Bacterial endotoxin reader verification plates and methods of use

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 is a continuation of U.S. Provisional Patent Application Serial No. 62 / 93, filed November 18, 2019. No. 6,883, the entirety of which is incorporated herein by reference. It shall be so. [Technical field]

[0002] This application is directed to the validation of endotoxin readers. More specifically, This includes temperature and / or optical verification of the [Background technology]

[0003] Endotoxin readers should be periodically verified for optical reading and temperature measurement performance. be. Summary of the Invention

[0004] In one aspect of the invention, a temperature verification plate (TVP) for an endotoxin reader is a body configured to be placed on the spindle and rotated by the spindle; The body has a temperature verification circuit including a temperature sensor and a temperature indicator; The sensor is adapted to measure the temperature of the body as it is rotated by the spindle of the reader. the temperature indicator is configured to light a temperature value measured by the temperature sensor; The temperature indicator is configured to optically represent a temperature of the object, the temperature indicator being read by an optical bench of the reader. It is possible to obtain.

[0005] In another aspect of the invention, the temperature sensor is an electronic temperature sensor, a thermistor, a thermocouple and / or The temperature indicator may be a resistance temperature detector. at least one LED (Light Emitting Diode) and / or at least one Liquid Crystal Display (LCD). The indicator represents the temperature value as a binary number.

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

[0007] In another aspect of the invention, the temperature indicator may be a single LED, 12 LEDs, 14 LEDs, Various LEDs or LCDs are available, such as 1 LED, 1 LCD, 12 LCDs, or 14 LCDs. or LCD configuration.

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

[0009] In another aspect of the invention, the temperature sensor is configured to measure a first repeating temperature for a first predetermined amount of time. Temperature measurements are taken at intervals and the temperature indicator outputs the average of the temperature measurements.

[0010] The first predetermined amount of time may be about 5 seconds, and the first repetition interval may be about 0.1 seconds. It's fine.

[0011] In yet another aspect of the invention, a method for validating the temperature performance of an endotoxin reader includes: and providing a temperature verification plate (TVP); and attaching said TVP to a spindle of said reader. The TVP is placed on a spindle, the spindle is used to rotate the TVP, and the heater of the reader is turned on. and maintaining the temperature of the TVP body at a predetermined temperature; and obtaining a temperature measurement of the body of the TVP from a temperature indicator of the TVP using obtaining a temperature measurement value of the body of the TVP using a temperature measurement sensor of the reader; The temperature measurement value obtained from the temperature indicator of the TVP and the temperature measurement sensor of the reader calculating and comparing the difference between the temperature measurements obtained from the temperature sensor and the temperature measurement obtained from the temperature sensor; If so, indicating a calibration error of the temperature measurement sensor of the reader.

[0012] In another aspect of the invention, the method further comprises: detecting a temperature measurement obtained from the TVP and a temperature sensor of the reader; A calibration factor is calculated based on the difference between the temperature measurements obtained from the temperature sensor and the temperature sensor. The calibration factor is then applied to the reader. and applying a predetermined temperature difference threshold to the temperature measurements obtained from the temperature measurement sensor. The value may be about 1° C., about 0.5° C., or about 0.1° C. The difference may be between two or more given The calculation may be performed in terms of temperature. The predetermined temperature may be 22°C and / or 37°C.

[0013] In another aspect of the invention, the method comprises the steps of: The difference between the measured temperature and the temperature measurements obtained from the reader's temperature sensor at two or more given temperatures. and calculating a calibration factor based on the temperature measurement obtained from the temperature measurement sensor of the reader. The calibration coefficients may be calculated using linear interpolation and / or mathematical regression. The decision can be made based on the above.

[0014] In yet another embodiment of the present invention, an optical verification plate (OVP) for an endotoxin reader comprises: The device may include a body having a plurality of openings located along a periphery thereof; a first predetermined radial distance from the center, whereby the aperture is positioned adjacent to the optical optics of the reader; The light generated by the reader's light source passes through the aperture, allowing the light to be aligned with the The intensity can be measured by a photodetector in the reader; the aperture is a filtered aperture and a The filtered aperture is included when rotating counterclockwise around the OVP. , spaced a second predetermined distance apart.

[0015] In another aspect of the invention, the filtered aperture comprises one or more neutral density filtered apertures. The optical filter includes a mouth and one or more wavelength-filtered openings. The tapped apertures are one or more short-pass filtered apertures, one or more Apertures with several long-pass filters, apertures with one or several band-pass filters , and / or one or more stopband filtered apertures. The filtered aperture includes at least one wavelength filtered aperture and a second neutral density filter. At least one wavelength-filtered aperture may include one long The aperture may include one aperture with a pass filter and one aperture with a short pass filter. Alternatively, the plurality of filters may be arranged to form a first predetermined angle with respect to the top surface of the body of the OVP. and / or one or more filters may be attached to the OVP. The OVP is attached to the body of the filter so as to form a first predetermined angle with respect to the filter floor. The first predetermined angle may be about 0 degrees, about 30 degrees, or between about 0 degrees and about 45 degrees. stomach.

[0016] In another embodiment, the OVP may include an entrance aperture and / or a registration aperture. The aperture may be located between the first filtered aperture and the registration aperture. , may be located between the entrance aperture and the final filtered aperture.

[0017] In yet another aspect of the present invention, a method for verifying the optical performance of an optical bench for an endotoxin reader is provided. The method includes providing a reader and an optical verification plate (OVP); Place the OVP on the target and rotate the OVP; use the optical bench of the reader to measure the Identifying the registration pattern; and detecting the light passing through the entrance aperture of the OVP using the photodetector of the reader. measuring the intensity of light emitted by a light source of the reader, the light being generated by the light source of the reader, and the value of the measurement being the input Emitted light (I i ) in the memory of the reader; and using a photodetector of the reader, Measure the intensity of light passing through at least one filtered aperture, Repeating for each of the apertures, the light being generated by a light source of the reader. , the value of the measurement is the intensity neutral measurement (I fN ) in the reader's memory, and N is the number of dimming frames. Add 1 for each filtered opening; N =(I fN / I i ) to set the dimming factor The transmittance (T N ) and store it in the reader's memory. Formula A mN =-log 10 (T N ) to determine the aperture with a neutral density filter. The measured absorbance (A mN ) is calculated and stored in the reader's memory. and A for each aperture with a neutral density filter. mN and a given absorbance value (A pN ) to the expression AError N =(A mN -A pN ) / A pN Calculate the percentage error using 3. Note the calculated absorbance percent error for each of the neutral density filtered apertures. AError N a given extinction absorbance error threshold Compare with AError N If is greater than a predefined extinction absorbance error threshold, the optical bench is out of spec. and detecting the presence of at least one wavelength filter using a photodetector of the reader. The intensity of the light passing through the aperture with the wavelength filter is measured and repeated for each aperture with the wavelength filter. and repeating the measurement, the light being generated by a light source of the reader, the value of the measurement being an intensity wavelength measurement. Value(I WN ) where N is incremented by 1 for each wavelength filtered aperture. and; expression WError N =I WN / I i Using the above, each of the wavelength-filtered apertures About I WN and I i The wavelength error (WError N ) for each of the wavelength-filtered apertures and storing them in memory; WError N Compare WError with a given wavelength error threshold. N is greater than the specified error wavelength threshold. and indicating that the optical bench is out of specification if the optical bench is greater than 100%.

[0018] In another aspect of the invention, the filtered aperture comprises one or more neutral density filtered apertures. The optical fiber may include a mouth and one or more wavelength filtered apertures. The wavelength-filtered aperture can be one or more short-pass filtered apertures, one or an aperture with multiple long-pass filters, one or multiple band-pass filters aperture with stop band filter, and / or aperture with one or more stop band filters The filtered aperture may include at least one wavelength filtered aperture and a second and a neutral density filtered aperture. The at least one wavelength filtered aperture may include , at least one aperture with a long-pass filter and one aperture with a short-pass filter and a mouth portion.

[0019] In another aspect of the invention, the one or more filters are disposed in a first position relative to the top surface of the body of the OVP. The OVP may be attached to form a predetermined angle of 1 and / or 1 or The filter or filters form a first predetermined angle with respect to the filter floor of the body of the OVP. The first predetermined angle may be about 0 degrees, about 30 degrees, or It may be about 0 degrees to about 45 degrees.

[0020] In yet another aspect of the present invention, the endotoxin reader comprises a control unit and Memory that stores executable code that performs an action when executed by a role unit and the action includes: using a spindle of the reader to place the Rotating the optical verification plate (OVP) and measuring the optical Identifying the registration pattern on the VP; and detecting the entrance aperture of the OVP using the photodetector of the reader. measuring the intensity of light passing through the light source, the light being generated by a light source of the reader; The value of is stored in the memory of the reader as the incident light (Ii); Measure the intensity of light passing through at least one filtered aperture using the attenuation filter. Repeat for each of the filtered apertures, where the light is The value of the measurement is the intensity neutral measurement (I fN ) is stored in the reader's memory, and N is Add 1 for each neutral density filtered aperture; N =(I fN / I i ) , the transmittance (T N ) and store it in the reader's memory. and storing it in formula A mN =-log 10 (T N ) with a neutral density filter The actual absorbance (A mN ) is calculated and stored in the reader's memory. and storing the A for each aperture with a neutral density filter. mN and a given absorbance value (A pN ) to the expression AError N =(A mN -A pN ) / A pN Percentage error using Calculate the absorbance percentage error for each of the neutral density filter apertures. Compare by storing in memory;AError N The specified extinction absorbance error Compare with the threshold and AError N If is greater than a given extinction absorbance error threshold, the optical bench indicates that the reading is out of specification; and The intensity of the light passing through the aperture with the wavelength filter was measured, and and repeating the process, where light is generated by a light source of the reader, and the value of the measurement is an intensity wavelength. Measurement value (I WN ) in memory, where N is incremented by 1 for each wavelength-filtered aperture. WError N =I WN / I i Using the wavelength filter, I about each WN and I i The wavelength error (WErr) of the optical bench is calculated by evaluating the ratio of or N ) and storing it in memory; and for each of the wavelength-filtered apertures WError N Compare WError with a given wavelength error threshold. N is a given error wavelength threshold If it is greater than the value, indicating that the optical bench is out of specification.

[0021] In yet another aspect of the present invention, the endotoxin reader comprises a control unit and Memory that stores executable code that performs an action when executed by a role unit and the action includes: using a spindle of the reader to place the and rotating the mounted temperature verification plate (TVP); and activating the heater in the reader to obtain the T The temperature of the VP body is maintained at a specified temperature; and the TVP is measured using the optical bench of the reader. Obtaining a temperature measurement value of the body of the TVP from the temperature indicator and storing it in memory; Obtaining a temperature measurement value of the body of the TVP using the temperature measurement sensor and storing it in memory; Temperature measurements taken from the VP temperature indicator and from the reader's temperature measurement sensor calculating the difference between the temperature measurements, storing in memory and comparing; and determining if the difference is greater than a predetermined temperature difference threshold. and indicating a calibration error of the temperature measurement sensor of the reader when the temperature measurement error is greater than the threshold.

[0022] In another aspect of the 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 and applying a calibration factor to temperature measurements obtained from a temperature measurement sensor of the reader based on the calibration factor. Hmm, perform an additional action.

[0023] In another aspect of the invention, the code, when executed by the control unit, Temperature measurements taken from the TVP at two or more predefined temperatures and the reader at two or more predefined temperatures Calculate the calibration factor based on the difference between the temperature measurement obtained from the temperature sensor in the Further actions are taken, including applying the temperature measurements obtained from the measurement sensors.

[0024] In another aspect of the invention, the code when executed by the control unit determining said calibration coefficients using linear interpolation and / or mathematical regression. Perform the action.

[0025] Advantages of the present invention will become apparent from the following description of embodiments thereof shown and described by way of example. As will become more apparent to those skilled in the art, the present invention can be implemented in a variety of different ways. Embodiments are possible, the details of which may be varied in various respects.

[0026] These and other features and advantages of the present invention will become apparent from the following detailed description of the preferred embodiments when considered in conjunction with the accompanying drawings, in which: These will now be specifically exemplified in the embodiments of the present invention as examples. [Brief description of the drawings]

[0027] [Figure 1A]FIG. 1A is an isometric view of an exemplary reader and validation plate in accordance with an exemplary embodiment of the disclosed technology. [Figure 1B] FIG. 1B is a block diagram of an example reader in accordance with an example embodiment of the disclosed techniques. [Figure 2A] FIG. 2A is a cross-sectional view of an exemplary reader in accordance with an exemplary embodiment of the disclosed technology. [Figure 2B] FIG. 2B is a cross-sectional view of an exemplary reader in accordance with an exemplary embodiment of the disclosed technology. [Figure 2C] FIG. 2C is a cross-sectional view of an exemplary reader in accordance with an exemplary embodiment of the disclosed technology. [Diagram 3] FIG. 3 is an isometric view of an exemplary temperature verification plate in accordance with an exemplary embodiment of the disclosed technology. [Figure 4] FIG. 4 is a top view of an exemplary temperature verification plate in accordance with an exemplary embodiment of the disclosed technology. [Diagram 5] FIG. 5 is a block diagram of an exemplary temperature verification plate in accordance with an exemplary embodiment of the disclosed technology. [Figure 6] FIG. 6 is a flow diagram of an exemplary method of using a temperature verification plate, in accordance with an exemplary embodiment of the disclosed technology. [Figure 7] FIG. 7 is a flow diagram of an exemplary method for verifying a reader's temperature measurement using a temperature verification plate, in accordance with an exemplary embodiment of the disclosed technology. [Figure 8A] FIG. 8A is an isometric view of an exemplary reader and optical validation plate in accordance with an exemplary embodiment of the disclosed technology. [Figure 8B] FIG. 8B is a cross-sectional view of an exemplary reader and optical validation plate in accordance with an exemplary embodiment of the disclosed technology. [Figure 9A] FIG. 9A is a top view of an exemplary optical validation plate in accordance with an exemplary embodiment of the disclosed technology. [Figure 9B] FIG. 9B is a cross-sectional view of an exemplary optical validation plate in accordance with an exemplary embodiment of the disclosed technology. [Figure 9C] FIG. 9C is a cross-sectional view of an exemplary optical validation plate in accordance with an exemplary embodiment of the disclosed technology. [Figure 10] FIG. 10 is a plot of transmittance versus wavelength for exemplary shortpass and longpass filters in accordance with an exemplary embodiment of the disclosed technology. [Figure 11A] FIG. 11A is a flow diagram of an exemplary method for verifying an optical measurement of a reader using an optical verification plate, according to an exemplary embodiment of the disclosed technology. [Figure 11B] FIG. 11B is a flow diagram of an exemplary method for verifying an optical measurement of a reader using an optical verification plate, according to an exemplary embodiment of the disclosed technology.

[0028] Please note that all drawings are schematic and are not drawn to scale. The relative dimensions and proportions of parts in these figures are for clarity and convenience of the drawings. Corresponding or similar features in different embodiments may be used in the drawings. The same reference numbers are generally used to refer to the same components. Accordingly, the drawings and description may be construed as follows: It is intended to be illustrative in nature and not limiting. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0029] Approximate terms used throughout this specification and claims are intended to describe the basic function to which they relate. applied to modify any quantitative expression that may be permissibly changed without resulting in a change in Accordingly, a value modified by a term such as "about" may be limited to the precise value specified. Without being limited thereto, in at least some instances, the approximation may refer to the accuracy of an instrument for measuring the value. The range limitations may be combined and / or interchangeable, and such The scope includes all subcomponents described herein unless the context or language indicates otherwise. Unless otherwise indicated in the operational examples or otherwise, the scope of the present invention is limited to the scope of the present invention. All numerical values ​​referring to amounts of ingredients, reaction conditions, etc. used in the claims are intended to be understood as including the following: or expressions are to be understood as being modified in all instances by the term "about." It should be.

[0030] "Optional" or "optionally" means that the subsequently described event or circumstance occurs. or that subsequently specified substances may or may not be present, The description also includes examples of events or situations occurring or substances being present, and It is intended to include instances in which the circumstances do not occur or the materials are not present.

[0031] As used herein, the terms "comprise" and "comprise" are used interchangeably. "ising", "includes", "including", "has," "having," or any other variation thereof, is a non-exclusive For example, a process that includes a list of elements The term "method, article, or apparatus" is not necessarily limited to only those elements expressly listed. The present invention includes other elements not disclosed herein or inherent in such process, method, article or apparatus. Good too.

[0032] The singular forms "a," "an," and "the" are clear from the context. Unless otherwise indicated, plural reference words are included.

[0033] As used herein, a "processor" refers to a device that processes signals and performs general calculation and computing functions. The signals processed by the processor can be digital signals, data signals, computer computer instruction, processor instruction, message, bit, bitstream, or In general, the process may include other means for detecting and / or receiving the signal. The processor is based on multiple single and multi-core processors and co-processors, as well as multiple other A variety of single and multi-core processor and co-processor architectures, including The processor may be a variety of processors for performing various functions. It can include modules such as:

[0034] As used herein, "memory" includes volatile and / or non-volatile memory. Non-volatile memory can be, for example, ROM (read only memory), P ROM (Programmable Read-Only Memory), EPROM (Erasable PROM), and Volatile memory includes, for example, For example, RAM (random access memory), synchronous RAM (SRAM), dynamic RAM (DRAM), etc. DRAM (DRAM), Synchronous DRAM (SDRAM), Double Data Rate S DRAM (DDRSDRAM), Direct RAM Bus RAM (DRRAM) The memory can also include a drive (disk). An operating system that controls or allocates resources on a computing device. The memory can also store data for use by the processor. It can be remembered.

[0035] As used herein, a "controller" refers to a device that includes various components, such as a processor and memory. The controller may include a microcontroller having an on-board processor and memory. A cross controller may also be included.

[0036] As used herein, a "drive" may refer to, for example, a magnetic drive, a solid-state drive, a front-end drive, a floppy drives, tape drives, Zip drives, flash memory cards, and / or or a memory stick. In addition, the drive can be a CD-ROM ( Compact disc ROM), CD recordable drive (CD-R drive), CD rewritable CD-RW drive, and / or Digital Video ROM drive (D The drive can be a hard disk drive (HDD ROM). The operating system and / or programs that control or allocate the Ram can be stored.

[0037] Some portions of the following detailed description refer to operations on data bits within a computer memory. It is presented in terms of algorithms and symbolic representations of operations. The descriptions and representations are the ones that will most effectively convey the substance of their work to others skilled in the art. An algorithm is, here, and generally, a means used to A step is considered to be a self-consistent sequence of steps (instructions) that leads to a certain result. These quantities usually, but not necessarily, are quantities that require physical manipulations. but which can be stored, transferred, combined, compared, and otherwise manipulated by electrical, magnetic, or optical means These signals may be referred to as bits, values, elements, symbols, characters, terms, or It is sometimes convenient, mainly for reasons of common usage, to call things objects or numbers. A specific arrangement of steps requiring physical manipulations or transformations of logical or physical quantities or expressions. Without loss of generality, it is sometimes convenient to refer to them as modules or code devices. be.

[0038] However, all of these and similar terms should be associated with the appropriate physical quantities. are merely convenient labels applied to these quantities. Unless otherwise specifically noted, the terms "processing" or "computing" are used throughout this specification. Use of terms such as "calculating" or "calculating" or "determining" or "displaying" or "determining" The discussion herein refers to the memory or registers or other such information storage devices of a computer system. Manipulating and transforming data represented as physical (electronic) quantities in storage, transmission or display devices the operation of a computer system or similar electronic computing device (such as a particular calculator) It will be understood that the term refers to processing.

[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 may be embodied in software, firmware, or hardware, and may be embodied in software. When implemented, it is used on different platforms by various operating systems. Note that the .ini file exists on the form and can be downloaded to be operated from there. The embodiments also include computer programs that can be executed on a computing system. It may also be present in rum products.

[0040] The present embodiments also relate to an apparatus for performing the operations herein, the apparatus comprising: It may be specially constructed for the purpose, such as a particular computer, or Selectively activated or reconfigured by a computer program stored in the computer Such computer programs may include non-transient computers. Computer readable storage media, such as, but not limited to, a floppy drive (disk disk), optical drive (disk), CD-ROM, magneto-optical drive (disk), read Read-only memory (ROM), Random Access Memory (RAM), EPROM, EEPROM M, magnetic or optical cards, application specific integrated circuits (ASICs), or storage of electronic instructions The data may be stored on any type of media suitable for connection to a computer system bus. Furthermore, the computers referred to in this specification may include a single processor. or employ multiple processor designs to increase computing power It can be an architecture.

[0041] The algorithms and displays presented herein may be implemented using a particular computer or other apparatus. The present invention is not inherently related to the teachings of various general purpose systems. The method may be used in conjunction with a ram or with more specialized apparatus for performing the method steps. It may prove useful to build a The structure for this will become apparent from the following description. In addition, the embodiments may be modified in any particular manner. The present invention is not described with reference to any programming language. Various programming languages ​​may be used herein. It will be appreciated that the teachings of the described embodiments may be practiced using the following: References to specific language are provided for the purpose of disclosing the enablement and best mode of the embodiments. This is what we have in mind.

[0042] In addition, the language used herein has been chosen primarily for readability and educational purposes. and may not have been selected to define or encompass the subject matter of the invention. Accordingly, the disclosure of the embodiments is intended to exemplify the scope of the embodiments, which are set forth in the claims. These are intended to be illustrative and not limiting.

[0043] Turning now to FIG. 1-7, the reaction wells of the reaction disk in the endotoxin reader 100 Bacterial endotoxin test results may be adversely affected if temperature measurements are not within specifications Additionally, the light source 130 and / or light detector 135 of the reader 100 are operating within specifications. If not, the results may be adversely affected. The light source and the sensor are The optical response of the plate (disk) 103 is measured, and the light source and the sensor are 3 may 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 Temperature Verification Plate (TVP) 3 00 and / or Optical Verification Plate (OVP) 800, etc. This is performed using a verification plate 200 that is removably attached to 105.

[0045] The TVP 300 wirelessly transmits the temperature at a specific location on the TVP's body 335 to the reader 100. The TVP 300 may report the temperature of the heater 110 and the temperature sensor 115 of the reader 100. may be used to verify that the temperature is operating correctly. The sensor 115 may be one or more infrared temperature sensors. The heater 110 of the reader 100 includes an upper heater 110a and a lower heater 110b. The temperature sensor 115 of the reader 100 may measure the temperature at a predetermined location on the TVP 300. The reaction chamber of the reader 100 is set to a desired temperature and the temperature at a desired location on the TVP is maintained at a desired temperature. The upper temperature sensor 115a and the lower temperature sensor 115b are connected to each other to maintain the temperature of the temperature sensor 140 at a predetermined temperature. The upper heater 110a may include a sensor 115b. The lower heater 110b heats the lower surface 337 of the TVP 300 at a predetermined location. Heat is applied in a predetermined location to maintain a predetermined temperature. In an embodiment, the predetermined temperature is about 37° C. In some embodiments, the predetermined temperature may be set by the TVP 300 when the reader 1 is in use. 00, the first predetermined half from the center of the spindle 105 on the TVP 300 The first predetermined radial distance is also The temperature sensor 115 of the DA 100 measures the temperature of the TVP 300 at the center of the spindle 105. This first predetermined radial distance may be the radial distance from "A The spindle 105 and the aperture 125 of the optical bench 120 of the reader 100 are The distance between the centers is also equal to a first predetermined radial distance "A." The forward distance also refers to the distance between the spindle 105 and the location of the reaction wells on the reaction plate 103. In one exemplary embodiment, the first predetermined radial distance "A" may be equal to approximately 9 In an exemplary embodiment, the aperture 125 allows light to pass but does not allow the optical bench to It may be a window that prevents dust and / or fluid from entering the 120.

[0046] Alternatively stated, the purpose of the TVP300 and OVP800 is to verify the operation of temperature control and the optical measurement ability of the reader 100 at the location of the reaction wells on the reaction plate Therefore, the radial distance "A" in the embodiment of the reader 100 is the distance between the center of the spindle 105 when placed on the reader 100 and the location of the reaction well reaction plate 103, the distance between the center of the spindle 105 and the location where the temperature sensor 115 and the heater 110 are used to measure and maintain a predetermined temperature on the TVP300, 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 TVP300 and the location where the temperature sensor 115 and the heater 110 are used to measure and maintain a predetermined temperature on the TVP300, the radial distance between the center of the TVP300 and the location of the TVP temperature sensor 315, the radial distance between the center of the TVP300 and the location of the TVP temperature indicator 320, the radial distance between the center of the spindle 105 and the location on the OVP800 where the optical bench 120 of the reader 100 outputs light to the OVP800 and measures the light passing through the OVP800 using the light source 130 and the photodetector 135, the radial distance between the center of the spindle 105 and the opening 805 of the OVP800, the radial distance between the center of the OVP80 and the location where the optical bench 120 of the reader 100 outputs light and the like. when placed on the reader 100 and the location of the reaction well reaction plate 103, the distance between the center of the spindle 105 and the location where the temperature sensor 115 and the heater 110 are used to measure and maintain a predetermined temperature on the TVP300, 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 TVP300 and the location where the temperature sensor 115 and the heater 110 are used to measure and maintain a predetermined temperature on the TVP300, the radial distance between the center of the TVP300 and the location of the TVP temperature sensor 315, the radial distance between the center of the TVP300 and the location of the TVP temperature indicator 320, the radial distance between the center of the spindle 105 and the location on the OVP800 where the optical bench 120 of the reader 100 outputs light to the OVP800 and measures the light passing through the OVP800 using the light source 130 and the photodetector 135, the radial distance between the center of the spindle 105 and the opening 805 of the OVP800, the radial distance between the center of the OVP80 and the location where the optical bench 120 of the reader 100 outputs light and the like. when placed on the reader 100 and the location of the reaction well reaction plate 103, the distance between the center of the spindle 105 and the location where the temperature sensor 115 and the heater 110 are used to measure and maintain a predetermined temperature on the TVP300, 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 TVP300 and the location where the temperature sensor 115 and the heater 110 are used to measure and maintain a predetermined temperature on the TVP300, the radial distance between the center of the TVP300 and the location of the TVP temperature sensor 315, the radial distance between the center of the TVP300 and the location of the TVP temperature indicator 320, the radial distance between the center of the spindle 105 and the location on the OVP800 where the optical bench 120 of the reader 100 outputs light to the OVP800 and measures the light passing through the OVP800 using the light source 130 and the photodetector 135, the radial distance between the center of the spindle 105 and the opening 805 of the OVP800, the radial distance between the center of the OVP80 and the location where the optical bench 120 of the reader 100 outputs light and the like. when placed on the reader 100 and the location of the reaction well reaction plate 103, the distance between the center of the spindle 105 and the location where the temperature sensor 115 and the heater 110 are used to measure and maintain a predetermined temperature on the TVP300, 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 TVP300 and the location where the temperature sensor 115 and the heater 110 are used to measure and maintain a predetermined temperature on the TVP300, the radial distance between the center of the TVP300 and the location of the TVP temperature sensor 315, the radial distance between the center of the TVP300 and the location of the TVP temperature indicator 320, the radial distance between the center of the spindle 105 and the location on the OVP800 where the optical bench 120 of the reader 100 outputs light to the OVP800 and measures the light passing through the OVP800 using the light source 130 and the photodetector 135, the radial distance between the center of the spindle 105 and the opening 805 of the OVP800, the radial distance between the center of the OVP80 and the location where the optical bench 120 of the reader 100 outputs light and the like. when placed on the reader 100 and the location of the reaction well reaction plate 103, the distance between the center of the spindle 105 and the location where the temperature sensor 115 and the heater 110 are used to measure and maintain a predetermined temperature on the TVP300, 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 TVP300 and the location where the temperature sensor 115 and the heater 110 are used to measure and maintain a predetermined temperature on the TVP300, the radial distance between the center of the TVP300 and the location of the TVP temperature sensor 315, the radial distance between the center of the TVP300 and the location of the TVP temperature indicator 320, the radial distance between the center of the spindle 105 and the location on the OVP800 where the optical bench 120 of the reader 100 outputs light to the OVP800 and measures the light passing through the OVP800 using the light source 130 and the photodetector 135, the radial distance between the center of the spindle 105 and the opening 805 of the OVP800, the radial distance between the center of the OVP80 and the location where the optical bench 120 of the reader 100 outputs light and the like. when placed on the reader 100 and the location of the reaction well reaction plate 103, the distance between the center of the spindle 105 and the location where the temperature sensor 115 and the heater 110 are used to measure and maintain a predetermined temperature on the TVP300, 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 TVP300 and the location where the temperature sensor 115 and the heater 110 are used to measure and maintain a predetermined temperature on the TVP300, the radial distance between the center of the TVP300 and the location of the TVP temperature sensor 315, the radial distance between the center of the TVP300 and the location of the TVP temperature indicator 320, the radial distance between the center of the spindle 105 and the location on the OVP800 where the optical bench 120 of the reader 100 outputs light to the OVP800 and measures the light passing through the OVP800 using the light source 130 and the photodetector 135, the radial distance between the center of the spindle 105 and the opening 805 of the OVP800, the radial distance between the center of the OVP80 and the location where the optical bench 120 of the reader 100 outputs light and the like. when placed on the reader 100 and the location of the reaction well reaction plate 103, the distance between the center of the spindle 105 and the location where the temperature sensor 115 and the heater 110 are used to measure and maintain a predetermined temperature on the TVP300, 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 TVP300 and the location where the temperature sensor 115 and the heater 110 are used to measure and maintain a predetermined temperature on the TVP300, the radial distance between the center of the TVP300 and the location of the TVP temperature sensor 315, the radial distance between the center of the TVP300 and the location of the TVP temperature indicator 320, the radial distance between the center of the spindle 105 and the location on the OVP800 where the optical bench 120 of the reader 100 outputs light to the OVP800 and measures the light passing through the OVP800 using the light source 130 and the photodetector 135, the radial distance between the center of the spindle 105 and the opening 805 of the OVP800, the radial distance between the center of the OVP80 and the location where the optical bench 120 of the reader 100 outputs light and the like. when placed on the reader 100 and the location of the reaction well reaction plate 103, the distance between the center of the spindle 105 and the location where the temperature sensor 115 and the heater 110 are used to measure and maintain a predetermined temperature on the TVP300, 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 TVP300 and the location where the temperature sensor 115 and the heater 110 are used to measure and maintain a predetermined temperature on the TVP300, the radial distance between the center of the TVP300 and the location of the TVP temperature sensor 315, the radial distance between the center of the TVP300 and the location of the TVP temperature indicator 320, the radial distance between the center of the spindle 105 and the location on the OVP800 where the optical bench 120 of the reader 100 outputs light to the OVP800 and measures the light passing through the OVP800 using the light source 130 and the photodetector 135, the radial distance between the center of the spindle 105 and the opening 805 of the OVP800, the radial distance between the center of the OVP80 and the location where the optical bench 120 of the reader 100 outputs light and the like. The light is output to the OVP 800, and the light passes through the OVP 800 using the light source 130 and the light detector 135. The radial distance between the location on the OVP800 where the light is measured. The radial distance between the opening 805 of the P800 and / or the inside of the spindle 105 The intermediate layer between the center and the location of the light source 130 and / or the light detector 135 on the optical bench 120. It may be equivalent to the radial distance.

[0047] The TVP 300 includes a temperature verification circuit 301, which is connected to a TVP controller 305. 310, a temperature sensor 315, and a temperature indicator 320. Also, the TVP 300 includes a switch 325 and a resistor for balancing the TVP 300. A counterweight 330, a body 335, and a temperature sensor 315 in the body 335. The body 335 may include a temperature sensor channel 316. The TVP300 is heated to 100°C and the reaction disk is cooled to 100°C. The body 335 may be constructed of a material having the same emissivity as the body of the reaction disk. The body 335 may be constructed from the same materials as, but not limited to, polystyrene. olefin, cyclic olefin copolymer, and / or glycol modified polyethylene terephthalate In some embodiments, the body 335 may be constructed of one or more of the following: To aid in optical absorption, carbon may be added to give the polystyrene a black color. Additionally, one or more components of the temperature verification circuit 301 are disposed below the top surface 336 of the body 335. The battery 310, the temperature indicator 320, and the temperature sensor 31 The body 335 may have a cover such as a cover 5. The body 335 may also have a cover 5. It may have an opposing bottom surface 337 .

[0048] The controller 305 includes a memory 307 and a processor 306. The battery 310 , the controller 305 of the temperature verification circuit 301 of the TVP 300, the temperature sensor 315, and The switch 325 connects the battery 310 to the temperature indicator 320. It is possible to control (start and stop) the flow of current between other components of the authentication circuit 301. and the like to turn on and off the temperature verification circuit 301. The temperature sensor 315 The temperature sensor 315 measures the temperature and provides the value of the measurement to the controller 305. The temperature sensor may be an electronic temperature sensor such as a resistor, thermocouple, and / or a resistance temperature detector. The radial distance between the center of the VP 300 and the temperature sensor 315 is also A first predetermined distance between the center of the aperture 125 of the optical bench 120 of the optical bench 100 and the The radial distance "A" may be equal to the radial distance "A". Thus, in the exemplary embodiment, TVP30 The temperature sensor 315 of the TVP 300 is connected to the temperature sensor 115 of the reader 100. The same exact temperature measurement from the center of the TVP300 (and spindle 105) The temperature of the body 335 of the TVP 300 is measured at various radial positions. This is shown in FIG. 2C. Here, the field of view 117 of the reader temperature sensor 115 is the plate temperature sensor 3 As can be seen, the top view of the reader upper temperature sensor 115a includes a path of 15. Field 117a includes the path of plate temperature sensor 315. In addition, the reader lower temperature sensor The lower field of view 117b of sensor 115b includes the path of travel of plate temperature sensor 315.

[0049] The optical bench 120 detects reactions occurring within the reaction wells of a reaction disk (reaction plate). The photodetector 135 has a light source 130 and a photodetector 135 for measuring the optical response of the photodetector 135. 35 includes a power circuit for supplying power to the photodetector 135 and a digital circuit for converting the output of the photodetector 135 into a digital signal. The device may further include a printed circuit board having signal processing circuitry for digitalizing the signal. This allows a digitized output to be provided from the light detector 135. 0 includes a printed circuit board having power circuitry for supplying power to the light source 130. The controller 305 can use the temperature indicator 320 to In an exemplary embodiment, the temperature indicator 5 optically represents the temperature value measured by the The counter 320 is at least one that can change state (on / off) to indicate a "1" or a "0." Each of the display elements may include one visual element 321. In an exemplary embodiment, the visual element 321 may include: Whether it is an LED light as shown in Figure 2A, or an LCD as shown in Figure 2B In another embodiment, at least one visual element 321 of the temperature indicator 320 may be , may include at least one LED light and / or LCD. The timing controller 320 synchronizes the orientation of the TVP 300 with the timing of the measurement by the photodetector 135. In order to register the temperature indicator 320 with the reader 100, When the visual element 321 passes under the photodetector 135, the reader 100 measures It is possible.

[0050] In an exemplary embodiment, the temperature indicator 320 is a single LED light or LED An array of lights, including at least one LED light for optically representing values. In an exemplary embodiment, the array of LED lights is coupled to photodetector 135 of reader 100. 1 flashes to represent the temperature measurement of the temperature sensor 315 in binary form readable by In some embodiments, the temperature measurement bits may be an array of two LED lights. The default value is less than or equal to the number of LED lights available to represent the temperature of the temperature indicator 320. At one time, the temperature measurement is taken by the TVP300 over one revolution of the TVP300. In another embodiment, the temperature of the temperature measuring sensor 315 may be transmitted to the photodetector 135. If the measurement is greater than a single bit and the temperature indicator 320 is used to represent the temperature, With one LED light available, the temperature readings are 1 per revolution of the TVP300. may be transmitted by the TVP 300 to the photodetector 135 of the reader 100 at the rate of .

[0051] In some exemplary embodiments, the temperature measurement of the temperature sensor 315 is a 12-bit number. and the temperature indicator 320 has 12 LED lights available to indicate temperature. If so, the temperature measurements are taken by the TVP300 during one rotation of the TVP300. 0 may be sent to the photodetector 135.

[0052] In another exemplary embodiment, the temperature measurement of the temperature sensor 315 is a 12-bit number. When the degree indicator 320 has one LED light available to represent temperature, The temperature reading is taken by the TVP300 after 12 revolutions of the TVP300. The bit may be transmitted to the TVP 135, one bit being transmitted per revolution of the TVP 300. In this example, the rotation speed of the TVP300 is indicated by the following bit for each rotation (either "ON" or "OFF"). The LED timing may be coordinated to turn the LED on or off (either "ON" or "OFF").

[0053] In another exemplary embodiment, the temperature sensor 315 may be used to represent a temperature measurement. The temperature indicator 320 with multiple LED lights can be used to indicate multiple rotations of the TVP 300. The temperature measurement can be transmitted to the photodetector 135 of the reader 100 using the The 2-bit temperature reading can be represented by 2, 3, 4, or 6 LEDs. The 12-bit binary number is then converted to a value for 6, 4, 3, or 2 revolutions of the TVP300. The temperature indicator 320 will then transmit the temperature signal to the photodetector 135. The indicator 320 is a binary temperature indicator that is not divisible by the number of LEDs in the temperature indicator 320. It even transmits measurements; for example, a 13-bit temperature measurement is three times that of the TVP300. During rotation it can be represented by five LEDs.

[0054] In an exemplary embodiment, the temperature indicator 320 is A single LCD or an array of 12 LCDs that vary in opacity to represent a binary value The display may include at least one LCD that optically represents a value, such as a change in the opacity of the LCD. The illumination allows light generated by the light source 130 to pass through the LCD and onto the photodetector 135. 1, which can represent a "1" or the 130. This can block light from reaching the photodetector 135, representing a "0". In an embodiment, the bit value of the temperature measurement is used to represent the temperature on the temperature indicator 320. When the number of LCDs available for temperature measurement is less than or equal to the number of LCDs available for temperature measurement, the temperature readings are taken over one revolution of the TVP300. The TVP 300 may then transmit the signal to the photodetector 135 of the reader 100. In this embodiment, the temperature measurement value of the temperature measurement sensor 315 is greater than one bit number, and the temperature indicator When the 320 has one LCD available to display temperature, the temperature reading is 1 photodetector 100 by TVP300 with a speed of 1 bit per 300 revolutions 35.

[0055] In an exemplary embodiment, the temperature indicator 320 is A single LCD or an array of 12 LCDs that vary in opacity to represent a binary value The display may include at least one LCD that optically represents a value, such as a change in the opacity of the LCD. The illumination allows light generated by the light source 130 to pass through the LCD and onto the photodetector 135. 1, which can represent a "1" or a "2" generated by the light source 130. Reduce the light that penetrates the photodetector 135 or is generated by the light source 130. The temperature sensor can block light from reaching the photodetector 135, representing a "0". The temperature measurement in 315 is a 12-bit number, and the temperature indicator 320 is With 12 LCDs available, temperature readings can be taken in one revolution of the TVP300. TVP300 transmits the signal to the photodetector 135 of the reader 100, which in turn transmits the signal to the photodetector 135 of the reader 100. The temperature value may be transmitted to the reader 100 from 1.00. One LCD which is a 2-bit number and is available for the temperature indicator 320 to display the temperature If the TVP300 has a temperature reading, the temperature reading is read by the TVP300 after it has rotated 12 times. The TVP 300 transmits the temperature signal to the reader 100. In this embodiment, the rotation speed of the TVP is set to the following value per rotation: The bit can be used to either "pass light" or "block light." The LCD timing is adjusted to show the "BLOCKING LIGHT" good.

[0056] In another exemplary embodiment, the temperature sensor 315 may be used to represent a temperature measurement. A temperature indicator 320 having multiple LCD lights is provided to indicate multiple rotations of the TVP 300. The temperature measurement may be transmitted to the photodetector 135 of the reader 100 using a 12-bit The temperature readings of the device may be displayed by 2, 3, 4 or 6 LCDs. The 12-bit binary number then records the temperature during 6, 4, 3, or 2 revolutions of the TVP300. The temperature indicator 320 will transmit the signal to the photodetector 135. The temperature indicator 320 is a binary temperature measurement that is not divisible by the number of LCDs in the temperature indicator 320. For example, a 13-bit temperature measurement may be transmitted over three revolutions of the TVP300. can be represented by five LCDs.

[0057] Transmits temperature values ​​from the TVP300 to the Reader 100 using light as opposed to radio frequency This allows for use in areas where radio frequencies are highly regulated or where potential radio interference exists. This allows the TVP300 to be used in areas where there is a possibility of The P300 design allows the use of an existing optical bench 120 and provides an RF receiver or This also eliminates the need to integrate a transceiver into the reader 100 .

[0058] Turning to a method 600 for measuring temperature using a TVP 300, in 601 the method includes: The process proceeds to step 605 where the TVP 300 is started. The TVP 300 starts when the switch 325 is in the "ON" position. At 605, the TVP is set to a first predetermined length of time. During this time, at least one temperature measurement is taken using the temperature sensor 315 and the measurement is stored in a computer. In an exemplary embodiment, the at least one temperature measurement is sent to the temperature controller 305. The measurements may be taken for a first predetermined amount of time using the temperature sensor 315, and the measurements may be Additionally, measurements may be provided to the controller 305 when more than one temperature measurement is obtained. The first predetermined amount of time is taken at a first repeat interval and provided to the controller 305. The temperature measurements taken during the first predetermined amount of time may be provided as one or more When the temperature measurements are provided to the controller 305 for a first predetermined amount of time, In an exemplary embodiment, the first predetermined length The time period for the first repetition may be about 5 seconds and the first repetition interval may be about 0.1 seconds. .

[0059] At 610, the value of the at least one temperature measurement obtained at 405 is converted into a temperature indicator. The controller 305 of the TVP 300 then uses the data 320 to generate a second predetermined amount of time. In an exemplary embodiment, the second predetermined period of time is approximately 0.4 seconds. This value may be an average of temperature measurements taken over a first predetermined amount of time. Prior to output, the controller 305 may convert the values ​​from numeric to binary. In an exemplary embodiment, the numerical value is converted to a 12-bit binary value and a temperature indicator However, the numbers may be output using 12 LEDs of 320. The resolution may be converted to a different number of LEDs or LCDs in the temperature indicator 320. It is contemplated that the temperature indicator 320 and the controller 305 may also output validation information to inform the reader 100 that the measurement is valid. In an embodiment, the verification information is an extra "1" at the beginning and end of the 12-bit number. In some cases, the total number of bits is 14, and only the middle 12 bits represent the temperature measurement value. It outputs the temperature as a 12-bit number, plus an extra 2 bits for validation. In some embodiments, the temperature indicator 320 outputs a temperature signal measured during one revolution of the TVP. It has 12 LEDs or LCDs so that it can transmit set values ​​and verification information. or allows the transmission of measurements and validation information during the 14 revolutions of the TVP300. As shown, a single LED or LCD may be used. The method then returns to 601. 605. In an exemplary embodiment, the switch 32 As long as 5 is in the "ON" position, the TVP300 remains activated.

[0060] A block of components 106 of the reader 100 that interacts with the reader's controller 145 A diagram of this is shown in FIG. 1B. As can be seen, the controller 145 includes a memory 119 and and a CPU (processor) 118 for executing a program stored in a memory 119. The controller includes a user interface 113, a spindle 105, and a plate 103. , the optical bench 120, and the reaction cavity environment 155. In some embodiments, the user interface 113 also interacts with the controller 145. In one embodiment, the housing 101 includes a reaction cavity 140 and and a heater 110 and / or a temperature sensor 11 for adjusting the temperature in the plate 103. 5. Plate 1 03 provides position information to the controller 145. The optical bench 120 includes a photodetector 13. 5 provides information regarding the intensity of the light received by the temperature sensor 145 to the controller 145. The reaction cavity environmental augmenter 155, such as the augmenter 115, is configured to accommodate reaction wells on a reaction plate. The temperature of the plate 103 at the position is measured and provided to the controller 145. The controller 145 uses this information to determine whether or not the heater 110 should be activated within the enclosure 101. The user interface 113 allows the user to input the test parameters to the controller 145. and the controller 145 displays the test results to the user. The motorized spindle 105 can transmit position information to the controller 102. 16, and a controller 145 may be provided to the user interface 113 It may also be possible to adjust the rotation of the plate 103 via.

[0061] Let's look at how to verify the temperature measurement performance 700 of the reader 100 (temperature verification mode). , 701, start the TVP300 by moving the switch to the "ON" position, etc. , and the TVP 300 measures the temperature at the temperature sensor 115 according to the method of 600. As you can see, the TVP300 measures and outputs the temperature. When rotated by the spindle 105 of the 100, the temperature of the body 335 of the TVP300 is measured. In 705, the reader 100, via the user interface 113, In verification mode, the reader 100 uses the spindle 105 to read the TVP 710. Rotate the TVP300 and keep it rotating during the temperature verification mode. The temperature sensor of the reader is operated under the same conditions as those used when a reaction plate is present in the detector 100. In 715, the heater 110 is turned on and the heater 115 is turned on. The temperature sensor 115 of the reader is operated by the controller 145 of the reader to detect the TVP The body 335 of 300 is heated and maintained at a predetermined temperature.

[0062] At 720, the body of the TVP is maintained at a predetermined temperature for at least a first predetermined amount of time. Once held, the reader 100 uses the reader's temperature sensor 115 to measure the temperature of the TVP 300's body. and the TVP 300 uses the temperature indicator 320 in accordance with method 600. The reader 100 uses an optical bench 120 to obtain and output temperature measurements. 00, and optionally a verification bit. 100 obtains temperature measurements of the bottom surface 337 and / or top surface 336 on the body 335. In an exemplary embodiment, the temperature measurements are sent from the TVP 300 in a 12-bit binary format. Optionally, the temperature measurement from the TVP300 may be The temperature verification circuit 301 of the TVP300 is converted to a decimal number and the following formula is used to verify the temperature. May be adjusted for measurement range:

number

[0063] At 725, the reader 100 reads the TVP temperature measurement from the TVP 300 as and a reader temperature measurement, also known as a temperature measurement, obtained from the reader's temperature sensor 115. Also known as the TVP temperature measurement, the difference is calculated and compared. If the difference between the temperature sensor value and the reader temperature measurement is less than or equal to a predefined temperature difference threshold, the reader’s temperature sensor The calibration of 15 may be verified and notified to the user via the user interface 113. If the difference between the TVP temperature measurement and the reader temperature measurement is greater than a predefined temperature difference threshold, the temperature The calibration of the temperature sensor 115 is not verified and the user is not prompted to change the temperature through the user interface 113. In one embodiment, the predetermined temperature difference threshold is approximately 1° C. In another embodiment, the predetermined temperature difference threshold may be about 0.5° C. In another embodiment, the predetermined temperature difference threshold may be about 0.1 degrees Celsius.

[0064] In some embodiments, steps 715-725 include steps of: This may be repeated to obtain the temperature difference between the TVP 300 and the reader 100. For example, The temperature difference between the P300 and the reader 100 may be evaluated at both 22°C and 37°C. stomach.

[0065] In optional step 730, a user input is provided to bring the temperature sensor 115 back into calibration. A calibration coefficient is applied to the output value of the temperature sensor 115 of the reader through the interface 113 or the like. If only a single predetermined temperature point is used, the temperature sensor 115 may be calibrated using A single point offset may be used to obtain a calibration factor for the two predetermined temperatures. If degree points are employed, a straight line is used to obtain a calibration factor for calibrating the temperature sensor 115. Interpolation may be performed. If more than two predetermined temperature points are employed, the temperature sensor 115 Other interpolation methods, such as mathematical regression, may be used to obtain the calibration coefficients for calibrating In an exemplary embodiment, the mathematical regression may be a polynomial regression.

[0066] 1A-2C and 8A-11, the optical verification plate (OVP) 800 , can be used to verify that the reader's optical bench 120 is working correctly. The OVP 800 includes a number of openings 805 located along the periphery of the body 801 of the OVP 800. The center of each opening 805 is a first predetermined distance from the center of the body 801 of the OVP 800. 8. The apertures 805 are spaced a radial distance "A" apart such that the apertures 805 are spaced apart from the optical bench 1. 20 can be aligned with a light source 130 and a light detector 135, and the light generated by the light detector 135 The light emitted 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 openings 805 may include filtered openings. 806, some of the filtered apertures may have neutral density filters 810. (Aperture with neutral density filter 811), one or more apertures have a wavelength filter (wavelength Long filter with aperture 850), Short pass filter with aperture 815 (Short pass filter with aperture aperture 816), long pass filter 820 (aperture with long pass filter 821) , bandpass filters (apertures with bandpass filters), and / or stop bands The optical filter may include at least one of the following: .

[0067] In an exemplary embodiment, the filtered opening 806 of the OVP 800 comprises at least Includes one wavelength filtered aperture 850 and seven neutral density filtered apertures 811. In an exemplary embodiment, each of the seven neutral density filtered apertures of the OVP 800 In an exemplary embodiment, the neutral density filters The optical density value may be about .01-3. In another exemplary embodiment, a neutral density filter In a further exemplary embodiment, the optical density value of the dimming filter may be about .01-2. The optical density value of the filter may be about 0.1-1.2. The optical density value of the neutral density filter may be about 0.1-1.15. The mouth 806 rotates counterclockwise around the OVP 800 a second predetermined distance "B". They may be spaced apart.

[0068] In an exemplary embodiment, at least one wavelength filtered aperture 850 is An opening 821 with a long-pass filter and an opening 815 with a short-pass filter are provided. In an exemplary embodiment, the short pass filter 815 may include a m, and the long pass filter 820 has a cutoff of about 410 nm. In an exemplary embodiment, the light source 130 of the optical bench may have a The light may be outputted having a wavelength of 5 nm. At least one wavelength filter, such as a long pass filter 815 and / or a long pass filter 820. By examining the output of light source 130 through tapped aperture 850, reader 100 can determine: Verify that the spectrum of light output by light source 130 is within or out of specifications It is possible.

[0069] The spectral transmittance curves of the short-pass filter 815 and the long-pass filter 820 are shown in Figure 10. As can be seen, a short pass filter 815 and a long pass filter 820 has a very narrow transition band (the band between the stop band and the pass band). Thus, some embodiments of the OVP 800 may be implemented using a single stop having a sufficiently narrow transition band. Use a short-band or bandpass filter to filter the short-pass filter 815 and the long-pass filter It is contemplated that both of the pass filters 820 may be replaced.

[0070] In an embodiment, one or more filters 807 are provided on the top surface 835 of the OVP 800. The OVP 800 may be mounted to form a zero (0) degree angle with respect to the In other words, the filter(s) 807 are flat on the top surface 835 of the OVP 800. The one or more filters 807 may be flat, so that the light from the light source 130 It may be perpendicular (90°) to the direction of light traveling to the photodetector 135 of the optical bench 120 .

[0071] In another embodiment, the filter 807 is angled at a first predetermined angle relative to the top surface 835 of the OVP 800. One or more filters 807 may be attached to form a degree "F". In an exemplary embodiment, the first predetermined angle "F" may be between about 0 degrees and about 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 OVP filters on the filter bed 808. The filter or filters may be mounted below the top surface 835 of the OVF 800. The OVP 80 is rotated so as to form a zero (0) degree angle with respect to the filter floor 808 of the P800. 0. Thereby, the one or more filters 807 may be attached to the light source 1 30 to the light detector 135 of the optical bench 120. It is possible.

[0073] In another embodiment, the filter 807 is a first filter layer 808 for the filter bed 808 of the OVP 800. One or more filters 807 are attached to form a predetermined angle "F" of In an exemplary embodiment, the first predetermined angle "F" is between about 0 degrees and about 45 degrees. In another exemplary embodiment, the first predetermined angle "F" may be approximately 30 degrees. stomach.

[0074] The OVP 800 may also have an entrance aperture 825 and a registration aperture 830, which Both of them are unfiltered. All of the openings 805 have a smaller radius. The radii may be the same, except for the registration opening 830, which may be different. , the entrance aperture 825 is between the first filtered aperture 806a and the registration aperture 830. Further, in the exemplary embodiment, the registration aperture 830 is located at the entrance aperture 8 25 and the last filtered opening 806b. The distance between the mouth 806a and the entrance opening 825 may be a second predetermined distance "C." The distance between the entrance aperture 825 and the registration aperture 830 may be a third predetermined distance "D". The distance between the registration opening 830 and the last filtered opening 806b is a fourth predetermined In an exemplary embodiment, the second predetermined distance is approximately 16 mm. the third predetermined distance may be about 4 mm, and the fourth predetermined distance may be about 74 mm. In some embodiments, the reader 100 may detect the rotation of the OVP 800. It is contemplated that the enrollment pattern 845 may be used to determine the angle. In some embodiments, the registration pattern 845 may include a registration opening 830. In one embodiment, the registration pattern 845 includes both the registration aperture 830 and the entrance aperture 825. That's fine.

[0075] In the exemplary embodiment, the reader 100 rotates across the optical bench 120. The recording pattern 845 is then recognized, and a predetermined number of filtered apertures 806 are then The next opening 805 across the hole may be programmed to know that the hole is the next opening 805 across the hole. The filter values ​​and order of the filtered aperture 806 are programmed into the reader 100. 1, so that the processor 118 of the reader 100 can analyze the performance of the optical bench 120. The results can be output to the user via the user interface 113. become.

[0076] In some exemplary embodiments, the OVP 800 is configured to It may also have a balancer 840 for balancing the OVP 800 while it is rotating. The balancer 840 may include, but is not limited to, counterweights, weight reduction recesses, and and / or may include one or more of the weight reduction holes.

[0077] 11A-B show the optical performance of the optical bench 120 of the reader 100 using the OVP 800. 11 shows an exemplary method 1100 for measuring and verifying absorbance, or optical density, and error 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 The optical bench 120 is used to identify the registration pattern 845 on the OVP. , the reader 100 reads the optical bench 12 at the exact moment that the aperture 805 passes through the optical bench. This allows for timing of sampling by 0. The reader uses a light source 130 to pass light through the entrance aperture 825 and receive it on a light detector 135. This measurement is based on the intensity of the light incident on the i ) stored in memory 119 can be.

[0078] In block 1115, the reader uses the light source 130 to provide at least one dimming filter. Light is passed through the filtered aperture 811 and the intensity of the light received by the photodetector 135 is measured. The value of this intensity measurement (I fN ) is stored in the memory 119, and N is the number of apertures with neutral density filters. The operation of block 1115 increments the number of apertures 811 with neutral density filters. This 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, the formula T N =( I fN / I i ) is used by the processor 118 to calculate the transmittance (T N ) is calculated and the memory 19. The operation of block 1120 stores the transmission of each neutral density filtered aperture 811. This is repeated until a value is calculated by the processor 118 and stored in the memory 119. Good too.

[0080] At block 1125, the measured absorbance (A mN ) is the formula A mN =-log 10 (T N ) for at least one neutral density filter-equipped aperture 811, The effective T N The value is 0 to 1. The operation of the block 1125 is to measure the actual absorbance for each of the neutral density filter apertures 811. This is repeated until a value is calculated by the processor 118 and stored in the memory 119. Good too.

[0081] At block 1130, at least one neutral density filter aperture 811 is The measured absorbance (A mN ) at a given absorbance value (A pN ) and the processor 118 Using the expression AError N =(A mN -A pN ) / A pN The percentage error is calculated using and the absorbance percent error is stored in memory 119. In an exemplary embodiment, The absorbance value of is the actual guaranteed absorbance of the neutral density filter at the neutral density filter aperture 811. The operation of block 1130 may be The absorbance percent error value is calculated by the processor 118 and stored in the memory 119. This may be repeated until

[0082] At block 1135, absorbance measurements of at least one neutral density filtered aperture are taken. Percentage error of 811 (AError N ) is calculated by the processor 118 based on a predetermined extinction coefficient. Luminous error threshold (AError p ) is compared to the predetermined dimming error. If the threshold is exceeded, the user is notified so that the optical bench 120 of the reader 100 The processor 118 may indicate that the user interface 118 is out of specification. 13. In an exemplary embodiment, a predetermined dimming error threshold The operation of block 1135 is to adjust the aperture ratio of each neutral density filter 81 to approximately 5%. 1 is completed using the processor 118, the results are stored in memory 119, and the user This may be repeated until it is output to the user via the user interface 113.

[0083] In block 1140, the reader uses the light source 130 to generate at least one wavelength frame. Light is passed through the filtered aperture 850 and the intensity of the light received by the photodetector 135 is measured. The value of this measurement is the intensity wavelength measurement I WN and N is the number of wavelength filters. The operation of block 1115 is incremented by one for each wavelength-filtered aperture 850. This may be repeated until a value has been measured for the opening 850 and stored in memory 119 .

[0084] In block 1145, the wavelength error (WError N ) is the processor 118, at least one of the incident light intensities passing through the wavelength filtered aperture 850 The measured value (I WN ) and the measured incident light intensity passing through the incident light aperture 825 (I i ) ratio Expression WError N =I WN / I i The optical vein is calculated by evaluating the This wavelength error for each wavelength filter is stored in memory 119. The operation of block 1145 The wavelength error value of the filtered aperture 850 is calculated by the processor 118 and stored in the memory 119. This may be repeated until the number of times the number of times is stored in the memory.

[0085] In block 1150, the processor 118 performs a filter for each wavelength-filtered aperture 850. The wavelength error is compared with a predetermined wavelength error threshold, and if the predetermined wavelength threshold is exceeded, the user is notified. , thereby indicating that the optical bench 120 of the reader 100 is out of specification. The difference threshold may be a predetermined wavelength error sum threshold or a predetermined individual wavelength error threshold. The processor may notify the user via the user interface 113. In an exemplary embodiment, the total wavelength error is no more than about 5% (more than 5%). Alternatively, the predetermined wavelength error sum threshold may be about 5%. In the embodiment, any individual wavelength error threshold may be about 2.5%, or alternatively stated In another embodiment, the predetermined individual wavelength error threshold may be about 2.5%. The wavelength error threshold is set at wavelengths greater than about 410 nm and / or less than about 400 nm. The operations of block 1150 may correspond to the output of light source 130 having a length. A comparison is completed for each wavelength filtered aperture 850 by 118 and the results are stored in memory. 119 and output to the user via the user interface 113. It may be repeated.

[0086] While the present invention has been described in connection with the specific embodiments set forth above, many alternatives, combinations and modifications are possible. It is apparent that many adaptations, modifications and variations will be apparent to those skilled in the art. The preferred embodiments of the present invention shown are for illustrative purposes only and are not intended to be limiting. Various modifications may be made without departing from the spirit and scope of the invention. Combinations of the above embodiments with other embodiments will be apparent to those skilled in the art upon studying the above description. It is understood that the above-mentioned technical solutions are within the scope of the present invention and are intended to be encompassed therein. The scope of the present invention is defined by the appended claims and is intended to be understood as including the claims literally or by their equivalents. All devices, processes, and methods that fall within the meaning of the claims are intended to be encompassed therein. It is intended that:

Claims

1. 1. A temperature verification plate (TVP) for an endotoxin reader, comprising: configured to be placed on a spindle of the reader and rotated by the spindle; Includes a body; the body having a temperature verification circuit including a temperature sensor and a temperature indicator; The temperature sensor detects the temperature of the body when rotated by the spindle of the reader. configured to measure a temperature; The temperature indicator optically indicates the value of the temperature measured by the temperature sensor. the temperature indicator being readable by an optical bench of the reader. Temperature Verification Plate (TVP).

2. The temperature sensor may be an electronic temperature sensor, a thermistor, a thermocouple, and / or a resistance temperature detector.

2. The TVP of claim 1 ,

3. The temperature indicator may include at least one light emitting diode (LED) and / or at least one liquid crystal display (LCD); the temperature indicator The TVP of claim 1 , wherein degree values ​​are represented as binary numbers.

4. The binary number determines the resolution of the temperature measured by the temperature sensor, and the binary number The TVP of claim 3 , wherein the number has two or more validation bits.

5. The TVP of claim 4 , wherein the binary number is a 12-digit number.

6. The temperature indicator may be a single LED, 12 LEDs, 14 LEDs, a single LED, 5. The TVP of claim 4 which is a CD, 12 LCDs, or 14 LCDs.

7. The temperature verification circuit further includes a battery and a switch; the battery is connected to the temperature verification circuit. when the switch is in the "ON" position, allows current to flow from the battery, and when the switch is in the "OFF" position, The TVP of claim 1 , which blocks current flow from the battery.

8. The temperature sensor measures the temperature at a first repeat interval for a first predetermined length of time.

2. The method of claim 1, wherein the temperature indicator outputs an average of the temperature measurements. TVP featured.

9. The first predetermined amount of time is about 5 seconds, and the first repetition interval is about 0.1 seconds. The TVP of claim 8.

10. 1. A method for verifying temperature performance of an endotoxin reader, comprising: providing a reader and a temperature verification plate (TVP); The TVP is placed on the spindle of the reader and the spindle is used to rotate the TVP. and operate the heater of the reader to maintain the temperature of the TVP body at a predetermined temperature. and The temperature indicator of the TVP is used to measure the temperature of the TVP using the optical bench of the reader. obtaining a temperature measurement of the body of the TVP using the temperature measurement sensor of the reader; obtaining a temperature measurement of the body; The temperature measurement obtained from the temperature indicator of the TVP and the calculating and comparing the difference between the temperature measurements obtained from a temperature measurement sensor; If the difference is greater than a predetermined temperature difference threshold, it indicates a calibration error of the temperature measurement sensor of the reader. and

11. The temperature measurements obtained from the TVP and the temperature measurements obtained from the temperature sensor of the reader and calculating a calibration factor based on the difference between the temperature measurement and the temperature measurement sensor of the reader.

11. The method of claim 10, further comprising applying the temperature measurement obtained from a sensor. 。

12. 10. The method of claim 10, wherein the predetermined temperature difference threshold is about 1° C., about 0.5° C., or about 0.1° C. The method described above.

13. The method of claim 10 , wherein the difference is calculated at two or more predetermined temperatures.

14. The method of claim 13, wherein the predetermined temperature is 22°C and / or 37°C.

15. The temperature measurements obtained from the TVP at two or more predetermined temperatures and A calibration factor is calculated based on the difference between the temperature measurement obtained from the temperature sensor of the reader and the temperature. and applying the calibration coefficient to the temperature measurements obtained from the temperature measurement sensor of the reader.

14. The method of claim 13, further comprising:

16. 16. The calibration coefficients are determined using linear interpolation and / or mathematical regression. The method described above.

17. 1. An optical verification plate (OVP) for an endotoxin reader; a body having a plurality of openings located along a periphery; The center of each opening is located a first predetermined radial distance away from the center of the body, allowing the aperture to be aligned with the optical bench of the reader to allow the optical Light generated by a source passes through the aperture and the intensity of the light is recorded on a photodetector of the reader. Make it more measurable; the openings include filtered and unfiltered openings; The filtered opening moves a second predetermined distance as it travels counterclockwise around the OVP. Spaced apart by a distance of 1.5 mm is an optical verification plate (OVP).

18. The filtered aperture may include one or more neutral density filter apertures and one or more and a wavelength filtered aperture.

19. The one or more wavelength filtered apertures may include one or more short pass filters. Aperture with filter, one or more apertures with long-pass filter, one or more apertures with long-pass filter A number of bandpass filtered apertures and / or one or more stop bands 20. The OVP of claim 18 comprising a filtered opening.

20. The filtered aperture includes at least one wavelength filtered aperture and a second attenuation filter. and a filtered opening.

21. The at least one wavelength filtered aperture is a long pass filtered aperture.

21. The OVP of claim 20, comprising a first section and one short pass filtered aperture.

22. The one or more filters are disposed at a first predetermined angle relative to a top surface of the body of the OVP. and / or one or more filters attached to the OVP to form to form a first predetermined angle with respect to a filter floor of the body of the OVP.

20. The OVP of claim 17 attached to the OVP.

23. The first predetermined angle is about 0 degrees, about 30 degrees, or between about 0 degrees and about 45 degrees.

23. The OVP according to claim 22.

24. The optical filter further includes an entrance aperture and / or a registration aperture; the entrance aperture includes a first filter. between the tapped aperture and the registration aperture; the registration aperture is closest to the entrance aperture; 20. The OVP of claim 17, located between a rear filtered opening.

25. 1. A method for verifying optical performance of an optical bench of an endotoxin reader, comprising: Providing a reader and an optical verification plate (OVP); placing the OVP on a spindle of the reader and rotating the OVP; identifying a registration pattern on the OVP using the optical bench of the reader; A photodetector in the reader is used to measure the intensity of light passing through the entrance aperture of the OVP. wherein the light is generated by a light source of the reader, and the value of the measurement is an input light (I ｉ ) in a memory of the reader; Using a photodetector of the reader, passing through at least one neutral density filtered aperture. Measure the light intensity and repeat for each of the neutral density filtered apertures. The light is generated by the light source of the reader, and the value of the measurement is an intensity neutral measurement ( I ｆＮ ) in the memory of the reader, N being each of the neutral density filtered apertures. and; Formula T Ｎ = (I ｆＮ / I ｉ ) for each of the apertures with neutral density filters. Transmittance (T Ｎ ) and storing it in the memory of the reader; Formula A ｍＮ = -log １０ (T Ｎ ) to each of the apertures with neutral density filters. The actual absorbance (A ｍＮ ) and storing it in the memory of the reader. To do; A for each of the neutral density filtered apertures ｍＮ and a given absorbance value (A ｐＮ ) and the formula AError Ｎ = (A ｍＮ -A ｐＮ ) / A ｐＮ Calculate the percentage error using 3. Note the calculated absorbance percent error for each of the neutral density filtered apertures. and comparing by storing in a AError Ｎ is compared with a predetermined extinction absorbance error threshold, and AError Ｎ The specified reduction if greater than a light absorbance error threshold, indicating that the optical bench is out of specification; The photodetector of the reader is used to measure the wavelength of light passing through at least one wavelength-filtered aperture. and repeating for each of said wavelength filtered apertures. Thus, the light is generated by the light source of the reader, and the measurement value is an intensity wavelength measurement. (I ＷＮ ) where N is incremented by one for each wavelength filtered aperture. Toto; ExpressionWError Ｎ = I ＷＮ / I ｉ to each of the wavelength-filtered apertures. Regarding I ＷＮ and the above I ｉ The wavelength error (WE) of the optical bench is calculated by evaluating the ratio of rror Ｎ ) and storing in memory; The WError for each of the wavelength filtered apertures Ｎ The specified wavelength error Compare with the difference threshold and Ｎ is greater than the predetermined error wavelength threshold, and indicating that the academic bench is out of specification.

26. The filtered aperture may be combined with one or more neutral density filtered apertures. and a number of wavelength filtered apertures.

27. The one or more wavelength filtered apertures may include one or more short pass filters. Aperture with filter, one or more apertures with long-pass filter, one or more apertures with long-pass filter A number of bandpass filtered apertures and / or one or more stop bands 27. The method of claim 26, comprising a filtered opening.

28. The filtered aperture includes at least one wavelength filtered aperture and a second attenuation filter. and a filtered opening.

29. The at least one wavelength filtered aperture is a long pass filtered aperture.

30. The method of claim 28, further comprising a first section and one short pass filtered aperture.

30. The one or more filters are disposed at a first predetermined angle relative to a top surface of the body of the OVP. and / or one or more filters attached to the OVP to form to form a first predetermined angle with respect to a filter floor of the body of the OVP. The method of claim 25, wherein the OVP is attached.

31. The first predetermined angle is about 0 degrees, about 30 degrees, or between about 0 degrees and about 45 degrees.

30. The method according to claim 30.

32. 1. An endotoxin reader comprising: A control unit; storing execution code that performs an action when executed by the control unit; and a memory for storing the The action is: The spindle of the reader is used to measure the optical detector placed on the spindle of the reader. Rotating an identification plate (OVP); identifying a registration pattern on the OVP using an optical bench of the reader; A photodetector of the reader is used to measure the intensity of light passing through the entrance aperture of the OVP. measuring the intensity of light passing through the reader, the light being generated by the light source of the reader; and the value of said measurement is stored in said memory of said reader as incident light (Ii); Toto; A photodetector of the reader is used to detect light passing through at least one neutral density filtered aperture. and repeating for each of said neutral density filtered apertures. Thus, the light is generated by the light source of the reader and the value of the measurement is an intensity neutral measurement. (I ｆＮ ) in the memory of the reader, N being each of the neutral density filtered apertures. 1 per part; Formula T Ｎ = (I ｆＮ / I ｉ ) for each of the apertures with neutral density filters. Transmittance (T Ｎ ) and storing it in the memory of the reader; Formula A ｍＮ = -log １０ (T Ｎ ) to each of the apertures with neutral density filters. The actual absorbance (A ｍＮ ) and storing it in the memory of the reader. Remembering and; A for each of the neutral density filter apertures ｍＮ and a given absorbance value (A ｐＮ ) and the formula AError Ｎ = (A ｍＮ -A ｐＮ ) / A ｐＮ Calculate the percentage error using The absorbance percent error calculated for each of the neutral density filtered apertures is then Comparison by memorizing in a mori; AError Ｎ is compared with a predetermined extinction absorbance error threshold, and AError Ｎ is the predetermined indicating that the optical bench is out of specification if the extinction absorbance error threshold is greater than the extinction absorbance error threshold; Passing at least one wavelength-filtered aperture using the photodetector of the reader. and repeating for each of the wavelength-filtered apertures. wherein the light is generated by the light source of the reader and the measurement value is an intensity wavelength measurement. Value (I ＷＮ ) where N increases by 1 for each wavelength filtered aperture. And; ExpressionWError Ｎ = I ＷＮ / I ｉ Using the above, each of the wavelength filter apertures Regarding I ＷＮ and the above I ｉ The wavelength error of the optical bench is calculated by evaluating the ratio of (WError Ｎ ) and storing in memory; The WError for each of the wavelength filtered apertures Ｎ at a given wavelength Compare with the error threshold, Ｎ is greater than the predetermined error wavelength threshold, and indicating that the optical bench is out of specification.

33. 1. An endotoxin reader comprising: A control unit; storing execution code that performs an action when executed by the control unit; and a memory for storing the The action is: The spindle of the reader is used to measure the temperature of the temperature sensor placed on the spindle of the reader. Rotating a TVP; Activating a heater in the reader to maintain the temperature of the TVP body at a predetermined temperature. Toto; obtaining temperature measurements of the body of the TVP from a temperature indicator of the TVP using an optical bench of the reader and storing the measurements in a memory; obtaining and storing in said memory a temperature measurement of said body of said TVP; The temperature measurements obtained from the temperature indicator of the TVP and the Calculating the difference between the temperature measurement value obtained from the temperature measurement sensor, storing it in memory, and comparing it. and; When the difference is greater than a predetermined temperature difference threshold, a calibration error of the temperature measurement sensor of the reader is and indicating.

34. The code, when executed by the control unit, The temperature measurements obtained from the TVP and the temperature measurements obtained from the temperature sensor of the reader The temperature measurement obtained from the temperature measurement sensor of the reader is based on a difference between the temperature measurement value and the temperature measurement value.

34. The bacterial cell of claim 33, further comprising the step of: applying a calibration factor to the constant value. Endotoxin reader.

35. The code, when executed by the control unit, The temperature measurements obtained from the TVP at two or more predetermined temperatures and the two or more locations A calibration function is calculated based on the difference between the temperature measurements obtained from the temperature sensor of the reader at a constant temperature. and applying the calculated temperature value to the temperature measurement value obtained from the temperature measurement sensor of the reader.

34. The endotoxin reader of claim 33, further comprising:

36. The code, when executed by the control unit, determining said calibration coefficients using linear interpolation and / or mathematical regression.

34. The endotoxin reader of claim 33, which performs the action of:

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