Bacterial endotoxin reader verification plate and method of use

Abstract

The invention relates to a bacterial endotoxin reader verification plate and a method of use. Verification plates, i.e., a temperature verification plate (TVP) and an optical verification plate (OVP), for a bacterial endotoxin reader are provided. The TVP has a body configured to be placed on and rotated by a spindle of the reader. The body has a temperature verification circuit having a temperature sensor and a temperature indicator. The temperature sensor is configured to measure a temperature of the body rotated by the main shaft of the reader. The temperature indicator optically represents a value of the temperature measured by the temperature sensor. The temperature indicator is readable through an optical table of the reader. The OVP has a body with a plurality of apertures positioned along a perimeter, the apertures being aligned with an optical stage of the reader. Light generated by a light source of the reader may pass through the aperture, and the intensity is measured by a photodetector of the reader.

Description

[0001] This application is a divisional application of an application filed on November 18, 2020, with application number 202080090726.2 and invention name “Bacterial Endotoxin Reader Validation Plate and Method of Use”. CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of priority to U.S. Provisional Patent Application Serial No. 62 / 936,883, filed on November 18, 2019, which is incorporated herein by reference in its entirety. Field of the Invention

[0003] The present application is directed to bacterial endotoxin reader validation. More specifically, the present application is directed to temperature and / or optical validation of bacterial endotoxin readers. Background of the Invention

[0004] Bacterial endotoxin readers require periodic validation of their optical reading and temperature measurement performance. Brief Summary of the Invention

[0005] In one aspect of the present invention, a temperature verification plate (TVP) for a bacterial endotoxin reader comprises: a body configured to be placed on and rotated by a spindle of the reader; the body having a temperature verification circuit comprising a temperature sensor and a temperature indicator; the temperature sensor configured to measure the temperature of the body while being rotated by the spindle of the reader; and the temperature indicator configured to optically represent a value of the temperature measured by the temperature sensor, wherein the temperature indicator is readable by an optical bench of the reader.

[0006] In another aspect of the present invention, the temperature sensor can be an electronic temperature sensor, a thermistor, a thermocouple, and / or a resistance temperature detector. The temperature indicator can be at least one light-emitting diode (LED) and / or at least one liquid crystal display (LCD). The temperature indicator can represent the temperature value as a binary number.

[0007] In another aspect of the present invention, a binary number determines a resolution of a temperature measured by the temperature sensor, wherein the binary number has two or more validation bits.The binary number may be a 12-bit number.

[0008] In another aspect of the present invention, the temperature indicator can have various LED or LCD configurations, such as a single LED, 12 LEDs, 14 LEDs, a single LCD, 12 LCDs, or 14 LCDs.

[0009] In another aspect of the present invention, the temperature verification circuit further includes a battery and a switch. The battery provides power to the temperature verification circuit. When the switch is in the "on" position, the switch allows current to flow from the battery, and when the switch is in the "off" position, the switch prevents current from flowing from the battery.

[0010] In another aspect of the present invention, the temperature sensor obtains temperature measurements at first recurring intervals during a first predetermined length of time.The temperature indicator outputs an average of the temperature measurements.

[0011] The first predetermined time length may be approximately 5 seconds, and the first recurring interval may be approximately 0.1 seconds.

[0012] In yet another aspect of the present invention, a method for verifying the temperature performance of a bacterial endotoxin reader includes providing a reader and a temperature verification plate (TVP); placing the TVP on a spindle of the reader, rotating the TVP upward using the spindle, and activating a heater of the reader to maintain a body temperature of the TVP at a predetermined temperature; obtaining a temperature measurement of the body of the TVP from a temperature indicator of the TVP using an optical stage of the reader; obtaining a temperature measurement of the body of the TVP using a temperature measurement sensor of the reader; calculating and comparing a difference between the temperature measurement obtained from the temperature indicator of the TVP and a temperature measurement obtained from the temperature measurement sensor of the reader; and indicating a reader temperature measurement sensor calibration error when the difference is greater than a predetermined temperature difference threshold.

[0013] In another aspect of the present invention, the method further includes calculating a calibration factor based on a difference between a temperature measurement obtained from the TVP and a temperature measurement obtained from the reader temperature sensor, and applying the calibration factor to the temperature measurement obtained from the reader temperature sensor. The predetermined temperature difference threshold may be approximately 1°C, approximately 0.5°C, or approximately 0.1°C. The difference may be calculated at two or more predetermined temperatures. The predetermined temperatures may be 22°C and / or 37°C.

[0014] In another aspect of the present invention, the method further includes calculating a calibration factor based on a difference between temperature measurements obtained from the TVP at two or more predetermined temperatures and temperature measurements obtained from the reader temperature sensor at two or more predetermined temperatures, and applying the calibration factor to the temperature measurements obtained from the reader temperature measurement sensor. The calibration factor may be determined using linear interpolation and / or mathematical regression.

[0015] In yet another aspect of the present invention, an optical verification plate (OVP) for a bacterial endotoxin reader may include: a body having a plurality of apertures positioned along a periphery of the body; the center of each aperture being positioned at a first predetermined radial distance away from the center of the body, thereby allowing the aperture to be aligned with an optical bench of the reader so that light generated by a light source of the reader can pass through the aperture and the intensity of the light can be measured by a photodetector of the reader; the apertures being comprised of filtered apertures and unfiltered apertures; and the filtered apertures being spaced apart by a second predetermined distance when proceeding counterclockwise around the OVP.

[0016] In another aspect of the present invention, the filter aperture may be composed of one or more neutral density filter apertures and one or more wavelength filter apertures. The one or more wavelength filter apertures may be composed of one or more short-pass filter apertures, one or more long-pass filter apertures, one or more band-pass filter apertures and / or one or more stop-band filter apertures. The filter aperture may be composed of at least one wavelength filter aperture and a second neutral density filter aperture. At least one wavelength filter aperture may be composed of a long-pass filter aperture and a short-pass filter aperture. One or more filters may be mounted on the OVP to form a first predetermined angle relative to the top surface of the OVP body, and / or one or more filters may be mounted on the OVP to form a first predetermined angle relative to the filter bed of the OVP body. The first predetermined angle may be approximately zero degrees, approximately 30 degrees, or between approximately zero and approximately 45 degrees.

[0017] In another aspect, the OVP may include an entrance aperture and / or a registration aperture. The entrance aperture may be positioned between the first filtering aperture and the registration aperture. The registration aperture may be positioned between the entrance aperture and the last filtering aperture.

[0018] In yet another aspect of the present invention, a method for verifying the optical performance of an optical stage of a bacterial endotoxin reader comprises: providing a reader and an optical verification plate (OVP); placing the OVP on a spindle of the reader and rotating the OVP upward; using the optical stage of the reader to identify a registration pattern on the OVP; using a photodetector of the reader to measure the intensity of light passing through an entrance aperture of the OVP, wherein the light is generated by a light source of the reader, and the measured value is used as incident light (I i ) is stored in a memory of the reader; the intensity of light passing through at least one neutral density filter aperture is measured using a photodetector of the reader, wherein the light is generated by a light source of the reader, and the measured value is used as an intensity neutral measurement value (I fN ) is stored in the reader's memory, where N is incremented once for each neutral density filter aperture, and the measurement is repeated for each neutral density filter aperture; using the formula T N = (I fN / I i ) Calculate the transmittance (T) of each neutral density filter holeN ) and stores it in the reader's memory; using formula A mN = -log 10 (T N ) calculates the measured absorbance (A) for each neutral density filter well mN ) and stores it in the reader's memory; by using the formula AError N =(A mN - A pN ) / A pN Calculate the percentage error to convert the A of each neutral density filter well mN With the predetermined absorbance value (A pN ) and the calculated absorbance percentage error for each neutral density filtered well is stored in memory; AError N is compared with a predetermined neutral density absorbance error threshold, and if AError N is greater than a predetermined neutral density absorbance error threshold, indicating that the optical bench is out of specification; measuring the intensity of light passing through at least one wavelength filter aperture using a photodetector of the reader, wherein the light is generated by a light source of the reader, and the measured value is used as an intensity wavelength measurement value (I WN ) is stored in memory, where N is incremented once for each wavelength filter hole, and the measurement is repeated for each wavelength filter hole; by using the formula WError N = I WN / I i Evaluate the I for each wavelength filter hole WN and I i The wavelength error (WError) of the optical bench is calculated by the ratio of N ), and store it in the memory; and WError for each wavelength filter hole N is compared with a predetermined wavelength error threshold, and if WError N If the error wavelength is greater than a predetermined threshold, it indicates that the optical bench does not meet the specifications.

[0019] In another aspect of the present invention, the filter aperture may include one or more neutral density filter apertures and one or more wavelength filter apertures. The one or more wavelength filter apertures may include one or more short-pass filter apertures, one or more long-pass filter apertures, one or more band-pass filter apertures and / or one or more stop-band filter apertures. The filter aperture may include at least one wavelength filter aperture and a second neutral density filter aperture. The at least one wavelength filter aperture may include at least one long-pass filter aperture and one short-pass filter aperture.

[0020] In another aspect of the present invention, one or more filters may be mounted on the OVP to form a first predetermined angle relative to the top surface of the OVP body, and / or one or more filters may be mounted on the OVP to form a first predetermined angle relative to the filter bed of the OVP body. The first predetermined angle may be approximately zero degrees, approximately 30 degrees, or between approximately zero and approximately 45 degrees.

[0021] In yet another aspect of the present invention, a bacterial endotoxin reader includes a control unit and a memory storing executable code that, when executed by the control unit, performs actions including: rotating an optical verification plate (OVP) positioned on a spindle of the reader upward using a spindle of the reader; identifying a registration pattern on the OVP using an optical stage of the reader; measuring an intensity of light passing through an incident aperture of the OVP using a photodetector of the reader, wherein the light is generated by a light source of the reader, and the measurement is stored in the memory of the reader as incident light (Ii); measuring an intensity of light passing through at least one neutral density filter aperture using a photodetector of the reader, wherein the light is generated by a light source of the reader, and the measurement is stored as an intensity neutral measurement (Ii). fN ) is stored in the reader's memory, where N is incremented once for each neutral density filter aperture, and the measurement is repeated for each neutral density filter aperture; using the formula T N = (I fN / I i ) Calculate the transmittance (T) of each neutral density filter hole N ), and store it in the reader's memory; using formula A mN = -log 10 (T N ) Calculate the measured absorbance (A) for each neutral density filter well mN ) and stores it in the memory of the reader, and stores it in the memory; by using the formula AError N = (A mN -A pN ) / A pN Calculate the percentage error to convert the A of each neutral density filter well mN With the predetermined absorbance value (A pN ) and store the calculated absorbance percentage error for each neutral density filtered well in memory; AError N is compared with a predetermined neutral density absorbance error threshold, and if AError Nis greater than a predetermined neutral density absorbance error threshold, indicating that the optical bench is out of specification; measuring the intensity of light passing through at least one wavelength filter aperture using a photodetector of the reader, wherein the light is generated by a light source of the reader, and the measured value is used as an intensity wavelength measurement value (I WN ) is stored in the memory, wherein N is incremented once for each wavelength filter hole, and the measurement is repeated for each wavelength filter hole; by using the formula WError N = I WN / I i Evaluate the I for each wavelength filter aperture WN and I i The wavelength error (WError) of the optical bench is calculated by the ratio of N ), and store it in the memory; and WError for each wavelength filter hole N is compared with a predetermined wavelength error threshold, and if WError N If the error wavelength is greater than a predetermined threshold, it indicates that the optical bench does not meet the specifications.

[0022] In yet another aspect of the present invention, a bacterial endotoxin reader includes: a control unit and a memory storing executable code that, when executed by the control unit, performs actions including: rotating a temperature verification plate (TVP) placed on the reader's spindle upward using the reader's spindle; activating a heater of the reader to maintain the temperature of a body of the TVP at a predetermined temperature; obtaining a temperature measurement of the TVP body from a temperature indicator of the TVP using the reader's optical stage and storing the temperature measurement in a memory; obtaining a temperature measurement of the TVP body using a temperature measurement sensor of the reader and storing the temperature measurement in a memory; calculating a difference between the temperature measurement obtained from the TVP's temperature indicator and the temperature measurement obtained from the reader's temperature measurement sensor, storing the difference in the memory, and comparing the difference; and indicating a reader temperature measurement sensor calibration error when the difference is greater than a predetermined temperature difference threshold.

[0023] In another aspect of the invention, when executed by the control unit, the code performs additional actions comprising applying a calibration factor to a temperature measurement obtained from a temperature measurement sensor of the reader based on a difference between the temperature measurement obtained from the TVP and the temperature measurement obtained from the reader temperature sensor.

[0024] In another aspect of the invention, when executed by the control unit, the code performs additional actions including calculating a calibration factor based on a difference between temperature measurements obtained from the TVP at two or more predetermined temperatures and temperature measurements obtained from the reader temperature sensor at two or more predetermined temperatures, and applying the calibration factor to temperature measurements obtained from the reader temperature measurement sensor.

[0025] In another aspect of the invention, the code, when executed by the control unit, performs additional actions including determining the calibration factor using straight-line interpolation and / or mathematical regression.

[0026] Advantages of the present invention will become more apparent to those skilled in the art from the following description of the embodiments thereof, which have been shown and described by way of illustration. As will be realized, the invention is capable of other and different embodiments, and its details are capable of modifications in various respects. BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0027] These and other features of the present invention, as well as advantages thereof, are particularly illustrated in the embodiments of the invention which will now be described by way of example with reference to the accompanying schematic drawings, in which: Figure 1A is an isometric view of an illustrative reader and verification pad according to an exemplary embodiment of the disclosed technology; Figure 1B is a block diagram of an illustrative reader according to an exemplary embodiment of the disclosed technology; Figure 2A is a cross-section of an illustrative reader according to an exemplary embodiment of the disclosed technology; Figure 2B is a cross-section of an illustrative reader according to an exemplary embodiment of the disclosed technology; Figure 2C is a cross-section of an illustrative reader according to an exemplary embodiment of the disclosed technology; Figure 3 is an isometric view of an illustrative temperature verification plate according to an exemplary embodiment of the disclosed technology; Figure 4 is a top view of an illustrative temperature verification plate according to an exemplary embodiment of the disclosed technology; Figure 5 is a block diagram of an illustrative temperature validation board according to an exemplary embodiment of the disclosed technology; Figure 6 is a flow chart of an example method of using a temperature verification plate according to an exemplary embodiment of the disclosed technology; Figure 7is a flow chart of an example method of validating a reader temperature measurement using a temperature validation plate according to an exemplary embodiment of the disclosed technology; Figure 8A is an isometric view of an illustrative reader and optical verification plate according to an exemplary embodiment of the disclosed technology; Figure 8B is a cross-section of an illustrative reader and optical verification plate according to an exemplary embodiment of the disclosed technology; Figure 9A is a top view of an illustrative optical verification plate according to an exemplary embodiment of the disclosed technology; Figure 9B is a cross-section of an illustrative optical verification plate according to an exemplary embodiment of the disclosed technology; Figure 9C is a cross-section of an illustrative optical verification plate according to an exemplary embodiment of the disclosed technology; Figure 10 is a graph of transmittance versus wavelength for illustrative short-pass and long-pass filters according to an exemplary embodiment of the disclosed technology; and Figures 11A-11B is a flow chart of an example method of verifying reader optical measurements using an optical verification plate in accordance with an example embodiment of the disclosed technology.

[0028] It should be noted that all of the drawings are diagrammatic and not drawn to scale. For clarity and convenience, the relative sizes and proportions of the various parts in these drawings have been shown exaggerated or reduced in size. The same reference numerals are generally used to refer to corresponding or similar features in different embodiments. Accordingly, the drawings and description are to be regarded as illustrative in nature and not restrictive. Detailed Description of the Preferred Embodiments

[0029] Approximate language used herein throughout the specification and claims can be used to modify any quantitative representation, which can be allowed to change without causing a change in the basic function associated therewith. Therefore, the value modified by one or more terms (such as "approximately") is not limited to the precise value specified. In at least some cases, approximate language can correspond to the precision of the instrument used to measure the value. Range limitations can be combined and / or interchangeable, and unless the context or language indicates otherwise, these ranges are identified and include all sub-ranges described herein. Except in the operating examples or when otherwise indicated, all numerals or expressions involving the amount of components, reaction conditions, etc. used in the specification and claims should be understood to be modified by the term "approximately" in all instances.

[0030] “Optional” or “optionally” means that the subsequently described event or circumstance may or may not occur, or the subsequently identified material may or may not exist, and that the description includes instances where the event or circumstance occurs or the material exists and instances where it does not occur or the material does not exist.

[0031] As used herein, the terms “comprises,” “comprising,” “includes,” “including,” “has,” “having,” or any other variation thereof, are intended to cover a non-exclusive inclusion. For example, a process, method, article, or apparatus that comprises a list of elements is not necessarily limited to only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus.

[0032] The singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise.

[0033] As used herein, a "processor" processes signals and performs general calculations and arithmetic functions. The signals processed by the processor may include digital signals, data signals, computer instructions, processor instructions, messages, bits, bit streams, or other means of receiving, transmitting, and / or detecting. Typically, a processor may be a variety of different processors including multiple single-core and multi-core processors and coprocessors and other multiple single-core and multi-core processor and coprocessor architectures. The processor may include various modules that perform various functions.

[0034] As used herein, "memory" may include volatile memory and / or non-volatile memory. Non-volatile memory may include, for example, ROM (read-only memory), PROM (programmable read-only memory), EPROM (erasable programm ...

[0035] As used herein, a "controller" may include various configurations (eg, a processor and memory). A controller may also include a microcontroller with an onboard processor and memory.

[0036] As used herein, a "drive" may be, for example, a magnetic drive, a solid-state drive, a floppy disk drive, a tape drive, a Zip drive, a flash memory card, and / or a memory stick. Furthermore, a drive may be a CD-ROM (Compact Disc ROM), a CD-Recordable Drive (CD-R Drive), a CD-Rewritable Drive (CD-RW Drive), and / or a Digital Video ROM Drive (DVD ROM). A drive may store an operating system and / or programs that control or allocate resources of a computing device.

[0037] Some portions of the detailed description that follows are presented in terms of algorithms and symbolic representations of operations on data bits within a computer memory. These algorithmic descriptions and representations are the means used by those skilled in the data processing arts to most effectively convey the substance of their work to others skilled in the art. An algorithm is herein, and generally, conceived of as a self-consistent sequence of steps (instructions) leading to a desired result. These steps are those requiring physical manipulations of physical quantities. Typically, although not necessarily, these quantities take the form of electrical, magnetic, or optical non-transitory signals capable of being stored, transferred, combined, compared, and otherwise manipulated. It is sometimes convenient, primarily for reasons of common usage, to refer to these signals as bits, values, elements, symbols, characters, terms, numbers, or the like. Furthermore, it is sometimes convenient to refer to certain arrangements of steps requiring physical manipulations or transformations of physical quantities or representations of physical quantities as modules or code devices, without loss of generality.

[0038] However, all of these and similar terms are to be associated with the appropriate physical quantities and are merely convenient labels applied to these quantities. Unless expressly stated otherwise (as will be apparent from the following discussion), it should be understood that throughout this description, discussions using terms such as "process" or "compute" or "calculate" or "determine" or "display" refer to the actions and processes of a computer system or similar electronic computing device (e.g., a specific computing machine) that manipulates and transforms data represented as physical (electronic) quantities within the computer system memory or registers or other such information storage, transmission, or display devices.

[0039] Certain aspects of the embodiments described herein include processing steps and instructions described herein in algorithmic form. It should be noted that the processing steps and instructions of the embodiments may be embodied in software, firmware, or hardware, and when embodied in software, may be downloaded to reside on and operate from different platforms used by various operating systems. The embodiments may also be in a computer program product executable on a computing system.

[0040] Embodiments also relate to apparatus for performing the operations described herein. The apparatus may be specially constructed for this purpose (e.g., a specific computer), or it may comprise a general-purpose computer selectively activated or reconfigured by a computer program stored in the computer. Such a computer program may be stored in a non-transitory computer-readable storage medium, such as, but not limited to, any type of drive, including a floppy disk drive (disk), an optical drive (disk), a CD-ROM, a magneto-optical drive (disk), a read-only memory (ROM), a random access memory (RAM), an EPROM, an EEPROM, a magnetic or optical card, an application-specific integrated circuit (ASIC), or any other type of medium suitable for storing electronic instructions, each electrically connected to a computer system bus. Furthermore, the computers referred to in this specification may include a single processor or may be architectures employing multiple processor designs to increase computing power.

[0041] The algorithms and displays presented herein are not inherently related to any particular computer or other device. Various general-purpose systems can also be used with programs according to the teachings of this article, or it may prove convenient to build more specialized devices to perform the method steps. The structures of various these systems will be presented from the following description. In addition, the embodiments are described without reference to any specific programming language. It will be understood that various programming languages can be used to implement the teachings of the embodiments as described herein, and any reference to a specific language below is provided for the enabling and best mode of the disclosed embodiments.

[0042] Furthermore, the language used in the specification has been selected primarily for readability and instructional purposes, and may not be selected to describe or limit the inventive subject matter. Accordingly, the disclosure of the embodiments is intended to be illustrative, but not limiting, of the scope of the embodiments, which are set forth in the claims.

[0043] Go to Figures 1A-7 If the temperature measurements at the reaction wells of a reaction disk within a bacterial endotoxin reader 100 are not within specifications, bacterial endotoxin reaction results may be negatively impacted. Furthermore, if the light source 130 and / or photodetector 135 of the reader 100 are not operating within specifications, results may be negatively impacted. The light source and sensor measure the optical response of a plate (disc) 103, which can be a reaction plate or a validation plate 200.

[0044] Verification of the temperature and / or optical performance of the reader 100 is performed using a verification plate 200 (eg, a temperature verification plate (TVP) 300 and / or an optical verification plate (OVP) 800 ) removably mounted to the spindle 105 of the reader 100 .

[0045] The TVP 300 can wirelessly report the temperature of a specific location on the TVP's body 335 to the reader 100. The TVP 300 can be used to verify that the heater 110 and temperature sensor 115 of the reader 100 are operating correctly. In an embodiment, the temperature sensor 115 can be one or more infrared temperature sensors. In an embodiment, the heater 110 of the reader 100 can be composed of an upper heater 110a and a lower heater 110b, and the temperature sensor 115 of the reader 100 can be composed of an upper temperature sensor 115a and a lower temperature sensor 115b. These sensors are used to maintain the temperature of the reaction chamber 140 of the reader 100 at a predetermined temperature, for example, by measuring and maintaining the temperature at a predetermined location on the TVP 300. The upper heater 110a heats the top surface 336 of the TVP 300 at the predetermined location, and the lower heater 110b heats the bottom surface 337 of the TVP 300 at the predetermined location to maintain the predetermined temperature. In an embodiment, the predetermined temperature can be approximately 37°C. In some embodiments, when the TVP 300 is rotated in the reader 100 during use, the predetermined temperature is maintained at a first predetermined radial distance away from the center of the spindle 105 on the TVP 300. The first predetermined radial distance may also be the radial distance away from the center of the spindle 105 where the temperature sensor 115 of the reader 100 measures the temperature of the TVP 300. The first predetermined radial distance is Figure 3 The distance between the spindle 105 and the center of the aperture 125 of the optical bench 120 of the reader 100 is also equal to the first predetermined radial distance "A." This first predetermined radial distance can also be equal to the distance between the spindle 105 and the location of the reaction well on the reaction plate 103. In one exemplary embodiment, the first predetermined radial distance "A" is approximately 98 mm. In an exemplary embodiment, the aperture 125 can be a window that allows light to pass through but prevents the intrusion of dust and / or fluids into the optical bench 120.

[0046] In other words, since the goal of the TVP 300 and OVP 800 is to verify the operation of the temperature control and optical measurement capabilities of the reader 100 at locations on reaction wells of a reaction plate, the radial distance "A" in embodiments of the reader 100 may correspond to the radial distance between the center of the spindle 105 and the location of the reaction wells of the reaction plate 103 when placed in the reader 100, the radial distance between the center of the spindle 105 and the location of the predetermined temperature on the TVP 300 using the temperature sensor 115 and the heater 110, the radial distance between the center of the spindle 105 and the location of the TVP temperature sensor 315, the radial distance between the center of the spindle 105 and the location of the TVP temperature indicator 320, the radial distance between the center of the spindle 105 and the location of the temperature sensor 115, the radial distance between the center of the spindle 105 and the location of the heater 110, the radial distance between the center of the TVP 300 and the location of the predetermined temperature on the TVP 300 using the temperature sensor 115 and the heater 110, and the radial distance between the center of the TVP 300 and the location of the TVP temperature indicator 320. The radial distance between the center of the TVP 300 and the location of the TVP temperature sensor 315, the radial distance between the center of the TVP 300 and the location of the TVP temperature indicator 320, the radial distance between the center of the spindle 105 and the location on the OVP 800 (at which location the optical bench 120 of the reader 100 uses the light source 130 and the photodetector 135 to output light onto the OVP 800 and measure the light passing through the OVP 800), the radial distance between the center of the spindle 105 and the hole 805 of the OVP 800, the radial distance between the center of the OVP 800 and the location on the OVP 800 (at which location the optical bench 120 of the reader 100 uses the light source 130 and the photodetector 135 to output light onto the OVP 800 and measure the light passing through the OVP 800), and the radial distance between the center of the OVP 800 and the location on the OVP 800. 800 , and / or the radial distance between the center of the spindle 105 and / or the locations of the light source 130 and the photodetector 135 of the optical bench 120 .

[0047] TVP 300 has a temperature verification circuit 301, which may include a TVP controller 305, a battery 310, a temperature sensor 315, and a temperature indicator 320. TVP 300 may also have a switch 325, a counterweight 330 for balancing TVP 300, a body 335, and a temperature sensor channel 316 within body 335 containing temperature sensor 315. Body 335 may be constructed from a material with the same emissivity as the reaction disk, allowing temperature sensor 115 of reader 100 to measure the temperature of both the reaction disk and TVP 300 with the same accuracy. Body 335 may be constructed from the same material as the reaction disk body. Body 335 may be constructed from, but is not limited to, one or more of polystyrene, cyclic olefin copolymer, and / or glycol-modified polyethylene terephthalate. In some embodiments, carbon may be added to body 335 to blacken the polystyrene to facilitate optical absorbance methods. Additionally, one or more components of the temperature verification circuit 301 can be located below the top surface 336 of the body 335 and can have a cover, such as the battery 310, the temperature indicator 320, and the temperature sensor 315. The body 335 can also have a bottom surface 337 located on the body 335 opposite the top surface 336.

[0048] Controller 305 includes memory 307 and processor 306. Battery 310 provides power to controller 305, temperature sensor 315, and temperature indicator 320 of temperature verification circuit 301 of TVP 300. Switch 325 switches temperature verification circuit 301 on and off, for example, by controlling (starting and stopping) the flow of current between battery 310 and other components of temperature verification circuit 301. Temperature sensor 315 measures temperature and provides the measurement to controller 305. Temperature sensor 315 can be an electronic temperature sensor, such as a thermistor, thermocouple, and / or resistance temperature detector. The radial distance between the center of TVP 300 and temperature sensor 315 can also be equal to a first predetermined radial distance "A," which is the same as the distance between spindle 105 and the center of aperture 125 of optical table 120 of reader 100. Thus, in an exemplary embodiment, when the temperature sensor 115 of the reader 100 measures the temperature of the body 335 of the TVP 300, the temperature sensor 315 of the TVP 300 measures the temperature of the body 335 of the TVP 300 at the same precise radial location from the center of the TVP 300 (and the spindle 105). Figure 2C, where the field of view 117 of the reader temperature sensor 115 includes the path of travel of the board temperature sensor 315. As can be seen, the upper field of view 117a of the reader upper temperature sensor 115a includes the path of travel of the board temperature sensor 315. Additionally, the lower field of view 117b of the reader lower temperature sensor 115b includes the path of travel of the board temperature sensor 315.

[0049] The optical workbench 120 has a light source 130 and a photodetector 135 for measuring the optical response of the reaction occurring in the reaction wells of the reaction disk (reaction plate). The photodetector 135 may include a printed circuit board having a power supply circuit for providing power to the photodetector 135 and also having a signal processing circuit for digitizing the output of the photodetector 135 to provide a digitized output from the photodetector 135. The light source 130 may include a printed circuit board having a power supply circuit for providing power to the light source 130. The controller 305 uses a temperature indicator 320 to optically represent the value of the temperature measured by the temperature sensor 315. In an exemplary embodiment, the temperature indicator 320 may be composed of at least one visual element 321 that can change state (on / off) to indicate "1" or "0". In an exemplary embodiment, the visual element 321 may be a Figure 2A LED lights as shown or Figure 2B In other embodiments, the temperature indicator 320 may be comprised of at least one LED light and / or an LCD. The temperature indicator 320 may be registered with the reader 100 so that the orientation of the TVP 300 matches the timing of the measurements taken by the photodetector 135. This allows the reader 100 to accurately measure each visual element 321 of the temperature indicator 320 as it passes under the photodetector 135.

[0050] In an exemplary embodiment, the temperature indicator 320 may be comprised of at least one LED (e.g., a single LED or an array of LEDs) to optically represent the value. In an exemplary embodiment, the LED array may be an array of 12 LEDs, which flash to represent the temperature measurement of the temperature sensor 315 in binary form, which can be read by the photodetector 135 of the reader 100. In some embodiments, when the bit value of the temperature measurement is less than or equal to the number of LEDs available to represent the temperature on the temperature indicator 320, the temperature measurement can be transmitted by the TVP 300 to the photodetector 135 of the reader 100 during a single rotation of the TVP 300. In other embodiments, when the temperature measurement value of the temperature sensor 315 is greater than a single bit and the temperature indicator 320 has one LED available to represent the temperature, the temperature measurement can be transmitted by the TVP 300 to the photodetector 135 of the reader 100 at a rate of one bit per rotation of the TVP 300.

[0051] In some exemplary embodiments, when the temperature measurement value of the temperature sensor 315 is a 12-bit number and the temperature indicator 320 has 12 LED lights that can be used to represent the temperature, the temperature measurement value can be transmitted by the TVP 300 to the photodetector 135 of the reader 100 during a single rotation of the TVP 300.

[0052] In another exemplary embodiment, when the temperature sensor 315 has a 12-bit temperature measurement and the temperature indicator 320 has an LED light that can be used to indicate the temperature, the temperature measurement can be transmitted by the TVP 300 to the photodetector 135 of the reader 100 after the TVP 300 rotates 12 times, with one bit transmitted for each rotation of the TVP 300. In this embodiment, the rotation speed of the TVP 300 can be coordinated with the timing of the LED so that with each rotation, the next bit is indicated ("on" or "off").

[0053] In other exemplary embodiments, a temperature indicator 320 having multiple LED lights that can be used to represent the temperature measurement of the temperature sensor 315 can transmit the temperature measurement to the photodetector 135 of the reader 100 using more than one rotation of the TVP 300. For example, a 12-bit temperature measurement can be represented by 2, 3, 4, or 6 LEDs, for which a 12-bit binary number would then be transmitted from the temperature indicator 320 to the photodetector 135 over the course of 6, 4, 3, or 2 rotations of the TVP 300. Furthermore, the temperature indicator 320 can even transmit a binary temperature measurement that is not evenly divisible by the number of LEDs of the temperature indicator 320; for example, a 13-bit temperature measurement can be represented by 5 LEDs over the course of three rotations of the TVP 300.

[0054] In an exemplary embodiment, temperature indicator 320 may be comprised of at least one LCD (e.g., a single LCD or an array of twelve LCDs) to optically represent the value, with changes in the opacity of these LCDs representing the temperature measurement of temperature sensor 315 in binary form. The change in opacity of the LCD allows light generated by light source 130 to pass through the LCD and strike photodetector 135, which may represent a "1," or reduces the amount of light generated by light source 130 striking photodetector 135, or prevents light generated by light source 130 from striking photodetector 135, which may represent a "0." In some embodiments, when the bit value of the temperature measurement is less than or equal to the number of LCDs available to represent the temperature on temperature indicator 320, the temperature measurement may be transmitted by TVP 300 to photodetector 135 of reader 100 during a single rotation of TVP 300. In other embodiments, when the temperature measurement value of the temperature measurement sensor 315 is greater than a single digit and the temperature indicator 320 has an LCD that can be used to represent the temperature, the temperature measurement value can be transmitted by the TVP 300 to the photodetector 135 of the reader 100 at a rate of one bit per rotation of the TVP 300.

[0055] In an exemplary embodiment, temperature indicator 320 may be comprised of at least one LCD (e.g., a single LCD or an array of 12 LCDs) to optically represent the value. These LCDs vary in opacity, representing the temperature measurement value of temperature sensor 315 in binary form. This variation in opacity allows light generated by light source 130 to pass through the LCD and strike photodetector 135, which may represent a "1," or reduces or prevents light generated by light source 130 from striking photodetector 135, which may represent a "0." When the temperature measurement value of temperature sensor 315 is a 12-bit number and temperature indicator 320 has 12 LCDs available for representing temperature, the temperature measurement value can be transmitted from TVP 300 to photodetector 135 of reader 100 during a single rotation of TVP 300, thereby transmitting the temperature value from TVP 300 to reader 100. When the temperature measurement value of the temperature sensor 315 is a 12-bit number and the temperature indicator 320 has an LCD that can be used to represent the temperature, the temperature measurement value can be transmitted by the TVP 300 to the photodetector 135 of the reader 100 after the TVP 300 rotates 12 times, thereby transmitting the temperature value from the TVP 300 to the reader 100. In this embodiment, the rotation speed of the TVP can be coordinated with the timing of the LCD so that with each rotation, the next bit indicates ("let light pass" or "block light").

[0056] In other exemplary embodiments, a temperature indicator 320 having multiple LCD lights that can be used to represent the temperature measurement of the temperature sensor 315 can transmit the temperature measurement to the photodetector 135 of the reader 100 using more than one rotation of the TVP 300. For example, a 12-bit temperature measurement can be represented by two, three, four, or six LCDs, for which a 12-bit binary number would then be transmitted from the temperature indicator 320 to the photodetector 135 over the course of six, four, three, or two rotations of the TVP 300. Furthermore, the temperature indicator 320 can even transmit a binary temperature measurement that is not evenly divisible by the number of LCDs of the temperature indicator 320; for example, a 13-bit temperature measurement can be represented by five LCDs over the course of three rotations of the TVP 300.

[0057] The use of light, rather than radio frequency, to transmit the temperature value from the TVP 300 to the reader 100 allows the TVP 300 to be used in areas where radio frequency is highly regulated or where potential radio interference may exist. Furthermore, the TVP 300 design allows the use of existing optical benches 120, which also eliminates the need to integrate an RF receiver or transceiver into the reader 100.

[0058] Turning to method 600 for measuring temperature using TVP 300, at 601, when TVP 300 is activated, the method proceeds to 605. When switch 325 is moved to the "on" position, TVP 300 may be activated. At 605, TVP 300 obtains at least one temperature measurement over a first predetermined time period using temperature sensor 315 and transmits the measurement to controller 305. In an exemplary embodiment, at least one temperature measurement may be obtained using temperature sensor 315 during the first predetermined time period and provided to controller 305. Furthermore, when more than one temperature measurement is obtained and provided to controller 305, the measurements may be obtained at first recurring intervals during the first predetermined time period. When one or more temperature measurements are provided to controller 305 during the first predetermined time period, controller 305 may average the temperature measurements obtained during the first predetermined time period. In an exemplary embodiment, the first predetermined time period may be approximately 5 seconds, and the first recurring interval may be approximately 0.1 seconds.

[0059] At 610 , the at least one temperature measurement value obtained at 605 is output (transmitted) by the controller 305 of the TVP 300 using the temperature indicator 320 for a second predetermined length of time. In an exemplary embodiment, the second predetermined length of time may be approximately 0.4 seconds. This value may be the average of the temperature measurements obtained during the first predetermined length of time. Before outputting the value, the controller 305 may convert the value from a numerical value to a binary value. In an exemplary embodiment, the numerical value may be converted to a 12-bit binary value and output using the 12 LEDs of the temperature indicator 320 . However, it is contemplated that the numerical value may be converted to a different binary resolution and output using a different number of LEDs or an LCD on the temperature indicator 320 . The temperature indicator 320 and controller 305 may also output verification information notifying the reader 100 that the measurement is valid. In an exemplary embodiment, the verification information may be an additional "1" bit at the beginning and end of the 12-bit number, for a total of 14 bits, with only the middle 12 bits indicating the temperature measurement value. In some embodiments where the temperature is output as a 12-bit number plus an additional 2 digits for verification, the temperature indicator 320 may have 12 LEDs or LCDs to enable the transmission of the measurement and verification information during a single rotation of the TVP, or a single LED or LCD may be used to enable the transmission of the measurement and verification information over 14 rotations of the TVP 300. The method then returns to 601 and proceeds to 605 while the TVP 300 remains activated. In an exemplary embodiment, the TVP 300 remains activated while the switch 325 remains in the "on" position.

[0060] A block diagram of the components 106 of the reader 100 that interact with the reader controller 145 is shown in FIG. Figure 1BAs shown in FIG. As can be seen, controller 145 consists of memory 119 and a CPU (processor) 118 that executes the program stored in memory 119. The controller interfaces with user interface 113, spindle 105, plate 103, optical bench 120, and reaction chamber environment enhancer 155. In some embodiments, user interface 113 may also interact with controller 145. In one embodiment, housing 101 may include at least one reaction chamber environment enhancer, such as heater 110 and / or temperature sensor 115, for regulating the temperature within reaction chamber 140 of housing 101 and plate 103. Plate 103 provides position information to controller 145. Optical bench 120 provides information to controller 145 regarding the intensity of light received by photodetector 135. Reaction chamber environment enhancer 155 (e.g., temperature sensor 115) provides controller 145 with measurements of the temperature of plate 103 at the reaction well locations on the reaction plate. Controller 145 uses this information to determine whether heater 110 should be activated within housing 101. The user interface 113 may allow the user to provide test parameters to the controller 145 and allow the controller 145 to display test results to the user. The spindle 105 having a motor may provide position information to the controller 145 and may also allow the controller 145 to adjust the rotation of the plate 103 through the user interface 113.

[0061] Turning to method 700 for verifying the temperature measurement performance of reader 100 (temperature verification mode), at 701 , TVP 300 is activated, for example, by moving a switch to the "on" position, and placed in reader 100. It measures and outputs the temperature at temperature sensor 115 according to method 600 . As can be seen, as TVP 300 is rotated by spindle 105 of reader 100 , it measures the temperature of body 335 of TVP 300 . At 705 , reader 100 is placed in temperature verification mode via user interface 113 . At 710 , reader 100 rotates TVP 300 upward using spindle 105 and maintains rotation while in temperature verification mode. Rotation of TVP 300 allows testing of reader temperature sensor 115 and heater 110 under the same conditions as when a reaction plate is present in reader 100 . At 715 , the heater 110 and the reader temperature sensor 115 are activated by the reader controller 145 to heat and maintain the body 335 of the TVP 300 at a predetermined temperature.

[0062] At 720, once the body of the TVP has been at the predetermined temperature for at least the first predetermined length of time, the reader 100 obtains a temperature measurement of the body of the TVP 300 using the reader temperature sensor 115, the TVP 300 obtains and outputs the temperature measurement using the temperature indicator 320 according to method 600, and the reader 100 receives the temperature measurement of the TVP 300 and, optionally, the verification bit, using the optical stage 120. In an exemplary embodiment, the reader 100 may obtain a temperature measurement of the bottom surface 337 and / or the top surface 336 on the body 335. In an exemplary embodiment, the temperature measurement may be output from the TVP 300 in a 12-bit binary format. Optionally, the temperature measurement from the TVP 300 may be converted from binary to decimal and scaled for the measurement range of the temperature verification circuit 301 of the TVP 300, for example, by using the following formula: ,in: N = 12-bit temperature received from TVP 300 (in degrees Celsius); UT = upper temperature limit of TVP 300 (in degrees Celsius); LT = lower temperature measurement limit of TVP 300 (in degrees Celsius).

[0063] At 725, reader 100 calculates the difference between the temperature measurement obtained from TVP 300 (also referred to as the TVP temperature measurement) and the temperature measurement obtained from reader temperature sensor 115 (also referred to as the reader temperature measurement) and compares the difference. At 730, if the difference between the TVP temperature measurement and the reader temperature measurement is less than or equal to a predetermined temperature difference threshold, the calibration of reader temperature sensor 115 is verified, and the user may be notified via user interface 113. If the difference between the TVP temperature measurement and the reader temperature measurement is greater than the predetermined temperature difference threshold, the calibration of temperature sensor 115 is not verified, and the user may be notified via user interface 113 of a temperature sensor calibration error. In one embodiment, the predetermined temperature difference threshold may be approximately 1°C. In another embodiment, the predetermined temperature difference threshold may be approximately 0.5°C. In yet another embodiment, the predetermined temperature difference threshold may be approximately 0.1°C.

[0064] In some embodiments, steps 715-725 may be repeated to obtain temperature differences between the TVP 300 and the reader 100 at additional predetermined temperature points. For example, the temperature difference between the TVP 300 and the reader 100 may be evaluated at both 22°C and 37°C.

[0065] In optional step 730, a calibration factor may be applied to the value of the output of the reader temperature sensor 115 (e.g., via the user interface 113) to return the temperature sensor 115 to calibration. When only a single predetermined temperature point is used, a single-point offset may be used to obtain the calibration factor for calibrating the temperature sensor 115. When two predetermined temperature points are used, linear interpolation may be performed to obtain the calibration factor for calibrating the temperature sensor 115. When three or more predetermined temperature points are used, other interpolation methods (e.g., mathematical regression) may be used to obtain the calibration factor for calibrating the temperature sensor 115. In an exemplary embodiment, the mathematical regression may be a polynomial regression.

[0066] Go to Figures 1A-2C and Figures 8A-11B An optical verification plate (OVP) 800 can be used to verify that the reader's optical bench 120 is operating correctly. The OVP 800 has a plurality of apertures 805 positioned along the perimeter of the body 801 of the OVP 800. The center of each aperture 805 is located at a first predetermined radial distance "A" away from the center of the body 801 of the OVP 800. This allows the aperture 805 to align with the light source 130 and the photodetector 135 of the optical bench 120, such that light generated by the photodetector 135 can pass through the aperture 805 and the intensity of the light can be measured by the photodetector 135. In an embodiment, the plurality of apertures 805 may be filtering apertures 806, some of which have neutral density filters 810 (neutral density filtering apertures 811), and one or more apertures have wavelength filters (wavelength filtering apertures 850), which wavelength filters (wavelength filtering apertures 850) may include at least one of a short-pass filter 815 (short-pass filtering apertures 816), a long-pass filter 820 (long-pass filtering apertures 821), a band-pass filter (band-pass filtering apertures), and / or a stop-band filter (stop-band filtering apertures).

[0067] In an exemplary embodiment, the filter apertures 806 of the OVP 800 may be comprised of at least one wavelength filter aperture 850 and seven (7) neutral density filter apertures 811. In an exemplary embodiment, each of the seven neutral density filter apertures of the OVP 800 may have a different optical density (darkness) value. In an exemplary embodiment, the neutral density filter optical density value may be between approximately 0.01-3. In another exemplary embodiment, the neutral density filter optical density value may be between approximately 0.01-2. In another exemplary embodiment, the neutral density filter optical density value may be between approximately 0.1-1.2. In another exemplary embodiment, the neutral density filter optical density value may be between approximately 0.1-1.15. When traveling counterclockwise around the OVP 800, the filter apertures 806 may be spaced apart by a second predetermined distance "B".

[0068] In an exemplary embodiment, the at least one wavelength filtering aperture 850 may be composed of a long-pass filter aperture 821 and a short-pass filter aperture 815. In an exemplary embodiment, the short-pass filter 815 may have a cutoff of approximately 400 nm, while the long-pass filter 820 may have a cutoff of approximately 410 nm. In an exemplary embodiment, the light source 130 of the optical bench may output light having a wavelength of approximately 405 nm + / - 5 nm. By using the photodetector 135 to examine the output of the light source 130 after it has passed through the at least one wavelength filtering aperture 850 (e.g., the short-pass filter 815 and / or the long-pass filter 820), the reader 100 can determine whether the spectrum of the light output by the light source 130 is within specification or has drifted.

[0069] The spectral transmittance curves of the short-pass filter 815 and the long-pass filter 820 are shown in FIG. Figure 10 As can be seen, the short-pass filter 815 and the long-pass filter 820 have very narrow transition bands (the band between the stop band and the pass band). Therefore, it is contemplated that some embodiments of the OVP 800 may replace both the short-pass filter 815 and the long-pass filter 820 with a single stop-band or band-pass filter having a sufficiently narrow transition band.

[0070] In an embodiment, the one or more filters 807 may be mounted on the OVP 800 to form an angle of zero (0) degrees relative to the top surface 835 of the OVP 800. In other words, the one or more filters 807 may be flat on the top surface 835 of the OVP 800. Thus, the one or more filters 807 may be perpendicular (90°) relative to the direction of light traveling from the light source 130 to the photodetector 135 of the optical bench 120.

[0071] In other embodiments, one or more filters 807 may be mounted such that the filter 807 forms a first predetermined angle "F" relative to the top surface 835 of the OVP 800. In an exemplary embodiment, the first predetermined angle "F" may be between approximately 0 degrees and approximately 30 degrees. In another exemplary embodiment, the first predetermined angle "F" may be approximately 30 degrees.

[0072] In another embodiment, the one or more filters 807 may be mounted below the top surface 835 of the OVP 800 on the filter bed 808. The one or more filters may be mounted to the OVP 800 such that they form an angle of zero (0) degrees relative to the filter bed 808 of the OVP 800. Thus, the one or more filters 807 may be perpendicular (90°) relative to the direction of light traveling from the light source 130 to the photodetector 135 of the optical bench 120.

[0073] In other embodiments, one or more filters 807 may be mounted such that the filters 807 form a first predetermined angle "F" relative to the filter bed 808 of the OVP 800. In an exemplary embodiment, the first predetermined angle "F" may be between approximately 0 degrees and approximately 45 degrees. In another exemplary embodiment, the first predetermined angle "F" may be approximately 30 degrees.

[0074] OVP 800 may also have an entrance aperture 825 and a registration aperture 830, both of which are unfiltered. All apertures 805 may have the same radius, except for registration aperture 830, which may have a smaller radius. In an exemplary embodiment, entrance aperture 825 may be located between first filtering aperture 806a and registration aperture 830. Furthermore, in an exemplary embodiment, registration aperture 830 may be located between entrance aperture 825 and final filtering aperture 806b. The distance between first filtering aperture 806a and entrance aperture 825 may be a second predetermined distance "C." The distance between entrance aperture 825 and registration aperture 830 may be a third predetermined distance "D." The distance between registration aperture 830 and final filtering aperture 806b may be a fourth predetermined distance "E." In an exemplary embodiment, the second predetermined distance may be approximately 16 mm, the third predetermined distance may be approximately 4 mm, and the fourth predetermined distance may be approximately 74 mm. It is contemplated that, in some embodiments, reader 100 may use registration pattern 845 to determine the rotation angle of OVP 800. In an exemplary embodiment, registration pattern 845 can include registration apertures 830. In another exemplary embodiment, registration pattern 845 can include both registration apertures 830 and entrance apertures 825.

[0075] In an exemplary embodiment, the reader 100 can be programmed to recognize the registration pattern 845 rotated through the optical bench 120 and then know that a predetermined number of filter apertures 806 will be the next aperture 805 through the optical bench. The values and sequence of filters for the filter apertures 806 can be programmed into the reader 100, allowing the processor 118 of the reader 100 to 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 may have a balancer 840 for balancing the OVP 800 as it rotates in the reader 100. The balancer 840 may include, but is not limited to, one or more of a counterweight, a weight-reducing groove, and / or a weight-reducing pocket.

[0077] Figures 11A-11BAn exemplary method 1100 for measuring and verifying the optical performance (measuring absorbance or optical density and error) of the optical table 120 of the reader 100 using the OVP 800 is shown. In block 1101, the OVP 800 is placed in the reader 100, and the reader 100 rotates the OVP 800. In block 1105, the reader 100 uses the optical table 120 to identify the registration pattern 845 on the OVP. This registration allows the reader 100 to time the sampling of the optical table 120 to the precise moment when the aperture 805 passes through the optical table. In block 1110, the reader uses the light source 130 to pass light through the incident aperture 825 and measures the intensity of the light received by the photodetector 135. This measurement is used as the incident light (I i ) is stored in memory 119.

[0078] In block 1115, the reader uses the light source 130 to pass light through at least one neutral density filter aperture 811 and measures the intensity of the light received by the photodetector 135. The value of this intensity measurement (I fN ) is stored in the memory 119, where N is incremented once for each neutral density filter aperture 811. The actions of block 1115 may be repeated until the value of each neutral density filter aperture 811 has been measured and stored in the memory 119.

[0079] In block 1120, for at least one neutral density hole 811, the transmittance (T N ) is processed by processor 118 using the formula T N =(I fN / I i ) is calculated and stored in the memory 119. The actions of block 1120 may be repeated until the transmittance value for each neutral density filter aperture 811 has been calculated by the processor 118 and stored in the memory 119.

[0080] In block 1125, for at least one neutral density filter well 811, the absorbance (A mN ) is processed by processor 118 using formula A mN = -log 10 (T N ) is calculated and stored in the memory 119, where the effective T N The value is between 0 and 1. The actions of block 1125 may be repeated until the measured absorbance value for each neutral density filter well 811 has been calculated by the processor 118 and stored in the memory 119 .

[0081] In block 1130, the absorbance (A) measured for at least one neutral density filter well 811 is mN ) and the predetermined absorbance value (A pN) is compared using the formula AError using processor 118 N = (A mN -A pN ) / A pN A percentage error is calculated and the absorbance percentage error is stored in memory 119. In an exemplary embodiment, the predetermined absorbance value may be the actual certified absorbance of the neutral density filter at the neutral density filter well 811. The actions of block 1130 may be repeated until an absorbance percentage error value for each neutral density filter well 811 is calculated by processor 118 and stored in memory 119.

[0082] In block 1135, the processor 118 converts the percent error (AError) of the absorbance measurement 811 of the at least one neutral density filtered well into N ) and the predetermined neutral density absorbance error threshold (AError p ) for comparison. If a predetermined neutral density error threshold has been exceeded, processor 118 may notify the user, thereby indicating that the optical bench 120 of reader 100 is not in compliance with specifications. Processor 118 may notify the user via user interface 113. In an exemplary embodiment, the predetermined neutral density error threshold may be approximately 5%. The actions of block 1135 may be repeated until a comparison has been completed for each neutral density filter aperture 811 by processor 118, and the results are stored in memory 119 and output to the user via user interface 113.

[0083] In block 1140, the reader uses the light source 130 to pass light through at least one wavelength filter aperture 850 and measures the value of the intensity of the light received by the photodetector 135. The measured value is stored as the intensity wavelength measurement value I WN , where N is incremented once for each wavelength filtering aperture 850 . The actions of block 1140 may be repeated until the value of each wavelength filtering aperture 850 has been measured and stored in memory 119 .

[0084] In block 1145, the wavelength error (WError) of the optical bench is N ) is processed by processor 118 using the formula WError N = I WN / I i By evaluating at least one measurement, value (I WN ) and the measured value of the incident light intensity passing through the incident light hole 825 (I iThe wavelength error of the optical bench is stored in the memory 119. The actions of block 1145 may be repeated until the wavelength error value for each wavelength filter aperture 850 has been calculated by the processor 118 and stored in the memory 119.

[0085] In block 1150, processor 118 compares the wavelength error of each wavelength filter aperture 850 to a predetermined wavelength error threshold and notifies the user if the predetermined wavelength threshold has been exceeded, thereby indicating that the optical bench 120 of reader 100 is out of specification. The predetermined error threshold may be a predetermined sum wavelength error threshold or a predetermined individual wavelength error threshold. The processor may notify the user via user interface 113. In an exemplary embodiment, the sum of the wavelength errors may not exceed (or be greater than) approximately 5%. In other words, the predetermined sum wavelength error threshold may be approximately 5%. In another embodiment, any individual wavelength error threshold may be approximately 2.5%. In other words, the predetermined individual wavelength error threshold may be approximately 2.5%. In another embodiment, the predetermined wavelength error threshold may correspond to the output of light source 130 having a wavelength greater than approximately 410 nm and / or less than approximately 400 nm. The actions of block 1150 may be repeated until the comparison for each wavelength filter aperture 850 has been completed by processor 118, the results stored in memory 119, and output to the user via user interface 113.

[0086] Although the present invention has been described in conjunction with the specific embodiments described above, it will be apparent that many alternatives, combinations, modifications, and variations will be apparent to those skilled in the art. Therefore, the preferred embodiments of the present invention described above are intended to be illustrative only, and not restrictive. Various changes may be made without departing from the spirit and scope of the present invention. Combinations of the above-described and other embodiments will be apparent to those skilled in the art upon studying the foregoing description and are intended to be encompassed therein. Accordingly, the scope of the present invention is defined by the appended claims, and all apparatus, processes, and methods within the meaning of the claims (whether literally or by equivalents) are intended to be encompassed therein.

Claims

1. An optical verification plate (OVP) for a bacterial endotoxin reader, comprising: a body having a plurality of apertures positioned along a perimeter of the body; a center of each aperture located at a first predetermined radial distance away from a center of the body, thereby allowing the aperture to be aligned with an optical bench of the reader so that light generated by a light source of the reader can pass through the aperture and an intensity of the light can be measured by a photodetector of the reader; The holes consist of filtered holes and unfiltered holes; The filter apertures are spaced apart a second predetermined distance when traveling counterclockwise around the OVP.

2. The OVP according to claim 1, wherein The filtering apertures are composed of one or more neutral density filter apertures and one or more wavelength filtering apertures.

3. The OVP according to claim 2, wherein: The one or more wavelength filter holes are composed of one or more short-pass filter holes, one or more long-pass filter holes, one or more band-pass filter holes and / or one or more stop-band filter holes.

4. The OVP according to claim 1, wherein The filtering hole is composed of at least one wavelength filtering hole and a second neutral density filtering hole.

5. The OVP according to claim 4, wherein The at least one wavelength filtering hole consists of a long-pass filtering hole and a short-pass filtering hole.

6. The OVP according to claim 1, wherein: One or more filters are mounted on the OVP to form a first predetermined angle relative to a top surface of the body of the OVP and / or wherein one or more filters are mounted on the OVP to form a first predetermined angle relative to a filter bed of the body of the OVP.

7. The OVP according to claim 6, wherein: The first predetermined angle is approximately zero degrees, approximately 30 degrees, or between zero degrees and 45 degrees.

8. The OVP according to claim 1, further comprising an entrance aperture and / or a registration aperture; the entrance aperture is located between the first filtering aperture and the registration aperture; the registration aperture is located between the entrance aperture and the last filtering aperture.

9. A method for verifying the optical performance of an optical bench of a bacterial endotoxin reader, comprising: Provide readers and optical verification plates (OVP); Place the OVP on the spindle of the reader and rotate the OVP upward; identifying a registration pattern on the OVP using the optical stage of the reader; The intensity of light passing through the entrance aperture of the OVP is measured using a photodetector of the reader, wherein the light is generated by the light source of the reader, and the measured value is used as the incident light I i stored in a memory of the reader; The intensity of light passing through at least one neutral density filter aperture is measured using a photodetector of the reader, wherein the light is generated by the light source of the reader, and the value of the measurement is used as an intensity neutral measurement value I fN storing in the memory of the reader, wherein N is incremented once for each neutral density filter aperture, and the measuring is repeated for each neutral density filter aperture; Use Formula T N = (I fN / I i ) Calculate the transmittance T for each of the neutral density filter holes N , and stored in the memory of the reader; Use Formula A mN = -log 10 (T N ) Calculate the absorbance A measured for each of the neutral density filter wells mN , and stored in the memory of the reader, and stored in the memory; By using the formula AError N =(A mN - A pN ) / A pN Calculate the percentage error to convert the A of each neutral density filter hole mN With the predetermined absorbance value A pN performing a comparison and storing in a memory the calculated percent absorbance error for each of the neutral density filtered wells; AError N is compared with a predetermined neutral density absorbance error threshold, and if the AError N is greater than the predetermined neutral density absorbance error threshold, indicating that the optical workbench does not meet the specifications; The intensity of light passing through at least one wavelength filter aperture is measured using the photodetector of the reader, wherein the light is generated by the light source of the reader, and the measured value is used as an intensity wavelength measurement value I WN storing in a memory, wherein N is incremented once for each wavelength filtering aperture, and the measuring is repeated for each of the wavelength filtering apertures; By using the formula WError N= I WN / I i Evaluate the I for each of the wavelength filter holes WN and the I i The wavelength error WError of the optical bench is calculated using the ratio N , and stored in a memory; and The WError for each wavelength filter hole N is compared with a predetermined wavelength error threshold, and if the WError N If the error wavelength is greater than the predetermined error wavelength threshold, it indicates that the optical workbench does not meet the specifications.

10. The method according to claim 9, wherein: The filtering apertures are composed of one or more neutral density filter apertures and one or more wavelength filtering apertures.

11. The method according to claim 10, wherein: The one or more wavelength filter holes are composed of one or more short-pass filter holes, one or more long-pass filter holes, one or more band-pass filter holes and / or one or more stop-band filter holes.

12. The method according to claim 9, wherein The filtering hole is composed of at least one wavelength filtering hole and a second neutral density filtering hole.

13. The method according to claim 12, wherein: The at least one wavelength filtering hole consists of a long-pass filtering hole and a short-pass filtering hole.

14. The method according to claim 9, wherein One or more filters are mounted on the OVP to form a first predetermined angle relative to a top surface of a body of the OVP and / or wherein one or more filters are mounted on the OVP to form a first predetermined angle relative to a filter bed of the body of the OVP.

15. The method according to claim 14, wherein The first predetermined angle is approximately zero degrees, approximately 30 degrees, or between zero degrees and 45 degrees.

16. A bacterial endotoxin reader, comprising: control unit; and A memory storing executable code, which, when executed by the control unit, performs actions including: Using the main shaft of the reader, the optical verification plate OVP placed on the main shaft of the reader is rotated upward; recognizing a registration pattern on the OVP using an optical stage of the reader; measuring the intensity of light passing through an entrance aperture of the OVP using a photodetector of the reader, wherein the intensity of the light passing through is measured, wherein the light is generated by a light source of the reader, and the measured value is stored in the memory of the reader as incident light Ii; The intensity of light passing through at least one neutral density filter aperture is measured using a photodetector of the reader, wherein the light is generated by the light source of the reader, and the value of the measurement is used as an intensity neutral measurement value I fN storing in the memory of the reader, wherein N is incremented once for each neutral density filter aperture, and the measuring is repeated for each neutral density filter aperture; Use Formula T N = (I fN / I i ) Calculate the transmittance T for each of the neutral density filter holes N , and stored in the memory of the reader; Use Formula A mN = -log 10 (T N ) Calculate the absorbance A measured for each of the neutral density filter wells mN , and stored in the memory of the reader, and stored in the memory; By using the formula AError N = (A mN - A pN ) / A pN Calculate the percentage error to convert the A of each neutral density filter hole mN With the predetermined absorbance value A pN performing a comparison and storing in a memory the calculated percent absorbance error for each of the neutral density filtered wells; AError N is compared with a predetermined neutral density absorbance error threshold, and if the AError N is greater than the predetermined neutral density absorbance error threshold, indicating that the optical workbench does not meet the specifications; The intensity of light passing through at least one wavelength filter aperture is measured using the photodetector of the reader, wherein the light is generated by the light source of the reader, and the measured value is used as an intensity wavelength measurement value I WN storing in a memory, wherein N is incremented once for each wavelength filtering aperture, and the measuring is repeated for each of the wavelength filtering apertures; By using the formula WError N= I WN / I i Evaluate the I for each of the wavelength filter holes WN and the I i The wavelength error WError of the optical bench is calculated using the ratio N , and stored in a memory; and The WError for each wavelength filter hole N is compared with a predetermined wavelength error threshold, and if the WError N If the error wavelength is greater than the predetermined error wavelength threshold, it indicates that the optical workbench does not meet the specifications.

Images