three different fluorescent dyes because the movable housing 606 can be positioned in three different positions. In each different position, each well 620 and light detector 630 will be aligned with a different detection module 616 to read a different fluorescent dye from each well 620.

[0233] exist Figures 24A-24CIn the embodiment shown in FIG, optical assembly 600 can detect a first fluorescent dye, a second fluorescent dye, and a third fluorescent dye. Detection module 616A is configured to detect the first fluorescent dye; detection module 616B is configured to detect the second fluorescent dye; detection module 616C is configured to detect the third fluorescent dye; detection module 616D is configured to detect the first fluorescent dye; detection module 616E is configured to detect the second fluorescent dye; detection module 616F is configured to detect the third fluorescent dye; detection module 616G is configured to detect the first fluorescent dye; detection module 616H is configured to detect the second fluorescent dye; detection module 616I is configured to detect the third fluorescent dye; and detection module 616J is configured to detect the first fluorescent dye. When movable housing 606 moves between the first position, the second position, and the third position, each slot 620 is excited and detected for each of the first fluorescent dye, the second fluorescent dye, and the third fluorescent dye.

[0234] In the first position, slot 620A is aligned with detection module 616A to detect the first fluorescent dye; slot 620B is aligned with detection module 616B to detect the second fluorescent dye; slot 620C is aligned with detection module 616C to detect the third fluorescent dye; slot 620D is aligned with detection module 616D to detect the first fluorescent dye; slot 620E is aligned with detection module 616E to detect the second fluorescent dye; slot 620F is aligned with detection module 616F to detect the third fluorescent dye; slot 620G is aligned with detection module 616G to detect the first fluorescent dye; and slot 620H is aligned with detection module 616H to detect the second fluorescent dye.

[0235] In the second position, slot 620A is aligned with detection module 616B to detect the second fluorescent dye; slot 620B is aligned with detection module 616C to detect the third fluorescent dye; slot 620C is aligned with detection module 616D to detect the first fluorescent dye; slot 620D is aligned with detection module 616E to detect the second fluorescent dye; slot 620E is aligned with detection module 616F to detect the third fluorescent dye; slot 620F is aligned with detection module 616G to detect the first fluorescent dye; slot 620G is aligned with detection module 616H to detect the second fluorescent dye; and slot 620H is aligned with detection module 616I to detect the third fluorescent dye.

[0236] In the third position, slot 620A is aligned with detection module 616C to detect the third fluorescent dye; slot 620B is aligned with detection module 616D to detect the first fluorescent dye; slot 620C is aligned with detection module 616E to detect the second fluorescent dye; slot 620D is aligned with detection module 616F to detect the third fluorescent dye; slot 620E is aligned with detection module 616G to detect the first fluorescent dye; slot 620F is aligned with detection module 616H to detect the second fluorescent dye; slot 620G is aligned with detection module 616I to detect the third fluorescent dye; and slot 620H is aligned with detection module 616J to detect the first fluorescent dye.

[0237] As can be seen, as the movable housing 606 moves between the first position, the second position, and the third position, each slot 620 will be excited and detected for each of the first fluorescent dye, the second fluorescent dye, and the third fluorescent dye. During the test, the movable housing 606 can be repositioned any number of times to repeat the excitation and detection of each slot 620 until satisfactory test results are obtained. Moreover, in an alternative embodiment, the movable housing 606 can include more detection modules to address additional fluorescent dyes. This will increase the number of positions to which the movable housing 606 can be moved, so that each slot 620 is excited and detected at a different fluorescent wavelength.

[0238] Optical assembly 600 is advantageous because it can excite and detect multiple different radiation wavelengths with a compact and simplified design. This makes optical assembly 600 suitable for use in a portable test device, as the compactness of optical assembly 600 reduces the overall size of the portable test device. Furthermore, optical assembly 600 allows the portable test device to test at many radiation wavelengths, which were not feasible with previous designs.

[0239] Optical components 700

[0240] Figure 25 7 is a cross-sectional side view of optical assembly 700. Optical assembly 700 includes tube array 702, sample stage 704, first housing 706, second housing 708, slot 710, first aperture 712, second aperture 714, first light emitting diode 720, second light emitting diode 722, third light emitting diode 724, first excitation path 726, second excitation path 728, third excitation path 730, excitation filter 732, first photodetector 740, second photodetector 742, first detection path 744, second detection path 746, first emission filter 748, second emission filter 750, first lens 752, and second lens 754.

[0241] The sample stage 704, the first housing 706, and the second housing 708 form the body of the optical assembly 700. The sample stage 704 includes a plurality of wells 710. The wells 710 are capable of receiving the tube array 702. The sample stage 704 also includes a heating element to heat the biological sample in the tube array 702. The sample stage 704 includes a first hole 712 extending from a first side of the sample stage 704 into the wells 710. The sample stage 704 also includes a second hole 714 extending from a second side of the sample stage 704 into the wells 710. The first housing 706 is located on the first side of the sample stage 704, and the second housing 708 is located on the second side of the sample stage 704.

[0242] The first housing 706 and the second housing 708 can both hold light emitting diodes and light detectors to excite and detect emissions from the biological sample in the tube array 702. Figure 8 In the embodiment shown in FIG, the light emitting diode is located in the first housing 706 and the light detector is located in the second housing 708. In alternative embodiments, the light detector can be located in the first housing 706 and the light emitting diode can be located in the second housing 708, or a mix of light emitting diodes and light detectors can be alternated in both the first housing 706 and the second housing 708. In each arrangement, one light emitting diode is positioned on one side of the slot 710 and one light detector is positioned on the opposite side of the slot 710.

[0243] As in Figure 25 As shown in FIG, a first LED 720, a second LED 722, and a third LED 724 are disposed within a first housing 706. The first LED 720, the second LED 722, and the third LED 724 are positioned in a triangular configuration. By emitting radiation at different wavelengths, each LED can excite a different fluorescent dye in a biological sample. In the illustrated embodiment, the first LED 720 excites the first fluorescent dye, the second LED 722 excites the second fluorescent dye, and the third LED 724 excites the third fluorescent dye. The first LED 720 is disposed in a first path 726 from the first LED 720 to the sample stage 704. The second LED 722 is disposed in a second path 728 from the second LED 722 to the sample stage 704. The third LED 724 is disposed in a third path 730 from the third LED 724 to the sample stage 704. An excitation filter 732 is disposed within the sample stage 704 to filter light from the first LED 720, the second LED 722, and the third LED 724. The excitation filter 732 is a triple bandpass filter capable of filtering radiation at wavelengths for the first, second, and third fluorescent dyes. In an alternative embodiment, a separate excitation filter can be used for each light emitting diode.

[0244] A first light detector 740 and a second light detector 742 are disposed in the second housing 708. The first light detector 740 is capable of detecting both the first fluorescent dye and the third fluorescent dye. The second light detector 742 is capable of detecting the second fluorescent dye. The first light detector 740 is disposed in a first path 744 extending from the first light detector 740 to the sample stage 704. The second light detector 742 is disposed in a second path 346 extending from the second light detector 742 to the sample stage 704. A first emission filter 748 is disposed in the first path 744 between the first light detector 740 and the sample stage 704. The first emission filter 748 is a dual-bandpass filter capable of filtering radiation at wavelengths specific to the first and third fluorescent dyes. A second emission filter 750 is disposed in the second path 746 between the second light detector 742 and the sample stage 704. The second emission filter 750 is a single-bandpass filter capable of filtering radiation at a wavelength specific to the second fluorescent dye. A first lens 752 is also positioned in the first path 744. A second lens 754 is also positioned in the second path 746. The first lens 752 and the second lens 754 will direct the emitted radiation from the biological sample in the tube 702 into the first photodetector 740 and the second photodetector 742, respectively.

[0245] The optical assembly 700 is designed so that the biological sample can be excited and detected at three different radiation wavelengths. Detecting and exciting at three different radiation wavelengths is advantageous because each biological sample can be tested for each of the first fluorescent dye, the second fluorescent dye, and the third fluorescent dye. It is also advantageous to use a first light detector 740 and a second light detector 742 because it will limit the crosstalk between the detection channels to improve detection performance. The design of the optical assembly 700 with a cluster of light emitting diodes and light detectors is also advantageous because it allows the optical assembly 700 to be designed with a compact structure. "Being compact" allows the optical assembly 700 to be used in a portable test device. Portable test devices need to be compact so that they can be easily transported and used on site.

[0246] Figure 26A is a side view of a first side of optical assembly 700 according to a first configuration. Figure 26Bis a side view of a second side of optical assembly 700 according to the first configuration. The optical assembly 700 includes a first housing 706, a second housing 708, a first LED 720 (including a first LED 720A, a first LED 720B, a first LED 720C, a first LED 720D, a first LED 720E, a first LED 720F, a first LED 720G, and a first LED 720H), a second LED 722 (including a second LED 722A, a second LED 722B, a second LED 722C, a second LED 722D, a second LED 722E, a second LED 722F, a second LED 722G, and a second LED 722H), a third LED 724 (including a third LED 724A, a third LED 724B, a third LED 724C, a third LED 724D, a third LED 724E, a third LED 724F, a third LED 724G, and a third LED 724H), and a first light detector 740. (including a first light detector 740A, a first light detector 740B, a first light detector 740C, a first light detector 740D, a first light detector 740E, a first light detector 740F, a first light detector 740G and a first light detector 740H) and a second light detector 742 (including a second light detector 742A, a second light detector 742B, a second light detector 742C, a second light detector 742D, a second light detector 742E, a second light detector 742F, a second light detector 742G and a second light detector 742H).

[0247] A first LED 720, a second LED 722, and a third LED 724 are positioned within the first housing 706. The first LED 720 is capable of stimulating a first fluorescent dye. The second LED 722 is capable of stimulating a second fluorescent dye. The third LED 724 is capable of stimulating a third fluorescent dye. The first LED 720, the second LED 722, and the third LED 724 are arranged in a triangular configuration within the first housing 706. As an example, this configuration can be seen with the first LED 720A, the second LED 722A, and the third LED 724A arranged in a triangular configuration. This triangular configuration is alternating throughout the first housing 706 to provide a compact design.

[0248] A first light detector 740 and a second light detector 742 are disposed within the second housing 708. The first light detector 740 is capable of detecting emissions from the first fluorescent dye and the third fluorescent dye. The second light detector 742 is capable of detecting emissions from the second fluorescent dye. The first light detector 740 and the second light detector 742 are stacked one on top of the other within the second housing 708. As an example, this configuration can be seen with a first light detector 740A and a second light detector 742A stacked one on top of the other. This stacked configuration is repeated throughout the second housing 708.

[0249] exist Figures 26A-26B In the configuration shown in FIG, the light emitting diodes are housed in a first housing 706 on a first side of the sample stage, and the light detectors are housed in a second housing 708 on a second side of the sample stage. A first light emitting diode 720 and a third light emitting diode 724 are positioned opposite a first light detector 740. A second light emitting diode 722 is positioned opposite a second light detector 742. When either the first light emitting diode 720 or the third light emitting diode 724 is activated, the first light detector 740 will read emission from the biological sample. When the second light emitting diode 722 is activated, the second light detector 742 will read emission from the biological sample.

[0250] exist Figures 26A-26B The first configuration of light emitting diodes and light detectors seen in is advantageous because it provides a compact arrangement capable of exciting and detecting at three different radiation wavelengths. This makes the optical assembly 700 suitable for use in a portable testing device.

[0251] Figure 27A is a side view of a first side of optical assembly 700 according to a second configuration. Figure 27Bis a side view of a second side of optical assembly 700 according to a second configuration. The optical assembly 700 includes a first housing 706, a second housing 708, a first LED 720 (including a first LED 720A, a first LED 720B, a first LED 720C, a first LED 720D, a first LED 720E, a first LED 720F, a first LED 720G, and a first LED 720H), a second LED 722 (including a second LED 722A, a second LED 722B, a second LED 722C, a second LED 722D, a second LED 722E, a second LED 722F, a second LED 722G, and a second LED 722H), a third LED 724 (including a third LED 724A, a third LED 724B, a third LED 724C, a third LED 724D, a third LED 724E, a third LED 724F, a third LED 724G, and a third LED 724H), and a first light detector 740. (including a first light detector 740A, a first light detector 740B, a first light detector 740C, a first light detector 740D, a first light detector 740E, a first light detector 740F, a first light detector 740G and a first light detector 740H) and a second light detector 742 (including a second light detector 742A, a second light detector 742B, a second light detector 742C, a second light detector 742D, a second light detector 742E, a second light detector 742F, a second light detector 742G and a second light detector 742H).

[0252] A first light-emitting diode 720, a second light-emitting diode 722, a third light-emitting diode 724, a first light detector 740, and a second light detector 742 are arranged in an alternating pattern within the first housing 706 and the second housing 708. The first light-emitting diode 720 can excite a first fluorescent dye. The second light-emitting diode 722 can excite a second fluorescent dye. The third light-emitting diode 724 can excite a third fluorescent dye. The first light detector 740 can detect emissions from the first fluorescent dye and the third fluorescent dye. The second light detector 742 can detect emissions from the second fluorescent dye.

[0253] The first LED 720, the second LED 722, and the third LED 724 are arranged in a triangular configuration within both the first housing 706 and the second housing 708. As an example, this configuration can be seen with the first LED 720A, the second LED 722A, and the third LED 724A arranged in a triangular configuration. The first photodetector 740 and the second photodetector 742 are arranged in a diagonal configuration within both the first housing 706 and the second housing 708. As an example, this configuration can be seen with the first photodetector 740B and the second photodetector 742B arranged in a diagonal configuration. The triangular configuration of the LEDs and the diagonal configuration of the photodetectors alternate throughout both the first housing 706 and the second housing 708.

[0254] exist Figures 27A-27B , a first light emitting diode 720 and a third light emitting diode 724 are positioned opposite a first light detector 740. A second light emitting diode 722 is positioned opposite a second light detector 742. When either the first light emitting diode 720 or the third light emitting diode 724 is activated, the first light detector 740 will read emission from the biological sample. When the second light emitting diode 722 is activated, the second light detector 742 will read emission from the biological sample.

[0255] exist Figures 27A-27B The second configuration of light emitting diodes and light detectors seen in is advantageous because it provides a compact arrangement capable of exciting and detecting at three different radiation wavelengths. This makes optical assembly 700 suitable for use in portable testing devices.

[0256] Optical components 800

[0257] Figure 28A is a perspective view of optical assembly 800 . Figure 28B is a bottom view of the optical assembly 800.

[0258] Optical assembly 800 includes a first housing portion 802, a second housing portion 804, a first optical housing 806, a second optical housing 808, a heating stage 810, and a plate 820. Heating stage 810 includes a slot 812. Plate 820 includes a hole 822.

[0259] Optical assembly 800 is capable of receiving an array of tubes for testing. Heating stage 810 receives the array of tubes in slots 812. Slots 812 are positioned on the top side of heating stage 810, and each slot 812 is configured to receive one tube from the array of tubes. Heating stage 810 forms the base of optical assembly 800 and heats a biological sample placed in each of the tubes in the array of tubes. In alternative embodiments, heating stage 810 may be a sample stage capable of receiving the array of tubes, and the tubes may be heated using a different means.

[0260] A plate 820 is also included in the optical assembly 800 and is placed above the top side of the heating stage 810. The plate 820 includes a plurality of holes 822 extending from the top side of the plate 820 to the bottom side of the plate 820. Each hole 822 in the plate 820 can be aligned with a slot 812 in the heating stage 810. When the array of tubes is placed in the heating stage 810, a tube can pass through each hole 822 in the plate 820 before being seated in the slot 812. In the embodiment shown, the plate 820 is made of an opaque material. This prevents radiation from escaping from the optical assembly 800 and prevents ambient light from entering the optical assembly 800. The plate 820 also acts as a thermal insulator to retain heat emitted from the heating stage 810 in the optical assembly 800.

[0261] A housing portion is also positioned on each side of the heating stage 810. The first housing portion 802 is positioned on a first side of the heating stage 810, and the second housing portion 804 is positioned on a second side of the heating stage 810. The first housing portion 802 and the second housing portion 804 are coupled to each other around the heating stage 810. The first housing portion 802 and the second housing portion 804 can be coupled to each other by any suitable means.

[0262] Optical assembly 800 also includes a first optical housing 806 and a second optical housing 808. First optical housing 806 is coupled to first housing portion 802 on a first side of heating stage 810. First optical housing 806 can be coupled to first housing portion 802 by any suitable means. First optical housing 806 can hold a first set of light-emitting diodes and a first set of light detectors. Second optical housing 808 is coupled to second housing portion 804 on a second side of heating stage 810. Second optical housing 808 can be coupled to second housing portion 804 by any suitable means. Second optical housing 808 can hold a second set of light-emitting diodes and a second set of light detectors.

[0263] First housing portion 802, second housing portion 804, first optical housing 806, and second optical housing 808 are made of an opaque material. This allows radiation passing through optical assembly 800 to remain in a path through first housing portion 802, second housing portion 804, first optical housing 806, and second optical housing 808. Furthermore, in alternative embodiments, optical assembly 800 can include a housing portion on each side of heating stage 810, can include a single housing piece, or any other suitable configuration.

[0264] Optical assembly 800 is advantageous because it has a compact design that allows a set of LEDs and a set of photodetectors to be positioned on either side of heating stage 810. This allows for more LEDs to be positioned within each set, increasing the overall capabilities of optical assembly 800. LEDs can excite biological samples at different wavelengths of radiation. Therefore, allowing for more LEDs to be positioned within optical assembly 800 is advantageous because the optical assembly will be able to excite and detect emissions corresponding to different fluorescent dyes.

[0265] Figure 29A is an exploded perspective view of a first side of optical assembly 800 . Figure 29B is an exploded perspective view of the first side of optical assembly 800 . Figure 29C is an exploded perspective view of a second side of optical assembly 800 . Figure 29D is an exploded perspective view of the second side of optical assembly 800 .

[0266] Optical assembly 800 includes a first housing portion 802, a second housing portion 804, a first optical housing 806, a second optical housing 808, a heating stage 810, a plate 820, a first LED assembly 830, a second LED assembly 832, a first photodetector assembly 834, a second photodetector assembly 836, an excitation filter 852, an excitation filter 862, an emission filter 872, and an emission filter 882. Heating stage 810 includes a slot 812, a passage 856, a passage 866, a passage 876, and a passage 886. Plate 820 includes an aperture 822. First housing portion 802 includes a passage 854 and a passage 874. Second housing portion 804 includes a passage 864 and a passage 884. First optical housing 806 includes a passage 850 and a passage 870. Second optical housing 808 includes a passage 860 and a passage 880. First LED assembly 830 includes LED 840, LED 842, and LED 844. Second LED assembly 832 includes LED 840, LED 842, and LED 844. First photodetector assembly 834 includes photodetector 846. Second photodetector assembly 836 includes photodetector 846.

[0267] Optical assembly 800 is capable of receiving an array of tubes for testing. Heating stage 810 receives the array of tubes in slots 812. Slots 812 are positioned on the top side of heating stage 810, and each slot 812 is configured to receive one tube in the array of tubes. Heating stage 810 forms the base of optical assembly 800 and heats a biological sample placed in each of the tubes in the array of tubes. Heating stage 810 also includes passages 856, 866, 876, and 886. Passages 856 and 876 extend from a first side of heating stage 810 to slots 812. Passages 866 and 886 extend from a second side of heating stage 810 to slots 812. Passages 856, 866, 876, and 886 provide pathways through which radiation can travel through optical assembly 800.

[0268] A plate 820 is also included in the optical assembly 800 and is placed above the top side of the heating stage 810. The plate 820 includes a plurality of holes 822 extending from the top side of the plate 820 to the bottom side of the plate 820. Each hole 822 in the plate 820 can be aligned with a slot 812 in the heating stage 810. When the array of tubes is placed in the heating stage 810, one tube can pass through each hole 822 in the plate 820 before being seated in a slot 812.

[0269] Housing portions are also positioned on each side of the heating stage 810. A first housing portion 802 is positioned on a first side of the heating stage 810, and a second housing portion 804 is positioned on a second side of the heating stage 810. The first housing portion 802 includes a passageway 854 and a passageway 874 extending from a first side of the first housing portion 802 to a second side of the first housing portion 802. The second housing portion 804 includes a passageway 864 and a passageway 884 extending from a first side of the second housing portion 804 to a second side of the second housing portion 804. The passageways 854, 864, 874, and 884 provide pathways through which radiation can travel through the optical assembly 800.

[0270] Optical assembly 800 also includes a first optical housing 806 and a second optical housing 808. First optical housing 806 is coupled to first housing portion 802 on a first side of heating stage 810. First optical housing 806 can be coupled to first housing portion 802 by any suitable means. First optical housing 806 includes passages 850 and 870 extending from the first side of first optical housing 806 to the second side of first optical housing 806. Second optical housing 808 is coupled to second housing portion 804 on a second side of heating stage 810. Second optical housing 808 can be coupled to second housing portion 804 by any suitable means. Second optical housing 808 includes passages 860 and 880 extending from the first side of second optical housing 808 to the second side of second optical housing 808. Passages 850, 860, 870, and 880 provide pathways through which radiation can travel through optical assembly 800.

[0271] An excitation filter 852 is positioned between the first optical housing 806 and the first housing portion 802. The excitation filter 852 is aligned with a passage 850 in the first optical housing 806 and a passage 854 in the first housing portion 802. An excitation filter 862 is positioned between the second optical housing 808 and the second housing portion 804. The excitation filter 862 is aligned with a passage 860 in the second optical housing 808 and a passage 864 in the second housing portion 804. In the illustrated embodiment, the excitation filter 852 and the excitation filter 862 are shown as a plurality of filters, but in alternative embodiments it can be one filter.

[0272] 804. Emission filter 872 is positioned between first optical housing 806 and first housing portion 802. Emission filter 872 is aligned with passageway 870 in first optical housing 806 and passageway 874 in first housing portion 802. Emission filter 882 is positioned between second optical housing 808 and second housing portion 804. Emission filter 882 is aligned with passageway 880 in second optical housing 808 and passageway 884 in second housing portion 804. In the illustrated embodiment, emission filter 872 and emission filter 882 are each shown as one filter, but in alternative embodiments they can be multiple filters.

[0273] A first LED assembly 830 and a first photodetector assembly 834 are positioned within first optical housing 806. Each LED in first assembly 830 is positioned within a passageway 850 within first optical housing 806. Each photodetector in first assembly 834 is positioned within a passageway 870 within first optical housing 806. First LED assembly 830 includes four clusters of three different LEDs, including LED 840, LED 842, and LED 844. Each of LED 840, LED 842, and LED 844 excites a biological sample at a different fluorescent wavelength. In the illustrated embodiment, LED 840 can excite a first fluorescent dye, LED 842 can excite a second fluorescent dye, and LED 844 can excite a third fluorescent dye. First photodetector assembly 834 includes eight photodetectors 846. In the illustrated embodiment, each photodetector 846 detects radiation in two different wavelength bands, in this case, the first fluorescent dye and the third fluorescent dye.

[0274] A second LED assembly 832 and a second photodetector assembly 836 are positioned within second optical housing 808. Each LED in second assembly 832 is positioned within a passageway 860 in second optical housing 808. Each photodetector in second assembly 836 is positioned within a passageway 880 in second optical housing 808. Second LED assembly 832 includes four clusters of three different LEDs, including LED 840, LED 842, and LED 844. Each of LED 840, LED 842, and LED 844 excites the biological sample at a different fluorescent wavelength. In the illustrated embodiment, LED 840 can excite a first fluorescent dye, LED 842 can excite a second fluorescent dye, and LED 844 can excite a third fluorescent dye. Second photodetector assembly 836 includes eight photodetectors 846. In the illustrated embodiment, each photodetector 846 detects radiation in a wavelength band, in this case, the second fluorescent dye.

[0275] Multiple excitation pathways extend through optical assembly 800 on both sides, allowing radiation to travel from first set of LEDs 830 and second set of LEDs 832 to heating stage 810. A first set of excitation pathways is formed on a first side of heating stage 810. Each of the first set of excitation pathways extends through a pathway 850, a pathway 854, and a pathway 856. Multiple pathways 850 are provided to accommodate each LED in first set 830. Thus, three pathways 850 are arranged to flow into one pathway 854. Furthermore, excitation filter 852 is also provided in the first set of excitation pathways, between pathway 850 and pathway 854. A second set of excitation pathways is formed on a second side of heating stage 810. Each of the second set of excitation pathways extends through a pathway 860, a pathway 864, and a pathway 866. Multiple pathways 860 are provided to accommodate each LED in second set 832. Thus, three pathways 860 are arranged to flow into one pathway 864. Furthermore, an excitation filter 862 is also positioned in the second set of excitation paths, between path 860 and path 864.

[0276] A plurality of emission pathways also extend through the optical assembly 800 on both sides so that radiation can travel from the heating stage 810 to the first set of light detectors 834 and the second set of light detectors 836. A first set of emission pathways is formed on a first side of the heating stage 810. Each of the first set of emission pathways extends through a pathway 876, a pathway 874, and a pathway 870. Furthermore, an emission filter 872 is disposed in each of the first set of emission pathways between pathway 874 and pathway 870. A second set of emission pathways is formed on a second side of the heating stage 810. Each of the second set of emission pathways extends through a pathway 886, a pathway 884, and a pathway 880. Furthermore, an emission filter 882 is disposed in each of the second set of emission pathways between pathway 884 and pathway 880.

[0277] To excite a biological sample positioned in heating station 810, LEDs from either first LED set 830 or second LED set 832 are activated. If an LED selected from first set 830 is activated, radiation travels through passage 850, excitation filter 852, passage 854, and passage 856 to well 812 of heating station 810. If an LED selected from second set 832 is activated, radiation travels through passage 860, excitation filter 862, passage 864, and passage 866 to well 812 of heating station 810.

[0278] Radiation emitted from a biological sample positioned in heating stage 810 will be detected by photodetectors in either the first set 834 or the second set 836. Each photodetector selected from the first set 834 will read emission that travels from well 812 of heating stage 810 through passage 876, passage 874, emission filter 872, and passage 870. Each photodetector selected from the second set 836 will read emission that travels from well 812 of heating stage 810 through passage 886, passage 884, emission filter 882, and passage 880.

[0279] The optical assembly 800 is advantageous because it allows for the placement of multiple light emitting diodes around each well 812 in the heating stage 810. This allows for the excitation of the biological sample in the well 812 at multiple different radiation wavelengths. Figures 29A-29D In the embodiment shown in , the biological sample can include a first fluorescent dye, a second fluorescent dye, and a third fluorescent dye, all of which can be excited by a light emitting diode. Optical assembly 800 is further advantageous because it is a compact design with no moving parts. The compact design allows optical assembly 800 to be used in a portable testing device to test biological materials on site.

[0280] Card 900

[0281] Figure 30A is a perspective view of card 900. Figure 30B is a side elevation view of card 900. Figure 30C 9 is a front elevational view of a card 900. The card 900 includes a body 902, slots 904, a handle or tab 906, and a code 908. Each slot 904 includes a first cavity 910, a second cavity 912, and a channel 914.

[0282] Card 900 is capable of receiving biological material that will undergo nucleic acid amplification and subsequent testing. Card 900 is formed by body 902. In the embodiment shown, body 902 is made of transparent plastic, but in alternative embodiments it can be made of any suitable material. Card 900 includes a plurality of slots 904 on body 902. During the manufacture of card 900, slots 904 are pressed into body 902. Body 902 also includes a handle 906 at the top side of body 902. In the embodiment shown, handle 906 is a rectangular protrusion from body 902 and allows the user to easily grasp card 900. Code 908 is also printed on body 902 of card 900. Code 908 is a machine-readable code that can be read by a machine code reader when card 900 is placed in a device for testing.

[0283] Each slot 904 on the card 900 includes a first cavity 910, a second cavity 912, and a passage 914. The first cavity 910 and the second cavity 912 are arranged separately from each other. The passage 914 extends between the first cavity 910 and the second cavity 912 and connects them. The first cavity 910 can receive a biological sample. After the biological sample is placed in the first cavity 910, it will travel through the passage 914 into the second cavity 912. The second cavity 912 can contain a reaction mixture with which the biological sample can be mixed. When the biological sample is in the second cavity 912, nucleic acid amplification can then be performed. The biological sample in the second cavity 912 can be excited and detected from the first side and the second side of the card 900.

[0284] Card 900 is a sample receptacle in which biological material can undergo nucleic acid amplification. Card 900 is advantageous over previous sample receptacle products for performing nucleic acid amplification because it has a simplified design and is easy to manage. In previous sample receptacles, there were many parts and components that were difficult to grip and maintain stable when dispersing biological material into the sample receptacle. Card 900 is formed from a main body 902, making it easy to manage. When the biological material is being dispersed, card 900 can be grasped by handle 906 or laid flat on a table. This allows card 900 to be used in the field with a portable test device because no separate holding platform or support structure is required to support card 900.

[0285] Card 900 is further advantageous because it can be preloaded with a reaction mixture in second cavity 912. This simplifies the process of preparing card 900 for testing. Furthermore, card 900 includes code 908. Code 908 is a machine-readable code that can be read by the device in which card 900 is placed. Code 908 can include information about the test protocol being performed with a particular card 900, including embedded end point call algorithms and reaction mixture traceability information. Code 908 can also include additional information that can be read by a portable testing device.

[0286] Figure 31A It is a front elevation view of the card 900 showing slot variants AD. Figure 31B is a front elevational view of card 900 showing slot variants E and H. Card 900 includes body 902 and slot 904, which includes slots 904A, 904B, 904C, 904D, 904E, 904F, 904G, and 904H. Slot 904 may include a first cavity 910, a second cavity 912, a channel 914, an air tube 916, and a third cavity 918.

[0287] Card 900 includes a body 902. A slot 904 is disposed on body 902. Slot 904 can take any number of shapes, some variations of which can be seen in FIG. Figures 31A-31B Each well 904 is capable of receiving a biological sample and mixing the biological sample with a reaction mixture pre-loaded in the well 904. The biological sample in each well 904 can then undergo nucleic acid amplification and testing.

[0288] Each of the grooves 904A includes a first cavity 910A, a second cavity 912A, and a channel 914A. The first cavity 910A and the second cavity 912A are spaced apart from each other. The first cavity 910A has a circular shape and a first depth. The second cavity 912A has an oval shape and a second depth. The channel 914A extends between and connects the first cavity 910A and the second cavity 912A. The channel 914A has varying depths, starting at a first depth at the first cavity 910A and ending at a second depth at the second cavity 912A. The first cavity 910A is capable of receiving a biological sample. After a biological sample is placed in the first cavity 910A, it travels through the channel 914A into the second cavity 912A. The second cavity 912A may contain a reaction mixture with which the biological sample can be mixed. While the biological sample is in the second cavity 912A, nucleic acid amplification can subsequently be performed.

[0289] Each of slots 904B includes a first cavity 910B, a second cavity 912B, a passage 914B, and an air tube 916B. The first cavity 910B and the second cavity 912B are arranged separately from each other. The first cavity 910B has a circular shape. The second cavity 912B has an oval shape. The passage 914B extends between the first cavity 910B and the second cavity 912B and connects them. The first cavity 910B can receive a biological sample. After the biological sample is placed in the first cavity 910B, it will pass through the passage 914B into the second cavity 912B. The air tube 916B is connected to the passage 914B and allows the air in the passage 914B to be exhausted as the biological sample passes through the passage 914B. The second cavity 912B can contain a reaction mixture with which the biological sample can be mixed. When the biological sample is in the second cavity 912B, nucleic acid amplification can then be performed.

[0290] Each of the grooves 904C includes a first cavity 910C, a second cavity 912C, and a channel 914C. The first cavity 910C and the second cavity 912C are arranged separately from each other. The first cavity 910C has a circular shape and a first depth. The second cavity 912C has an oval shape and has the same depth as the first cavity 910C. The channel 914C extends between the first cavity 910C and the second cavity 912C and connects them. The channel 914C has the same depth as both the first cavity 910C and the second cavity 912C. The first cavity 910C can receive a biological sample. After the biological sample is placed in the first cavity 910C, it will travel through the channel 914C to the second cavity 912C. The second cavity 912C can contain a reaction mixture with which the biological sample can be mixed. When the biological sample is in the second cavity 912C, nucleic acid amplification can then be performed.

[0291] Each tank 904D includes a first cavity 910D, a second cavity 912D, and a channel 914D. The first cavity 910D and the second cavity 912D are spaced apart from each other. The first cavity 910D has a circular shape. The second cavity 912D has a shape that resembles three overlapping circles. The channel 914D extends between and connects the first cavity 910D and the second cavity 912D. The first cavity 910D can receive a biological sample. After the biological sample is placed in the first cavity 910D, it travels through the channel 914D into the second cavity 912D. The second cavity 912D can contain a reaction mixture with which the biological sample can be mixed. While the biological sample is in the second cavity 912D, nucleic acid amplification can subsequently be performed. The shape of the second cavity 912D allows a light-emitting diode and a light detector to be positioned above each of the three overlapping circles. This allows three different light-emitting diodes and three different light detectors to be aligned with the second cavity 912D.

[0292] Each of the grooves 904E includes a first cavity 910E, a second cavity 912E, and a third cavity 918E. The first cavity 910E has a thin rectangular shape. The second cavity 912E has a circular shape. The third cavity 918E has a thin horseshoe shape. The first cavity 910E is directly connected to the second cavity 912E, and the second cavity 912E is directly connected to the third cavity 918E. The first cavity 910E can receive a biological sample. After the biological sample is placed in the first cavity 910E, it will move into the second cavity 912E. The second cavity 912E can contain a reaction mixture with which the biological sample can be mixed. When the biological sample is in the second cavity 912E, nucleic acid amplification can then be performed. Any excess air or fluid in the groove 904E can move into the third cavity 918E. In an alternative embodiment, the biological sample can be received in the third cavity 918E, and excess air or fluid can accumulate in the first cavity 910E.

[0293] Each of the slots 904F includes a first cavity 910F, a second cavity 912F, and a third cavity 918F. The first cavity 910F has a thin rectangular shape. The second cavity 912F has a circular shape. The third cavity 918F has a teardrop shape. The first cavity 910F is directly connected to the second cavity 912F, and the second cavity 912F is directly connected to the third cavity 918F. The first cavity 910F is capable of receiving a biological sample. After the biological sample is placed in the first cavity 910F, it will move into the second cavity 912F. The second cavity 912F may contain a reaction mixture with which the biological sample can be mixed. When the biological sample is in the second cavity 912F, nucleic acid amplification can subsequently be performed. Any excess air or fluid in the slot 904F may move into the third cavity 918F.

[0294] Each of the grooves 904G includes a first cavity 910G, a second cavity 912G, and a channel 914G. The first cavity 910G and the second cavity 912G are arranged separately from each other. The first cavity 910G has a circular shape. The second cavity 912G has a circular shape. The channel 914G extends between the first cavity 910G and the second cavity 912G and connects them. The first cavity 910G can receive a biological sample. After the biological sample is placed in the first cavity 910G, it will travel through the channel 914G to the second cavity 912G. The second cavity 912G can contain a reaction mixture with which the biological sample can be mixed. When the biological sample is in the second cavity 912G, nucleic acid amplification can then be performed.

[0295] Each of the slots 904H includes a first cavity 910H, a second cavity 912H, and a third cavity 918H. The first cavity 910H has a thin rectangular shape. The second cavity 912H has a rectangular shape with rounded corners. The third cavity 918H has a thin horseshoe shape. The first cavity 910H is directly connected to the second cavity 912H. A restriction member connects the second cavity 912H to the third cavity 918H. The first cavity 910H is capable of receiving a biological sample. After the biological sample is placed in the first cavity 910H, it will flow into the second cavity 912H. The second cavity 912H can contain a reaction mixture with which the biological sample can be mixed. The restriction member between the second cavity 912H and the third cavity 918H allows air to pass from the second cavity 912H to the third cavity 918H, but retains fluid in the second cavity 912H. While the biological sample is in the second cavity 912H, nucleic acid amplification can subsequently be performed.

[0296] Card 900 is advantageous because a plurality of differently shaped slots 904 may be used. Figures 31A-31B The slots 904A-904H shown in the figure are small samples in various shaped slots 904 that can be manufactured. Card 900 allows biological material to be placed in slots 904 and pass through each slot 904 to mix with the reaction mixture. The biological sample and reagent mixture can then undergo nucleic acid amplification and can be tested. Each slot 904 requires a small amount of reaction mixture and biological material to perform nucleic acid amplification and testing. This will save money on materials. Moreover, fewer biological samples need to be collected to complete the test.

[0297] Figure 32A is a side elevation view of card 900 showing a seal on card 900. Figure 32B is a front elevational view of the card 900 showing the first permanent seal 920 and the removable seal 922 . Figure 32C is a front elevation view of the card 900 after the removable seal 922 has been removed. Figure 32D 9 is a front elevational view of card 900 after application of second permanent seal 924. Card 900 includes body 902, slots 904, first permanent seal 920, removable seal 922, second permanent seal 924, and gasket 926. Each slot 904 includes a first cavity 910, a second cavity 912, and a channel 914.

[0298] Card 900 includes slots 904 disposed on body 902 of card 900. Each slot 904 on card 900 includes a first cavity 910, a second cavity 912, and a channel 914. First cavity 910 and second cavity 912 are spaced apart from each other. Channel 914 extends between and connects first cavity 910 and second cavity 912. First cavity 910 is capable of receiving a biological sample. After a biological sample is placed in first cavity 910, it travels through channel 914 into second cavity 912. Second cavity 912 may contain a reaction mixture with which the biological sample can be mixed. While the biological sample is in second cavity 912, nucleic acid amplification may then be performed.

[0299] Card 900 also includes a first permanent seal 920, a removable seal 922, a second permanent seal 924, and a gasket 926. The first permanent seal 920 is disposed on the body 902 of the card 900 and covers the channel 914 and the second cavity 912 of the slot 904. The removable seal 922 is disposed on the body 902 of the card 900 and covers the first cavity 910 of the slot 904. The second permanent seal 924 is attached to the top of the body 902 of the card 900, but does not initially seal the second permanent seal 924 to the body 902 of the card 900. The gasket 926 is attached to the second permanent seal 924.

[0300] A first permanent seal 920 and a removable seal 922 may be sealed to the card 900 prior to sealing the card 900. During manufacture of the card, a reaction mixture may be added to the second cavity 912 of the slot 904. The reaction mixture may be in liquid form, or it may be freeze-dried. After the reaction mixture is added, a first permanent seal 920 may be applied to the card 900 to seal the channel 914 and the second cavity 912 of the slot 904. A removable seal 922 may also be applied to the card 900 to seal the first cavity 910 of the slot 904. A second permanent seal 924 and a gasket 926 may also be attached to the top of the body 902 of the card 900. This may be seen in FIG. Figures 32A-32B .

[0301] When the user wishes to place biomaterial in the slot 904, the removable seal 922 can be removed from the body 902 of the card 900, as in Figure 32C910. This exposes the first cavity 910 of the groove 904. A biological sample can then be placed in the first cavity 910, typically by pipetting the biological sample in liquid form into the first cavity 910. When the biological sample is placed in the first cavity 910, it can travel through the channel 914 into the second cavity 912. When the biological sample reaches the second cavity 912, it can mix with the reaction mixture previously placed in the second cavity 912. After the biological sample is completely loaded into the card 900, the gasket 926 can be removed from the second permanent seal 924. The second permanent seal 924 can then be placed on the body 902 of the card 900 to completely seal the groove 904, as shown in FIG. Figure 32D In the embodiment shown, the second permanent seal 924 covers the first cavity 910 and the first permanent seal 920. In alternative embodiments, the second permanent seal 924 may cover only the first cavity 910, or it may cover a portion of the first cavity 910 and the first permanent seal 920.

[0302] Card 900 is advantageous because it allows the user to easily load a biological sample into the sample receptacle. Card 900 is further advantageous because it can be preloaded with a reaction mixture. After the biological sample is loaded into card 900, it is mixed with the reaction mixture to prepare it for nucleic acid amplification. This is a simple method for preparing a biological sample for testing. Furthermore, the seal provided on card 900 makes it easy for the user to load the biological sample into card 900 while preventing contamination of slot 904.

[0303] Card 1000

[0304] Figure 33A is a perspective view of the top side of card 1000. Figure 33B 10 is a perspective view of the bottom side of card 1000. Card 1000 includes body 1002 and slot 1004. Body 1002 includes first body portion 1010, second body portion 1012, and hinge 1014.

[0305] Card 1000 is capable of receiving biological material to be subjected to nucleic acid amplification and testing. Card 1000 is formed by body 1002. In the illustrated embodiment, body 1002 is made of transparent plastic, but in alternative embodiments, it can be any suitable material. Body 1002 includes a first body portion 1010, a second body portion 1012, and a hinge 1014. First body portion 1010 is rectangular in shape. Second body portion 1012 is T-shaped. The first long side of first body portion 1010 is attached to the top long portion of the T-shape of second body portion 1012 along hinge 1014. First body portion 1010 and second body portion 1012 can be folded toward each other or in opposite directions along hinge 1014. First body portion 1010 is wider than second body portion 1012, which allows first body portion 1010 to be protected when a biological sample is placed in first body portion 1010 or when second body portion 1012 is sealed with first body portion 1010.

[0306] A plurality of grooves 1004 are disposed on the first body 1010. Each groove 1004 is circular in shape, and the grooves 1004 are disposed in a line on the first body 1010. The grooves 1004 are capable of receiving a biological sample and a reaction mixture to be subjected to nucleic acid amplification.

[0307] The T-shape of the second body 1012 allows the vertical portion of the T to serve as a handle for the card 1000. The second body 1012 can be easily grasped by a user to hold and move the card 1000. Furthermore, a machine-readable code can be printed on the handle of the second body 1012. When the card 1000 is placed in the device, a code reader can read the machine-readable code on the second body 1012. The machine-readable code can indicate information such as which test protocol to run.

[0308] Card 1000 is advantageous because it allows a user to prepare biological samples for testing in a compact and easy-to-use sample reservoir. Biological material can be easily placed in slot 1004 and mixed with a reaction mixture. Furthermore, the design of card 1000 with a handle on second body 1012 makes card 1000 easy to grip and manipulate. Card 1000 allows a user to perform nucleic acid amplification on small sample amounts in slot 1004.

[0309] Figure 34A is a perspective view of the card 1000 when the second body 1012 is rotated down. Figure 34B is a perspective view of card 1000 with first permanent seal 1020. Figure 4C is a perspective view of the card 1000 with the first removable seal 1022. Figure 34D is a perspective view of a card 1000 that can be placed in a freeze dryer. Figure 34Eis a perspective view of a card 1000 having a second removable seal 1026 over a first removable seal 1022. Card 1000 includes a body 1002, a slot 1004, a permanent seal 1020, a first removable seal 1022, an opening 1024, and a second removable seal 1026. Body 1002 includes a first body portion 1010, a second body portion 1012, and a hinge 1014.

[0310] Card 1000 is capable of receiving biological material to be subjected to nucleic acid amplification. Card 1000 is formed from a body 1002. Body 1002 includes a first body portion 1010, a second body portion 1012, and a hinge 1014. First body portion 1010 and second body portion 1012 are attached along hinge 1014 and can be folded toward or away from each other along hinge 1014. A plurality of slots 1004 are disposed on first body portion 1010. Each slot 1004 is circular in shape, and slots 1004 are disposed in a line on first body portion 1010. In alternative embodiments, slots 1004 can be of any shape, including oval, rectangular, or teardrop-shaped. Slots 1004 are capable of receiving biological samples and reaction mixtures to be subjected to nucleic acid amplification.

[0311] To prepare the card 1000 for testing, the second body 1012 can first be folded down along the hinge 1014. This allows the user to grasp the second body 1012 to hold the card 1000 steady or to place the second body 1012 on a receptacle that supports the card 1000. While the card 1000 is held steady or supported, the reaction mixture can be dispensed into the well 1004, as in Figure 34A Typically, the reaction mixture is dispersed in liquid form.

[0312] Before or immediately after dispensing the reaction mixture into the tank 1004, a permanent seal 1020 may be applied to the first body 1010, such as in Figure 34B In the embodiment shown, the permanent seal 1020 is a permanent adhesive applied to the top side of the first body 1010 surrounding the groove 1004. In alternative embodiments, the permanent seal 1020 can be any suitable seal.

[0313] After the permanent seal 1020 has been applied and the reaction mixture has been dispensed into the groove 1004, a first removable seal 1022 is placed over the permanent seal 1020, as in Figure 34C. The first removable seal 1022 can be any material suitable for use as a seal and can be easily removed from the permanent seal 1020. The first removable seal 1022 has a plurality of openings 1024 therein. One opening 1024 is positioned above each slot 1004. The openings 1024 are provided to allow moisture-laden air to flow into and out of the slots 1004 during the remaining preparation steps.

[0314] After the first removable seal 1022 has been placed over the slot 1004, the card 1000 can be placed in a freeze dryer, such as in Figure 34D . The card 1000 can be inserted into the freeze dryer in any orientation. The freeze dryer will dry the liquid reaction mixture in the tank 1004. The opening 1024 in the first removable seal 1022 allows air to pass into and out of the tank 1004 during freeze drying.

[0315] After the reaction mixture in the well 1004 is lyophilized, a second removable seal 1026 can be placed over the opening 1024 in the first removable seal 1022, as in Figure 34E . The second removable seal 1026 can be any material suitable for use as a seal. Placing the second removable seal 1026 over the first removable seal 1022 will cover the opening 1024 in the first removable seal 1022. This will seal the lyophilized reaction mixture into the well 1004 and prevent contamination of the well 1004.

[0316] As can be seen from the above steps, card 1000 is easily prepared for nucleic acid amplification and testing. During preparation of card 1000, first removable seal 1022 and second removable seal 1026 are applied to card 1000 to protect card 1000 from contamination. When biological material is to be placed in slot 1004, first removable seal 1022 and second removable seal 1026 can be easily removed from card 1000. Card 1000 is further advantageous because it has a lyophilized reaction mixture pre-loaded into slot 1004. This makes it easy to prepare biological samples for nucleic acid amplification in card 1000. The ease of preparation makes card 1000 suitable for use in the field.

[0317] Figure 35A is a perspective view of card 1000 having first removable seal 1022 and second removable seal 1026. Figure 35B is a perspective view of the card 1000 with the first removable seal 1022 and the second removable seal 1026 removed to provide access to the slot 1004. Figure 35Cis a perspective view of the card 1000 when the second body 1012 is folded over the slot 1004, thereby sealing the slot 1004 with the permanent seal 1020. Figure 35D 10 is a perspective view of a card 1000 that has been prepared for testing. Card 1000 includes a body 1002, a slot 1004, a permanent seal 1020, a first removable seal 1022, an opening 1024, and a second removable seal 1026. Body 1002 includes a first body portion 1010, a second body portion 1012, and a hinge 1014.

[0318] Card 1000 is capable of receiving biological material to be subjected to nucleic acid amplification. Card 1000 is formed from a body 1002. Body 1002 includes a first body portion 1010, a second body portion 1012, and a hinge 1014. First body portion 1010 and second body portion 1012 are attached along hinge 1014 and can be folded toward or away from each other along hinge 1014. A plurality of slots 1004 are disposed on first body portion 1010. Each slot 1004 is circular in shape, and slots 1004 are arranged in a line on first body portion 1010. Slots 1004 are capable of receiving biological samples and reaction mixtures that can undergo nucleic acid amplification.

[0319] After the user has obtained the card 1000, the user can place a biological sample into the slot 1004 of the card 1000 to test the biological sample. Figure 35A To prepare the biological sample and card 1000 for testing, the first removable seal 1022 and the second removable seal 1026 are removed from the card 1000 by peeling them off the card 1000, as shown. Figure 35B 1004. This will expose the permanent seal 1020. After removing the first removable seal 1022 and the second removable seal 1026, the biological sample can be placed in the well 1004. Typically, the biological sample placed in the well 1004 is in liquid form. This liquid can then be mixed with the lyophilized reaction mixture placed in the well 1004 during preparation of the card 1000.

[0320] After the biological sample is placed in the groove 1004, the second body 1012 of the card 1000 can be folded toward the first body 1010 along the hinge 1014. Figure 35C As shown in FIG, the second body portion 1012 will contact the permanent seal 1020 on the first body portion 1010. This will permanently seal the groove 1004 of the card 1000, as shown in FIG. Figure 35D After the card 1000 is permanently sealed, the user can grasp the handle of the second body 1012 to place the card 1000 in the testing device.

[0321] Card 1000 is advantageous because a biological sample can be easily loaded into card 1000 by removing first removable seal 1022 and second removable seal 1026. After loading the biological sample, card 1000 can be folded over along hinge 1014 to form a permanent seal between first body 1010 and second body 1012. Card 1000 can then be placed in a device for testing. The ease with which biological material can be loaded into card 1000 and sealed for testing makes card 1000 suitable for use in the field.

[0322] Cover assembly 1100

[0323] Figure 36A is a perspective view of the cover assembly 1100 . Figure 36B 1 is a top view of a seal portion 1110 that may be used with a lid assembly 1100. The lid assembly 1100 includes a base portion 1102, a lid portion 1104, an aperture 1106, and a flange 1108. The seal portion 1110 includes a permanent seal 1112, a gasket 1114, and a tab 1116.

[0324] Lid assembly 1100 includes a base portion 1102 and a lid portion 1104. Lid portion 1104 is attached to base portion 1102 using a plurality of hinge members, allowing lid portion 1104 to be folded along the hinge members toward base portion 1102. Base portion 1102 includes a plurality of holes 1106. Each hole 1106 is sized to fit over a standard tube, allowing base portion 1102 to be attached to an array of tubes. Lid portion 1104 includes a plurality of flanges 1108. Each flange 1108 is sized to fit within a standard tube, allowing lid portion 1104 to be folded over base portion 1102 and each flange 1108 to be placed within a tube in an array of tubes to seal the tubes.

[0325] Also included with lid assembly 1100 is a sealing portion 1110. Sealing portion 1110 includes a permanent seal 1112, a gasket 1114, and a tab 1116. Permanent seal 1112 forms a first layer of sealing portion 1110, and gasket 1114 is positioned above permanent seal 1112 to form a second layer. Sealing portion 1110 can be placed on base portion 1102 of lid assembly 1100 such that permanent seal 1112 is positioned on base portion 1102 and gasket 1114 is positioned on the top side of permanent seal 1112. Gasket 1114 can be removed from permanent seal 1112 by peeling it away from permanent seal 1112. Tab 1116 extends outwardly from a first side of gasket 1114. Tab 1116 is a rectangular shape that can be grasped by a user to place seal 1110 on base portion 1102 of cap assembly 1100. A machine-readable code can also be printed on tab 1116. When the tube array carrying cap assembly 1100 and seal 1110 is placed in an apparatus for testing, the apparatus can scan the machine-readable code on tab 1116. The machine-readable code can indicate what test to run, including information about the endpoint embedding algorithm and reaction mixture traceability information.

[0326] When the seal portion 1110 is placed on the base portion 1102 of the lid assembly 1100, the lid portion 1104 can be folded over the base portion 1102 while the gasket 1114 is on the seal portion 1110. This will form a mechanical seal between the base portion 1102 and the lid portion 1104. When the gasket 1114 is removed, the permanent seal 1112 will be exposed. The lid portion 1104 can then be folded over the base portion 1102 to form a permanent seal between the base portion 1102 and the lid portion 1104.

[0327] Using a standard tube array is advantageous because it can be used with a variety of devices already on the market. One problem that arises when using a standard tube array is that the cap portion of the tube array may be removed, either intentionally or accidentally. This creates concerns about contamination of the biological sample in the tube array. Therefore, cap assembly 1100 is advantageous because it allows the user to form a permanent seal with the standard tube array. Cap assembly 1100 can be closed over gasket 1114 of seal portion 1110 to form a mechanical seal that can be opened and closed when preparing the tube array for testing. When a biological sample is placed in the tube array, gasket 1114 can be removed to expose permanent seal 1112. When cap assembly 1100 is closed over permanent seal 1112, the tube array is permanently sealed. This eliminates concerns about contamination of the biological sample in the tube array, which can be difficult to remove from the tube array.

[0328] Figure 37Ais a perspective view of the cover assembly 1100 attached to the tube array 1120. Figure 37B is a perspective view of the cap assembly 1100 with the sealing portion 1110 applied to the cap assembly 1100 . Figure 37C is a perspective view of the lid assembly 1100 in a closed position above the sealing portion 1110 . Figure 37D is a perspective view of the opened lid assembly 1100 and the gasket 1114 removed from the sealing portion 1110 . Figure 37E 1 is a perspective view of lid assembly 1100 in a closed position, forming a seal with permanent seal 1112. Lid assembly 1100 includes base portion 1102, lid portion 1104, aperture 1106, and flange 1108. Sealing portion 1110 includes permanent seal 1112, gasket 1114, and tab 1116. Tube array 1120 is also shown.

[0329] The lid assembly 1100 is capable of being placed on a tube array 1120. The tube array 1120 is a standard tube array readily available on the market. The lid assembly 1100 includes a base portion 1102 and a lid portion 1104. The lid portion 1104 is attached to the base portion 1102 using a plurality of hinge members, allowing the lid portion 1104 to be folded toward the base portion 1102 along the hinge members. The base portion 1102 includes a plurality of holes 1106. Each hole 1106 is sized to fit on a standard tube, allowing the base portion 1102 to be attached to the tube array 1120. The lid portion 1104 includes a plurality of flanges 1108. Each flange 1108 is sized to fit within a standard tube, allowing the lid portion 1104 to be folded over the base portion 1102 and placed within the tubes in the tube array 1120 to seal the tubes.

[0330] Also included with lid assembly 1100 is a sealing portion 1110. Sealing portion 1110 includes a permanent seal 1112, a gasket 1114, and a tab 1116. Permanent seal 1112 forms a first layer of sealing portion 1110, and gasket 1114 is positioned above permanent seal 1112 to form a second layer. Sealing portion 1110 can be placed on base portion 1102 of lid assembly 1100 such that permanent seal 1112 is positioned on base portion 1102 and gasket 1114 is positioned on the top side of permanent seal 1112. Gasket 1114 can be removed from permanent seal 1112 by peeling it away from permanent seal 1112. Tab 1116 extends outwardly from a first side of gasket 1114. The tab 1116 is a rectangular shape that can be grasped by a user to place the sealing portion 1110 on the base portion 1102 of the lid assembly 1100 .

[0331] To prepare the tube array 1120 for testing, biological material needs to be placed in each of the tubes in the tube array 1120, and the tube array 1120 needs to be sealed. To do this, the user first obtains the tube array 1120 and the cap assembly 1100. The cap assembly 1100 can be connected to the tube array 1120 by placing the holes 1106 of the cap assembly 1100 around each of the tubes in the tube array 1120, as shown in FIG. Figure 37A 1104. Holes 1106 form an interference fit with the tubes in tube array 1120 to retain cap assembly 1100 on tube array 1120. Furthermore, in alternative embodiments, holes 1106 and the tubes in tube array 1120 may have protrusions so that cap assembly 1100 snaps onto tube array 1120. Tube array 1120 is placed in holes 1106 of cap assembly 1100 so that, when cap assembly 1100 is closed, the members connecting the tubes in tube array 1120 are seated between base portion 1102 and cap portion 1104. This prevents cap assembly 1100 from being removed from tube array 1120 after cap assembly 1100 is permanently sealed. In alternative embodiments, cap assembly 1100 may be welded or bonded to tube array 1120 before tube array 1120 is sold.

[0332] After the cap assembly 1100 has been placed on the tube array 1120, the sealing portion 1110 can be placed on the base portion 1102 of the cap assembly 1100. The sealing portion 1110 includes a permanent seal 1112 as a first layer and a gasket 1114 as a second layer. The permanent seal 1112 will be placed on the base portion 1102 of the cap assembly 1100, and the gasket 1114 will face upward from the base portion 1102, as shown in FIG. Figure 37B As seen in.

[0333] After the sealing portion 1110 has been placed on the base portion 1102 of the cap assembly 1100, the reaction mixture can be placed into each of the tubes in the tube array 1120. Typically, the reaction mixture is pipetted into each of the tubes in the tube array 1120. After the reaction mixture is dispersed, it can be lyophilized. Lyophilization will dry the reaction mixture. After the reaction mixture is lyophilized, the cap portion 1104 of the cap assembly 1100 can be folded over the base portion 1102 and the sealing portion 1110. The flange 1108 of the cap portion 1104 can be inserted into each of the tubes in the tube array 1120. The cap portion 1104 will contact the gasket 1114 of the sealing portion 1110. This will form a mechanical seal between the cap portion 1104 and the base portion 1102 of the cap assembly 1100, as shown in FIG. Figure 37C11. The tube array 1120 can then be stored until the biological material is needed for testing. Furthermore, the lid assembly 1100 can be opened and closed over the gasket 1114 to provide access to the tube array 1120.

[0334] When biological material is to be placed in the tube array 1120 for testing, the lid assembly 1100 can be opened by separating the lid portion 1104 from the base portion 1102. This exposes each of the tubes in the tube array 1120. The biological material can then be dispensed into each of the tubes in the tube array 1120, typically by pipetting. Typically, the biological material is added to the tube array 1120 in liquid form and can be mixed with a reaction mixture previously placed in the tube array 1120. After the biological material has been added to the tube array 1120, the spacer 1114 and tab 1116 can be removed from the tube array 1120, as in Figure 37D This will expose the permanent seal 1112. The tab 1116 may have a machine readable code printed on it. The user may retain the tab 1116 to be scanned with a test device before discarding it.

[0335] After the permanent seal 1112 has been exposed, the lid portion 1104 of the lid assembly 1100 can be folded over the base portion 1102 of the lid assembly 1100. The flange 1108 on the lid portion 1104 can be placed in each of the tubes in the tube array 1120. The lid portion 1104 of the lid assembly 1100 will come into contact with the permanent seal 1112, which will form a permanent seal between the lid portion 1104 and the base portion 1102, as shown in FIG. Figure 37E The tube array 1100 and cap assembly 1100 can then be placed in a device to undergo nucleic acid amplification and testing.

[0336] Cap assembly 1100 is advantageous because it allows the user to permanently seal an array of standard tubes. Using an array of standard tubes allows the user to test biological samples using devices already available on the market. Placing cap assembly 1100 on an array of standard tubes allows the user to place the reaction mixture in the tubes and then close the tubes over seal 1110, which includes gasket 1114, until the tubes are ready for testing. At this point, the tubes can be opened and biological samples can be placed in them. Gasket 1114 can then be removed and cap assembly 1100 can be closed over permanent seal 1112. This permanently seals the array of tubes and prevents contamination of the biological samples in the tubes.

[0337] Sample container 1200

[0338] Figure 38Ais a front view of a sample receptacle 1200 including a tube array 1202 and a cap array 1204. Figure 38B 12 is a perspective view of the sample receptacle 1200 after the cover array 1204 has been placed on the tube array 1202. The sample receptacle 1200 includes the tube array 1202 and the cover array 1204. The tube array 1202 includes a groove 1206, a groove lip 1210, and a tube lip 1214. The cover array 1204 includes a flange 1208, a flange lip 1212, and a cover lip 1216.

[0339] The sample receptacle 1200 includes a tube array 1202 and a lid array 1204. The tube array 1202 includes a plurality of slots 1206. The slots 1206 extend downward from the base portion of the tube array 1202. Each slot 1206 is capable of receiving a reaction mixture and a biological material to be tested. Figures 38A-38B , grooves 1206 have a standard shape and configuration. In alternative embodiments, grooves 1206 can be any shape that can be tested. Lid array 1204 includes a plurality of flanges 1208. Flanges 1208 extend downwardly from a base portion of lid array 1204. Lid array 1204 can be placed on tube array 1202 to form sample receptacles 1200. Each flange 1208 on lid array 1204 can be placed in a groove 1206 on tube array 1202 to form a first mechanical seal between tube array 1202 and lid array 1204.

[0340] To strengthen the primary mechanical seal between tube array 1202 and cover array 1204, flange 1208 and groove 1206 may include a plurality of protrusions for enhancing the seal between tube array 1202 and cover array 1204. Grooves 1206 include groove lip 1210 on the upper inner perimeter of each groove 1206. Grooves 1210 may include a plurality of protrusions extending along the perimeter of groove 1206. Flange 1208 includes flange lip 1212 on the lower outer perimeter of each flange 1208. Flange lip 1212 may include a plurality of protrusions extending along the perimeter of flange 1208. When flange 1208 is placed in groove 1206, flange lip 1212 will contact groove lip 1210. The protrusions on both flange lip 1212 and groove lip 1210 will form a primary mechanical seal. The first mechanical seal is strengthened by the protrusions because the protrusions make it more difficult to remove the cover array 1204 from the tube array 1202.

[0341] A second mechanical seal may be formed between the base portion of the tube 1202 and the base portion of the cover array 1204. The base portion of the tube array 1202 includes a recessed area surrounding the groove 1206. Figures 38A-38BIn the embodiment shown in FIG, the recessed areas are shaped as a plurality of interconnected circles bisected in the middle. Cover array 1204 is designed to mimic this shape so that when cover array 1204 is placed on tube array 1202, it fits into the recessed areas on tube array 1202. This forms a second mechanical seal between tube array 1202 and cover array 1204. This also allows cover array 1204 to fit flush with tube array 1202, making it difficult to remove cover array 1204 from tube array 1202. In alternative embodiments, the shapes of the recessed areas in tube array 1202 and cover array 1204 can be any suitable shape.

[0342] To strengthen the secondary mechanical seal between tube array 1202 and lid array 1204, tube array 1202 and lid array 1204 may include a plurality of protrusions for enhancing the seal between the base portion of tube array 1202 and the base portion of lid array 1204. Tube array 1202 includes a tube lip 1214 on the upper inner periphery of the recessed area of tube array 1202. Tube lip 1214 may include a plurality of protrusions extending along the periphery of the recessed portion of tube array 1202. Lid array 1204 includes a lid lip 1216 on the outer periphery of the base portion of lid array 1204. Lid lip 1216 may include a plurality of protrusions extending along the periphery of the base portion of lid array 1204. When lid array 1204 is placed on tube array 1202, lid lip 1216 will contact tube lip 1214. The protrusions on both lid lip 1216 and tube lip 1214 will form a secondary mechanical seal. The secondary mechanical seal is strengthened by the protrusions because the protrusions make it more difficult to remove the cover array 1204 from the tube array 1202.

[0343] Sample receptacle 1200 is advantageous because it allows lid array 1204 to be securely positioned on tube array 1202. A problem with previous tube arrays is that lids can easily become detached from the tube array, either intentionally or accidentally. This raises concerns about contamination of the material in the tube array. To prevent this, sample receptacle 1200 provides a dual sealing mechanism. A first seal is formed between flange 1208 of lid array 1204 and groove 1206 of tube array 1202. A second seal is formed between the base of lid array 1204 and the base of tube array 1202. This dual sealing mechanism is advantageous because lid array 1204 is more difficult to remove from tube array 1202. Furthermore, the protrusions that engage lid array 1204 with tube array 1202 reinforce the first and second mechanical seals, making it more difficult to remove lid array 1204 from tube array 1202. In alternative embodiments, the second seal may be an adhesive seal or any other suitable seal.

[0344] Furthermore, cover array 1204 is placed into a recessed area in the base portion of tube array 1202. This allows cover array 1204 to sit flush with tube array 1202 and makes it difficult to intentionally or accidentally remove cover array 1204 from tube array 1202. Making cover array 1204 difficult to remove from tube array 1202 is advantageous because it alleviates concerns about contamination of materials in tube array 1202.

[0345] Figure 39A is a front view of a sample receptacle 1200 including a tube array 1202 and a cap array 1204. Figure 39B is a perspective view of the sample receptacle 1200 when the cap array 1204 has been placed on the tube array 1202. Figure 39C is a side view of the sample receptacle 1200 when the cap array 1204 has been placed on the tube array 1202. Figure 39D 12 is a top view of a sample receptacle 1200. The sample receptacle 1200 includes a tube array 1202 and a lid array 1204. The tube array 1202 includes a groove 1206, a groove lip 1210, and a tube lip 1214. The lid array 1204 includes a flange 1208, a flange lip 1212, and a lid lip 1216.

[0346] The sample receptacle 1200 includes a tube array 1202 and a lid array 1204. The tube array 1202 includes a plurality of slots 1206. The slots 1206 extend downward from the base portion of the tube array 1202. Each slot 1206 is capable of receiving a reaction mixture and a biological material to be tested. Figures 39A-39D In the embodiment shown in FIG, the well 1206 has an oblong oval shape with a first flat side and a second flat side. This shape allows the biological sample in the well 1206 to be read through both the first flat side and the second flat side.

[0347] The lid array 1204 includes a plurality of flanges 1208. The flanges 1208 extend downwardly from a base portion of the lid array 1204. The lid array 1204 can be placed on the tube array 1202 to form the sample receptacles 1200. Each flange 1208 on the lid array 1204 can be placed in a groove 1206 on the tube array 1202 to form a first mechanical seal between the tube array 1202 and the lid array 1204.

[0348] To strengthen the primary mechanical seal between tube array 1202 and cover array 1204, flange 1208 and groove 1206 may include a plurality of protrusions for enhancing the seal between tube array 1202 and cover array 1204. Grooves 1206 include groove lip 1210 on the upper inner perimeter of each groove 1206. Grooves 1210 may include a plurality of protrusions extending along the perimeter of groove 1206. Flange 1208 includes flange lip 1212 on the lower outer perimeter of each flange 1208. Flange lip 1212 may include a plurality of protrusions extending along the perimeter of flange 1208. When flange 1208 is placed in groove 1206, flange lip 1212 will contact groove lip 1210. The protrusions on both flange lip 1212 and groove lip 1210 will form a primary mechanical seal. The first mechanical seal is strengthened by the protrusions because the protrusions make it more difficult to remove the cover array 1204 from the tube array 1202.

[0349] A second mechanical seal may be formed between the base portion of the tube 1202 and the base portion of the cover array 1204. The base portion of the tube array 1202 includes a recessed area surrounding the groove 1206. Figures 39A-39D In the embodiment shown in FIG, the recessed area has a rectangular shape with rounded corners. Cover array 1204 is designed to mimic this shape so that when cover array 1204 is placed on tube array 1202, it fits into the recessed area on tube array 1202. This forms a second mechanical seal between tube array 1202 and cover array 1204. This also allows cover array 1204 to fit flush with tube array 1202, which makes it difficult to remove cover array 1204 from tube array 1202.

[0350] To strengthen the secondary mechanical seal between tube array 1202 and lid array 1204, tube array 1202 and lid array 1204 may include a plurality of protrusions for enhancing the seal between the base portion of tube array 1202 and the base portion of lid array 1204. Tube array 1202 includes a tube lip 1214 on the upper inner periphery of the recessed region of tube array 1202. Tube lip 1214 may include a plurality of protrusions extending along the periphery of the recessed region of tube array 1202. Lid array 1204 includes a lid lip 1216 on the outer periphery of the base portion of lid array 1204. Lid lip 1216 may include a plurality of protrusions extending along the periphery of the base portion of lid array 1204. When lid array 1204 is placed on tube array 1202, lid lip 1216 will contact tube lip 1214. The protrusions on both lid lip 1216 and tube lip 1214 will form a secondary mechanical seal. The secondary mechanical seal is strengthened by the protrusions, and the protrusions make the cover array 1204 more difficult to remove from the tube array 1202.

[0351] Sample receptacle 1200 is advantageous because it is very difficult to intentionally or accidentally remove cap array 1204 from tube array 1202. First, there is a double sealing mechanism between cap array 1204 and tube array 1202. Second, there are protrusions on both cap array 1204 and tube array 1202 that make it difficult to separate them. Third, cap array 1204 sits flush with tube array 1202, making it very difficult to remove cap array 1204 from tube array 1202. Making cap array 1204 difficult to remove from tube array 1202 is advantageous because it reduces concerns about contamination of biological samples in tube array 1202.

[0352] Sample receptacle 1200 is further advantageous because of the shape of slot 1206. Slot 1206 has a first flat side and a second flat side. This allows radiation to enter and exit slot 1206 from either side. The two flat sides of slot 1206 provide a wide base for such radiation to enter and exit the biological sample in slot 1206.

[0353] Figure 40A is a perspective view of the sample receptacle 1200 when the cap array 1204 has been placed on the tube array 1202. Figure 40B is a front view of the sample receptacle 1200 when the cap array 1204 has been placed on the tube array 1202. Figure 40C 1 is a bottom view of sample receptacle 1200. Sample receptacle 1200 includes tube array 1202 and lid array 1204. Tube array 1202 includes groove 1206, groove lip 1210, and tube lip 1214. Lid array 1204 includes flange 1208, flange lip 1212, and lid lip 1216. Also shown is adhesive 1220.

[0354] The sample receptacle 1200 includes a tube array 1202 and a lid array 1204. The tube array 1202 includes a plurality of grooves 1206. The grooves 1206 extend downward from the base portion of the tube array 1202. Each groove 1206 is capable of receiving a reaction mixture and a biological material to be tested. Figures 40A-40C In the embodiment shown in FIG, the wells 1206 have a hexagonal shape with a flat bottom. The hexagonal shape of the wells provides six different sides for each well 1206. This shape allows the biological material in each well 1206 to be read out through any of the six sides.

[0355] The lid array 1204 includes a plurality of flanges 1208. The flanges 1208 extend downwardly from a base portion of the lid array 1204. The lid array 1204 can be placed on the tube array 1202 to form the sample receptacles 1200. Each flange 1208 on the lid array 1204 can be placed in a groove 1206 on the tube array 1202 to form a first mechanical seal between the tube array 1202 and the lid array 1204.

[0356] To strengthen the primary mechanical seal between tube array 1202 and cover array 1204, flange 1208 and groove 1206 may include a plurality of protrusions for enhancing the seal between tube array 1202 and cover array 1204. Grooves 1206 include groove lip 1210 on the upper inner perimeter of each groove 1206. Grooves 1210 may include a plurality of protrusions extending along the perimeter of groove 1206. Flange 1208 includes flange lip 1212 on the lower outer perimeter of each flange 1208. Flange lip 1212 may include a plurality of protrusions extending along the perimeter of flange 1208. When flange 1208 is placed in groove 1206, flange lip 1212 will contact groove lip 1210. The protrusions on both flange lip 1212 and groove lip 1210 will form a primary mechanical seal. The first mechanical seal is strengthened by the protrusions because the protrusions make it more difficult to remove the cover array 1204 from the tube array 1202.

[0357] A second seal can be formed between the base portion of tubes 1202 and the base portion of cover array 1204. When cover array 1204 is placed over tube array 1202, the bottom side of the base portion of cover array 1204 will contact the top side of the base portion of tube array 1202. Adhesive 1220 can be placed between the bottom side of the base portion of cover array 1204 and the top side of the base portion of tube array 1202 to seal cover array 1204 to tube array 1202. Adhesive 1220 can be any suitable adhesive and can be applied using any suitable method.

[0358] Sample receptacle 1200 is advantageous because it is very difficult to intentionally or accidentally remove cap array 1204 from tube array 1202. There is a dual sealing mechanism between cap array 1204 and tube array 1202. The first seal is a mechanical seal, and the second seal is an adhesive seal. There are also protrusions on both cap array 1204 and tube array 1202 that make it difficult to separate them. Making cap array 1204 difficult to remove from tube array 1202 is advantageous because it reduces concerns about contamination of biological samples in tube array 1202.

[0359] Sample receptacle 1200 is further advantageous due to the shape of trough 1206. Trough 1206 has a hexagonal shape with six distinct sides. This allows radiation to enter and exit trough 1206 from any of the six sides. This allows three different light-emitting diodes to be positioned on three sides of trough 1206, and three photodetectors to be positioned on the remaining three sides of trough 1206. Each light-emitting diode can excite a biological sample in trough 1206 at a different wavelength of radiation, and each photodetector can detect a different wavelength of radiation emitted from the biological sample. This allows three different fluorescent dyes to be detected from trough 1206.

[0360] Although the present invention has been described with reference to one or more exemplary embodiments, it will be understood by those skilled in the art that various changes may be made to its elements and equivalents may be substituted without departing from the scope of the present invention. Furthermore, many modifications may be made to adapt specific situations or materials to the teachings of the present invention without departing from its substantial scope. Therefore, it is intended that the present invention is not limited to the specific embodiment or embodiments disclosed, but rather that the present invention encompasses all embodiments falling within the scope of the appended claims.

Claims

1. A portable testing device, comprising: a housing having an integral touch screen display and a container capable of placing a sample reservoir containing a mixture of a biological sample and a reagent therein; an optical assembly disposed in the housing, wherein the optical assembly is configured to amplify and detect a signal from the biological sample and reagent mixture in the sample reservoir, wherein the optical assembly includes an excitation filter extending across the entire optical assembly and an emission filter extending across the entire optical assembly; an electronics assembly configured to receive data from the optical assembly and transmit it for display on the touch screen display; and A power supply in the housing is provided to power the portable test device.

2. The portable testing device of claim 1 , wherein the housing of the portable testing device further comprises: an integrated handle to allow transport of the device; and A lid is provided on the container, the lid being movable between open and closed positions.

3. The portable testing device of claim 1 , further comprising: A machine-readable code reader in the housing is configured to read the machine-readable code.

4. The portable testing device of claim 1, wherein the container comprises a plurality of cavities configured to receive an array of tubes.

5. The portable testing device of claim 1, wherein the container includes a cavity configured to receive a card.

6. The portable testing device of claim 5, wherein the card comprises: a body defining the shape of the card; a plurality of slots integrally formed with the body, wherein each slot has a first cavity, a second cavity, and a passage connecting the first cavity to the second cavity; a first permanent seal covering the channel and the second cavity of each of the plurality of grooves; a removable seal covering the first cavity of each of the plurality of slots, the removable seal being removable to provide access to each of the plurality of slots; and A second permanent seal having a removable gasket attached to the body of the card sample receptacle, wherein the removable gasket can be removed and the second permanent seal can be placed on the body of the card to seal the first cavity of each of the plurality of slots.

7. The portable testing device of claim 1 , wherein the optical assembly further comprises: a heating component for heating the biological sample and reagent mixture in the sample receptacle; a plurality of light emitting diodes to excite the biological sample and reagent mixture in the sample receptacle, wherein the plurality of light emitting diodes are positioned on a first side of the excitation filter and the sample receptacle is positioned on a second side of the excitation filter; and A plurality of light detectors to detect signals from the biological sample and reagent mixture in the sample reservoir, wherein the plurality of light detectors are disposed on a first side of the emission filter and the sample reservoir is disposed on a second side of the emission filter.

8. An optical assembly for use in a portable testing device, the optical assembly comprising: A sample stage, wherein a sample reservoir containing a mixture of a biological sample and a reagent can be placed, the sample stage comprising: a plurality of cavities shaped to receive the sample receptacles; and a heating component for heating the biological sample and reagent mixture in the sample receptacle; a first housing portion disposed on a first side of the sample stage, the first housing portion comprising: a first excitation filter disposed in the first housing portion; a first set of light emitting diodes positioned on a first side of the first excitation filter; a first emission filter disposed in the first housing portion; and a first set of photodetectors positioned on a first side of the first emission filter; and a second housing portion disposed on a second side of the sample stage, the second housing portion comprising: a second excitation filter disposed in the second housing portion; a second set of light emitting diodes positioned on a first side of the second excitation filter; a second emission filter disposed in the second housing portion; and A second set of photodetectors is positioned on a first side of the second emission filter.

9. The optical assembly of claim 8, wherein the sample stage further comprises: a first set of holes, wherein each hole extends from a bottom side of the sample stage to one of the plurality of cavities; a second set of apertures, wherein each aperture extends from the first side of the sample stage to one of the plurality of cavities; a third set of holes, wherein each hole extends from a bottom side of the sample stage to one of the plurality of cavities; and A fourth set of holes, wherein each hole extends from the second side of the sample stage to one of the plurality of cavities.

10. The optical assembly of claim 9, further comprising: A plurality of lenses, wherein one lens is positioned in each of the second set of apertures in the sample stage.

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