Verification plate and instructions for use of a bacterial endotoxin reader.

Abstract

To provide verification plates for a bacterial endotoxin reader, namely, a temperature verification plate (TVP) and an optical verification plate (OVP).SOLUTION: A TVP 300 has a body configured to be placed on a spindle of a reader and rotated by the spindle. The body has a temperature verification circuit with a temperature sensor and a temperature indicator 320. The temperature sensor is configured to measure a temperature of the body rotated by the spindle of the reader. The temperature indicator optically represents a value of the temperature measured by the temperature sensor. The temperature indicator is readable by an optical bench of the reader. An OVP has a body with a plurality of apertures located along a periphery that lines up with the optical bench of the reader. Light produced by a light source of the reader can pass through the aperture, and the intensity is measured by a photodetector of the reader.SELECTED DRAWING: Figure 3

Description

Cross-reference to Related Applications

[0001] This application claims the benefit of priority of U.S. Provisional Patent Application Serial No. 62 / 93 6,883, filed on November 18, 2019, the entire disclosure of which is incorporated herein by reference and made a part hereof.

Technical Field

[0002] This application is directed to the verification of endotoxin readers in bacteria. More specifically, it is directed to the temperature and / or optical verification of endotoxin readers in bacteria. in bacteria.

Background Art

[0003] Endotoxin readers in bacteria need to periodically verify their optical reading performance and temperature measurement performance. There is.

Summary of the Invention

[0004] In one aspect of the present invention, a temperature verification plate (TVP) for an endotoxin reader in bacteria has a body configured to be placed on a spindle of the reader and rotated by the spindle; the said body has a temperature verification circuit including a temperature sensor and a temperature indicator; said temperature sensor is configured to measure the temperature of the body when rotated by the spindle of the reader; said temperature indicator is configured to optically represent the value of the temperature measured by the temperature sensor, and the temperature indicator is readable by the optical bench of the reader. is configured to measure the temperature of the body when rotated by the spindle of the reader; said temperature indicator is configured to optically represent the value of the temperature measured by the temperature sensor, and the temperature indicator is readable by the optical bench of the reader. is configured to optically represent the value of the temperature measured by the temperature sensor, and the temperature indicator is readable by the optical bench of the reader. is configured to optically represent the value of the temperature measured by the temperature sensor, and the temperature indicator is readable by the optical bench of the reader.

[0005] In another aspect of the present invention, the temperature sensor may be an electronic temperature sensor, a thermistor, a thermocouple, and / or a resistance temperature detector. The temperature indicator may be at least one light-emitting diode. ​​​​It is an LED and / or at least one liquid crystal display (LCD). Temperature The indicator displays the temperature value as a binary number.

[0006] In another aspect of the present invention, the binary number determines the resolution of the temperature measured by the temperature sensor. A binary number has two or more verification bits. A binary number can be a 12-digit number.

[0007] In another aspect of the present invention, the temperature indicator is a single LED, 12 LEDs, 14 LEDs Various LEDs are available, such as a single LED, a single LCD, 12 LCDs, or 14 LCDs. Alternatively, it can have an LCD configuration.

[0008] In another aspect of the present invention, the temperature verification circuit further includes a battery and a switch. The battery is It supplies power to the temperature verification circuit. When the switch is in the "ON" position, It allows current to flow from the battery, and when the switch is in the "OFF" position, the battery It blocks the flow of current from the source.

[0009] In another aspect of the present invention, the temperature sensor performs a first repetition for a first predetermined length of time. Temperature measurements are taken at intervals. The temperature indicator outputs the average of the temperature measurements.

[0010] The first predetermined time may be about 5 seconds, and the first repetition interval may be about 0.1 seconds. It's okay to have it.

[0011] In yet another aspect of the present invention, a method for verifying the temperature performance of a bacterial endotoxin reader is: Reader and to provide a temperature verification plate (TVP); and to provide the TVP to the spin of the leader Place it on the dollar, rotate the TVP using the spindle, and activate the heater of the leader. To maintain the temperature of the TVP main unit at a predetermined temperature; and the optical bench of the reader Using the temperature indicator of the TVP, the temperature measurement value of the TVP body is obtained. ; Obtaining the temperature measurement value of the main body of the TVP using the temperature measurement sensor of the reader; The temperature measurement obtained from the temperature indicator of the TVP and the temperature measurement sensor of the reader The difference between the obtained temperature measurement and the result is calculated and compared; and the difference exceeds a predetermined temperature difference threshold. If the value is large, this may indicate a calibration error in the reader's temperature measurement sensor.

[0012] In another aspect of the present invention, the method involves a temperature measurement obtained from the TVP and the temperature sensor of the reader. The calibration coefficient is calculated based on the difference between the temperature measurement obtained from the sensor and the leader. This further includes applying it to temperature measurements obtained from a temperature measurement sensor. A predetermined temperature difference threshold. The value may be approximately 1°C, approximately 0.5°C, or approximately 0.1°C. The difference is between two or more predetermined values. The calculation may also be based on temperature. The specified temperature may be 22°C and / or 37°C.

[0013] In another aspect of the present invention, the method is used to obtain the temperature from the TVP at two or more predetermined temperatures. The difference between the measured value and the temperature measurements obtained from the reader's temperature sensor at two or more predetermined temperatures. Based on this, the calibration coefficient is calculated, and the temperature measurement obtained from the reader's temperature sensor is used. This further includes applying it to the values. Calibration coefficients are calculated using linear interpolation and / or mathematical regression. It can be decided by doing so.

[0014] In yet another aspect of the present invention, the optical verification plate (OVP) for the bacterial endotoxin reader is: The body may include multiple openings located along its periphery; the center of each opening is within the body. It is located a predetermined radius distance from the center, thereby the aperture is the optical bend of the leader. By allowing it to be aligned with the light source of the leader, the light generated by the light source passes through the aperture, The intensity can be measured by the reader's photodetector; the aperture is a filtered aperture and Including an open aperture without a filter; the open aperture with a filter rotates counterclockwise around the OVP. They then separate by a second predetermined distance.

[0015] In another aspect of the present invention, the filtered aperture is an aperture with one or more light-reducing filters. It includes an aperture and one or more wavelength filters. A taped opening is one or more short-pass filtered openings, one or more A number of long-pass filtered openings, one or more band-pass filtered openings , and / or may include one or more apertures with stopband filters. The filtered aperture consists of at least one wavelength-filtered aperture and a second light-reducing filter. It may include an aperture with a wavelength filter. At least one aperture with a wavelength filter may have one long It may include an aperture with a pass filter and one aperture with a short pass filter. Alternatively, multiple filters may form a first predetermined angle with respect to the top surface of the OVP body. It may be attached to the OVP, and / or one or more filters may be attached to the OVP It is mounted on the OVP so as to form a first predetermined angle with respect to the filter bed of the main body. This is also acceptable. The first predetermined angle may be about 0 degrees, about 30 degrees, or about 0 to about 45 degrees. stomach.

[0016] In another embodiment, the OVP may include an entrance aperture and / or a registered aperture. The opening may be located between the first filter-equipped opening and the registration opening. The registration opening may be located between the incident opening and the last filter-equipped opening.

[0017] In yet another aspect of the present invention, a method for verifying the optical performance of the optical bench of an endotoxin reader comprises providing a reader and an optical verification plate (OVP); placing the OVP on the spindle of the reader and rotating the OVP; using the optical bench of the reader to identify the registration pattern on the OVP; measuring the intensity of light passing through the incident opening of the OVP using the photodetector of the reader, the light being generated by the light source of the reader, and the measured value being stored in the memory of the reader as the incident light (I , , ,<000,0199>; , , , , , , , , ); measuring the intensity of light passing through at least one light attenuation filter-equipped opening using the photodetector of the reader, and repeating for each light attenuation filter-equipped opening, the light being generated by the light source of the reader, and the measured value being stored in the memory of the reader as the intensity neutral measurement value (I ) with N increasing by 1 for each light attenuation filter-equipped opening; calculating the transmittance (T fN ) for each light attenuation filter-equipped opening using the formula T =(I N / I fN / I i ) and storing it in the memory of the reader; calculating the measured absorbance (A ) for each light attenuation filter-equipped opening using the formula A N =-log (T mN ) and storing it in the memory of the reader; and storing in the memory 10 (T N ) and storing it in the memory of the reader; comparing each A for each light attenuation filter-equipped opening with a predetermined absorbance value (A<00000,10>) and storing it in the memory; and comparing each A mN for each light attenuation filter-equipped opening with a predetermined absorbance value (A pN ) to the expression AError N =( A mN -A pN ) / A pN The percentage error is calculated using Note the absorbance percentage error calculated for each of the apertures with the light-reducing filters. By storing the information in the log, comparisons can be made; AError N A predetermined attenuation absorbance error threshold Compared to AError N If the value is greater than a predetermined attenuation absorbance error threshold, the optical bench will To indicate that it is outside the normal range; and to use the reader's photodetector to apply at least one wavelength filter. The intensity of light passing through the aperture with the wavelength filter is measured, and the process is repeated for each of the apertures with the wavelength filter. The light is generated by the light source of the reader, and the measured value is an intensity wavelength measurement. Value (I WN ) is stored in memory as, and N increases by 1 for each wavelength-filtered aperture. thing and; expression WError N =I WN / I i Using each of the wavelength-filtered apertures, I WN and I i By evaluating the ratio, the wavelength error (WError) of the optical bench can be measured. N ) calculate and store in memory; for each of the wavelength-filtered apertures WError N This is compared with a predetermined wavelength error threshold, and WError N If the predetermined error wavelength threshold is If the value is excessive, this includes indicating that the optical bench is outside of specifications.

[0018] In another aspect of the present invention, the filtered aperture is an aperture with one or more light-reducing filters. It may include an aperture and one or more apertures with wavelength filters. A wavelength-filtered aperture is one or more short-pass filtered apertures, one Alternatively, multiple long-pass filtered apertures, or one or more band-pass filters. Includes an opening with a stopband filter, and / or one or more openings with stopband filters. That's fine. The filtered aperture has at least one wavelength filtered aperture and a second It may also include an aperture with a light-reducing filter. At least one aperture with a wavelength filter is , at least one aperture with a long-pass filter and one aperture with a short-pass filter It may also include the mouth.

[0019] In another aspect of the present invention, one or more filters are positioned relative to the upper surface of the OVP body. It may be mounted on the OVP to form a predetermined angle of 1, and / or 1 Alternatively, multiple filters form a first predetermined angle with respect to the filter floor of the OVP body. It may be mounted on the OVP as shown. The first predetermined angle is about 0 degrees, about 30 degrees, or A range of approximately 0 to 45 degrees is also acceptable.

[0020] In yet another aspect of the present invention, the bacterial endotoxin reader is a control unit and a control Memory that stores the executable code that performs an action when executed by the role unit. The action includes: using the leader's spindle, placing on the leader's spindle Rotating the modified optical verification plate (OVP); and using the reader's optical bench. Identifying the registered pattern on the VP; and using the reader's photodetector to determine the incident aperture of the OVP. This involves measuring the intensity of light passing through a device, where the light is generated by the reader's light source and measured. The value is stored in the reader's memory as incident light (Ii), and the reader's photodetector Using this method, the intensity of light passing through at least one aperture with a light-reducing filter is measured, and the light-reducing filter The process is repeated for each of the filter-equipped openings, and the light is directed by the light source of the leader. The generated and measured values ​​are the strength neutral values ​​(I fN ) is stored in the reader's memory, and N is The number increases by 1 for each aperture with a light-reducing filter; formula T N =(I fN / I i ) using For each aperture with a light-reducing filter, the transmittance (T N ) calculates the reader's memory To store in; Formula A mN = -log 10 (T N Using an aperture with a light-reducing filter, Measured absorbance (A) for each of these ( mN ) calculates and stores in the reader's memory, and in memory Remembering; A for each of the apertures with light-reducing filters mN and a predetermined absorbance value (A pN ) to the expression AError N =( A mN -A pN ) / A pN Percentage error using The absorbance percentage error calculated for each aperture with a light-reducing filter is calculated as follows: Comparing by storing in memory; AError N The predetermined light reduction absorbance error Compared to the threshold, AError N If it is greater than a predetermined attenuation absorbance error threshold, the optical bench To indicate that it is outside of specifications; and to use the reader's photodetector to determine at least one wavelength The intensity of light passing through the filter-equipped aperture is measured, and for each of the wavelength-filtered apertures... The process is repeated, with light generated by the light source of the reader, and the measured value being intensity wavelength. Measurement value (I WN ) is stored in memory as, and N increases by 1 for each wavelength-filtered aperture. ru, koto; expression WError N =I WN / I i Using the wavelength-filtered aperture, I about that WN and I i By evaluating the ratio, the wavelength error (WErr) of the optical bench can be measured. or N ) calculate and store in memory; for each of the wavelength-filtered apertures WError N This is compared with a predetermined wavelength error threshold, and WError N The predetermined error wavelength threshold This includes indicating that the optical bench is out of specification if it is greater than the value.

[0021] In yet another aspect of the present invention, the bacterial endotoxin reader is a control unit and a control Memory that stores the executable code that performs an action when executed by the role unit. The action includes: using the leader's spindle, placing on the leader's spindle Rotate the heated temperature verification plate (TVP); and activate the heater of the leader. Maintaining the temperature of the VP unit at a predetermined temperature; and using the reader's optical bench to measure the TVP Obtain the temperature measurement value of the TVP main unit from the temperature indicator and store it in memory; Reader The temperature measurement of the TVP unit is obtained using a temperature measurement sensor and stored in memory; T Temperature measurements obtained from the VP's temperature indicator and from the reader's temperature measurement sensor The process involves calculating the difference between the measured temperature and the actual temperature, storing it in memory, and comparing the results; and the difference being such that the difference exceeds a predetermined temperature difference threshold. When the value is large, it indicates a calibration error in the reader's temperature measurement sensor.

[0022] In another aspect of the present invention, the code, when executed by the control unit, Based on the difference between the temperature measurement obtained from the TVP and the temperature measurement obtained from the reader's temperature sensor. This includes applying a calibration coefficient to the temperature measurement value obtained from the reader's temperature sensor. Hmm, let's take additional action.

[0023] In another aspect of the present invention, the code, when executed by the control unit, Temperature measurements obtained from TVP at two or more predetermined temperatures and readers at two or more predetermined temperatures The calibration coefficient is calculated based on the difference between the temperature measurement obtained from the temperature sensor and the reader's temperature. Perform additional actions, including applying them to temperature measurements obtained from the measuring sensor.

[0024] In another aspect of the present invention, when the code is executed by the control unit This includes an additional step of determining the calibration coefficient using linear interpolation and / or mathematical regression. Perform the action.

[0025] The advantages of the present invention can be seen from the following description of embodiments of the present invention, which have been illustrated and described by example. This will become clearer to those skilled in the art. As understood, the present invention is different from other different Possible embodiments exist, and their details can be modified in various ways.

[0026] These and other features of the present invention, as well as their advantages, are described with reference to the attached perspective view. For example, this will be specifically illustrated in the embodiments of the present invention that will be described below. [Brief explanation of the drawing]

[0027] [Figure 1A]Figure 1A is an isometric view of an exemplary leader and verification plate according to an exemplary embodiment of the disclosed technology. [Figure 1B] Figure 1B is a block diagram of an exemplary leader according to an exemplary embodiment of the disclosed technology. [Figure 2A] Figure 2A is a cross-sectional view of an exemplary leader according to an exemplary embodiment of the disclosed technology. [Figure 2B] Figure 2B is a cross-sectional view of an exemplary leader according to an exemplary embodiment of the disclosed technology. [Figure 2C] Figure 2C is a cross-sectional view of an exemplary leader according to an exemplary embodiment of the disclosed technology. [Figure 3] Figure 3 is an isometric view of an exemplary temperature verification plate according to an exemplary embodiment of the disclosed technology. [Figure 4] Figure 4 is a top view of an exemplary temperature verification plate according to an exemplary embodiment of the disclosed technology. [Figure 5] Figure 5 is a block diagram of an exemplary temperature verification plate according to an exemplary embodiment of the disclosed technology. [Figure 6] Figure 6 is a flowchart of an exemplary method using a temperature verification plate according to an exemplary embodiment of the disclosed technology. [Figure 7] Figure 7 is a flowchart of an exemplary method for verifying a reader's temperature measurement using a temperature verification plate, according to an exemplary embodiment of the disclosed technology. [Figure 8A] Figure 8A is an isometric view of an exemplary reader and optical verification plate according to an exemplary embodiment of the disclosed technology. [Figure 8B] Figure 8B is a cross-sectional view of an exemplary reader and optical verification plate according to an exemplary embodiment of the disclosed technology. [Figure 9A] Figure 9A is a top view of an exemplary optical verification plate according to an exemplary embodiment of the disclosed technology. [Figure 9B] Figure 9B is a cross-sectional view of an exemplary optical verification plate according to an exemplary embodiment of the disclosed technology. [Figure 9C] Figure 9C is a cross-sectional view of an exemplary optical verification plate according to an exemplary embodiment of the disclosed technology. [Figure 10] Figure 10 shows a plot of transmittance versus wavelength for exemplary short-pass and long-pass filters according to exemplary embodiments of the disclosed technology. [Figure 11A] Figure 11A is a flowchart illustrating an exemplary method for verifying optical measurements of a reader using an optical verification plate, according to an exemplary embodiment of the disclosed technology. [Figure 11B] Figure 11B is a flowchart illustrating an exemplary method for verifying optical measurements of a reader using an optical verification plate, according to an exemplary embodiment of the disclosed technology.

[0028] It should be noted that all drawings are schematic and not drawn to scale. Yes. The relative dimensions and proportions of these parts of the diagram are for the clarity and convenience of the drawing. The corresponding or similar features in different embodiments are shown in an exaggerated or reduced manner. The same reference number is generally used for reference. Therefore, the drawings and descriptions are, It is essentially illustrative and not considered restrictive. [Modes for carrying out the invention]

[0029] The approximants used throughout this specification and the claims refer to the basic functions to which they relate. Applied to modify any quantitative expression that can be tolerated to change without causing a change in the actual value. Therefore, values ​​modified by terms such as "approximately" may not be the exact value specified. Not limited to. In at least some examples, the approximation refers to the precision of the instrument used to measure a value. It can correspond to the following. The range limitations are combinatorial and / or interchangeable, and such The scope is all sub-subjects described herein unless the context or language indicates otherwise. This specifies and includes the scope. Unless otherwise shown in the operating examples or elsewhere, this specification and All numerical values ​​used in the patent claims, including amounts of ingredients, reaction conditions, etc. The expression is understood to be modified in all cases by the term "approximately". It should.

[0030] "Optional" or "optionally" means that if the event or situation described thereafter occurs, It is not necessary, or it is not necessary for a substance identified later to be present or not. Furthermore, the description includes examples of events or situations occurring or substances existing, and also events. This also includes examples where the situation does not occur or where the materials are not available.

[0031] As used herein, the terms "comprise" and "include" are used to mean "compr." ising), includes, includes, "Has," "having," or any other variation are non-exclusive. It is intended to cover the specifics of including a list of elements. Methods, articles, or apparatus are not necessarily limited to those elements, but are expressly listed. Includes other elements not included or elements specific to such process, method, article or apparatus That's good too.

[0032] The singular forms "a," "an," and "the" are clearly indicated in the context. Unless otherwise indicated, it may include multiple reference words.

[0033] As used herein, "processor" refers to a system that processes signals and performs general calculation and arithmetic functions. The processor performs the following: The signals processed by the processor are digital signals, data signals, and composite signals. Transmitter instructions, processor instructions, messages, bits, bitstreams, or receive, send This may include other means of being able to trust and / or detect. Generally, the process Ssa utilizes multiple single and multi-core processors and coprocessors, as well as other multiple A variety of architectures, including single and multi-core processors and coprocessors. It can be a variety of processors. A processor can perform various functions. It can include modules.

[0034] As used herein, “memory” includes volatile memory and / or non-volatile memory. It is possible to do so. Examples of non-volatile memory include ROM (read-only memory) and P ROM (Programmable Read-Only Memory), EPROM (Erasable Promo), Examples include EEPROM (Electrically Erasable PROM). Examples of volatile memory include For example, RAM (Random Access Memory), Synchronous RAM (SRAM), Dynamic DRAM (Digital RAM), Synchronous DRAM (SDRAM), Double Data Rate S Examples include DRAM (DDRSDRAM) and Direct RAM Bus RAM (DRRAM). Memory can also include drives (disks). Operating systems that control or allocate resources to a device It can store data. Memory also stores data for the processor to use. It is possible to remember.

[0035] As used herein, "controller" refers to various components such as a processor and memory. It may include components. The controller has an onboard processor and memory. It can also include a cross controller.

[0036] As used herein, "drive" refers to, for example, magnetic drives, semiconductor drives, and fluid drives. Zip drives, tape drives, Zip drives, flash memory cards, and / Alternatively, it can be a memory stick. Furthermore, the drive can be a CD-ROM ( CompactDisk ROM), CD recordable drive (CD-R drive), CD rewritable CD-RW drive and / or digital video ROM drive (D It can be a VD ROM. The drive is a resource of the computing device. The operating system and / or program that control or assigns the system It can remember Ram.

[0037] Some parts of the following detailed explanation relate to data bits in computer memory These are presented in terms of algorithms and symbolic representations of operations. The descriptions and expressions are intended to best convey the nature of the work to those skilled in the field of data processing technology. It is a means used to achieve a desired outcome. An algorithm, in this context and in general, is a desired outcome. It is considered to be a series of self-consistent steps (commands) leading to the result. These require the physical manipulation of physical quantities. Usually, these quantities are not necessarily so. While it does not have electrical, magnetic, or optical capabilities for storage, transfer, combination, comparison, and other operations, it does not. These signals take the form of non-transient signals. These signals can be expressed as bits, values, elements, symbols, characters, terms, etc. Calling them "numbers" or similar terms is sometimes convenient, mainly for general usage reasons. A specific arrangement of steps that require physical manipulation or transformation of the representation of a rational or physical quantity, It is sometimes convenient to call them modules or code devices without losing generality. be.

[0038] However, all of these and similar terms should be associated with appropriate physical quantities. These are merely convenient labels applied to these quantities. This will become clear from the following discussion. Unless otherwise specified, throughout this specification, “processing” or “computer” Use terms such as "calculation," "decision," "display," or "determination." The discussion concerns the memory or registers or other such information records of a computer system. Manipulate and transform data that is represented as a physical (electronic) quantity within a memory, transmission, or display device. The operation of a computer system or similar electronic computing device (such as a specific calculator) It should be understood as referring to the process.

[0039] Certain aspects of the embodiments described herein are described herein in the form of algorithms. The process steps and instructions of the embodiment include: It can be embodied in software, firmware, or hardware, and in software When implemented, different platforms used by various operating systems Please note that it resides on a form and can be downloaded to be operated from there. Furthermore, the embodiment is a computer program that can be run on a computing system. It can also be found in rum products.

[0040] Furthermore, this embodiment also relates to an apparatus for performing the operations described herein. This apparatus is This could be something specifically built for a particular purpose, such as a particular computer, or Selectively activated or reconfigured by computer programs stored in the computer. This may include a general-purpose computer. Such a computer program may be a non-transient computer. Computer-readable storage media, for example, not limited to, but including floppy drives (disk drives) (Disc), optical drive (disc), CD-ROM, magneto-optical drive (disc), reading ROM (Remote Access Memory), Random Access Memory (RAM), EPROM, EEPRO M, magnetic or optical card, application-specific integrated circuit (ASIC), or electronic instruction storage. It can be stored on any type of suitable medium, each with an electrical connection to the computer system bus. It is connected to. Furthermore, the computer referred to herein has a single processor It includes, or employs, multiple processor designs to enhance computing power. This can be used as an architecture.

[0041] The algorithms and representations presented herein are not applicable to specific computers or other devices. It is not essentially related to the program described herein. Various general-purpose systems follow the instructions in this specification. It may also be used with a ram, or with more specialized equipment to perform the method steps It may also prove that building these various systems is convenient. The structure will become clear from the following description. In addition, the embodiment can be any particular program It will not be explained in accordance with the programming language. Various programming languages ​​are described herein. It will be understood that the following can be used to carry out the teaching of the embodiments described, References to specific languages ​​are provided for the feasibility and best mode disclosure of the embodiments. It is.

[0042] In addition, the languages ​​used in this specification have been selected primarily for readability and educational purposes. It may not have been selected to define or encompass the subject matter of the invention. Therefore, the disclosure of embodiments exemplifies the scope of embodiments described in the claims. This is intended to be a generalization, not a limitation.

[0043] Looking at Figure 1-7, we see the reaction wells of the reaction disk in the bacterial endotoxin reader 100. If temperature measurements are not within specifications, it may negatively affect the results of bacterial endotoxin tests. Furthermore, the light source 130 and / or photodetector 135 of the reader 100 operate within the specified range. If not done, it may negatively affect the results. The light source and sensor are plate (display) The optical response of the light source and sensor is measured on the plate (disk) 10. 3 may be a reaction plate or verification plate 200.

[0044] The temperature and / or optical performance of the leader 100 is verified using the Temperature Verification Plate (TVP) 3. Spindle of Leader 100, such as 00 and / or Optical Verification Plate (OVP) 800 This is performed using a verification plate 200 that is detachably attached to 105.

[0045] The TVP300 wirelessly transmits the temperature of a specific location on the TVP unit 335 to the reader 100. It may be reported. TVP300 is a heater 110 and a temperature sensor 115 of the reader 100. It may be used to verify that it is working correctly. In one embodiment, temperature The sensor 115 may be one or more infrared temperature sensors. The heater 110 of the leader 100 includes an upper heater 110a and a lower heater 110b. However, the temperature sensor 115 of the reader 100 measures the temperature at a predetermined location on the TVP 300. The reaction of the leader 100 is determined and maintained at a predetermined temperature at a predetermined location on the TVP. To maintain the temperature of the Vity 140 at a predetermined temperature, the upper temperature sensor 115a and the lower temperature sensor It may include a 115b. The upper heater 110a heats the upper surface 336 of the TVP 300 to the TV The lower heater 110b heats the lower surface 337 of the TVP300 at a predetermined location on P300. Heat in a designated location and maintain a predetermined temperature. In this embodiment, the predetermined temperature is approximately 37°C. It may be present. In some embodiments, a predetermined temperature is set so that the TVP300 is in use while the reader 1 While rotating within 00, the first predetermined half is from the center of the spindle 105 on TVP300 It is maintained at a distance of the radial distance. This first predetermined radial distance is also Lee The temperature sensor 115 of the DA100 measures the temperature of the TVP300, center of the spindle 105. It may also be the radial distance from. This first predetermined radial distance is shown as "A" in Figure 3. This is represented as follows: The spindle 105 and the aperture 125 of the optical bench 120 of the leader 100 The distance between the centers is also equal to the first predetermined radial distance "A". The directional distance is also the distance between the spindle 105 and the location of the reaction well on the reaction plate 103. It may be equal to . In one exemplary embodiment, the first predetermined radial distance "A" is about 9 It is 8 mm. In an exemplary embodiment, the aperture 125 allows light to pass through, but the optical bench It may be a window to prevent dust and / or fluids from entering 120.

[0046] Alternatively, the purpose of TVP300 and OVP800 is to react on a reaction plate. Verify the operation of the temperature control and optical measurement capabilities of the reader 100 at the well location. Therefore, the radial distance "A" in the embodiment of leader 100 is The distance between the center of the spindle 105 and the location of the reaction well reaction plate 103 when it is placed Using the radial distance between the center of the spindle 105, the temperature sensor 115, and the heater 110 The radial distance between the location on the TVP300 where a predetermined temperature is measured and maintained, and the spin Radial distance between the center of the dollar 105 and the location of the TVP temperature sensor 315, spindle 1 Radial distance between the center of 05 and the location of the TVP temperature indicator 320, spindle 1 The radial distance between the center of 05 and the location of the temperature sensor 115, and the center of the spindle 105 and The radial distance between the location of heater 110, the center of TVP300 and temperature sensor 115 The radius between the location where a predetermined temperature is measured and maintained on the TVP300 using heater 110 Directional distance, radial distance between the center of TVP300 and the location of TVP temperature sensor 315, The radial distance between the center of TVP300 and the location of TVP temperature indicator 320, The center of the handle 105 and the optical bench 120 of the reader 100 output light to the OVP800. The OVP8 measures the light passing through the OVP800 using the light source 130 and the photodetector 135. The radial distance between the location on 00, the center of the spindle 105 and the opening 8 of the OVP800 The radial distance between 05, the center of OVP80 and the optical bench 120 of leader 100, The signal is output to the OVP800, and the light source 130 and photodetector 135 are used to pass the signal through the OVP800. The radial distance between the location on the OVP800 where the light is being measured, and the center of the OVP800 and the OVP800. The radial distance between P800 and the opening 805, and / or within the spindle 105. The halfway between the heart and the location of the light source 130 and / or photodetector 135 of the optical bench 120. It may be equivalent to the radial distance.

[0047] The TVP300 has a temperature verification circuit 301, which is connected to the TVP controller 305. Even if it has a battery 310, a temperature sensor 315, and a temperature indicator 320 Good. Also, the TVP300 is for balancing the Switch 325 and the TVP300. The counterweight 330, the main body 335, and the temperature sensor 315 inside the main body 335 It may also have a temperature sensor channel 316. The main body 335 is the temperature sensor of the reader 100. 115 measures the temperature of the reaction disk and TVP300 with the same precision, It may be constructed of a material having the same emissivity as the disk. The body 335 is the body of the reaction disk. It may be constructed from the same material as the main body 335, but is not limited to polystyrene. , cyclic olefin copolymers, and / or glycol-modified polyethylene terephthalates The body 335 of some embodiments may be constructed from one or more of the following: Furthermore, carbon may be added to blacken the polystyrene in order to assist with the optical absorption method. Furthermore, one or more components of the temperature verification circuit 301 are located below the upper surface 336 of the main body 335. The battery 310, temperature indicator 320, and temperature sensor 31 may be located in the same position. It may have a cover such as 5. Also, the main body 335 has an upper surface 336 on the main body 335. It may have a bottom surface 337 located on the opposite side.

[0048] The controller 305 has memory 307 and processor 306. The battery 310 is , the controller 305 of the temperature verification circuit 301 of the TVP300, temperature sensor 315, and The switch 325 supplies power to the temperature indicator 320. The switch 325 connects the battery 310 to the temperature indicator. Controlling (starting and stopping) the flow of current between other components of the circuit 301. The temperature verification circuit 301 is turned on and off by means of the above. The temperature sensor 315 detects the temperature It measures and provides the measured value to the controller 305. The temperature sensor 315 is a thermistor. It may also be an electronic temperature sensor such as a thermocouple and / or resistance temperature detector. The radial distance between the center of the VP300 and the temperature sensor 315 is also the distance between the spindle 105 and the leader. The first predetermined distance is the same as the distance between the center of the aperture 125 of the optical bench 120 and 100. It may be equal to the radial distance "A". Therefore, in the exemplary embodiment, TVP30 The temperature sensor 315 of the 0 is connected to the main unit 335 of the reader 100, and the temperature sensor 115 of the TVP300 is connected to the main unit 335 The same precise measurement of the temperature from the center of the TVP300 (and spindle 105) The temperature of the main body 335 of the TVP300 is measured at a radial position. This is shown in Figure 2C. Here, the field of view 117 of the reader's temperature sensor 115 is the same as that of the plate temperature sensor 3 It includes 15 paths. As you can see, the top view of the reader's upper temperature sensor 115a. Field 117a includes the path of the plate temperature sensor 315. Furthermore, the lower temperature sensor of the leader The lower field of view 117b of the 115b includes the path of movement of the plate temperature sensor 315.

[0049] The optical bench 120 shows the reaction occurring in the reaction well of the reaction disk (reaction plate). It has a light source 130 and a photodetector 135 for measuring the optical response of the light source. 35 is a power circuit for supplying power to the photodetector 135 and the output of the photodetector 135 A printed circuit board may further include a signal processing circuit for digitalization, This allows the photodetector 135 to provide a digitized output. 0 includes a printed circuit board having a power circuit for supplying power to the light source 130. This is possible. The controller 305 uses the temperature indicator 320 to control the temperature sensor 31 The temperature value measured by 5 is optically represented. In an exemplary embodiment, the temperature indicator Cata 320 can change its state (on / off) to indicate "1" or "0" less Each may include one visual element 321. In an exemplary embodiment, the visual element 321 is Even if it is an LED light as shown in Figure 2A, or an LCD as shown in Figure 2B Good. In other embodiments, at least one visual element 321 of the temperature indicator 320 is , may include at least one LED light and / or LCD. Temperature indicator The 320 synchronizes the orientation of the TVP300 with the timing of the measurement by the photodetector 135. To do so, it may be registered with the leader 100. This will enable each of the temperature indicators 320 The reader 100 accurately measures when the visual element 321 passes under the photodetector 135. It is possible.

[0050] In an exemplary embodiment, the temperature indicator 320 is a single LED light or LED Even if it includes at least one LED light to optically represent a value, such as an array of lights Good. In an exemplary embodiment, the array of LED lights is connected to the photodetector 135 of the reader 100. A blinking light represents the temperature measurement of the temperature sensor 315 in binary, readable by the light. It may be an array of two LED lights. In some embodiments, the temperature measurement bit The value is less than or equal to the number of LED lights available to represent the temperature of the temperature indicator 320. At one point, the temperature measurement was taken by the TVP300 during one rotation of the TVP300. The temperature of the temperature measuring sensor 315 may be transmitted to the photodetector 135. In other embodiments, the temperature of the temperature measuring sensor 315 may be transmitted to the photodetector 135. The measured value is greater than a single bit, and the temperature indicator 320 is used to represent the temperature. When there is one possible LED light, the temperature measurement is 1 per rotation of the TVP300. The TVP300 may transmit to the photodetector 135 of the reader 100 at the speed of bits. .

[0051] In some exemplary embodiments, the temperature measurement value of the temperature sensor 315 is 12 bits. The temperature indicator 320 has 12 LED lights available to indicate the temperature. If present, the temperature measurement is taken by the TVP300 reader 10 during one rotation of the TVP300. It may be transmitted to the photodetector 135.

[0052] In another exemplary embodiment, the temperature measurement value of the temperature sensor 315 is 12 bits, When the degree indicator 320 has one LED light available to indicate temperature, The temperature measurement was taken by the TVP300 after 12 rotations using the light detection of the reader 100. It may also be transmitted to the device 135, and one bit is transmitted for each rotation of the TVP300. In terms of form, the rotation speed of the TVP300 is indicated by the next bit ("ON") after each rotation. The timing of the LED may be adjusted to show "OFF".

[0053] In other exemplary embodiments, it is available to represent the temperature measurement of the temperature sensor 315. The temperature indicator 320, which has multiple LED lights, shows the multiple rotations of the TVP300. This allows the temperature measurement to be transmitted to the photodetector 135 of the reader 100. For example, 1 A 2-bit temperature measurement can be represented by 2, 3, 4, or 6 LEDs. In this case, the 12-bit binary number is then rotated 6, 4, 3, or 2 times in the TVP300. The temperature will be transmitted from the temperature indicator 320 to the photodetector 135. The dicator 320 is a binary temperature that is not divisible by the number of LEDs on the temperature indicator 320. Sometimes it even transmits measurement values; for example, a 13-bit temperature measurement is sent three times by the TVP300. The rotation can be represented by five LEDs.

[0054] In an exemplary embodiment, the temperature indicator 320 measures the temperature of the temperature sensor 315. A single LCD or an array of 12 LCDs with varying opacity to represent values ​​in binary. It may include at least one LCD that optically displays values, such as the opacity of the LCD. Due to this process, the light generated by the light source 130 passes through the LCD and enters the photodetector 135. It is possible to make it possible to represent "1", or to generate by the light source 130 The amount of light that enters the photodetector 135 is reduced, or the light generated by the light source 130 This prevents light from entering the photodetector 135, and can represent "0". In this embodiment, the bit value of the temperature measurement represents the temperature on the temperature indicator 320. When the number of available LCDs is less than or equal to the number of times the TVP300 rotates, the temperature measurement will be taken during one rotation. The data may be transmitted to the photodetector 135 of the reader 100 by the TVP300. Other implementations In this state, the temperature measurement value of the temperature sensor 315 is greater than 1 bit, and the temperature indicator When the 320 has one LCD available to display temperature, the temperature measurement is TVP The photodetector 1 of the reader 100 is driven by the TVP300 at a speed of 1 bit per rotation of 300. It may be sent to 35.

[0055] In an exemplary embodiment, the temperature indicator 320 measures the temperature of the temperature sensor 315. A single LCD or an array of 12 LCDs with varying opacity to represent values ​​in binary. It may include at least one LCD that optically displays values, such as the opacity of the LCD. Due to this process, the light generated by the light source 130 passes through the LCD and enters the photodetector 135. It is possible to make it possible to represent "1", or generated by the light source 130 To reduce the amount of light entering the photodetector 135, or generated by the light source 130 This prevents light from entering the photodetector 135, allowing it to represent "0". Temperature sensor 315 temperature measurements are 12 bits, and temperature indicator 320 represents the temperature If there are 12 LCDs available, the temperature measurement will be taken while the TVP300 is rotating. TVP300 transmits to the photodetector 135 of the reader 100, thereby TVP3 A temperature value may be transmitted from 00 to the reader 100. The temperature measurement value of the temperature sensor 315 is 1 It is a 2-bit number, and one LCD is available for the temperature indicator 320 to represent the temperature. If present, the temperature measurement will be taken by the TVP300 after 12 rotations. The data is transmitted to the photodetector 135 of the da 100, thereby transmitting the temperature from the TVP300 to the reader 100. A degree value may be transmitted. In this embodiment, the rotation speed of the TVP is the following for each rotation. Bits ("passing light" or "blocking light") Even if the timing of the LCD is adjusted to show "BLOCKING LIGHT") good.

[0056] In other exemplary embodiments, it is available to represent the temperature measurement of the temperature sensor 315. The temperature indicator 320, which has multiple LCD lights, shows the multiple rotations of the TVP300. The temperature measurement may be transmitted to the photodetector 135 of the reader 100 using this method. For example, 12 bits The temperature reading may be displayed by 2, 3, 4, or 6 LCDs, in which case The 12-bit binary number is then used to determine the temperature during the 6, 4, 3, or 2 rotations of the TVP300. The indicator 320 will transmit data to the photodetector 135. Furthermore, the temperature indicator... TA320 is a binary temperature measurement that is not divisible by the number of LCDs in the temperature indicator 320. It may even transmit data; for example, a 13-bit temperature measurement over three rotations of the TVP300. It can be represented by five LCDs.

[0057] In contrast to radio frequencies, light is used to transmit temperature values ​​from the TVP300 to the reader 100. This is because there are areas where radio frequencies are highly restricted or where there is potential radio interference. In areas where this is possible, it will be possible to use the TVP300. Furthermore, this TV The P300 design allows the use of the existing optical bench 120, as well as an RF receiver. This also eliminates the need to integrate the transceiver into the leader 100.

[0058] Looking at the temperature measurement method 600 using TVP300, in 601 the method is: Proceed to step 605 where TVP300 is started. TVP300 is in the "ON" position when switch 325 is in the "ON" position. It may start when moved to a different location. In 605, TVP is set to a first predetermined length. During this time, at least one temperature measurement is obtained using the temperature sensor 315, and the measurement is converted Send to Trolla 305. In an exemplary embodiment, at least one temperature measurement is, The measurement may be acquired using the temperature sensor 315 during a first predetermined length of time, and the measurement value is It may be provided to the Trolla 305. Furthermore, two or more temperature measurements can be obtained. Obtained at a first repeating interval during a first predetermined length of time, and supplied to the controller 305. It may be provided. One or more temperature measurements obtained during a first predetermined length of time. When the temperature measurement is provided to the controller 305 during a first predetermined length of time, It may be averaged by controller 305. In an exemplary embodiment, a first predetermined length The duration may be approximately 5 seconds, and the first repetition interval may be approximately 0.1 seconds. .

[0059] In 610, the value of at least one temperature measurement obtained in 405 is the temperature indicator Using the 320, the controller 305 of the TVP300 controls a second predetermined length of time. It is output (transmitted). In an exemplary embodiment, the length of the second predetermined time is approximately 0.4 seconds. It may exist. This value is the average of temperature measurements obtained during a first predetermined length of time. It may be. Prior to output, the controller 305 converts the value from numerical to binary. Good. In an exemplary embodiment, the numerical value is converted to a 12-bit binary value, and the temperature indicator The output may be generated using 12 LEDs of 320. However, the numerical values ​​are different binary values. The resolution may be converted to a different number of LEDs or LCDs for the temperature indicator 320. It is intended that the output may be used. Temperature indicator 320 and controller The 305 can also output verification information to inform the reader 100 that the measurement is valid. Yes, it is possible. In the embodiment, the verification information is an extra "1" at the beginning and end of the 12-bit number. It may have a total of 14 bits, with only the middle 12 bits representing the temperature measurement value. It shows that the temperature is output as a 12-bit number, with an additional 2 bits for verification. In some embodiments that output the temperature indicator 320, the temperature is measured during one rotation of the TVP. It has 12 LEDs or an LCD so that it can transmit fixed values ​​and verification information. It is also possible to transmit measurement and verification information during the 14 rotations of the TVP300. As shown, a single LED or LCD may be used. Then, the method returns to 601. Then, with TVP300 still running, the process proceeds to 605. In an exemplary embodiment, switch 32 As long as position 5 is in the "ON" position, the TVP300 remains activated.

[0060] Block of component 106 of the leader 100 interacting with the leader controller 145 The diagram is shown in Figure 1B. As you can see, the controller 145 is connected to the memory 119 and and a CPU (processor) 118 that executes the program stored in memory 119. The controller consists of a user interface 113, a spindle 105, and a plate 103. It interfaces with an optical bench 120 and a reaction cavity environment 155. In that embodiment, the user interface 113 also interacts with the controller 145. It may be used. In one embodiment, the housing 101 has a reaction cavity 140 of the housing 101 and heater 110 and / or temperature sensor 11 for regulating the temperature inside plate 103 Plate 1 may have at least one reaction cavity environment augmenter, such as plate 5. 03 provides position information to the controller 145. The optical bench 120 has a photodetector 13 Information regarding the intensity of light received by 5 is provided to the controller 145. The reaction cavity environment augmenter 155, such as SA115, is used on reaction wells on reaction plates. The temperature measurement of plate 103 at the position is provided to the controller 145, and the controller -RA 145 uses this information to determine whether the heater 110 should be activated within the enclosure 101. The user interface 113 allows the user to test the controller 145. This enables the provision of a meter, and the controller 145 displays the test results to the user. This may make it possible to do so. The spindle 105, which has a motor, transmits position information to the controller 1 16 can be provided, and the controller 145 can provide the user interface 113 It is also possible to adjust the rotation of plate 103 via this.

[0061] Let's look at the method for verifying the temperature measurement performance of the reader 100 (temperature verification mode). In 701, start the TVP300 by moving the switch to the "ON" position. The reader 100 is placed, and the TVP300 is connected to the temperature sensor 115 according to the 600 method. It measures and outputs the temperature. As you can see, the TVP300 is the reader. When rotated by a 100 spindle 105, the temperature of the TVP300 body 335 is measured. In 705, the leader 100, via the user interface 113, controls the temperature. Enter verification mode. At 710, the leader 100 uses the spindle 105 to perform TVP Rotate the 300 and maintain rotation during temperature verification mode. The rotation of the TVP300 is Under the same conditions used when the reaction plate is present in the Da 100, the temperature sensor of the leader This makes it possible to test the SA115 and heater110. In 715, heater110 The reader's temperature sensor 115 is activated by the reader's controller 145, and TVP The main body 335 of unit 300 is heated and maintained at a predetermined temperature.

[0062] In 720, the main body of the TVP maintains a predetermined temperature for at least a first predetermined length of time. When held, the reader 100 uses the reader's temperature sensor 115 to control the main body of the TVP300. The temperature measurement is obtained, and the TVP300 uses the temperature indicator 320 according to method 600. The reader 100 acquires and outputs temperature measurements using the optical bench 120, and TVP3 The temperature measurement of 00 and optionally a verification bit are received. In an exemplary embodiment, the reader 100 obtains temperature measurements of the bottom surface 337 and / or top surface 336 on the main body 335. Alternatively, in an exemplary embodiment, the temperature measurement is in 12-bit binary format, TVP300 or It may also be output as follows. Optionally, temperature measurements from TVP300 can be 1 / 2. It is converted to a base-0 number, and the temperature verification circuit 301 of the TVP300 is determined using the following formula, etc. It may be adjusted to fit the measurement range:

number

[0063] In 725, the leader 100 uses the TVP temperature measurement value obtained from TVP300 as The temperature measurement values, also known as the reader temperature measurement values, were obtained from the reader's temperature sensor 115. The difference with the temperature measurement, also known as TVP temperature measurement, is calculated and compared. If the difference between the value and the reader temperature measurement is less than or equal to a predetermined temperature difference threshold, the reader's temperature sensor 1 The 15 calibrations have been verified and the user has been notified via the user interface 113. i. If the difference between the TVP temperature measurement and the reader temperature measurement is greater than a predetermined temperature difference threshold, The calibration of the temperature sensor 115 was not verified, and the temperature was not communicated to the user through the user interface 113. A calibration error in the temperature sensor is notified. In one embodiment, a predetermined temperature difference threshold is approximately 1°C. It may be present. In another embodiment, the predetermined temperature difference threshold may be approximately 0.5°C. In another embodiment, the predetermined temperature difference threshold may be approximately 0.1°C.

[0064] In some embodiments, steps 715-725 are performed at an additional predetermined temperature point. This may be repeated to obtain the temperature difference between TVP300 and reader100. For example, TV The temperature difference between P300 and Leader 100 can be evaluated at both 22°C and 37°C. stomach.

[0065] In the optional step 730, the user input is used to return the temperature sensor 115 to calibration. Through the surface 113, etc., the calibration coefficient is appropriate for the output value of the reader's temperature sensor 115. It may be used. If only a single predetermined temperature point is used, the temperature sensor 115 is calibrated. A single-point offset may be used to obtain a calibration coefficient for two predetermined temperatures. If a degree point is adopted, in order to obtain a calibration coefficient for calibrating the temperature sensor 115, a straight line Interpolation may be performed. If three or more predetermined temperature points are taken, the temperature sensor 115 Even if other interpolation methods such as mathematical regression are used to obtain calibration coefficients for calibration, Good. In an exemplary embodiment, the mathematical regression may be a polynomial regression.

[0066] Looking at Figures 1A-2C and 8A-11, the optical verification plate (OVP) 800 is The optical bench 120 of the reader can be used to verify that it is functioning correctly. The OVP800 has multiple openings 805 located along the periphery of the main body 801 of the OVP800. It has the following: The center of each opening 805 is from the center of the main body 801 of the OVP800 to a first predetermined distance. It is located at a radial distance "A", which allows aperture 805 to be positioned on optical bench 1 20 light sources 130 and photodetectors 135 can be arranged in a row, and generated by the photodetectors 135 The light can pass through the aperture 805 and the intensity of the light can be measured by the photodetector 135. This makes it possible to do so. In the embodiment, the multiple openings 805 are filtered openings. It may also be section 806, and some of the filtered apertures have a light-reducing filter 810. (Aperture 811 with light-reducing filter), one or more apertures have wavelength filters (wave Long-pass filter with aperture 850), short-pass filter 815 (with short-pass filter) Aperture 816), long-pass filter 820 (aperture 821 with long-pass filter) , bandpass filter (aperture with bandpass filter), and / or stopband It may include at least one of the following: a stopband filter (aperture with stopband filter). .

[0067] In an exemplary embodiment, the filtered opening 806 of the OVP800 is at least It includes one wavelength-filtered aperture 850 and seven attenuation-filtered apertures 811. This is also good. In an exemplary embodiment, each of the seven apertures with light-reducing filters of the OVP800 These may have different optical density (darkness) values. In an exemplary embodiment, the neutral density filter The optical density value may be about 0.01-3. In another exemplary embodiment, a light-reducing filter The optical density value may be about 0.01-2. In further exemplary embodiments, the attenuation function The optical density value of the filter may be about 0.1–1.2. In further exemplary embodiments... The optical density value of the neutral density filter may be approximately 0.1-1.15. When the mouth portion 806 rotates counterclockwise around the OVP800, it moves only by a second predetermined distance "B" It's okay to keep them apart.

[0068] In an exemplary embodiment, at least one wavelength-filtered aperture 850 is one A single aperture 821 with a long-pass filter and an aperture 815 with a short-pass filter are provided. It may include. In an exemplary embodiment, the short-pass filter 815 is approximately 400n It may have a cutoff of m, and the long-pass filter 820 has a cutoff of approximately 410 nm. It may have. In an exemplary embodiment, the light source 130 of the optical bench is approximately 405+ / - Light with a wavelength of 5 nm may be output. Using the photodetector 135, a short pathfinder may be used. At least one wavelength filter such as the Luta 815 and / or Long Pass Filter 820 By examining the output of the light source 130 passing through the aperture 850, the leader 100 determines that Check whether the light spectrum emitted by light source 130 is within or outside the specifications. It is possible.

[0069] Figure 10 shows the spectral transmittance curves of the short-pass filter 815 and the long-pass filter 820. As shown, the short-pass filter 815 and the long-pass filter 820 It has a very narrow transition band (the band between the stopband and the passband). However, In some embodiments of the OVP800, a single stop with a sufficiently narrow transition bandwidth Short-pass filter 815 and long-pass filter using a band or bandpass filter It is thought that both pass filters 820 can be replaced.

[0070] In this embodiment, one or more filters 807 are located on the upper surface 835 of the OVP 800. It may be mounted on the OVP800 so as to form a zero (0) degree angle. Alternatively, one or more filters 807 are placed on the upper surface 835 of the OVP 800. It may be flat. Thereafter, one or more filters 807 will be able to block light from the light source 130. The optical bench 120's photodetector 135 can be perpendicular (90°) to the direction of light traveling to it.

[0071] In another embodiment, the filter 807 is at a first predetermined angle with respect to the upper surface 835 of the OVP 800 One or more filters 807 may be attached so as to form an angle “F” in degrees. In an exemplary embodiment, the first predetermined angle “F” may be from about 0 degrees to about 30 degrees. In another exemplary embodiment, the first predetermined angle “F” may be about 30 degrees.

[0072] In another embodiment, one or more filters 807 may be attached below the upper surface 835 of the OVP 800 on the filter bed 808. One or more filters may be attached to the OVP 800 so as to form an angle of zero (0) degrees with respect to the filter bed 808 of the OVP 800. Thereby, one or more filters 807 may be perpendicular (9 0°) to the direction of light traveling from the light source 130 to the photodetector 135 of the optical bench 120. In other embodiments, one or more filters 807 may be attached so as to form a first predetermined angle “F” with respect to the filter bed 808 of the OVP 800. In an exemplary embodiment, the first predetermined angle “F” may be from about 0 degrees to about 45 degrees. In another exemplary embodiment, the first predetermined angle “F” may be about 30 degrees.

[0073] The OVP 800 may also have an incident aperture 825 and a registration aperture 830, both of which are not filter - equipped. All apertures 805 may have the same radius, except for the registration aperture 830 which may have a smaller radius. In an exemplary embodiment, the incident aperture 825 may be located between the first filter - equipped aperture 806a and the registration aperture 830. Further, in an exemplary embodiment, the registration aperture 830 may be the incident aperture 8

[0074] The OVP 800 may also have an incident aperture 825 and a registration aperture 830, neither of which is equipped with a filter. All apertures 805 may have the same radius, except for the registration aperture 830 which may have a smaller radius. In an exemplary embodiment, the incident aperture 825 may be located between the first filter - equipped aperture 806a and the registration aperture 830. Further, in an exemplary embodiment, the registration aperture 830 may be the incident aperture 8 25.​​​​​ It may be located between 25 and the last filtered opening 806b. The distance between the first filtered opening 806a and the incident opening 825 may be a second predetermined distance "C". The distance between the incident opening 825 and the registration opening 830 may also be a third predetermined distance "D". The distance between the registration opening 830 and the last filtered opening 806b may be a fourth predetermined distance "E". In an exemplary embodiment, the second predetermined distance may be about 16 mm, the third predetermined distance may be about 4 mm, and the fourth predetermined distance may be about 74 m. In some embodiments, it is contemplated that the reader 100 may use the registration pattern 845 to determine the rotational angle of the OVP 800. In an exemplary embodiment, the registration pattern 845 may include the registration opening 830. In another exemplary embodiment, the registration pattern 845 may include both the registration opening 830 and the incident opening 825.

[0075] In an exemplary embodiment, the reader 100 recognizes the registration pattern 845 that rotates across the optical bench 120, and then may be programmed to know that a predetermined number of filtered openings 806 are the next openings 805 across the optical bench. The filter values and order of the filtered openings 806 may be programmed into the reader 100, whereby the processor 118 of the reader 100 can analyze the performance of the optical bench 120 and output the results to the user via the user interface 113.

[0076] In some exemplary embodiments, the OVP 800 is such that the OVP 800 is within the reader 100. It may have a balancer 840 to balance the OVP800 while it is rotating. The Balancer 840 is not limited to, but includes counterweights, weight reduction recesses and / or it may include one or more of the weight-reducing holes.

[0077] Figures 11A-B show the optical performance of the optical bench 120 of the reader 100 using the OVP800. An exemplary method 1100 for measuring and verifying (absorbance, or optical density, and error) is shown. (Measure the difference). In block 1101, OVP800 is placed on leader 100, Leader 100 rotates OVP800. In block 1105, Leader 100, The registration pattern 845 on the OVP is identified using the optical bench 120. The leader 100, at the exact moment the aperture 805 passes through the optical bench 12 This makes it possible to time the sampling using 0. In block 1110 The reader uses the light source 130 to pass light through the incident aperture 825 and receives it with the photodetector 135. The intensity of the incident light is measured. This measurement is taken from the incident light (I i ) stored in memory 119 It can be done.

[0078] In block 1115, the leader uses the light source 130 to generate at least one dimming filter Light is passed through the diaphragm-equipped aperture 811, and the intensity of the light received by the photodetector 135 is measured. This intensity measurement value (I fN ) is stored in memory 119, and N is each open with a dimming filter. It increases by 1 for each aperture 811. The operation of block 1115 is as follows: each aperture 81 with a light-reducing filter This process may be repeated until a value of 1 is measured and stored in memory 119.

[0079] In block 1120, for at least one dimming aperture 811, formula T N =( I fN / I i ) is used by the processor 118 to determine the transmittance (T N ) is calculated, memory 1 It is stored in 19. The operation of block 1120 is the transmission of light through each aperture 811 with a light-reducing filter. The process is repeated until the value is calculated by the processor 118 and stored in memory 119. That's good too.

[0080] In block 1125, the measured absorbance (A mN ) is Equation A mN = -log 10 (T N Using ), process for at least one aperture 811 with a light-reducing filter It is calculated by 118 and stored in memory 119, valid T N The value is between 0 and 1. The operation of the 1125 is determined by the measured absorbance of each aperture 811 with a light-reducing filter. The process is repeated until the value is calculated by the processor 118 and stored in memory 119. That's good too.

[0081] In block 1130, for at least one aperture 811 with a light-reducing filter Measured absorbance (A mN ) has a predetermined absorbance value (A pN ) was compared to the 118 processor Use the expression AError N =( A mN -A pN ) / A pN The percentage error is calculated using The absorbance percentage error is then stored in memory 119. In an exemplary embodiment, The absorbance value is the actual guaranteed absorbance of the light-reducing filter at aperture 811 with the light-reducing filter. It may be. The operation of block 1130 is for each aperture 811 with a dimming filter The percent error value of the absorbance is calculated by the processor 118 and stored in the memory 119 and may be repeated until.

[0082] In block 1135, the measured absorbance value of at least one aperture 811 with a dimming filter The percent error (AError N ) is compared by the processor 118 with a predetermined dimming absorbance error threshold (AError p ). If the processor 118 exceeds the predetermined dimming error threshold, it can notify the user, thereby indicating that the optical bench 120 of the reader 100 is out of specification. The processor 118 may notify the user via the user interface 1 13. In an exemplary embodiment, the predetermined dimming error threshold may be about 5%. The operation of block 1135 is such that the comparison for each aperture 81 1 with a dimming filter is completed using the processor 118, the result is stored in the memory 119, and the result is output to the user via the user interface 113 and may be repeated until.

[0083] In block 1140, the reader uses the light source 130 to pass light through at least one aperture 850 with a wavelength filter and measures the intensity value of the light received by the photodetector 135. The value of this measurement is stored as the intensity wavelength measurement value I , and N increases by 1 for each aperture 850 with a wavelength filter. The operation of block 1115 may be repeated until the value is measured for each aperture 850 with a wavelength filter WN and stored in the memory 119. and may be repeated until the value is measured for each aperture 850 with a wavelength filter and stored in the memory 119.

[0084] ​In block 1145, the wavelength error (WError) of the optical bench is measured. N ) is a processor According to 118, at least one of the incident light intensities passing through the wavelength-filtered aperture 850 Measurement value (I WN ) and the measured value of the incident light intensity passing through the incident light aperture 825 (I i The ratio of ) WError expression N =I WN / I i It is calculated by evaluating using the optical ven. This wavelength error is stored in memory 119. The operation of block 1145 is to determine each wavelength The wavelength error value of the ruta aperture 850 is calculated by the processor 118 and stored in memory 119. This may be repeated until it is stored in memory.

[0085] In block 1150, the processor 118 controls each wavelength-filtered aperture 850 The wavelength error is compared with a predetermined wavelength error threshold, and if it exceeds the predetermined wavelength threshold, the user is notified. This indicates that the optical bench 120 of the reader 100 is outside of specifications. The difference threshold may be a predetermined sum of wavelength errors threshold, or a predetermined individual wavelength error threshold. The processor may also notify the user via the user interface 113. i. In exemplary embodiments, the sum of wavelength errors shall not exceed approximately 5% (i.e., not exceed 5%). Alternatively, to put it another way, the given total wavelength error threshold may be approximately 5%. In terms of form, any individual wavelength error threshold may be approximately 2.5%, or alternatively, The predetermined individual wavelength error threshold may be about 2.5%. In another embodiment, The wavelength error threshold is for wavelengths greater than approximately 410 nm and / or waves smaller than approximately 400 nm. It may also correspond to the output of a light source 130 having a length. The operation of block 1150 is by the processor The comparison for each wavelength-filtered aperture 850 is completed by 118, and the results are stored in memory. It is stored in 119 and repeated until it is output to the user via the user interface 113. It may be repeated.

[0086] Although the present invention has been described in relation to the specific embodiments described above, many alternatives and combinations exist. It is obvious that the combination, modification, and deformation will be obvious to those skilled in the art. Therefore, the above The preferred embodiments of the present invention shown are for illustrative purposes only and do not represent a limited or restrictive set of embodiments. No. Various modifications can be made without departing from the spirit and scope of the present invention. The above embodiments can be combined with other embodiments by studying the above description. This is clear to the subject and is intended to be encompassed therein. Therefore, the scope of the present invention The scope is defined by the attached claims and is patented literally or by equivalent. All devices, processes, and methods that fall within the scope of the request are included therein. That is the intention.

Claims

1. An optical verification plate (OVP) for a bacterial endotoxin reader; It includes a body with multiple openings located along its periphery; The center of each opening is located at a first predetermined radial distance from the center of the main body, thereby allowing the opening to be aligned with the optical bench of the reader, so that light generated by the light source of the reader passes through the opening and the intensity of the light can be measured by the photodetector of the reader; The opening includes a plurality of filtered openings and a plurality of unfiltered openings; The plurality of filter-equipped openings are spaced apart by a second predetermined distance when the OVP is rotated counterclockwise once. The plurality of filterless openings include an entrance opening and a registration opening, and the entrance opening and the registration opening constitute a registration pattern. Optical verification plate (OVP).

2. The OVP according to claim 1, wherein the filtered aperture includes one or more light-reducing filter apertures and one or more wavelength-filtered apertures.

3. The OVP according to claim 2, wherein the one or more wavelength-filtered apertures include one or more short-pass filtered apertures, one or more long-pass filtered apertures, one or more band-pass filtered apertures, and / or one or more stop-band filtered apertures.

4. The OVP according to claim 1, wherein the filtered aperture includes at least one wavelength-filtered aperture and a second light-reducing aperture.

5. The OVP according to claim 4, wherein the at least one wavelength-filtered aperture includes one long-pass filtered aperture and one short-pass filtered aperture.

6. The OVP according to claim 1, wherein one or more filters are attached to the OVP such that they form a first predetermined angle with respect to the upper surface of the OVP body, and / or, one or more filters are attached to the OVP such that they form a first predetermined angle with respect to the filter bed of the OVP body.

7. The OVP according to claim 6, wherein the first predetermined angle is about 0 degrees, about 30 degrees, or about 0 degrees to about 45 degrees.

8. The OVP according to claim 1, wherein the entrance opening is located between the first filtered opening and the registered opening; and the registered opening is located between the entrance opening and the last filtered opening.

9. A method for verifying the optical performance of an optical bench for a bacterial endotoxin reader, To provide a reader and optical verification plate (OVP); The OVP is placed on the spindle of the leader and the OVP is rotated; The reader uses the optical bench to identify the registered pattern on the OVP; The photodetector of the reader is used to measure the intensity of light passing through the incident aperture of the OVP, wherein the light is generated by the light source of the reader, and the measured value is the incident light (I ｉ ) is stored in the memory of the reader as; The photodetector of the reader is used to measure the intensity of light passing through at least one aperture with a light-reducing filter, and this is repeated for each of the apertures with a light-reducing filter, wherein the light is generated by the light source of the reader, and the measured value is an intensity neutral value (I ｆＮ ) is stored in the memory of the reader, and N increases by 1 for each aperture with a light-reducing filter; Formula T Ｎ = (I ｆＮ / I ｉ Using the above, the transmittance (T) for each of the apertures with the light-reducing filter is calculated. Ｎ ) to be calculated and stored in the memory of the reader; Formula A ｍＮ = -log １０ (T Ｎ ) is used to calculate the measured absorbance (A ｍＮ ) for each of the apertures with the light attenuation filter, store it in the memory of the reader, and store it in the memory; A for each of the apertures with the light-reducing filters ｍＮ and a predetermined absorbance value (A ｐＮ ) and the formula AERROR Ｎ = (A ｍＮ -A ｐＮ ) / A ｐＮ The percentage error is calculated using the method described above, and the absorbance percentage errors calculated for each of the apertures with the light-reducing filters are stored in memory for comparison; AError Ｎ This is compared with a predetermined attenuation absorbance error threshold, and AError Ｎ If the value is greater than the predetermined attenuation absorbance error threshold, it indicates that the optical bench is out of specification; The photodetector of the reader is used to measure the intensity of light passing through at least one wavelength-filtered aperture, and this is repeated for each of the wavelength-filtered apertures, wherein the light is generated by the light source of the reader, and the measured value is the intensity wavelength measurement value (I ＷＮ ) is stored in memory as such, and N increases by 1 for each wavelength-filtered aperture; Formula Werror Ｎ = I ＷＮ / I ｉ Using the above, the I for each of the wavelength-filtered apertures ＷＮ and the aforementioned I ｉ By evaluating the ratio with the optical bench wavelength error (Werror Ｎ ) calculates and stores in memory; For each of the wavelength-filtered apertures, the Werr Ｎ The Werr is compared with a predetermined wavelength error threshold. Ｎ A method comprising indicating that the optical bench is out of specification if it is greater than the predetermined error wavelength threshold.

10. The method according to claim 9, wherein the filtered aperture includes one or more apertures with light-reducing filters and one or more apertures with wavelength filters.

11. The method according to claim 10, wherein the one or more wavelength-filtered apertures include one or more short-pass filtered apertures, one or more long-pass filtered apertures, one or more band-pass filtered apertures, and / or one or more stop-band filtered apertures.

12. The method according to claim 9, wherein the filtered aperture includes at least one wavelength-filtered aperture and a second light-reducing filtered aperture.

13. The method according to claim 12, wherein the at least one wavelength-filtered aperture includes one long-pass filtered aperture and one short-pass filtered aperture.

14. The method according to claim 9, wherein one or more filters are mounted on the OVP such that they form a first predetermined angle with respect to the upper surface of the OVP body, and / or one or more filters are mounted on the OVP such that they form a first predetermined angle with respect to the filter bed of the OVP body.

15. The method according to claim 14, wherein the first predetermined angle is about 0 degrees, about 30 degrees, or about 0 degrees to about 45 degrees.

16. The leader of bacterial endotoxins, Control unit and; It includes a memory that stores executable code that performs an action when executed by the control unit, The aforementioned Action is, Using the spindle of the leader, the optical verification plate (OVP) placed on the spindle of the leader is rotated; Identifying the registered pattern on the OVP using the optical bench of the reader; The photodetector of the reader is used to measure the intensity of light passing through the incident aperture of the OVP, wherein the light is generated by the light source of the reader, and the measured value is stored in the memory of the reader as incident light (Ii); The photodetector of the reader is used to measure the intensity of light passing through at least one aperture with a light-reducing filter, and this is repeated for each of the apertures with a light-reducing filter, wherein the light is generated by the light source of the reader, and the measured value is an intensity neutral value (I ｆＮ ) is stored in the memory of the reader, and N increases by 1 for each aperture with a light-reducing filter; Formula T Ｎ = (I ｆＮ / I ｉ Using the above, the transmittance (T) for each of the apertures with the light-reducing filter is calculated. Ｎ ) to be calculated and stored in the memory of the reader; Formula A ｍＮ = -log １０ (T Ｎ Using the above, the measured absorbance (A) for each of the apertures with the light-reducing filter is calculated. ｍＮ ) calculates and stores in the memory of the reader, and stores in memory; A for each of the apertures with the light-reducing filters ｍＮ and a predetermined absorbance value (A ｐＮ ) and the formula AERROR Ｎ = (A ｍＮ -A ｐＮ ) / A ｐＮ The percentage error is calculated using the method described above, and the absorbance percentage errors calculated for each of the apertures with the light-reducing filters are stored in memory for comparison; AError Ｎ This is compared with a predetermined attenuation absorbance error threshold, and AError Ｎ If the value is greater than the predetermined attenuation absorbance error threshold, it indicates that the optical bench is out of specification; The photodetector of the reader is used to measure the intensity of light passing through at least one wavelength-filtered aperture, and this is repeated for each of the wavelength-filtered apertures, wherein the light is generated by the light source of the reader, and the measured value is the intensity wavelength measurement value (I ＷＮ ) is stored in memory as such, and N increases by 1 for each wavelength-filtered aperture; Formula Werror Ｎ = I ＷＮ / I ｉ Using the above, the I for each of the wavelength-filtered apertures ＷＮ and the aforementioned I ｉ By evaluating the ratio with the optical bench, the wavelength error (Werror Ｎ ) calculates and stores in memory; For each of the wavelength-filtered apertures, the Werr Ｎ The Werr is compared with a predetermined wavelength error threshold. Ｎ A bacterial endotoxin reader, which includes indicating that the optical bench is out of specification if the error wavelength is greater than the predetermined error wavelength threshold.

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