Clinical analyzer automated system diagnosis

Abstract

To provide a method of diagnosing faults in clinical analyzers.SOLUTION: A method for operating, and diagnosing faults in, a laboratory instrument comprising a plurality of subsystems may comprise performing an analytic sequence and a set of diagnostic steps. Such a method may be performed using a diagnostic reagent comprising paramagnetic particles and not including an antibody component. The set of diagnostic steps may comprise, for each vessel in a set of vessels, adding a diagnostic reagent that comprises paramagnetic particles and does not include an antibody component. Such a method may also include evaluating a set of the instrument's subsystems in the order opposite to the order in which those subsystems are used during analysis.SELECTED DRAWING: None

Description

TECHNICAL FIELD

[0001] (Related Application) This relates to and claims the benefit of U.S. Provisional Patent Application No. 62 / 785,863, filed on December 28, 2018 with the United States Patent and Trademark Office, entitled "Clinical Analyzer Automated System Diagnostics". That application is hereby incorporated herein by reference in its entirety.

BACKGROUND ART

[0002] Automated clinical analyzers are well known in the art, and are generally used for automated or semi-automated analysis of patient samples. Typically, prepared patient samples such as blood, urine, and spinal fluid are placed on such an analyzer in sample containers such as test tubes. The analyzer pipettes the patient sample and one or more reagents into a reaction cell (e.g., a reaction vessel, cuvette or flow cell), and analysis of the sample for a particular analyte of interest is usually performed, with the results of the analysis reported.

[0003] Historically, maintaining such analyzers has generally required customers, field service, and manufacturing engineers to manually perform diagnostic routines, including manually filling test tubes with test solutions, loading them into the analyzer, requesting tests on the tubes using the analyzer user interface, and processing them through the instrument. During this process, the analyzer may become unavailable for actual sample processing, which can result in significant downtime over the entire lifetime of the machine. In addition, if there is a fault in the machine, the individual responsible for correcting it (e.g., a field service engineer) may not have any information regarding the root cause of the fault, and thus may need to initiate arbitrary operations during an extended diagnostic test period to determine what kind of remedy may be required, which may further increase the downtime of the instrument.

[0004] Therefore, there is a need for a method to diagnose malfunctions in clinical analyzers that overcome the limitations of prior art. [Overview of the project] [Means for solving the problem]

[0005] In certain aspects of this disclosure, a method can be implemented for operating a laboratory instrument comprising multiple subsystems and for diagnosing malfunctions in the laboratory instrument. Such a method may include performing an analytical step sequence to analyze a biological sample, wherein the analytical step sequence may utilize a set of subsystems among the multiple subsystems in a first order. Such a method may also include performing a set of diagnostic steps to identify malfunctions in the laboratory instrument. In such a case, performing a set of diagnostic steps may include evaluating each subsystem within the set of subsystems in a second order, wherein the second order in which the subsystems within the set of subsystems are evaluated may be the reverse of the first order in which the set of subsystems are used in the analytical step sequence.

[0006] According to certain aspects of this disclosure, a method for operating and diagnosing malfunctions in laboratory equipment may be implemented to include performing an analytical step sequence and a diagnostic step sequence. In such a method, the analytical step sequence may include adding an assay reagent to a reaction vessel, comprising paramagnetic particles and an antibody adapted to bind to an analyte. A set of diagnostic steps may include adding a diagnostic reagent to each vessel in a set of vessels, comprising paramagnetic particles but not containing an antibody component.

[0007] According to certain aspects of this disclosure, a method for diagnosing malfunctions in laboratory equipment can be implemented. Such a method may include washing each container from a set of containers, using a digital camera to capture one or more particle retention images, and calculating retention values ​​based on one or more particle retention images.

[0008] In particular aspects of this disclosure, a method for diagnosing a malfunction in a laboratory instrument comprising multiple subsystems can be implemented. Such a method may include performing a set of diagnostic steps to identify a malfunction in the laboratory instrument. In such a method, each diagnostic step in the set of diagnostic steps may correspond to a subsystem in the multiple subsystems. Such a method may also include detecting a malfunction in the laboratory instrument during the execution of the diagnostic steps from the set of diagnostic steps, and providing an output that identifies the subsystem corresponding to the diagnostic step in which the malfunction in the laboratory instrument was detected.

[0009] According to certain aspects of this disclosure, methods for operating laboratory instruments and diagnosing malfunctions in laboratory instruments can be implemented. In some embodiments, such methods may include performing an analytical step sequence to analyze a biological sample. Such an analytical step sequence may include transferring a portion of the biological sample from a sample container to a reaction vessel; generating an analytical mixture by transferring a first reagent containing alkaline phosphatase (ALP) from a reagent pack to the reaction vessel; removing any portion of the analytical mixture that is not bound to the analyte from the reaction vessel using an assay washing subsystem; and adding a substrate adapted to react with ALP to produce chemiluminescent light in the reaction vessel, and detecting the chemiluminescent light produced by the substrate reacting with ALP using a light meter. Such a method may also include performing a set of diagnostic steps, which include evaluating the assay washing subsystem by performing a set of washing efficiency check steps for each of one or more containers in a set. Such washing efficiency check steps may include adding, for each container, a combination of ALP solution, a second reagent containing paramagnetic particles, and a washing buffer to the container. Such a cleaning efficiency check process may also include, for each container, the steps of exposing the container to a magnetic field, adding an additional cleaning buffer to the container, and rapidly rotating the contents of the container. Such a cleaning efficiency check process may also include, for each container, aspirating a fluid from the container, adding it to the container which has been adapted to react with ALP to produce chemiluminescent light, and using an illuminometer to measure the chemiluminescent light from the container after it has been placed in an illuminometer container chamber.

[0010] According to certain aspects of this disclosure, methods for operating laboratory instruments and diagnosing malfunctions in laboratory instruments can be implemented. Such methods may include performing an analytical step sequence for analyzing a biological sample, utilizing a plurality of subsystems comprising a sample dispensing subsystem, a reagent dispensing subsystem, an assay washing subsystem, and a chemiluminescence detection subsystem. In such a method, the analytical step sequence may include generating an analytical mixture by transferring a first reagent containing ALP from a reagent pack to a reaction vessel using the reagent dispensing subsystem; removing any portion of the analytical mixture not bound to the analyte from the reaction vessel using the assay washing subsystem; adding a substrate adapted to react with ALP to produce chemiluminescent light to the reaction vessel; and detecting the chemiluminescent light produced by the substrate reacting with ALP using the chemiluminescence detection subsystem. Such methods may also include performing a set of diagnostic steps, including evaluating the plurality of subsystems using an illuminometer provided by the chemiluminescence detection subsystem, and, in parallel with this evaluation, using machine vision to evaluate one or more subsystems among the plurality of subsystems.

[0011] According to certain aspects of this disclosure, a method can be implemented for operating a laboratory instrument comprising multiple subsystems and for diagnosing a malfunction in the laboratory instrument. Such a method may include performing an analytical step sequence and a diagnostic step sequence. In such a method, the analytical step sequence may include: transferring a portion of a biological sample from a sample container to a reaction vessel; generating an analytical mixture by transferring a first reagent containing ALP from a reagent pack to the reaction vessel using a reagent dispensing subsystem; removing any portion of the analytical mixture not bound to the analyte from the reaction vessel using an assay washing subsystem; adding a substrate adapted to react with ALP to produce chemiluminescent light in the reaction vessel; and detecting the chemiluminescent light produced by the substrate reacting with ALP using a chemiluminescence detection subsystem. In such a method, a set of diagnostic steps may include: adding a substrate to a test vessel; and determining, based on the detected chemiluminescent light using a chemiluminescence detection subsystem, that a malfunction exists in the laboratory instrument. Such a method may also include performing a set of extended diagnostic steps based on the determination that a malfunction exists in the laboratory instrument. Such a set of magnification diagnostic steps may include, for each of a plurality of magnification test containers, adding a predetermined volume of test fluid to the magnification test container, capturing an image of the magnification test container, and determining the volume of the test fluid in the magnification test container using the image of the magnification test container. In such a method, the test fluid may be selected from the group consisting of a substrate adapted to react with ALP to produce chemiluminescent light, a washing buffer, a first reagent containing ALP, and a second reagent containing paramagnetic particles.

[0012] In certain aspects of this disclosure, a non-temporary computer-readable medium can be implemented on which data is stored that configures a computer to operate in a manner such as that described in any of the preceding paragraphs.

[0013] According to certain aspects of this disclosure, a machine can be implemented comprising a sample dispensing subsystem, a reagent dispensing subsystem, an assay washing subsystem, a chemiluminescence detection subsystem, and means for automatically diagnosing malfunctions in the operation of the machine.

[0014] Various additional embodiments are described below. These embodiments may relate to individual features and combinations of features. The general description above and the detailed description below are It should be understood that any discrepancies are illustrative and explanatory, and do not limit the broader concepts on which the embodiments disclosed herein are based. The present invention provides, for example, the following: (Item 1) A method for operating a laboratory instrument comprising multiple subsystems and diagnosing a malfunction in the laboratory instrument, wherein the method is: a) Performing an analytical process sequence to analyze a biological sample, wherein the analytical process sequence utilizes and performs a set of subsystems from the plurality of subsystems of the laboratory instrument in a first order. b) Performing a set of diagnostic steps to identify a malfunction in the laboratory equipment, i) Performing the set of diagnostic steps includes evaluating each subsystem within the set of subsystems in a second order, ii) A method comprising performing the second order in which each subsystem in the set of subsystems is evaluated in the reverse of the first order in which the set of subsystems are used in the analysis process sequence. (Item 2) a) The set of subsystems, i) Sample dispensing subsystem, ii) comprising a chemiluminescence detection subsystem, b) The first sequence includes using the sample dispensing subsystem to dispense biological fluid into the reaction vessel before using the chemiluminescence detection subsystem to detect chemiluminescent light from the reaction vessel, c) The method of item 1, wherein the second sequence includes evaluating the operation of the chemiluminescence detection subsystem before evaluating the operation of the sample dispensing subsystem. (Item 3) a) Evaluating the chemiluminescence detection subsystem for each of one or more containers in a set, i) Adding a substrate adapted to react with ALP to produce chemiluminescent light to the container, ii) After the substrate adapted to react with ALP to produce chemiluminescent light is added to the container, the container is heated, iii) After the container has been heated and placed in the illuminance meter container chamber, a set of substrate blank check steps is performed, which includes measuring the chemiluminescent light from the container using an illuminance meter provided by the chemiluminescence detection subsystem, b) The method of item 2, wherein each of the one or more containers in the set is empty when the substrate adapted to react with ALP to produce chemiluminescent light is added to each of the containers. (Item 4) The method described above is a) Determining that there is a malfunction in the laboratory equipment based on the chemiluminescent light detected while performing the set of substrate blank check steps, b) Addressing the failure by taking one or more measures, i) Changing the bottle used to store the substrate which is adapted to react with ALP to produce chemiluminescent light, and The method of item 3, comprising taking action, selected from the group consisting of: ii) dealing with a line used to transport the substrate adapted to react with ALP to produce chemiluminescent light. (Item 5) The method described above is a) Determining that there is a malfunction in the laboratory equipment based on the chemiluminescent light detected while performing the set of substrate blank check steps, b) expanding the evaluation of the chemiluminescence detection subsystem by performing a set of containerless light check steps, wherein the set of containerless light check steps, i) when no container is present in the luminometer container chamber, measuring the light detected in the luminometer container chamber by the luminometer, ii) causing the light source provided by the chemiluminescence detection subsystem to emit light at one or more intensities, iii) for each of the one or more intensities, measuring the light detected by the luminometer when the light source provided by the chemiluminescence detection subsystem is emitting light at said intensity, the expanding comprising, the method according to item 3, comprising (Item 6) The method, a) determining the fault in the laboratory apparatus based on the light detected during the set of containerless light check steps, b) addressing the fault by performing one or more measures, wherein the one or more measures, i) purifying the luminometer box provided by the chemiluminescence detection subsystem, ii) recalibrating the luminometer, iii) replacing the luminometer, the addressing being selected from the group consisting of, the method according to item 5, comprising (Item 7) The method, a) determining that the laboratory apparatus has a fault based on the chemiluminescence light detected while performing the set of substrate blank check steps, b) expanding the evaluation of the chemiluminescence detection subsystem by performing a set of substrate volume check steps, wherein the set of substrate volume check steps, i) adding a predetermined volume of the substrate adapted to react with ALP to generate chemiluminescence light to a test container, ii) measuring the actual volume of the substrate adapted to react with ALP in the test vessel to generate chemiluminescent light, using one or more images of the test vessel captured by a digital camera; and expanding, the method according to item 3, comprising. (Item 8) The method comprises: a) determining the fault in the laboratory apparatus based on the actual volume of the substrate adapted to react with ALP in the test vessel to generate chemiluminescent light; and b) addressing the fault by performing one or more measures, wherein the one or more measures are i) replacing a substrate dispensing probe; and ii) replacing a substrate dispensing syringe; selected from the group consisting of, addressing, the method according to item 7, comprising. (Item 9) Evaluating the sample dispensing subsystem comprises: a) for each of a set of one or more sample vessels, i) adding a predetermined amount of ALP solution to the sample vessel using a reagent pipettor; and ii) using a sample pipettor provided by the sample dispensing subsystem, transferring a portion of the ALP solution from the sample vessel to a corresponding reaction vessel in a set of one or more reaction vessels; and b) for each of the set of one or more reaction vessels corresponding to the sample vessel in the set of one or more sample vessels, i) adding a substrate adapted to react with ALP to generate chemiluminescent light to the reaction vessel; and ii) after the reaction vessel is rotated at high speed, incubated, and placed in a luminometer vessel chamber, measuring the chemiluminescent light from the reaction vessel using a luminometer provided by the chemiluminescence detection subsystem, performing a set of luminometer sample volume check steps, the method according to item 2, comprising. (Item 10) The method comprises: a) Determining that there is a malfunction in the laboratory equipment based on the chemiluminescent light detected while performing the aforementioned set of illuminance meter sample volume check process, b) The method of item 9, comprising addressing the fault by checking the position of the sample pipette. (Item 11) The method described above is a) Determining that there is a malfunction in the laboratory equipment based on the chemiluminescent light detected while performing the aforementioned set of illuminance meter sample volume check process, b) To expand the evaluation of the sample dispensing subsystem by performing a set of camera sample volume check steps, wherein the set of camera sample volume check steps is i) For each of the multiple magnified diagnostic sample containers, A) Dispense a first volume of washing buffer into the magnified diagnostic sample container using a reagent pipette, B) Using the sample pipette, a second volume of washing buffer is aspirated from the magnified diagnostic sample container, C) After aspirating the second volume of washing buffer, capture one or more digital camera images of the magnified diagnostic sample container, ii) For each of the first set of magnified diagnostic reaction vessels, A) Dispensing a third volume of washing buffer into the magnification diagnostic reaction vessel using the sample pipette, B) After dispensing the third volume of washing buffer, capture one or more digital camera images of the magnified diagnostic reaction vessel, iii) For each of the second set of magnified diagnostic reaction vessels, A) Dispense a fourth volume of washing buffer into the magnification diagnostic reaction vessel using the sample pipette, B) The method of item 9, comprising capturing one or more digital camera images of the magnification diagnostic reaction vessel after dispensing the fourth volume of washing buffer. (Item 12) The method described above is a) Determining the malfunction in the laboratory equipment based on the images captured during the execution of the set of camera sample volume check steps, b) The method according to item 11, comprising addressing the malfunction by replacing the sample dispensing syringe. (Item 13) The method described above is a) Determining that there is a malfunction in the laboratory equipment based on the chemiluminescent light detected while performing the aforementioned set of illuminance meter sample volume check process, b) By performing a set of sample volume linearity check steps, the sample dispensing subsystem To expand the evaluation of the stem, the aforementioned set of sample volume linearity check steps is i) For each of one or more test sample containers in a set, A) Add a predetermined amount of ALP solution to the test sample container using a reagent pipette, B) Using the sample pipette, transfer a portion of the ALP solution from the test sample container to a corresponding test reaction vessel in one or more test reaction vessels of a set, wherein the portion of the ALP solution transferred from the test sample container has an amount corresponding to the test reaction vessel to which the portion of the ALP solution was transferred, a subset of the set of test reaction vessels. ii) For each of the one or more test reaction vessels in the set of one or more test sample containers that corresponds to a test sample container in the set of one or more test sample containers, A) Adding the substrate, which is adapted to react with ALP to produce chemiluminescent light, to the reaction vessel, B) The method of item 9, comprising measuring chemiluminescent light from the reaction vessel using the illuminometer provided by the chemiluminescence detection subsystem, after the reaction vessel has been rotated at high speed, heated, and placed in an illuminometer container chamber. (Item 14) The method described above is a) Determining the malfunction in the laboratory equipment based on the chemiluminescent light detected in the sample volume linearity check step, b) The method of item 13, comprising addressing the malfunction by replacing the sample dispensing motor. (Item 15) The method described above is a) Determining that there is a malfunction in the laboratory equipment based on the chemiluminescent light detected while performing the aforementioned set of illuminance meter sample volume check process, b) To expand the evaluation of the sample dispensing subsystem by performing a set of sample dilution check steps, wherein the set of sample dilution check steps is i) Adding a predetermined volume of ALP solution to each of several test sample containers using the reagent pipette, ii) For each of the first set of test dilution containers, A) Using the sample pipette, transfer a first amount of the ALP solution from the corresponding test sample container to the test dilution container, B) Adding a second amount of washing buffer to the test dilution container using the reagent pipette, C) Mixing the contents of the test dilution container, D) Using the sample pipette, transfer a third amount of fluid from the dilution container to the corresponding reaction container, iii) For each of the second set of test dilution containers, A) Using the sample pipette, transfer a fourth amount of the ALP solution from the corresponding test sample container to the test dilution container, B) Add a fifth volume of washing buffer to the test dilution container using a reagent pipette, C) Mixing the contents of the test dilution container, D) Transferring the third amount of fluid from the dilution container to the corresponding reaction container using the sample pipette, iv) Adding the substrate adapted to react with ALP to produce chemiluminescent light to each of the test reaction vessels corresponding to the test dilution vessel, v) The test reaction vessel is rotated at high speed, heated, and placed inside the illuminance meter container chamber. The method of item 9, further comprising: measuring chemiluminescent light from the test reaction vessel using an illuminometer provided by the chemiluminescence detection subsystem; and then expanding. (Item 16) The method described above is a) Determining the malfunction in the laboratory equipment based on the chemiluminescent light detected in the illuminance meter sample volume check step, b) The method according to item 15, comprising addressing the aforementioned problem by checking the immersion height of the sample dispensing tip. (Item 17) The aforementioned sample pipette, a) A precision pipette for samples, b) The method according to item 9, selected from a set of sample pipettes consisting of a fixed-volume sample pipette and a sample pipette. (Item 18) a) The set of subsystems includes an assay washing subsystem, b) The analysis step sequence includes using the sample dispensing subsystem to dispense the biological fluid into the reaction vessel and using the chemiluminescence detection subsystem to detect chemiluminescence light from the reaction vessel, and using the assay washing subsystem to remove unbound material from the reaction vessel, c) The method of item 2, wherein the set of diagnostic steps includes evaluating the operation of the assay washing subsystem between evaluating the operation of the sample dispensing subsystem and evaluating the operation of the chemiluminescence detection subsystem. (Item 19) a) The instrument comprises a reagent dispensing subsystem, b) The analytical step sequence includes using the reagent dispensing subsystem to dispense reagents into the reaction vessel before using the assay washing subsystem to remove unbound material from the reaction vessel, c) The method of item 18, wherein the set of diagnostic steps includes evaluating the operation of the reagent dispensing subsystem before evaluating the operation of the assay washing subsystem. (Item 20) a) Evaluating the operation of the reagent dispensing subsystem before evaluating the operation of the assay washing subsystem includes evaluating the operation of the reagent dispensing subsystem using a digital camera, b) The method of item 19, wherein the set of diagnostic steps includes evaluating the operation of the assay washing subsystem, and then evaluating the operation of the reagent dispensing subsystem using an illuminometer provided by the emission detection subsystem. (Item 21) Evaluating the operation of the reagent dispensing subsystem using a digital camera is possible. a) Using an ultrasound probe to ultrasonically mix the diagnostic reagents in the diagnostic reagent pack, b) For each container in a set of containers, the reagent pipette is used to transfer the diagnostic reagent from the diagnostic reagent pack to the container, c) Using the digital camera to capture one or more reagent resuspension images, wherein each of the one or more reagent resuspension images includes an image of the containers in the set of containers after the diagnostic reagent has been added to the containers. d) The method according to item 20, comprising performing a reagent resuspension check using one or more reagent resuspension images. (Item 22) a) Using the assay washing subsystem to remove unbound material from the reaction vessel The reagent, which is dispensed into the reaction vessel before use, comprises paramagnetic particles and an antibody component adapted by binding to the analyte. b) The method according to item 21, wherein the diagnostic reagent contains paramagnetic particles and does not contain antibody components. (Item 23) The method described above is a) Determining that there is a malfunction in the laboratory equipment based on the reagent resuspension check, b) Addressing the failure by taking one or more measures, i) Replacing the ultrasonic probe, ii) Calibrating the ultrasound in the aforementioned laboratory equipment, The method of item 21, comprising taking action, selected from the group consisting of: iii) replacing the ultrasonic transducer of the laboratory instrument. (Item 24) Evaluating the operation of the reagent dispensing subsystem using the illuminance meter for each of one or more containers in a set, a) Add a predetermined volume of ALP solution to the container using a reagent pipette, b) Adding a substrate adapted to react with ALP to produce chemiluminescent light to the container, c) The method of item 20, comprising performing a set of illuminometer reagent volume check steps, which includes measuring chemiluminescent light from the container using the illuminometer provided by the chemiluminescence detection subsystem after the container has been rotated at high speed, heated, and placed in the illuminometer container chamber. (Item 25) The method described above is a) Determining that there is a malfunction in the laboratory equipment based on the chemiluminescent light detected while performing the aforementioned set of illuminance meter reagent volume check process, b) The method of item 24, comprising addressing the obstruction by rearranging the position of the reagent pipette. (Item 26) The method described above is a) Determining that there is a malfunction in the laboratory equipment based on the chemiluminescent light detected while performing the aforementioned set of illuminance meter reagent volume check process, b) To expand the evaluation of the reagent dispensing subsystem by performing a set of camera reagent volume check steps for each of the multiple test containers, wherein the set of camera reagent volume check steps is i) Add a predetermined volume of washing buffer to the test container using the reagent pipette, ii) The method of item 24, comprising capturing one or more images of the test container, and further comprising zooming in. (Item 27) The method described above is a) Determining the malfunction in the laboratory equipment based on the images captured during the execution of the set of camera reagent volume check steps, b) Addressing the failure by taking one or more measures, i) Replace the reagent dispensing syringe, ii) The method of item 26, comprising taking action selected from the group consisting of replacing the reagent dispensing motor. (Item 28) a) The above method, i) Determining that there is a malfunction in the laboratory equipment based on the chemiluminescent light detected while performing the illuminance meter reagent volume check step described above, ii) To expand the evaluation of the reagent dispensing subsystem by performing a set of reagent volume linearity check steps for each of the multiple test containers, wherein the set of reagent volume linearity check steps is A) Adding a predetermined volume of a mixture of ALP solution and washing buffer to the test container, B) Adding the substrate, which is adapted to react with ALP to produce chemiluminescent light, to the test container, C) After the container has been rotated at high speed, heated, and placed in the illuminance meter container chamber, the chemiluminescent light from the container is measured using an illuminance meter provided by the chemiluminescence detection subsystem, including, b) The plurality of test containers include a subset of three test containers, c) The method of item 24, wherein, for each of the subsets of the three test containers provided by the plurality of test containers, the mixture of ALP solution and washing buffer added to the test container provided by the subset of test containers has a different ratio of ALP solution to washing buffer than the mixture of ALP solution and washing buffer added to the test containers provided by the other subsets of the plurality of test containers. (Item 29) The method described above is a) Determining the malfunction in the laboratory equipment based on the chemiluminescent light detected in the reagent volume linearity check step, b) Addressing the failure by taking one or more measures, i) Check the verticality of the reagent pipette, ii) Replacing the tip of the reagent pipette, iii) The method of item 28, comprising taking action selected from the group consisting of replacing an ultrasonic transducer. (Item 30) The method described above is a) Determining that there is a malfunction in the laboratory equipment based on the chemiluminescent light detected while performing the aforementioned set of illuminance meter reagent volume check process, b) To expand the evaluation of the reagent dispensing subsystem by performing a set of reagent pipette carryover check steps for each of the multiple test containers, wherein the set of reagent pipette carryover check steps is i) Adding the ALP solution to the test container using the reagent pipette, ii) After adding the ALP solution, add the washing buffer to the test container using the reagent pipette, iv) Adding the substrate adapted to react with ALP to produce chemiluminescent light to the test container, v) After adding the substrate adapted to react with ALP to produce chemiluminescent light, the test container is rotated at high speed, vi) The method of item 24, comprising measuring chemiluminescent light from the container using an illuminometer provided by the chemiluminescence detection subsystem after the container has been placed in a chamber at a temperature. (Item 31) The method described above is a) Chemiluminescent light detected in the reagent pipette carryover check step Based on this, the failure in the laboratory equipment is determined, b) Addressing the failure by taking one or more measures, i) Replacing the tip of the reagent pipette, ii) Investigating the state of the washing tower provided by the assay washing subsystem, The method according to item 30, comprising taking action, selected from the group consisting of replacing the washing and dispensing pump. (Item 32) A method for operating laboratory equipment and diagnosing a malfunction in said laboratory equipment, wherein the method is: a) Performing an analytical step sequence for analyzing a biological sample, wherein the analytical step sequence includes adding an assay reagent containing paramagnetic particles and an antibody adapted to bind to the analyte to a reaction vessel, b) A method comprising performing a set of diagnostic steps to evaluate the operation of the laboratory instrument, wherein the set of diagnostic steps includes adding a diagnostic reagent to each container in a set of containers, the diagnostic reagent containing paramagnetic particles and not containing antibody components. (Item 33) a) The assay reagent has paramagnetic particles of a first concentration, b) The diagnostic reagent has paramagnetic particles of a second concentration, c) The method according to item 32, wherein the first concentration is lower than the second concentration. (Item 34) a) The concentration of XL1 is 0.3 mg / mL to 2.0 mg / mL. b) The method according to item 33, wherein the second concentration is 4.0 mg / mL. (Item 35) The aforementioned set of diagnostic steps, a) For each container in the set of containers, i) A test mixture is prepared by combining the diagnostic reagent added to the container with a portion of the washing buffer, ii) Exposing the test mixture to a magnetic field in the container, iii) Removing the container from the magnetic field, iv) After the container has been removed from the magnetic field, the test mixture contained in the container is mixed, b) Using a digital camera to capture one or more particle resuspension images, wherein each of the one or more particle resuspension images includes an image of the containers in the set of containers after the test mixture contained in the containers has been mixed. c) The method according to item 32, comprising performing a resuspension check using the one or more particle resuspension images. (Item 36) For each container in the set of containers, the test mixture contained in the container is mixed. a) Moving the container to a high-speed rotating mixing position on the washing wheel, b) The method according to item 35, comprising rapidly rotating and mixing the test mixture contained in the container. (Item 37) The method described above is a) Determining that there is a malfunction in the laboratory equipment based on the resuspension check, b) Addressing the failure by taking one or more measures, i) Arranging the high-speed rotating mixer on the washing wheel at the high-speed rotating mixing position, ii) The method of item 36, comprising taking action selected from the group consisting of replacing the high-speed rotary mixer. (Item 38) For each container in the set of containers, the test mixture contained within the container is mixed before the container is moved to the high-speed rotating mixing position on the washing wheel. a) Moving the container to the pipette position in the laboratory equipment, b) The method according to item 35, comprising ultrasonically mixing the test mixture contained in the container using a reagent pipette. (Item 39) The method described above is a) Determining that there is a malfunction in the laboratory equipment based on the resuspension check, b) Addressing the failure by taking one or more measures, i) Arranging the reagent pipette in the pipette position within the laboratory equipment, ii) The method according to item 38, comprising taking action selected from the group consisting of checking the perpendicularity of the reagent pipette. (Item 40) The aforementioned set of diagnostic steps, a) For each of the containers in the set, before adding the diagnostic reagent to the container, the diagnostic reagent is ultrasonically mixed using an ultrasonic probe, b) Using a digital camera to capture one or more reagent resuspension images, wherein each of the one or more reagent resuspension images includes an image of the containers in the set of containers after the diagnostic reagent has been added to the containers. c) The method according to item 32, comprising performing a reagent resuspension check using one or more reagent resuspension images. (Item 41) The method described above is a) Determining that there is a malfunction in the laboratory equipment based on the reagent resuspension check, b) Addressing the failure by taking one or more measures, i) Replacing the ultrasonic probe, ii) Calibrating the ultrasound in the aforementioned laboratory equipment, The method of item 40, comprising taking action, selected from the group consisting of: iii) replacing the ultrasonic transducer of the laboratory instrument. (Item 42) A method for diagnosing malfunctions in laboratory equipment, wherein the method is a) Washing each container from a set of containers, b) Using a digital camera to capture one or more particle-holding images, wherein each of the one or more particle-holding images includes an image of the containers in the set of containers after the containers have been washed. c) A method comprising performing a set of diagnostic steps, which include calculating retention values ​​based on one or more particle retention images. (Item 43) a) The set of containers includes a plurality of containers, b) The set of diagnostic steps includes, for each container in the set of containers, generating a test mixture by combining a reagent containing paramagnetic particles added to the container with a portion of the washing buffer, c) The method according to item 42, wherein the test mixture in each container of the set of containers comprises 50 μL of reagent and 150 μL of washing buffer. (Item 44) The method described above is a) To determine that there is a malfunction in the laboratory equipment based on the retained value, b) Addressing the failure by taking one or more measures, i) Arranging suction probes at the reaction vessel positions within the laboratory equipment, ii) The method of item 42, comprising taking action, selected from the group consisting of inspecting the magnetic function of the laboratory instrument. (Item 45) The aforementioned holding value is, a) A grayscale value derived from one or more particle-retaining images, b) The method described in item 42, calculated based on the particle retention calibration curve. (Item 46) a) The particle retention calibration curve is prepared using a plurality of calibration mixtures, each of which contains a portion of a reagent that includes paramagnetic particles and a portion of the washing buffer, b) The method according to item 45, wherein the plurality of calibration mixtures comprises a set of calibration mixtures, and each calibration mixture in the set of calibration mixtures has a different reagent-to-wash buffer ratio than any other calibration mixture in the set of calibration mixtures. (Item 47) The aforementioned set of calibration mixtures a) 50:150, b) 40:160, c) 35:165, d) The method according to item 46, comprising a calibration mixture having the reagent-to-wash buffer ratio of 25:175. (Item 48) a) Using the plurality of calibration mixtures, the particle retention calibration can be created. i) For each calibration mixture, A) Sending the container containing the calibration mixture to the washing wheel, B) Mixing the container containing the calibration mixture at high speed at a substrate high-speed rotation position on the washing wheel, C) Capturing a grayscale image of the container containing the calibration mixture after it has been mixed, ii) Creating the calibration curve using the captured grayscale image of the container containing the calibration mixture, b) The set of containers includes a plurality of containers, c) The set of diagnostic steps described above applies to each container within the set of containers, i) A test mixture is prepared by combining the reagent added to the container with a portion of the washing buffer, ii) After the test mixture is prepared in the container, it is washed at least twice with the washing buffer, iii) After the container has been washed at least twice, the fluid is drawn out of the container using a suction probe, iv) After the fluid has been aspirated from the container by the suction probe, a large amount of washing buffer is added to the container such that the volume of washing buffer added to the container is equal to the volume of the test mixture that was in the container before aspiration. v) After the aforementioned volume of the washing buffer is added to the container, the container is rotated at high speed at a substrate high-speed rotation position on the washing wheel to mix the contents, d) The method of item 46, wherein the one or more particle-holding images include grayscale images of each container in the set of containers, captured after the containers have the volume of the washing buffer added to them and are rapidly rotated and mixed at a high-speed rotation position of the substrate on the washing wheel. (Item 49) A method for diagnosing a malfunction in laboratory equipment comprising multiple subsystems, wherein the method is: a) Performing a set of diagnostic steps to identify a malfunction in the laboratory equipment, wherein each diagnostic step in the set of diagnostic steps corresponds to a subsystem in the plurality of subsystems. b) Detecting a malfunction of the laboratory equipment during the execution of one of the diagnostic steps in the set of diagnostic steps, c) A method comprising providing an output that identifies the subsystem corresponding to the diagnostic step while the malfunction is detected in the laboratory instrument. (Item 50) a) The plurality of subsystems, i) Sample dispensing subsystem, ii) Reagent dispensing subsystem, iii) Assay washing subsystem and iv) A chemiluminescence detection subsystem, including, b) The instrument is adapted to analyze a biological sample for the presence of an analyte by performing a set of analytical steps, and the analytical steps are: i) Transferring a portion of the biological sample from the sample container to the reaction vessel using the sample dispensing subsystem, ii) Producing an analytical mixture by transferring a first reagent containing alkaline phosphatase (ALP) from a reagent pack to the reaction vessel using the reagent dispensing subsystem, iii) Using the assay washing subsystem, remove from the reaction vessel any portion of the analytical mixture that is not bound to the analyte, iv) The method according to item 49, comprising adding a substrate adapted to react with ALP to produce chemiluminescent light to the reaction vessel, and detecting the chemiluminescent light produced by the substrate in reaction with ALP using the chemiluminescence detection subsystem. (Item 51) A method for operating laboratory equipment and diagnosing a malfunction in said laboratory equipment, wherein the method is: a) Performing an analytical step sequence for analyzing a biological sample, wherein the analytical step sequence is, i) Transferring a portion of the biological sample from the sample container to the reaction vessel, ii) Producing an analytical mixture by transferring a first reagent containing alkaline phosphatase (ALP) from the reagent pack to the reaction vessel, iii) Using an assay washing subsystem to remove any portion of the analytic mixture that is not bound to the analyte from the reaction vessel, iv) A procedure comprising adding a substrate adapted to react with ALP to produce chemiluminescent light to the reaction vessel, and using an illuminometer to detect the chemiluminescent light produced by the substrate in reaction with ALP, b) Performing a set of diagnostic steps, which includes performing a set of cleaning efficiency check steps for each of one or more containers in a set, wherein the set of cleaning efficiency check steps is i) A) ALP solution and, B) A second reagent containing paramagnetic particles, C) Combination with washing buffer, To add to the aforementioned container, ii) Performing a set of cleaning steps, A) Exposing the container to a magnetic field, B) Adding an additional washing buffer to the container, C) The contents of the container The act of performing, which includes, rotating at high speed one or more times, iii) Suctioning fluid from the container, iv) After aspirating the fluid from the container, add the substrate which is adapted to react with ALP to produce chemiluminescent light, v) Keeping the container warm, vi) A method comprising measuring chemiluminescent light from a container after it has been placed in an illuminometer container chamber using the illuminometer. (Item 52) a) The second reagent containing paramagnetic particles does not contain an antibody component, b) The method according to item 51, wherein the analytical step sequence comprises adding a third reagent containing paramagnetic particles to the reaction vessel, the paramagnetic particles provided by the third reagent being coated with an antibody component adapted to bind to an analyte. (Item 53) a) The analysis process sequence is i) Before transferring the first reagent containing ALP to the reaction vessel, transfer the third reagent containing paramagnetic particles to the reaction vessel, ii) The reaction vessel is kept warm between transferring the third reagent containing paramagnetic particles to the reaction vessel and transferring the first reagent containing ALP to the reaction vessel. iii) The process includes warming the reaction vessel between transferring the third reagent containing ALP to the reaction vessel and detecting the chemiluminescent light produced by the substrate in reaction with the ALP using the illuminometer, b) The method according to item 51, wherein each container in the set of containers is heated only once during the execution of the set of diagnostic steps. (Item 54) The method described above is a) Determining that there is a defect in the laboratory equipment based on the chemiluminescent light detected while performing the set of cleaning efficiency check steps, b) The method according to item 51, comprising arranging the pick-and-place actuator positions at the container positions to address the obstruction. (Item 55) The method described above is a) Determining that there is a defect in the laboratory equipment based on the chemiluminescent light detected while performing the set of cleaning efficiency check steps, b) Extending the evaluation of the assay washing subsystem by performing a set of wash buffer volume check steps, wherein the set of wash buffer volume check steps is i) Using one or more probes to add a predetermined volume of washing buffer to one or more test containers, ii) Moving each of the test containers to which the predetermined volume of the washing buffer has been added to the camera position on the washing wheel, iii) To capture an image of one or more test containers to which the predetermined volume of washing buffer has been added, iv) The actual volume of the washing buffer added to each of the one or more test containers The method according to item 51, comprising using the capture image to determine, and including zooming. (Item 56) The method described above is a) Determining the malfunction in the laboratory equipment based on the actual volume of the washing buffer added to one or more test containers, b) The method of item 55, comprising addressing the fault by replacing the one or more probes used to add the washing buffer to the one or more test containers. (Item 57) The method described above is a) Determining that there is a defect in the laboratory equipment based on the chemiluminescent light detected while performing the set of cleaning efficiency check steps, b) Extending the evaluation of the assay washing subsystem by performing a set of residual volume check steps, wherein the set of residual volume check steps is i) Using one or more probes to add a predetermined volume of washing buffer to one or more test containers, ii) For each test container to which the predetermined volume of washing buffer has been added, A) Moving the test container to the suction position corresponding to the probe used to add the predetermined amount of washing buffer to the test container, B) Aspirating fluid from the test container using a suction probe positioned at the suction position where the test container has been moved, C) After the fluid is drawn out, move the test container to the camera position, D) After the fluid is drawn out there, capture one or more images of the test container, E) The method of item 51, comprising the step of determining the residual volume remaining in the test container based on the one or more captured images of the test container. (Item 58) The method described above is a) Determining the malfunction in the laboratory equipment based on the residual volume detected in the residual volume check step, b) Addressing the failure by taking one or more measures, i) Replacing one or more suction probes, ii) Arranging one or more suction probes at the suction position where it is positioned, iii) The method of item 57, comprising taking action selected from the group consisting of replacing the peristaltic pump tube. (Item 59) The method described above is a) Determining that there is a defect in the laboratory equipment based on the chemiluminescent light detected while performing the set of cleaning efficiency check steps, b) Extending the evaluation of the assay washing subsystem by performing a set of aspiration probe carryover check steps, wherein the set of aspiration probe carryover check steps is performed for each of one or more test containers in a set. i) Adding the ALP solution to the test container, ii) After adding the ALP solution, the washing buffer is added to the test container, iii) Aspirating the ALP solution from the test container using a suction probe. , iv) Adding the substrate adapted to react with ALP to produce chemiluminescent light to the test container, v) After adding the substrate adapted to react with ALP to produce chemiluminescent light, the test container is rotated at high speed, vi) The method of item 51, comprising measuring chemiluminescent light from the container after it has been heated and placed in the illuminometer container chamber using the illuminometer. (Item 60) The method described above is a) Determining the malfunction in the laboratory equipment based on the chemiluminescent light detected in the suction probe carryover check step, b) Addressing the failure by taking one or more measures, i) Replacing one or more suction probes, ii) Investigating the state of the washing tower provided by the assay washing subsystem, iii) The method of item 59, comprising taking action, selected from the group consisting of replacing the washing and dispensing pump. (Item 61) A method for operating laboratory equipment and diagnosing a malfunction in said laboratory equipment, wherein the method is: a) Performing an analytical process sequence for analyzing a biological sample, i) The analysis process sequence is A) Sample dispensing subsystem, B) Reagent dispensing subsystem, C) Assay washing subsystem, D) A chemiluminescence detection subsystem is provided, and multiple subsystems are used, ii) Performing the aforementioned analysis process sequence A) Producing an analytical mixture by transferring a first reagent containing alkaline phosphatase (ALP) from a reagent pack to the reaction vessel using the reagent dispensing subsystem, B) Using the assay washing subsystem, remove the portion of the analytical mixture that is not bound to the analyte from the reaction vessel, C) Adding a substrate adapted to react with ALP to produce chemiluminescent light to the reaction vessel, and using the chemiluminescence detection subsystem to detect the chemiluminescent light produced by the substrate in reaction with ALP, b) Performing a set of diagnostic steps, wherein the diagnostic steps are i) Evaluating the plurality of subsystems using an illuminance meter provided by the chemiluminescence detection subsystem, ii) A method comprising using machine vision to evaluate one or more subsystems among the plurality of subsystems, in parallel with evaluating the plurality of subsystems using an illuminance meter provided by the chemiluminescence detection subsystem. (Item 62) a) The sample dispensing subsystem, i) Sample precision subsystem, ii) A subsystem for constant sample volumeization, b) The analysis process sequence is i) Using the sample constant volume subsystem, the sample container is transferred to the reaction vessel. The transfer of a fixed amount of the biological sample, The method of item 61, comprising transferring a portion of the biological sample from a sample container to a reaction vessel by performing a step selected from the group consisting of: ii) transferring the portion of the biological sample from the sample container to the reaction vessel using the sample dispensing subsystem. (Item 63) a) The analytical step sequence includes adding an analytical reagent to the reaction vessel, which comprises paramagnetic particles coated with an antibody component adapted to bind to the analyte, b) The method according to item 61, wherein the set of diagnostic steps includes adding an analytical reagent containing paramagnetic particles and lacking an antibody component to a container that acts as the reaction vessel in the evaluation of the instrument. (Item 64) A method for operating a laboratory instrument comprising multiple subsystems and diagnosing a malfunction in the laboratory instrument, wherein the method is: a) Performing an analytical process sequence, i) Transferring a portion of the biological sample from the sample container to the reaction vessel, ii) Producing an analytical mixture by transferring a first reagent containing alkaline phosphatase (ALP) from a reagent pack to the reaction vessel using a reagent dispensing subsystem, iii) Using an assay washing subsystem to remove any portion of the analytic mixture that is not bound to the analyte from the reaction vessel, iv) Adding a substrate adapted to react with ALP to produce chemiluminescent light to the reaction vessel, and detecting the chemiluminescent light produced by the substrate in reaction with ALP using a chemiluminescence detection subsystem, b) Performing a set of diagnostic steps, i) Add the substrate, which is adapted to react with ALP to produce chemiluminescent light, to the test container. ii) Performing the following actions, including determining that a fault exists in the laboratory equipment based on chemiluminescent light detected using the chemiluminescence detection subsystem: c) Based on the determination that the defect is present in the laboratory equipment, perform a set of magnification diagnostic steps, for each of the multiple magnification test containers: i) Adding a predetermined volume of test fluid to the enlarged test container, ii) To capture an image of the enlarged test container, iii) Determining the volume of the test fluid in the enlarged test container using the image of the enlarged test container, The aforementioned test fluid is A) The substrate adapted to react with ALP to produce chemiluminescent light, B) Washing buffer and C) The first reagent containing ALP, D) A method comprising determining, performing, and a second reagent containing paramagnetic particles, selected from the group consisting of D and M. (Item 65) a) Performing the set of diagnostic steps described above for each of one or more containers in the set, i) The container contains the substrate adapted to react with ALP to produce chemiluminescent light, ii) After the substrate adapted to react with the ALP to produce chemiluminescent light is added to the container, the container is heated, iii) Performing a set of substrate blank check steps, which includes using the chemiluminescence detection subsystem to measure chemiluminescent light from the container after it has been placed in a temperature-controlled illuminometer container chamber, b) The method of item 64, comprising determining that the malfunction is present in the laboratory instrument based on chemiluminescent light detected using the chemiluminescence detection subsystem, or determining that at least one of a set of containers is contaminated with ALP based on detecting light emitted from the container using the chemiluminescence detection subsystem. (Item 66) The method according to item 65, wherein the test fluid added to the enlarged test container is the substrate adapted to react with ALP to produce chemiluminescent light. (Item 67) The method of item 64, wherein, for each of the plurality of magnified test containers, determining the volume of the test fluid in the magnified test container using the image of the magnified test container includes determining the volume of the fluid using the distance between the bottom of the meniscus in the magnified test container and the bottom of the magnified test container. (Item 68) Performing the aforementioned set of diagnostic steps a) Perform ultrasonic mixing on the diagnostic reagents in the reagent pack, b) Transferring a portion of the diagnostic reagent from the reagent pack to the particle test container, c) After the transfer of a portion of the diagnostic reagent, capture an image of the test container, d) The method according to item 64, which determines whether a defect exists in the laboratory equipment based on the grayscale values ​​of the image of the test container. (Item 69) The method according to item 68, wherein the diagnostic reagent comprises uncoated paramagnetic particles and does not contain any paramagnetic particles coated with an antibody component. (Item 70) A non-temporary computer-readable medium storing data that configures a computer to operate a laboratory instrument comprising multiple subsystems and to perform a method for diagnosing a malfunction in the laboratory instrument, wherein the method a) Performing an analytical process sequence to analyze a biological sample, wherein the analytical process sequence utilizes and performs a set of subsystems from the plurality of subsystems of the laboratory instrument in a first order. b) Performing a set of diagnostic steps to identify a malfunction in the laboratory equipment, i) Performing the set of diagnostic steps includes evaluating each subsystem in the first set of subsystems in a second order, ii) A method comprising performing the second order in which each subsystem in the set of subsystems is evaluated in the reverse of the first order in which the set of subsystems are used in the analysis process sequence. (Item 71) a) The set of subsystems, i) Sample dispensing subsystem, ii) comprising a chemiluminescence detection subsystem, b) The first sequence includes using the sample dispensing subsystem to dispense biological fluid into the reaction vessel before using the chemiluminescence detection subsystem to detect chemiluminescent light from the reaction vessel, c) A non-temporary computer-readable medium as described in item 70, wherein the second sequence includes evaluating the operation of the chemiluminescence detection subsystem before evaluating the operation of the sample dispensing subsystem. (Item 72) a) Evaluating the chemiluminescence detection subsystem for each of one or more containers in a set, i) Add a substrate adapted to react with ALP to produce chemiluminescent light to the container. To do, ii) After the substrate adapted to react with the ALP to produce chemiluminescent light is added to the container, the container is heated, iii) Performing a set of substrate blank check steps, which includes measuring the chemiluminescent light from the container after it has been placed in a heated illuminometer container chamber using an illuminometer provided by the chemiluminescence detection subsystem, b) A non-transient computer-readable medium as described in item 71, in which each of the one or more containers in the set is empty when the substrate adapted to react with ALP to produce chemiluminescent light is added to each of the containers. (Item 73) The method described above is a) Determining that there is a malfunction in the laboratory equipment based on the chemiluminescent light detected while performing the set of substrate blank check steps, b) Providing a notice to address the said failure by taking one or more measures, i) Changing the bottle used to store the substrate which has been adapted to react with ALP to produce chemiluminescent light, A non-temporary computer-readable medium according to item 72, comprising providing, selected from the group consisting of: ii) decontaminating a line used to transport the substrate adapted to react with ALP to produce chemiluminescent light. (Item 74) The method described above is a) Determining that there is a malfunction in the laboratory equipment based on the chemiluminescent light detected while performing the set of substrate blank check steps, b) To extend the evaluation of the chemiluminescence detection subsystem by performing a set of containerless light check steps, wherein the set of containerless light check steps is i) When no container is present in the illuminance meter container chamber, the illuminance meter measures the light detected in the illuminance meter container chamber, ii) The light source included in the chemiluminescence detection subsystem emits light at one or more intensities, iii) A non-transient computer-readable medium according to item 72, comprising magnification, which includes measuring the light detected by the illuminance meter when the light source provided by the chemiluminescence detection subsystem is emitting light at each of the one or more intensities. (Item 75) The method described above is a) Determining the malfunction in the laboratory equipment based on the light detected during the set of containerless light check steps, b) Providing a notice to address the said failure by taking one or more measures, i) Purifying the illuminance meter box provided by the chemiluminescence detection subsystem, ii) Recalibrating the illuminance meter, iii) A non-temporary computer-readable medium as described in item 74, comprising providing, selected from the group consisting of replacing the illuminance meter. (Item 76) The method described above is a) Determining that there is a malfunction in the laboratory equipment based on the chemiluminescent light detected while performing the set of substrate blank check steps, b) By performing a set of substrate volume check steps, the chemiluminescence detection subsystem To expand the evaluation of the system, the aforementioned set of substrate volume checking steps is i) Adding a predetermined volume of the substrate, adapted to react with ALP to produce chemiluminescent light, to a test container, ii) The method of item 72, comprising: measuring the actual volume of the substrate adapted to react with ALP in the test container to produce chemiluminescent light using one or more images of the test container captured by a digital camera; (Item 77) The method described above is a) Determining the obstruction in the laboratory based on the actual volume of the substrate adapted to react with ALP in the test container to produce chemiluminescent light, b) Providing a notice to address the said failure by taking one or more measures, i) Replace the substrate dispensing probe, ii) Providing a non-temporary computer-readable medium as described in item 76, which is selected from the group consisting of replacing a substrate dispensing syringe. (Item 78) Evaluating the sample dispensing subsystem includes performing a set of illuminometer sample volume check steps, and the set of illuminometer sample volume check steps is a) For each of one or more sample containers in a set, i) Add a predetermined amount of ALP solution to the sample container using a reagent pipette, ii) Using a sample pipette provided by the sample dispensing subsystem, transfer a portion of the ALP solution from the sample container to a corresponding reaction vessel in one or more reaction vessels of a set; b) For each of the one or more reaction vessels in the set of one or more sample containers that corresponds to a sample container in the set of one or more sample containers, i) Adding a substrate adapted to react with ALP to produce chemiluminescent light to the reaction vessel, ii) After the reaction vessel has been rotated at high speed, heated, and placed in the illuminance meter container chamber, measuring the chemiluminescent light from the reaction vessel using an illuminance meter provided by the chemiluminescence detection subsystem, including the non-transient computer-readable media described in item 71. (Item 79) The method described above is a) Determining that there is a malfunction in the laboratory equipment based on the chemiluminescent light detected while performing the aforementioned set of illuminance meter sample volume check process, b) A non-temporary computer-readable medium as described in item 78, which includes providing a notification to address the malfunction by checking the sample pipette position. (Item 80) The method described above is a) Determining that there is a malfunction in the laboratory equipment based on the chemiluminescent light detected while performing the aforementioned set of illuminance meter sample volume check process, b) To expand the evaluation of the sample dispensing subsystem by performing a set of camera sample volume check steps, wherein the set of camera sample volume check steps is i) For each of the multiple magnified diagnostic sample containers, A) Dispense a first volume of washing buffer into the magnified diagnostic sample container using a reagent pipette, B) Using the sample pipette, a second volume of washing buffer is aspirated from the magnified diagnostic sample container, C) After aspirating the second volume of washing buffer, one or more of the magnified diagnostic sample containers To capture digital camera images, ii) For each of the first set of magnified diagnostic reaction vessels, A) Dispensing a third volume of washing buffer into the magnification diagnostic reaction vessel using the sample pipette, B) After dispensing the third volume of washing buffer, capture one or more digital camera images of the magnified diagnostic reaction vessel, iii) For each of the second set of magnified diagnostic reaction vessels, A) Dispense a fourth volume of washing buffer into the magnification diagnostic reaction vessel using the sample pipette, B) A non-temporary computer-readable medium as described in item 78, comprising capturing one or more digital camera images of the magnified diagnostic reaction vessel after dispensing the fourth volume of washing buffer. (Item 81) The method described above is a) Determining the malfunction in the laboratory equipment based on the images captured during the execution of the set of camera sample volume check steps, b) A non-temporary computer-readable medium as described in item 80, which includes providing notification to address the failure by replacing the sample dispensing syringe. (Item 82) The method described above is a) Determining that there is a malfunction in the laboratory equipment based on the chemiluminescent light detected while performing the aforementioned set of illuminance meter sample volume check process, b) Expanding the evaluation of the sample dispensing subsystem by performing a set of sample volume linearity check steps, wherein the set of sample volume linearity check steps i) For each of one or more test sample containers in a set, A) Add a predetermined amount of ALP solution to the test sample container using a reagent pipette, B) Using the sample pipette, transfer a portion of the ALP solution from the test sample container to a corresponding test reaction vessel in one or more test reaction vessels of a set, such that the portion of the ALP solution transferred from the test sample container has an amount corresponding to a subset of the test reaction vessels into which the portion of the ALP solution was transferred. ii) For each of the one or more test reaction vessels in the set of one or more test sample containers that corresponds to a test sample container in the set of one or more test sample containers, A) Adding the substrate, which is adapted to react with ALP to produce chemiluminescent light, to the reaction vessel, B) A non-transient computer-readable medium as described in item 78, including magnification, which includes measuring chemiluminescent light from the reaction vessel using the illuminometer provided by the chemiluminescence detection subsystem after the reaction vessel has been rotated at high speed, heated, and placed in the illuminometer container chamber. (Item 83) The method described above is a) Determining the malfunction in the laboratory equipment based on the chemiluminescent light detected in the sample volume linearity check step, b) A non-temporary computer-readable medium as described in item 82, which includes providing notification to address the failure by replacing the sample dispensing motor. (Item 84) The method described above is a) Determining that there is a malfunction in the laboratory equipment based on the chemiluminescent light detected while performing the aforementioned set of illuminance meter sample volume check process, b) To expand the evaluation of the sample dispensing subsystem by performing a set of sample dilution check steps, wherein the set of sample dilution check steps is i) Adding a predetermined volume of ALP solution to each of several test sample containers using the reagent pipette, ii) For each of the first set of test dilution containers, A) Using the sample pipette, transfer a first amount of the ALP solution from the corresponding test sample container to the test dilution container, B) Adding a second amount of washing buffer to the test dilution container using the reagent pipette, C) Mixing the contents of the test dilution container, D) Using the sample pipette, transfer a third amount of fluid from the dilution container to the corresponding reaction container, iii) For each of the second set of test dilution containers, A) Using the sample pipette, transfer a fourth amount of the ALP solution from the corresponding test sample container to the test dilution container, B) Add a fifth volume of washing buffer to the test dilution container using a reagent pipette, C) Mixing the contents of the test dilution container, D) Transferring the third amount of fluid from the dilution container to the corresponding reaction container using the sample pipette, iv) Adding the substrate adapted to react with ALP to produce chemiluminescent light to each of the test reaction vessels corresponding to the test dilution vessel, v) A non-transient computer-readable medium as described in item 78, including magnification, which includes measuring chemiluminescent light from the test reaction vessel using an illuminometer provided by the chemiluminescence detection subsystem after the test reaction vessel has been rotated at high speed, heated, and placed in an illuminometer container chamber. (Item 85) The method described above is a) Determining the malfunction in the laboratory equipment based on the chemiluminescent light detected in the illuminance meter sample volume check step, b) A non-temporary computer-readable medium as described in item 84, which includes providing notification to address the aforementioned failure by checking the immersion height of the sample dispensing tip. (Item 86) The aforementioned sample pipette, a) A precision pipette for samples, b) A non-temporary computer-readable medium as described in item 78, selected from a set of sample pipettes consisting of a fixed-volume sample pipette and a non-temporary computer-readable medium. (Item 87) a) The set of subsystems includes an assay washing subsystem, b) The analysis step sequence includes using the sample dispensing subsystem to dispense the biological fluid into the reaction vessel and using the chemiluminescence detection subsystem to detect chemiluminescent light from the reaction vessel, and further includes using the assay washing subsystem to remove unbound material from the reaction vessel, c) A non-temporary computer-readable medium as described in item 71, wherein the set of diagnostic steps includes evaluating the operation of the assay washing subsystem between evaluating the operation of the sample dispensing subsystem and evaluating the operation of the chemiluminescence detection subsystem. (Item 88) a) The instrument comprises a reagent dispensing subsystem, b) Before the analytical step sequence uses the assay washing subsystem to remove unbound material from the reaction vessel, the reagent is dispensed into the reaction vessel. This includes using a drug dispensing subsystem. c) A non-temporary computer-readable medium as described in item 87, wherein the set of diagnostic steps includes evaluating the operation of the reagent dispensing subsystem before evaluating the operation of the assay washing subsystem. (Item 89) a) Evaluating the operation of the reagent dispensing subsystem before evaluating the operation of the assay washing subsystem includes evaluating the operation of the reagent dispensing subsystem using a digital camera, b) The non-temporary computer-readable medium according to item 88, wherein the set of diagnostic steps includes evaluating the operation of the assay washing subsystem, and then evaluating the operation of the reagent dispensing subsystem using an illuminometer provided by the emission detection subsystem. (Item 90) Evaluating the operation of the reagent dispensing subsystem using a digital camera is possible. a) Using an ultrasound probe to ultrasonically mix the diagnostic reagents in the diagnostic reagent pack, b) For each container in a set of containers, the reagent pipette is used to transfer the diagnostic reagent from the diagnostic reagent pack to the container, c) Using the digital camera to capture one or more reagent resuspension images, wherein each of the one or more reagent resuspension images includes an image of the containers in the set of containers after the diagnostic reagent has been added to the containers. d) A non-temporary computer-readable medium as described in item 89, comprising performing a reagent resuspension check using one or more reagent resuspension images. (Item 91) a) The reagent dispensed into the reaction vessel before using the assay washing subsystem to remove unbound material from the reaction vessel comprises paramagnetic particles and an antibody component adapted by binding to the analyte, b) A non-temporary computer-readable medium as described in item 90, wherein the diagnostic reagent contains paramagnetic particles and does not contain antibody components. (Item 92) The method described above is a) Determining that there is a malfunction in the laboratory equipment based on the reagent resuspension check, b) Addressing the failure by taking one or more measures, i) Replacing the ultrasonic probe, ii) Calibrating the ultrasound in the aforementioned laboratory equipment, iii) a non-temporary computer-readable medium as described in item 90, comprising taking action selected from the group consisting of replacing the ultrasonic transducer of the laboratory instrument. (Item 93) Evaluating the operation of the reagent dispensing subsystem using the illuminance meter for each of one or more containers in a set, a) Add a predetermined volume of ALP solution to the container using a reagent pipette, b) Adding a substrate adapted to react with ALP to produce chemiluminescent light to the container, c) A non-temporary computer-readable medium according to item 88, comprising performing a set of illuminometer reagent volume check steps, which includes measuring chemiluminescent light from the container using the illuminometer provided by the chemiluminescence detection subsystem after the container has been rotated at high speed, heated, and placed in the illuminometer container chamber. (Item 94) The method described above is a) Determining that there is a malfunction in the laboratory equipment based on the chemiluminescent light detected while performing the aforementioned set of illuminance meter reagent volume check process, b) A non-temporary computer-readable medium according to item 93, comprising providing a notification to address the malfunction by rearranging the position of the reagent pipette. (Item 95) The method described above is a) Determining that there is a malfunction in the laboratory equipment based on the chemiluminescent light detected while performing the aforementioned set of illuminance meter reagent volume check process, b) To expand the evaluation of the reagent dispensing subsystem by performing a set of camera reagent volume check steps for each of the multiple test containers, wherein the set of camera reagent volume check steps is i) Add a predetermined volume of washing buffer to the test container using the reagent pipette, ii) A non-temporary computer-readable medium as described in item 93, which includes capturing and zooming in on one or more images of the test container. (Item 96) The method described above is a) Determining the malfunction in the laboratory equipment based on the images captured during the execution of the set of camera reagent volume check steps, b) Providing a notice to address the said failure by taking one or more measures, i) Replace the reagent dispensing syringe, ii) A non-temporary computer-readable medium as described in item 95, comprising providing, selected from the group consisting of replacing a reagent dispensing motor. (Item 97) a) The above method, i) Determining that there is a malfunction in the laboratory equipment based on the chemiluminescent light detected while performing the illuminance meter reagent volume check step described above, ii) To expand the evaluation of the reagent dispensing subsystem by performing a set of reagent volume linearity check steps for each of the multiple test containers, wherein the set of reagent volume linearity check steps is A) Adding a predetermined volume of a mixture of ALP solution and washing buffer to the test container, B) Adding the substrate, which is adapted to react with ALP to produce chemiluminescent light, to the test container, C) After the container has been rotated at high speed, heated, and placed in the illuminance meter container chamber, the chemiluminescent light from the container is measured using an illuminance meter provided by the chemiluminescence detection subsystem, including, b) The plurality of test containers include a subset of three test containers, c) A non-temporary computer-readable medium according to item 93, wherein, for each of the subsets of the three test containers provided by the plurality of test containers, the mixture of ALP solution and washing buffer added to the test container provided by the subset of test containers has a different ratio of ALP solution to washing buffer than the mixture of ALP solution and washing buffer added to the test container provided by the other subsets provided by the plurality of test containers. (Item 98) The method described above is a) Determining the malfunction in the laboratory equipment based on the chemiluminescent light detected in the reagent volume linearity check step, b) Providing a notice to address the said failure by taking one or more measures, i) Check the verticality of the reagent pipette, ii) Replacing the tip of the reagent pipette, iii) A non-temporary computer-readable medium as described in item 97, which includes providing, selected from the group consisting of replacing an ultrasonic transducer. (Item 99) The method described above is a) Determining that there is a malfunction in the laboratory equipment based on the chemiluminescent light detected while performing the aforementioned set of illuminance meter reagent volume check process, b) To expand the evaluation of the reagent dispensing subsystem by performing a set of reagent pipette carryover check steps for each of the multiple test containers, wherein the set of reagent pipette carryover check steps is i) Adding the ALP solution to the test container using the reagent pipette, ii) After adding the ALP solution, add the washing buffer to the test container using the reagent pipette, iv) Adding the substrate adapted to react with ALP to produce chemiluminescent light to the test container, v) After adding the substrate adapted to react with ALP to produce chemiluminescent light, the test container is rotated at high speed, vi) a non-temporary computer-readable medium as described in item 93, including magnification, which includes measuring chemiluminescent light from a container after it has been placed in a warmed and heated illuminometer container chamber using an illuminometer provided by the chemiluminescence detection subsystem. (Item 100) The method described above is a) Determining the malfunction in the laboratory equipment based on the chemiluminescent light detected in the reagent pipette carryover check step, b) Providing a notice to address the said failure by taking one or more measures, i) Replacing the tip of the reagent pipette, ii) Investigating the state of the washing tower provided by the assay washing subsystem, iii) providing a non-temporary computer-readable medium as described in item 99, which is selected from the group consisting of replacing a washing and dispensing pump. (Item 101) A non-temporary computer-readable medium storing data that configures a computer to operate a laboratory instrument comprising multiple subsystems and to perform a method for diagnosing a malfunction in the laboratory instrument, wherein the method a) Performing an analytical step sequence for analyzing a biological sample, wherein the analytical step sequence includes adding an assay reagent containing paramagnetic particles and an antibody adapted to bind to the analyte to a reaction vessel, b) Performing a set of diagnostic steps to evaluate the operation of the laboratory instrument, the set of diagnostic steps comprising adding a diagnostic reagent to each container in a set of containers, wherein the diagnostic reagent contains paramagnetic particles and does not contain antibody components, in a non-temporary computer-readable medium. (Item 102) a) The assay reagent has paramagnetic particles of a first concentration, b) The diagnostic reagent has paramagnetic particles of a second concentration, c) A non-temporary computer-readable medium as described in item 101, wherein the first concentration is lower than the second concentration. (Item 103) a) The concentration of XL1 is 0.3 mg / mL to 2.0 mg / mL. b) A non-temporary computer-readable medium as described in item 102, wherein the second concentration is 4.0 mg / mL. (Item 104) The aforementioned set of diagnostic steps, a) For each container in the set of containers, i) A test mixture is prepared by combining the diagnostic reagent added to the container with a portion of the washing buffer, ii) Exposing the test mixture to a magnetic field in the container, iii) Removing the container from the magnetic field, iv) After removing the container from the magnetic field, a step of mixing the test mixture contained in the container, b) Using a digital camera to capture one or more particle resuspension images, wherein each of the one or more particle resuspension images includes an image of the containers in the set of containers after the test mixture contained in the containers has been mixed. c) A non-temporary computer-readable medium as described in item 101, comprising performing a resuspension check using one or more particle resuspension images. (Item 105) Mixing the test mixture contained in each of the containers within the set of containers is: a) Moving the container to a high-speed rotating mixing position on the washing wheel, b) A non-temporary computer-readable medium according to item 104, comprising rapidly rotating and mixing the test mixture contained in the container. (Item 106) The method described above is a) Determining that there is a malfunction in the laboratory equipment based on the resuspension check, b) Providing a notice to address the said failure by taking one or more measures, i) Arranging the high-speed rotating mixer on the washing wheel at the high-speed rotating mixing position, ii) A non-temporary computer-readable medium according to item 105, comprising providing, selected from the group consisting of replacing the high-speed rotary mixer. (Item 107) Mixing the test mixture contained in each of the containers within the set of containers is: a) Moving the container to the pipette position within the laboratory equipment, b) A non-temporary computer-readable medium according to item 104, comprising ultrasonically mixing the test mixture contained in the container using a reagent pipette. (Item 108) The method described above is a) Determining that there is a malfunction in the laboratory equipment based on the resuspension check, b) Providing a notice to address the said failure by taking one or more measures, i) Arranging the reagent pipette in the laboratory equipment at the pipette position, ii) providing a non-temporary computer-readable medium as described in item 107, which is selected from the group consisting of checking the perpendicularity of the reagent pipette. (Item 109) The aforementioned set of diagnostic steps, a) For each of the containers in the set, before adding the diagnostic reagent to the container, ultrasonic The diagnostic reagent is ultrasonically mixed using a wave probe, b) Using a digital camera to capture one or more reagent resuspension images, wherein each of the one or more reagent resuspension images includes an image of the containers in the set of containers after the diagnostic reagent has been added to the containers. c) A non-temporary computer-readable medium as described in item 101, comprising performing a reagent resuspension check using one or more reagent resuspension images. (Item 110) The method described above is a) Determining that there is a malfunction in the laboratory equipment based on the reagent resuspension check, b) Providing a notice to address the said failure by taking one or more measures, i) Replacing the ultrasonic probe, ii) Calibrating the ultrasound in the aforementioned laboratory equipment, iii) Providing, selected from the group consisting of replacing the ultrasonic transducer of the laboratory instrument, a non-temporary computer-readable medium as described in item 109. (Item 111) A non-temporary computer-readable medium storing data that configures a computer to operate in order to perform a method for diagnosing a malfunction in laboratory equipment comprising multiple subsystems, wherein the method a) Washing each container from a set of containers, b) Using a digital camera to capture one or more particle-holding images, wherein each of the one or more particle-holding images includes an image of the containers in the set of containers after the containers have been washed. c) A non-temporary computer-readable medium comprising performing a set of diagnostic steps, which include calculating retention values ​​based on one or more particle retention images. (Item 112) a) The set of containers includes a plurality of containers, b) The set of diagnostic steps includes, for each container in the set of containers, generating a test mixture by combining a reagent containing paramagnetic particles added to the container with a portion of the washing buffer, c) A non-temporary computer-readable medium as described in item 111, wherein the test mixture in each container of the set of containers contains 50 μL of reagent and 150 μL of washing buffer. (Item 113) The method described above is a) To determine that there is a malfunction in the laboratory equipment based on the retained value, b) Providing a notice to address the said failure by taking one or more measures, i) Arranging the suction probe at the reaction vessel position within the laboratory equipment, ii) Providing, selected from the group consisting of inspecting the magnetic function of the laboratory instrument, a non-temporary computer-readable medium as described in item 111. (Item 114) The aforementioned holding value is, a) A grayscale value derived from one or more particle-retaining images, b) A non-temporary computer-readable medium as described in item 111, calculated based on the particle retention calibration curve. (Item 115) a) The particle retention calibration curve is prepared using a plurality of calibration mixtures, each of which contains a portion of a reagent that includes paramagnetic particles and a portion of the washing buffer, b) The non-temporary computer-readable medium according to item 114, wherein the plurality of calibration mixtures comprises a set of calibration mixtures, each calibration mixture in the set of calibration mixtures having a different reagent-to-wash buffer ratio than any other calibration mixture in the set of calibration mixtures. (Item 116) The aforementioned set of calibration mixtures a) 50:150, b) 40:160, c) 35:165, d) A non-temporary computer-readable medium according to item 115, comprising a calibration mixture having the reagent-to-wash buffer ratio of 25:175. (Item 117) a) Using the plurality of calibration mixtures, the particle retention calibration can be created. i) For each calibration mixture, A) Sending the container containing the calibration mixture to the washing wheel, B) Mixing the container containing the calibration mixture at high speed at a substrate high-speed rotation position on the washing wheel, C) Capturing a grayscale image of the container containing the calibration mixture after it has been mixed, ii) Creating the calibration curve using the captured grayscale image of the container containing the calibration mixture, b) The set of containers includes a plurality of containers, c) The set of diagnostic steps described above applies to each container within the set of containers, i) A test mixture is prepared by combining the reagent added to the container with a portion of the washing buffer, ii) After the test mixture is prepared in the container, it is washed at least twice with the washing buffer, iii) After the container has been washed at least twice, the fluid is drawn out of the container using a suction probe, iv) After the fluid has been aspirated from the container by the suction probe, a large amount of washing buffer is added to the container such that the volume of washing buffer added to the container is equal to the volume of the test mixture that was in the container before aspiration. v) After the aforementioned volume of the washing buffer is added to the container, the container is rotated at high speed at a substrate high-speed rotation position on the washing wheel to mix the contents, d) The non-temporary computer-readable medium according to item 115, wherein the one or more particle-holding images include grayscale images of each container in the set of containers, captured after the container has the volume of the washing buffer added to the container and has been rapidly rotated and mixed at a high-speed rotation position of the substrate on the washing wheel. (Item 118) A non-temporary computer-readable medium storing data that configures a computer to operate in order to perform a method for diagnosing a malfunction in laboratory equipment comprising multiple subsystems, wherein the method a) Performing a set of diagnostic steps to identify a malfunction in the laboratory equipment, wherein each diagnostic step in the set of diagnostic steps corresponds to a subsystem in the plurality of subsystems. b) Detecting a malfunction in the laboratory equipment during the execution of the diagnostic process from the set of diagnostic processes, c) A non-temporary computer-readable medium that provides an output identifying the subsystem corresponding to the diagnostic step while the malfunction in the laboratory instrument is detected. (Item 119) a) The plurality of subsystems, i) Sample dispensing subsystem, ii) Reagent dispensing subsystem, iii) Assay washing subsystem and iv) A chemiluminescence detection subsystem, including, b) The instrument is adapted to analyze a biological sample for the presence of an analyte by performing a set of analytical steps, and the analytical steps are: i) Transferring a portion of the biological sample from the sample container to the reaction vessel using the sample dispensing subsystem, ii) Producing an analytical mixture by transferring a first reagent containing alkaline phosphatase (ALP) from a reagent pack to the reaction vessel using the reagent dispensing subsystem, iii) Using the assay washing subsystem, remove from the reaction vessel any portion of the analytical mixture that is not bound to the analyte, iv) A non-temporary computer-readable medium according to item 118, comprising adding a substrate adapted to react with ALP to produce chemiluminescent light to the reaction vessel, and detecting the chemiluminescent light produced by the substrate in reaction with ALP using the chemiluminescence detection subsystem. (Item 120) A non-temporary computer-readable medium storing data that configures a computer to operate a laboratory instrument comprising multiple subsystems and to perform a method for diagnosing a malfunction in the laboratory instrument, wherein the method a) Performing an analytical step sequence for analyzing a biological sample, wherein the analytical step sequence is, i) Transferring a portion of the biological sample from the sample container to the reaction vessel, ii) Producing an analytical mixture by transferring a first reagent containing alkaline phosphatase (ALP) from the reagent pack to the reaction vessel, iii) Using an assay washing subsystem to remove any portion of the analytic mixture that is not bound to the analyte from the reaction vessel, iv) A procedure comprising adding a substrate adapted to react with ALP to produce chemiluminescent light to the reaction vessel, and using an illuminometer to detect the chemiluminescent light produced by the substrate in reaction with ALP, b) Performing a set of diagnostic steps, which includes performing a set of cleaning efficiency check steps for each of one or more containers in a set, wherein the set of cleaning efficiency check steps is i) A) ALP solution and, B) A second reagent containing paramagnetic particles, C) Combination with washing buffer, To add to the aforementioned container, ii) Performing a set of cleaning steps, A) Exposing the container to a magnetic field, B) Adding an additional washing buffer to the container, C) The contents of the container The act of performing, which includes, rotating at high speed one or more times, iii) Suctioning fluid from the container, iv) After aspirating the fluid from the container, add the substrate which is adapted to react with ALP to produce chemiluminescent light, v) Keeping the container warm, vi) Using the illuminance meter, after being placed in the illuminance meter container chamber, the container A non-temporary computer-readable medium, including the measurement of chemiluminescent light. (Item 121) a) The second reagent containing paramagnetic particles does not contain an antibody component, b) The non-transient computer-readable medium according to item 120, wherein the analytical step sequence comprises adding a third reagent containing paramagnetic particles to the reaction vessel, the paramagnetic particles provided by the third reagent being coated with an antibody component adapted to bind to an analyte. (Item 122) a) The analysis process sequence is i) Before transferring the first reagent containing ALP to the reaction vessel, transfer the third reagent containing paramagnetic particles to the reaction vessel, ii) The reaction vessel is kept warm between transferring the third reagent containing paramagnetic particles to the reaction vessel and transferring the first reagent containing ALP to the reaction vessel, iii) The process includes warming the reaction vessel between transferring the third reagent containing ALP to the reaction vessel and detecting the chemiluminescent light produced by the substrate in reaction with the ALP using the illuminometer, b) A non-temporary computer-readable medium as described in item 120, wherein each container in the set of containers is heated only once during the execution of the set of diagnostic steps. (Item 123) The method described above is a) Determining that there is a defect in the laboratory equipment based on the chemiluminescent light detected while performing the set of cleaning efficiency check steps, b) A non-temporary computer-readable medium according to item 120, comprising providing notification to address the fault by arranging pick-and-place actuator positions at the container positions. (Item 124) The method described above is a) Determining that there is a defect in the laboratory equipment based on the chemiluminescent light detected while performing the set of cleaning efficiency check steps, b) Extending the evaluation of the assay washing subsystem by performing a set of wash buffer volume check steps, wherein the set of wash buffer volume check steps is i) Using one or more probes to add a predetermined volume of washing buffer to one or more test containers, ii) Moving each of the test containers to which the predetermined volume of the washing buffer has been added to the camera position on the washing wheel, iii) To capture an image of one or more test containers to which the predetermined volume of washing buffer has been added, iv) A non-temporary computer-readable medium as described in item 120, including zooming, including using the capture image to determine the actual volume of the washing buffer added to each of the one or more test containers. (Item 125) The method described above is a) Determining the malfunction in the laboratory equipment based on the actual volume of the washing buffer added to one or more test containers, b) A non-temporary computer-readable medium as described in item 124, which includes providing notification of addressing the failure by replacing one or more of the probes used to add the washing buffer to the one or more test containers. (Item 126) The method described above is a) Determining that there is a defect in the laboratory equipment based on the chemiluminescent light detected while performing the set of cleaning efficiency check steps, b) Extending the evaluation of the assay washing subsystem by performing a set of residual volume check steps, wherein the set of residual volume check steps is i) Using one or more probes to add a predetermined volume of washing buffer to one or more test containers, ii) For each test container to which the predetermined volume of washing buffer has been added, A) Moving the test container to the suction position corresponding to the probe used to add the predetermined amount of washing buffer to the test container, B) Aspirating fluid from the test container using a suction probe positioned at the suction position where the test container has been moved, C) After the fluid is drawn out, move the test container to the camera position, D) After the fluid is drawn out there, capture one or more images of the test container, E) determining a residual volume remaining in the test vessel based on the captured one or more images of the test vessel, and expanding, the non-transitory computer-readable medium of item 120, comprising. (Item 127) The method comprises, a) determining the fault in the laboratory apparatus based on the residual volume detected in the residual volume checking step; and b) providing a notification to address the fault by performing one or more actions, wherein the one or more actions comprise i) replacing one or more aspiration probes; ii) aligning the one or more aspiration probes at the aspiration position where it is arranged; and iii) replacing a peristaltic pump tube, selected from the group consisting of, providing, the non-transitory computer-readable medium of item 126, comprising. (Item 128) The method comprises, a) determining that there is a fault in the laboratory apparatus based on chemiluminescent light detected while performing the set of washing efficiency checking steps; and b) expanding the evaluation of the assay washing subsystem by performing a set of aspiration probe carryover checking steps, wherein the set of aspiration probe carryover checking steps comprises, for each of the set of one or more test vessels, i) adding the ALP solution to the test vessel; ii) adding a wash buffer to the test vessel after adding the ALP solution; iii) aspirating the ALP solution from the test vessel using an aspiration probe; iv) adding the substrate adapted to react with ALP to generate chemiluminescent light to the test vessel; v) rotating the test vessel at high speed after adding the substrate adapted to react with ALP to generate chemiluminescent light; vi) measuring chemiluminescent light from the container after it has been incubated and placed in the luminometer container chamber using a luminometer; and expanding. The non-transitory computer-readable medium of item 120, comprising. (Item 129) The method comprises: a) determining the fault in the laboratory apparatus based on the chemiluminescent light detected in the aspiration probe carryover check step; b) providing a notification to address the fault by performing one or more actions, wherein i) replacing one or more aspiration probes; ii) inspecting the condition of the wash tower provided by the assay wash subsystem; iii) replacing a wash dispense pump; selected from the group consisting of. The non-transitory computer-readable medium of item 128, comprising providing. (Item 130) A non-transitory computer-readable medium storing data that operatively configures a computer to operate a laboratory apparatus comprising a plurality of subsystems and to perform a method of diagnosing a fault in the laboratory apparatus, wherein the method comprises: a) performing an analytical process sequence for analyzing a biological sample, wherein i) the analytical process sequence utilizes a plurality of subsystems, A) a sample dispense subsystem; B) a reagent dispense subsystem; C) an assay wash subsystem; D) a chemiluminescence detection subsystem. ii) performing the analytical process sequence comprises: A) generating an analytical mixture by transferring a first reagent comprising alkaline phosphatase (ALP) from a reagent pack to the reaction vessel using the reagent dispense subsystem; B) removing the portion of the analytical mixture that is not bound to the analyte from the reaction vessel using the assay wash subsystem. C) Adding a substrate adapted to react with ALP to produce chemiluminescent light to the reaction vessel, and using the chemiluminescence detection subsystem to detect the chemiluminescent light produced by the substrate in reaction with ALP, b) Performing a set of diagnostic steps, wherein the diagnostic steps are i) Evaluating the plurality of subsystems using an illuminance meter provided by the chemiluminescence detection subsystem, ii) a non-temporary computer-readable medium, including performing the following: using machine vision to evaluate one or more subsystems among the plurality of subsystems in parallel with evaluating the plurality of subsystems using an illuminance meter provided by the chemiluminescence detection subsystem. (Item 131) a) The sample dispensing subsystem, i) Sample precision subsystem, ii) A subsystem for constant sample volumeization, b) The analysis process sequence is i) Transferring a fixed amount of the biological sample from the sample container to the reaction vessel using the sample constant volume subsystem, A non-temporary computer-readable medium according to item 130, comprising transferring a portion of the biological sample from a sample container to a reaction vessel by performing a step selected from the group consisting of: ii) transferring a portion of the biological sample from a sample container to a reaction vessel using the sample dispensing subsystem. (Item 132) a) The analytical step sequence includes adding an analytical reagent to the reaction vessel, which contains paramagnetic particles coated with an antibody component adapted to bind to the analyte, b) The set of diagnostic steps acts as the reaction vessel in the evaluation of the instrument. A non-temporary computer-readable medium as described in item 130, comprising adding an analytical reagent containing paramagnetic particles and lacking an antibody component to a container. (Item 133) A non-temporary computer-readable medium storing data that configures a computer to operate a laboratory instrument comprising multiple subsystems and to perform a method for diagnosing a malfunction in the laboratory instrument, wherein the method a) Performing an analytical process sequence, i) Transferring a portion of the biological sample from the sample container to the reaction vessel, ii) Producing an analytical mixture by transferring a first reagent containing alkaline phosphatase (ALP) from a reagent pack to the reaction vessel using a reagent dispensing subsystem, iii) Using an assay washing subsystem to remove any portion of the analytic mixture that is not bound to the analyte from the reaction vessel, iv) Adding a substrate adapted to react with ALP to produce chemiluminescent light to the reaction vessel, and detecting the chemiluminescent light produced by the substrate in reaction with ALP using a chemiluminescence detection subsystem, b) Performing a set of diagnostic steps, i) Add the substrate, which is adapted to react with ALP to produce chemiluminescent light, to the test container. ii) Performing the following actions, including determining that a fault exists in the laboratory equipment based on chemiluminescent light detected using the chemiluminescence detection subsystem: c) Based on the determination that the defect is present in the laboratory equipment, perform a set of magnification diagnostic steps, for each of the multiple magnification test containers: i) Adding a predetermined volume of test fluid to the enlarged test container, ii) To capture an image of the enlarged test container, iii) Determining the volume of the test fluid in the enlarged test container using the image of the enlarged test container, The aforementioned test fluid is A) A substrate adapted to react with ALP to produce chemiluminescent light, B) Washing buffer and C) the first reagent comprising ALP, and D) a second reagent comprising paramagnetic particles, selected from the group consisting of, determining, and comprising performing, non-transitory computer-readable medium. (Item 134) a) performing the set of diagnostic steps comprises, for each of the one or more containers in the set, i) adding the substrate adapted to react with ALP to generate chemiluminescent light to the container, ii) incubating the container after the substrate adapted to react with ALP to generate chemiluminescent light is added to the container, iii) using the chemiluminescence detection subsystem to measure chemiluminescent light from the container after the container is incubated and placed in the luminometer container chamber, comprising performing a set of substrate blank check steps including b) determining that the fault is present in the laboratory apparatus based on chemiluminescent light detected using the chemiluminescence detection subsystem comprises determining that at least one container in the set of containers is contaminated with ALP based on detecting light emitted from the container using the chemiluminescence detection subsystem, The non-transitory computer-readable medium according to Item 133. (Item 135) The non-transitory computer-readable medium according to Item 134, wherein the test fluid added to the expanded test container is the substrate adapted to react with ALP to generate chemiluminescent light . (Item 136) The non-transitory computer-readable medium according to Item 133, wherein for each of the plurality of expanded test containers, determining the volume of the test fluid in the expanded test container using the image of the expanded test container comprises determining the volume of the fluid using the distance between the bottom of the meniscus in the expanded test container and the bottom of the expanded test container. (Item 137) Performing the set of diagnostic steps comprises a) performing ultrasonic mixing on the diagnostic reagent in the reagent pack, b) Transferring a portion of the diagnostic reagent from the reagent pack to the particle test container, c) After the transfer of a portion of the diagnostic reagent, capture an image of the test container, d) A non-temporary computer-readable medium as described in item 133, which determines whether a malfunction exists in the laboratory equipment based on a grayscale value of the image of the test container. (Item 138) The non-transient computer-readable medium described in item 137, wherein the diagnostic reagent comprises uncoated paramagnetic particles and does not contain any paramagnetic particles coated with antibody components. (Item 139) A machine that tests biological samples for the presence of an analyte and has self-diagnostic capabilities, wherein the machine a) Sample dispensing subsystem, b) Reagent dispensing subsystem, c) Assay washing subsystem, d) Chemiluminescence detection subsystem, e) A machine comprising means for automatically diagnosing a malfunction in the operation of the machine. [Brief explanation of the drawing]

[0015] [Figure 1] An exemplary assay is shown.

[0016] [Figure 2A] A cross-sectional perspective view of the illuminance meter is shown. [Figure 2B] A cross-sectional perspective view of the illuminance meter is shown.

[0017] [Figure 3A] An example of a washing wheel is shown. [Figure 3B] An example of a washing wheel is shown.

[0018] [Figure 4] An exemplary pipetting system is shown.

[0019] [Figure 5] An example probe washing sequence is shown.

[0020] [Figure 6] An exemplary computer system is shown.

[0021] [Figure 7] This illustrates an exemplary process that can be used to evaluate the operation of a clinical analyzer.

[0022] [Figure 8] The following describes the steps that can be used to create a calibration curve.

[0023] [Figure 9] This shows a process that can be used to perform a cleaning efficiency check. [Modes for carrying out the invention]

[0024] Various embodiments are described in detail with reference to the drawings, and similar reference numerals represent similar parts and assemblies through several drawings. References to various embodiments do not limit the claims appended herein. In addition, none of the examples described herein are intended to be limiting, but merely describe some of the many possible embodiments of the appended claims.

[0025] Referring here to Figure 1, the figure shows an exemplary assay 100 that may be performed by an automated clinical analyzer. Assay 100 begins in step 1. A reaction vessel 105 (e.g., a cuvette) may be used for assay 100. A pipette 110 is used to place a first reagent 115 containing iron particles 120 at a concentration of 0.3–2.0 mg / mL into the reaction vessel 105. The first reagent 115 also contains an antibody or antigen that has been adapted to bind only to the analyte in the patient sample 165, which the assay means to measure. In assay 100, the iron particles 120 are coated with the antibody or antigen.

[0026] In step 2, the patient sample 165 is added to the reaction vessel 105 using pipette 110. Pipette 110 may be purified, replaced, or have a new tip at each step. In addition, in some analyzers, different pipettes may be used at different stages (e.g., a first pipette for dispensing the patient sample, a second pipette for dispensing the reagent, a third pipette for aspiration and / or washing).

[0027] In step 3, the reaction vessel 105 containing the patient sample 165 and the first reagent 115 (containing iron particles 120) is mixed to produce a mixture 170. In addition (or alternatively), in some analyzers, the contents of vessel 105 may not only be mixed but also exposed to a heat source (i.e., incubation). During the binding process, the antibody or antigen on the iron particles 120 of the first reagent 115 binds to the target analyte in the patient sample 165. The binding process may result in the binding of the analyte in the patient sample 165 to the antigen or antibody coated on the iron particles 120.

[0028] In step 4, the reaction vessel 105 is moved near one or more magnets 130 that attract iron particles 120 to one or more sides of the reaction vessel 105 (e.g., the peripheral portion). A pipette 110 is used to wash the reaction vessel 105 with a cleaning agent 150. During washing, the magnets 130 hold the iron particles 120 to one or more sides of the reaction vessel 105. The iron particles 120 and the bound analytes of the patient sample 165 remain in the reaction vessel 105 after washing is completed by the magnets 130. Other components of the patient sample 165 cannot be present in the reaction vessel 105 after washing is completed and have been washed away by the cleaning agent 150.

[0029] In step 5, a second reagent 155 containing alkaline phosphatase ("ALP") (generally at a concentration of 0.01 mg / L to 2.0 mg / L) can be placed in the reaction vessel 105 using a pipette 110, along with the iron particles 120 and the conjugated analyte of the patient sample 165. The second reagent 155 and the iron particles 120 can be mixed and / or warmed. The second reagent 155 may still contain antibodies attached to ALP that conjugate to the analyte of the patient sample 165 attached to the iron particles 120.

[0030] In step 6, the magnet 130 pulls the iron particles 120 to one or more sides of the reaction vessel 105. The iron particles 120 here have the bound analytes of the patient sample 165 and the ALP of the second reagent 155 bound to them. The unbound portions of the second reagent 155 are washed off with additional cleaning agent 150 added to the reaction vessel 105 with a pipette 110, and the unbound fluid can be aspirated from the reaction vessel 105.

[0031] In step 7, the substrate material 180 is added to the reaction vessel 105 using a pipette 110. The substrate material 180 is mixed and heated using a heat source 125 (for example, the reaction vessel 105 is placed in an incubator). The substrate material 180 reacts with the ALP enzyme, and This generates light 135 (i.e., photons).

[0032] In step 8, the light 135 emitted by the reaction between the substrate material 180 and the ALP attached to the iron particles 120 can be measured using an illuminometer, as discussed below in the context of Figure 2, to generate an output signal that can be processed to produce a relative light unit ("RLU") value (i.e., output response) indicating the results of assay 100. For example, a larger RLU value indicates more light, showing a larger amount of analyte to the patient sample 165 than a smaller RLU value indicates.

[0033] Referring here to Figures 2A and 2B, Figure 2A shows a cross-sectional perspective view of the illuminometer for performing assay 100, and Figure 2B provides an enlarged view of a portion of Figure 2A, as indicated by the dashed circle in Figure 2A. The cross-section of the cross-sectional perspective view is indicated by cross-hatching. The cross-sectional perspective view shows the cap 415, the chassis 405, the illuminometer computer system compartment 435, the PMT cover 450, the stand 440, the motor 425, the thermal barrier 445, the reaction vessel chamber 610, and the calibration unit 460. The illuminometer output signal socket 465a and the illuminometer output signal socket 465b are also shown.

[0034] Figure 2A provides an overview of the chamber opening 430 that provides access to the reaction vessel chamber 610. The reaction vessel 105 is shown seated within the reaction vessel chamber 610. The optical path 640 intersects the reaction vessel chamber 610 near the bottom of the chamber. The PMT 630 may be a photomultiplier tube or any other suitable photodetector or photodetector. The PMT 630 may include a sensing element (not shown in detail) that detects light from the optical path 640 and / or the reaction vessel chamber 610. The PMT 630 is arranged in the optical path 640 and adjacent to an opening 635 that passes through the intersection of the optical path 640 and the reaction vessel chamber 610. The opening 635 allows light to enter the PMT 630 and for the sensing element to receive the light. The reaction vessel chamber 610 intersects with the light path 640 when the reaction vessel 105 is placed inside the reaction vessel chamber 610, and the substance or sample in the reaction vessel 105 can emit photons that can be seen in the light path 640 and in the opening 635. The opening 635 can be limited to, for example, a diameter of 8.5 centimeters to limit the field of view of the meniscus in the reaction vessel 105. At the other end of the light path 640, a calibration unit opening 645 can be arranged in the light path 640. The calibration unit 460 may include a light-emitting diode ("LED") 620 and a photodiode 625. The LED 620 and photodiode 625 can provide a regulated internal light source used to calibrate the PMT 630. The reaction vessel 105 is not required in the illuminometer, for example, during calibration. Although the illuminometer is described as including the reactor 105, it is an optional component of the system and may not necessarily be part of the illuminometer.

[0035] Referring here to Figures 3A and 3B, these figures show a washing wheel 270 that can be used in performing assay 100 as shown in Figure 1. The washing wheel 270 includes a plurality of holders 272 (e.g., holes). As shown, the washing wheel 270 includes 27 holders 272. In other embodiments, the washing wheel 270 may include fewer than 27 holders 272. Each holder 272 is configured to receive a container 105 (e.g., a reaction vessel), and the container 105 and the holder 272 in which it is received are axially symmetric and axially symmetric with respect to each other when fitted together.

[0036] In the embodiment shown in Figures 3A and 3B, 27 stations S are defined, mounted on the frame 262 of the clinical analyzer, and a cleaning wheel 270 moves the holders 272 around them. Specifically, the cleaning wheel 270 rotates about axis A1, thereby moving the holders 272 from station to station about a rotational displacement R1. In the exemplary cleaning wheel 270 shown in Figures 3A and 3B, the cleaning wheel 270 is indexed 13 and 1 / 3 degrees per cycle, thereby advancing each of the 27 holders 272 by one station per cycle.

[0037] In Figure 3A, stations S are labeled relative to the washing wheel 270 at a given position, and individual stations are designated using the letter "S" followed by the station number. Not all stations S are labeled, but this can be determined by counting between the labeled stations S. In Figure 3B, station designation using the letter "S" followed by the station number is omitted. However, correspondence between the figures can be established by mapping the in / out stations in Figure 3B to station S1 in Figure 3A, and mapping the stations labeled QS in Figure 3B to station S2 in Figure 3A. The various stations and their roles in assay 100, as shown in Figure 1, are described below.

[0038] In some clinical analyzers, station S0 may be a non-functional station, but it may be possible to transfer container 105 between adjacent stations. Station S1 is an inlet / outlet station. Container 105 is introduced at station S1 into one of the holders 272 of the washing wheel 270. This may be done, for example, after the first reagent 115 (step 1) and sample 165 (step 2) have been added to the reaction vessel (e.g., in a reaction construction carriage not shown in Figures 3A-3B), and then the contents of the container have been mixed or warmed (step 3) (e.g., in a warming wheel not shown in Figures 3A-3B). From station S1, container 105 is rotated to other stations S and finally returned to station S1, where it is removed from the holder 272 of the washing wheel 270.

[0039] After container 105 is added to the washing wheel 270 at station S1, it is rotated to station S2, where washing solution 150 is dispensed (start of stage 4). The contents of container 105 are then rotated through stations S3-S8, where the paramagnetic particles 120 in the reaction vessel are attracted to the sides of the container. The contents of the container that are not bound to the paramagnetic particles attracted to the sides of the container by the magnet are then attracted to station S9 (labeled as station A1 in Figure 3B). The container is then moved to station S10 (labeled as D1 in Figure 3B), where washing buffer is added to it and the contents of the container are rapidly rotated and mixed. This is then repeated for stations S11-S18 (i.e., the container can be magnetized at positions S11-S16, its contents are attracted at position S17 / A2, then additional buffer is added and mixed at position S18 / D2). Next, the container is subjected to another magnetization / attraction procedure at positions S19-S25, at which point step 4 of assay 100 can be fully handled.

[0040] After step 4, the container can be moved to position S1, from which it can be moved to the reaction construction carriage for dispensing the second reagent 155 using a pick-and-place device (step 5). At this point, it can then be returned to the wash wheel either directly or with additional mixing and / or warming (e.g., in a warming wheel) for an additional magnetization + aspiration cycle (i.e., step 6). Generally, the additional magnetization + aspiration cycle in step 6 is performed in the same manner as described above for step 4 (i.e., the wash buffer is dispensed at positions QS, D1 and D2, and the contents of the buffer are aspirated at positions A1, A2 and A3, etc.). However, at the end of step 4, instead of moving directly to the In / Out position and being removed from the wash wheel, the reaction vessel is moved to station S26, where the substrate 180 is dispensed (i.e., the start of step 7) and the contents of the vessel are mixed. From there, the vessel can be rotated to the In / Out position, and from this position, it can be moved to another part of the analyzer (e.g., a warming wheel) to further advance the ALP / substrate reaction, thereby completing step 7. Finally, at the end of step 7, the reaction vessel can be moved to an illuminometer as shown in Figures 2A-2B to measure the light produced by the ALP / substrate reaction, as shown in step 8 of assay 100 from Figure 1.

[0041] Referring now to Figure 4, the figure shows an exemplary pipetting system 510 which can be used to move a pipette between various probe-receiving stations for dispensing and / or aspirating various fluids, as previously described in the context of performing assay 100. In Figure 4, the exemplary pipetting system 510 is configured to transfer fluid between a first probe-receiving station PS1 (e.g., a reagent pack, sample container, etc.) and a second probe-receiving station PS2 (e.g., a station along the periphery of a wash wheel 270). This can be done in part using a first actuator 514 mounted on a first frame 512 mounted on the frame of the instrument. In the example of Figure 4, the first actuator 514 is a linear actuator that provides movement along a displacement d1. The coding convention is defined with respect to the displacement d1. Specifically, the first direction d1+ and the opposite second direction d1- are defined with respect to the displacement d1.

[0042] In addition to the first frame 512, the exemplary pipetting system 510 in Figure 4 also includes a second frame 516. The second frame 116 may be mounted on the first actuator 514, and the second actuator 518 may be mounted on the second frame 516. As shown, the second actuator 518 is a linear actuator that provides movement along a displacement d2. The coding convention is defined with respect to the displacement d2. Specifically, the first direction d2+ and the opposite second direction d2- are defined with respect to the displacement d2. As shown, the displacements d1 and d2 are perpendicular. In other embodiments, the displacements d1 and d2 may be non-perpendicular (e.g., curved, parallel, etc.).

[0043] As shown in Figure 4, the probe P, including the probe tip PT, can be mounted on a second actuator 518. Thus, in the exemplary pipetting system 510 of Figure 4, the probe P and probe tip PT can be moved to multiple positions in a two-dimensional space, including probe receiving stations PS1 and PS2, by acting on the first and second actuators 514 and 518. In other embodiments, an additional frame and / or additional actuators may be provided (for example, between the first frame 512 and the instrument frame) to enable the probe P and probe tip PT to be moved to multiple positions in a three-dimensional space.

[0044] Probe P can define axis A. Probe receiving station PS can define axis A0. Probe P can be positioned at the corresponding probe receiving station PS when axes A and A0 are aligned within an acceptable tolerance.

[0045] In typical uses such as fluid dispensing and aspiration, as described in the context of Figures 1 and 3, the first actuator 514 axially aligns the probe P with the desired probe receiving stations PS, PS1, thereby aligning it along axes A and A0. As shown in Figure 4, the probe P and probe receiving station PS1 of the exemplary pipetting system 510 are aligned when the first actuator 514 is in the operating position dp1. When the probe P is aligned with the probe receiving stations PS, PS1, the second actuator 518 may move the probe P along its axis A, thereby along the probe path 300 (for example, away from the operating position ap1 of the second actuator 518). When probe P dispenses and / or aspirates fluid in its working position within the probe receiving station, probe P may retract along the probe path 300, and then actuator 1 514 moves second frame 516, thereby moving probe P, probe tip PT, and probe path 300 to additional receiving stations within range of the pipette system.

[0046] In practice, clinical analyzers may incorporate multiple pipetting systems for purposes such as enabling specialization of various assemblies. For example, in some cases, the pipetting system used to transfer reagents from a reagent pack to a reaction vessel may differ from the pipetting system used to transfer samples from a sample container to a reaction vessel. In this type of system, the pipetter used to transfer reagents may have additional specialization to assist in this task. As an example, a reagent pipetter may be equipped with a tip that allows sonication mixing of the reagents in the reagent pack before aspirating for transport to the reaction vessel, thereby ensuring that the aspirated reagent is not affected by any precipitation that may occur in the reagent pack. Sample pipettes may be similarly specialized. As an example, a portion of the sample may be moved directly to a specific test (performed by a sample precision pipetter) or (via a sample constant volume (aliquot) pipetter) to a later test (possibly including a reflection test). There may be multiple sample pipettes adapted to move directly into a holding area (e.g., a sample wheel) where a portion of the sample can be held for use. Multiple pipette systems may also be incorporated for purposes other than supporting multiple workflows. For example, some instruments may be provided in a multiple pipette system to avoid individual pipetting systems becoming bottlenecks.

[0047] One or more pipetting systems, as shown in Figure 4, may be present in a clinical analyzer implemented based on this disclosure. However, such pipetting systems are not required, and other types of pipetting arrangements may exist in combination with or as alternatives to the system shown in Figure 4. For example, in some embodiments, various container positions (e.g., positions S0-S27 from Figure 3) may have dedicated pipettes that can move up and down to interact with the container (e.g., dispensing fluid and aspirating fluid) at each of those positions (e.g., wash buffer dispensing positions in the wash wheel as shown in Figures 3A-3B), but without the additional degrees of freedom shown in Figure 4. Therefore, the consideration of the above variations, such as the pipetting system 510 in Figure 4, should be understood as merely illustrative and not treated as limitation.

[0048] Referring now to Figure 5, the figure shows an exemplary array that can be used to clean a probe in a pipette system 510 as shown in Figure 4. The probe cleaning array includes a hollow probe P, a frame 516, a probe actuator 518, a probe cleaner 530, and a probe cleaner actuator 520. The probe actuator 518 acts on the hollow probe P relative to the frame 516. The hollow probe P includes a tip PT. The probe actuator 518 moves the hollow probe P vertically along the probe path 300. The probe cleaner 530 includes a cavity 532 adapted to receive at least a portion of the hollow probe P when the probe cleaner 530 is in the deployed position pw2, cleans the hollow probe P as it intersects with the probe path 300 when the probe cleaner 530 is in the deployed position pw2 (shown by a dashed line), and cleans the probe path 300 when the probe cleaner 530 is in the accommodating position pw1. The probe cleaning machine actuator 520 moves the probe cleaning machine 530 between the deployed position pw2 and the retracted position pw1. The probe cleaning machine actuator 520 operates the probe cleaning machine 530 with respect to the frame 516.

[0049] In certain embodiments, the probe actuator 520 is adapted to move the hollow probe P between a housed probe position and a probe cleaning position. The probe washer can be moved in correspondence with respect to the probe path 300 by a third actuator 520 (e.g., to an operating position pw2) so that the probe washer 530 (e.g., the purification cavity 532 of the probe washer 530 and / or the bottom wall 534 of the purification cavity 532) intersects with the probe path 300 when cleaning or adjusting the probe P, thereby allowing the probe P to enter and exit the purification cavity 532 of the probe washer 530. The probe washer 530 can also be moved in correspondence with respect to the probe path 300 by a third actuator 120 (e.g., to an operating position pw1) so that the probe washer 530 cleans the probe path 300 when the probe P is dispensing, aspirating, adjusting for dispensing, and / or adjusting for aspirating, thereby allowing the probe P to pass through the probe washer 530.

[0050] When shaft A and the cavity shaft are aligned, the second actuator 518 can advance probe P to a cleaning position where at least a portion of probe P is inside the cleaning cavity 532 of the probe cleaning machine 530. Once probe P or a portion thereof enters the cleaning cavity, probe P can be cleaned internally and / or externally. Once probe P is cleaned, the second actuator 518 can retract probe P to a housing position, thereby removing probe P or a portion thereof from the cleaning cavity 532 of the probe cleaning machine 530.

[0051] As with the embodiments previously provided herein, it should be understood that the probe washing arrangement in Figure 5 is intended to be illustrative and should not be treated as an limitation. For example, in some analyzers, the probe washing arrangement may include a purification fluid supply unit, a pump for transferring the purification fluid into and / or out of the probe washing machine 530, and one or more valves for configuring the fluid flow through the probe washing machine. The fact that these additional components are not explicitly shown in Figure 5 should not be treated as meaning that analyzers implemented based on this disclosure will not necessarily lack such features. Similarly, in some cases, an analyzer may be equipped with a washing station separate from the pipette assembly as an alternative to, or in addition to, the washing arrangement shown in Figure 5. Such a washing station may include, for example, a washing tower into which a probe can be inserted for a purification and washing dispensing pump for dispensing the dispensing fluid into and / or inside the washing tower. Therefore, while the mobile cleaning array shown in Figure 5 may exist in some analyzers implemented to include the functionality described in this document, it should be understood that such a mobile cleaning configuration is illustrative only and should not be treated as limiting the scope of protection provided by this (or any related) document.

[0052] Referring here to Figure 6, the figure shows an exemplary computer system 49 that can be integrated with or connected to a clinical analyzer and can control various operations of the analyzer, such as by sending commands to the washing wheel 270, pipette assembly 110 and / or other components. As shown in Figure 6, such a computer system 49 may include a processor 51, memory 53, mass storage memory device 55, input / output (I / O) interface 57, and human-machine interface (HMI) 59. The computer system 49 is connected to a network 63 Alternatively, it may be operably coupled to one or more external resources 61 via the I / O interface 57. The external resources may include, but are not limited to, servers, databases, mass storage devices, peripheral devices, cloud-based network services, or any other suitable computer resources that can be used by the computer system 49.

[0053] The processor 51 may include one or more devices selected from a microprocessor, microcontroller, digital signal processor, microcomputer, central processing unit, field-programmable gate array, programmable logic device, state machine, logic circuit, analog circuit, digital circuit, or any other device that manipulates signals (analog or digital) based on operation instructions stored in memory 53. Memory 53 may include, but is not limited to, a single memory device or multiple memory devices, including read-only memory (ROM), random access memory (RAM), volatile memory, non-volatile memory, static random access memory (SRAM), dynamic random access memory (DRAM), flash memory, cache memory, or any other device capable of storing information. The mass storage memory device 55 may include data storage devices such as hard drives, optical drives, tape drives, non-volatile solid-state devices, or any other device capable of storing information.

[0054] The processor 51 may operate under the control of an operating system 65 residing in memory 53. The operating system 65 may manage computer resources such that computer program code, embodied as one or more computer software applications such as application 67 residing in memory 53, may have instructions to be executed by the processor 51. In an alternative embodiment, the processor 51 may execute application 67 directly, in which case the operating system 65 may be omitted. One or more data structures 69 may also reside in memory 53 and may be used by the processor 51, the operating system 65, or application 67 to store or manipulate data.

[0055] The I / O interface 57 may provide a machine interface that operably connects the processor 51 to other devices and systems such as the network 63 or external resources 61. An application 67 may thereby work collaboratively with the network 63 or external resources 61 by communicating via the I / O interface 57 to provide various features, functions, applications, processes, or modules, including embodiments of the present invention. The application 67 may also have program code executed by one or more external resources 61, or otherwise depend on functions or signals provided by other systems or network components outside the computer system 49. In fact, given that virtually infinite hardware and software configurations are possible, those skilled in the art will understand that different versions of the present invention may include applications provided by computing resources (hardware and software) distributed among multiple computers or other external resources 61 located outside the computer system 49, or provided as a service over the network 63, such as a cloud computing service.

[0056] The HMI 59 may be operably coupled to the processor 51 of the computer system 49 in a known manner to enable the user to directly interact with the computer system 49. The HMI 59 may include a video or alphanumeric display, a touchscreen, a speaker, and any other suitable audio and visual indicators capable of providing data to the user. The HMI 59 may also include input and control devices such as an alphanumeric keyboard, a pointing device, a keypad, a push button, a control knob, and a microphone, which can accept commands or inputs from the user and transfer the inputs to the processor 51.

[0057] The database 71 may reside on a mass storage memory device 55 and may be used to collect and organize data used by the various systems and modules described herein. The database 71 may include data and supporting data structures for storing and organizing the data. Specifically, the database 71 may be arranged in any database organization or structure, including, but not limited to, relational databases, hierarchical databases, network databases, or combinations thereof. A database management system in the form of a computer software application executed as instructions on a processor 51 may be used to access information or data stored in the records of the database 71 in response to queries, and queries may be dynamically determined and executed by the operating system 65, other applications 67, or one or more modules.

[0058] Referring now to Figure 7, the figure illustrates a process that may be performed under computer control, as shown in Figure 6, to identify and / or remedy a malfunction in an analyzer having components such as those exemplified and considered in the context of Figures 1-5. In various embodiments, the execution of these processes may be manually triggered (e.g., by the operation of computer-provided controls), performed on a scheduled basis (e.g., periodically), or based on external factors (e.g., when the disclosed technology is used as part of a manufacturing process to facilitate quality assurance, the process shown in Figure 7 may be performed automatically at the end of the instrument's manufacturing process to verify its proper function). Their performance may also be triggered in other ways, such as based on a combination of scheduling and external factors (e.g., periodically, but only when the instrument is not being used to analyze samples).

[0059] If those performances are triggered at a high level, the process in Figure 7 can be understood as being organized into two major categories: a first category of process that detects faults using machine vision and images captured by a digital camera, and a second category of process that detects faults using an illuminometer, as described in the context of Figures 2A-2B, which is used to detect chemiluminescent light during step 8 of assay 100 shown in Figure 1. As shown in Figure 7, several approaches to automated diagnostics can take advantage of the presence of multiple diagnostic modes, i.e., camera and illuminometer-based fault detection, and can allow various diagnostic sequences (shown in Figure 7 as steps 1a-4a and steps 1b-5b) to be executed in parallel. Similarly, since the illuminometer-based diagnostic process will generally consume more time to allow for warming or similar activities, in some embodiments, including camera-based fault detection, the entire camera-based fault detection sequence can be performed during the initial check from the illuminometer-based diagnostic process. As an example, in the embodiment following Figure 7, all camera processes 1a-4a can be completed while the first illuminance meter diagnostic process 1b is being performed. Therefore, while the spatial relationships in Figure 7 may generally be seen as representing various temporal relationships (for example, the fact that sequences 1a-4a and 1b-5b are adjacent to each other reflects that the processes of those sequences can be executed in parallel), it should be understood that having temporal relationships corresponding to the spatial relationships in Figure 7 is not mandatory and should not be seen as limiting the protections provided by this document or any related documents.

[0060] Referring here to the process sequences 1a-4a in Figure 7, these steps can generally be understood as identifying obstacles in the handling of paramagnetic particles in the instrument using machine vision analysis of digital camera images. Starting with step 1a, this step determines whether there is an obstacle in the extraction of the reagent containing paramagnetic particles from the reagent pack into the instrument. To make this determination, some embodiments may utilize special diagnostic reagents from special diagnostic reagent packs (referred to as ASD packs in Figure 7) that differ from assay reagents in that they lack any type of antibody component that may bind to the analyte in the patient sample, and may also have higher concentrations than the reagents used in the assay (e.g., 2.0 mg / mL or more of paramagnetic particles in the diagnostic paramagnetic particle reagent versus 0.2-2.0 mg / mL of paramagnetic particles in the paramagnetic particle reagent, 4.2 mg / L of ALP in the diagnostic ALP solution used in the assay versus 0.1-2.0 mg / L of ALP in the ALP solution). Such diagnostic reagent packs may have similar external factors to standard reagent packs and may be loaded in the same way as standard reagent packs.

[0061] In embodiments using diagnostic reagent packs as described above, the instrument may be configured to store the diagnostic reagent pack in a reagent storage area upon loading, and then automatically transfer it from the storage area to the reagent aspiration area when the diagnosis is to be performed. Once the diagnostic reagent pack has been moved from its storage location, step 1a may be performed using a two-step process. Firstly, the PmP diagnostic reagent is processed and transferred to the reaction vessel in the same manner as the first reagent 115 is present in the assay. For example, this may include applying an ultrasonic mixture to the PmP diagnostic reagent in the reagent pack and, after mixing, transferring a predetermined volume of the PmP diagnostic reagent (e.g., 50 μL) to the reaction vessel using a reagent pipette. Secondly, the mixed reagents in the reaction vessel are imaged by a digital camera (e.g., a camera positioned close to the dispensing position of the reaction vessel, or a camera positioned elsewhere on the apparatus to which the reaction vessel is moved for imaging purposes), and a darkness check is performed on the captured image(s) to determine whether there was a problem in handling the PmP diagnostic reagent (e.g., if the mixed reagents in the reaction vessel have a grayscale value that is brighter or darker than expected). In addition, in some embodiments, this may be performed on multiple vessels (e.g., five vessels) either in parallel or sequentially to provide additional information that can be used to determine whether there was a problem in handling the PmP diagnostic reagent.

[0062] After the handling of the PmP diagnostic reagent in the reagent pack has been evaluated, the embodiment following Figure 7 may proceed to remedy (if a fault is identified) or to the next diagnostic step 2a. In scenarios where a fault is identified, remedy may be carried out by a computer, as shown in Figure 6, providing a message to its interface indicating that there was a fault in the handling of the PmP diagnostic reagent in the reagent pack (e.g., a fault in the resuspension of paramagnetic particles). This type of message may also include information about one or more steps to be taken to remedy the fault, such as replacing the tip of the reagent pipette used when performing sonication, recalibrating the ultrasound, or replacing the ultrasonic transducer of the instrument. If this remedy is unsuccessful, a telephone may be positioned to request that a remote service engineer be dispatched to the instrument, and the remote service engineer may be notified of where the fault occurred (e.g., in the resuspension of paramagnetic particles in the reagent pack) and what remedy activities have already been attempted. In this way, the remote service engineer is eliminated from the need to perform an initial diagnostic check of the equipment upon arrival. Instead, the person can be pre-equipped with knowledge of where the fault occurred and the tools and / or spare parts that can potentially be used to correct the fault (e.g., a replacement camera in the case of a fault in a photograph rather than in the operation of the equipment). Alternatively, if the remedy is successful (as can be confirmed, for example, by re-running diagnostic step 1a), the process can proceed to the subsequent diagnostic step 2a.

[0063] Referring here to step 2a, which checks for defects during resuspension in the reaction vessel, this step can be used to determine whether the equipment is capable of resuspending paramagnetic particles in the reaction vessel after they have been magnetized. This can be done, for example, by processing 50 μL of PmP diagnostic reagent using a reagent pipette (e.g., sonication mixing in the reagent pack) and supplying it to the reaction vessel along with 150 μL of washing buffer. This combination can then be sent to a washing wheel if it can be magnetized under computer control as shown in Figure 6 (potentially without activities related to further reagent dispensing, fluid aspiration, or high-speed rotational mixing). After magnetization, the reaction vessel can be returned to the pipette position and subjected to sonication mixing to resuspend the particles in the solution. Finally, the resuspended mixture can be imaged by a digital camera for darkness checking in the same manner as described for diagnostic step 1a above. Furthermore, in some embodiments, checking for defects during resuspension in the reaction vessel can be performed in multiple (e.g., five) reaction vessels, similar to how step 1a, which checks for proper handling of reagents in reagent packs to provide additional data for identifying defects, can be performed in multiple reaction vessels.

[0064] After the functionality of the equipment for resuspending particles in the reaction vessel has been evaluated, the embodiment following Figure 7 may proceed to relief (if a fault is identified) or to the next diagnostic step 3a. In a scenario where a fault is identified, relief may be carried out by a computer, as shown in Figure 6, providing a message on its interface indicating that there was a fault in resuspending particles in the reaction vessel, and may be accompanied by one or more steps that can be used to relieve the fault, such as checking that the reagent pipette is properly aligned in the reaction vessel at pipetting position and that the reagent pipette is properly vertical. Similar to relief in the context of the previous step 1a, if this is unsuccessful, the service may be placed with a service engineer, who may be pre-equipped to handle the fault directly if one is detected, and who does not need to go through the diagnostic process himself upon arrival. Alternatively, if relief is successful (as can be verified by re-running the diagnostic step 2a in which a fault was identified), the process may proceed to the subsequent diagnostic step 3a.

[0065] Referring here to step 3a, which checks for defects in resuspension within the washing wheel, this step can be used to determine whether there is a defect in the instrument's ability to resuspend paramagnetic particles without relying on sonication. This can be done, for example, by processing 50 μL of PmP diagnostic reagent using a reagent pipette (e.g., sonication in the reagent pack) and supplying it to the reaction vessel along with 150 μL of washing buffer. This combination can then be sent to a washing wheel, which can be subjected to magnetization and high-speed rotation mixing (potentially without activities associated with dispensing additional washing buffer or aspirate, or two or more aspiration + magnetization steps). After high-speed rotation mixing, the reaction vessel can be imaged (e.g., using a camera at the reagent pipette position after it has been returned to its position, or using a camera positioned close to the high-speed rotation mixing station of the washing wheel), and the image(s) can be used for darkness checks, as described in the context of the preceding diagnostic steps 1a-2a. Similarly, as with the previous diagnostic steps 1a-2a, this evaluation can be performed multiple times (e.g., in five different reaction vessels) to provide additional data for diagnosing defects or to ensure that each of the multiple high-speed rotating mixing positions on the washing wheel has been properly evaluated.

[0066] After the functionality of the equipment for resuspending particles in the washing wheel has been evaluated, the embodiment following Figure 7 may proceed to relief (if a fault is identified) or to the next diagnostic step 4a. In a scenario where a fault is identified, relief may be carried out by a computer, as shown in Figure 6, providing a message on its interface indicating that there was a fault in resuspending particles in the washing wheel, and may be accompanied by one or more steps that can be used to verify that the high-speed rotary mixer is properly positioned in the reaction vessel and / or to replace the high-speed rotary mixer. Similar to relief in the context of the preceding steps 1a-2a, if this is unsuccessful, the service may be placed on a service engineer, who may be pre-equipped to handle the fault directly if one is detected, and who does not need to go through the diagnostic process himself upon arrival. Alternatively, if relief is successful (as can be verified by re-running the diagnostic step 3a in which a fault was identified), the process may proceed to the subsequent diagnostic step 4a.

[0067] Referring here to step 4a, which checks for defects in the retention of paramagnetic particles, this step can be used to determine whether there is a defect in the ability of the instrument to rinse the reaction vessel after the assay. In some embodiments, performing this step may involve two subprocesses: one to create a particle retention calibration curve (which may be performed concurrently with other diagnostic steps, or beforehand, such as before or at the time the instrument is set up), and the other to use that calibration curve to identify defects in the operation of the instrument. Starting with the creation of the calibration curve, Figure 8 shows a set of steps that may be performed in some embodiments to create this curve. As shown in Figure 8, the creation of the calibration curve may begin with the creation of multiple calibration mixtures 801 and the dispensing of those calibration mixtures into multiple containers 802. This may include adding the PmP diagnostic reagent (also referred to herein as the ASD reagent) and washing buffer to each of several containers, for example, adding 50 μL of ASD reagent and 150 μL of washing buffer to five containers, adding 40 μL of ASD reagent and 160 μL of washing buffer to five containers, adding 35 μL of ASD reagent and 165 μL of washing buffer to five containers, adding 25 μL of ASD reagent and 175 μL of washing buffer to five containers, for a total of 20 containers with ASD reagent solutions of various concentrations.802 After the calibration mixture has been dispensed into the containers,802 each container may be moved to the washing wheel of the instrument803 and rotated at high speed to a station on the washing wheel to the substrate high-speed rotation position (i.e., the position on the washing wheel where the substrate 180 is dispensed during step 7 in Figure 1 in assay 100)804.804 thereafter the containers are rotated at high speed and imaged805. Next, if there are more containers 806, the process is repeated until all containers are rotated at high speed and imaged 805, at which point the images of the various containers with their various concentrations of ASD solution are used 807 to create a calibration curve of grayscale values ​​showing the various concentrations of paramagnetic particles in the mixture.

[0068] To use a calibration curve, when available, a computer as shown in Figure 6 can cause the instrument to generate a test mixture of ASD reagent and washing buffer (e.g., 50 μL of ASD reagent and 150 μL of washing buffer) in each of several containers (e.g., five containers), and then send those containers to the washing wheel to undergo a complete washing process (e.g., adding washing buffer, high-speed rotation mixing, and aspirating the containers to be tested at least twice) without adding substrate or ALP. The washed containers can then be returned to the washing buffer dispensing position into which another portion of washing buffer (e.g., 200 μL) can be dispensed, at which point they can be sent to the substrate high-speed rotation position on the washing wheel, rotated at high speed, and imaged. The images are then compared to a previously generated calibration curve to determine if there were any problems in the washing process, such as excess particles being retained. If a malfunction is detected, the relief may proceed as described for the previous diagnostic steps 1a-3a, with a relief step that includes arranging suction probes in the reaction vessel and / or checking the magnetic function of the instruments to ensure they are functioning properly.

[0069] Referring here to the process sequences 1b–5b in Figure 7, these steps can generally be understood as testing various subsystems of the instrument in the reverse order in which those subsystems are used in the assay, with each subsequent test generally leveraging one or more previously validated subsystems. Following the general framework, the substrate blank check 1b may test the instrument's chemiluminescence detection subsystem (i.e., an illuminometer as shown in Figures 2A–2B, along with its components used to dispense into the reaction vessel in step 7 of assay 100 as shown in Figure 1) to ensure that it does not produce a false photodetection signal. This may be done, for example, by adding a substrate adapted to produce chemiluminescent light in the presence of ALP to several containers (e.g., 10 containers), warming the containers as they would be used in the assay (e.g., warming for 48 seconds), and then using an illuminometer to detect the luminance for each of the containers after warming. In this case, if the illuminometer detects an unexpectedly high amount of light being generated from the container (e.g., more than approximately 6,000 RLU), it will indicate a fault because there must be ALP in the container to generate more light than expected from the blank reading. Therefore, if a fault is detected, it can be remedied by changing the substrate bottle of the instrument (i.e., the bottle that holds the substrate before it is dispensed into the container) and / or by decontaminating the substrate line of the instrument (i.e., the tube or other carrier that transfers the substrate from the substrate bottle to the reaction vessel) to ensure that none of these components act as a source of contamination. If these steps are successful, the process can proceed to the next diagnostic step 2b. Otherwise, a second line support (e.g., a support engineer) may perform a call step, or extended diagnostic step, to help further identify and / or remedy the fault.

[0070] In embodiments where the remedy for a substrate blank check 1b failure can be addressed by performing an extended diagnostic and / or remedy step, the extended step includes performing a darkness count, LED and linearity check 1.1 to determine whether the unexpected (and unwanted) light readings are caused by the illuminometer itself rather than by contamination causing a chemiluminescence reaction. This includes taking the reading in the illuminometer in the absence of a container to confirm that no unexpected signal was detected, turning on the LED 620 and reading the signal in the illuminometer to confirm that the detected signal corresponds to illumination from the LED, and varying the light intensity of the LED (e.g., illuminating with 0.5, 0.8 and 1.2 pW) to confirm that the readings obtained by the illuminometer at each illuminance level correspond to expected signal values. If these extended diagnostic checks 1.1 fail, remedy steps may be performed, including cleaning the illuminometer box, recalibrating the illuminometer, and / or replacing the illuminometer (or, as with any other remedy steps, a computer, such as the one shown in Figure 6, may indicate that they should be performed). Alternatively, if this extended diagnostic check 1.1 does not identify the root cause of the failure in the substrate blank check 1b, a second line support resource (e.g., a field service engineer) may be called, or in some embodiments, an additional extended diagnostic and remedy sequence 1.2 may be initiated.

[0071] In embodiments where failures in the dark count, LED, and linearity check 1.1 are treated to trigger additional extended diagnostic / remedy steps in order to identify the root cause of failures in the substrate blank check 1b, these additional steps may include a substrate volume check 1.2 performed by a camera. In embodiments in which this type of check is performed, it may be carried out by dispensing a predetermined volume of substrate into a plurality of containers (e.g., dispensing 200 μL of substrate into each of 10 containers), then capturing images of those containers, and calculating the volume of substrate in each of them (e.g., based on the distance between the substrate meniscus and the bottom of the container along the cross-section of the container). If this check reveals that the substrate has not been properly dispensed, it can be remedied by taking measures such as replacing the substrate dispensing probe. If the substrate volume check 1.2 then fails to identify the root cause of failures in the substrate blank check 1b, or if additional remedy activities do not address the failure, a second line support resource may be called to address the failure. Alternatively, if the substrate volume check 1.2 identifies the root cause of the failure in the substrate blank check 1b (and if a root cause is identified), and the remediation step successfully addresses the root cause and eliminates the failure in the substrate blank check 1b (or if there was no failure in the substrate blank check 1b), the diagnostic process can proceed to the next step 2b to evaluate the operation of the assay washing subsystem (i.e., components on the instrument that ensure unbound particles are properly removed from the reaction vessel during the assay, such as aspiration probes, washing towers and / or probe washing systems as shown in Figure 5).

[0072] Referring here to the washing efficiency check step 2b, in some embodiments this can be carried out by a process as shown in Figure 9. First, in the process of that figure, the ASD reagent and ALP solution (preferably ALP solution from the ASD pack) are dispensed into a reaction vessel using a reagent pipette to produce a test mixture (e.g., a mixture of 50 μL of ASD reagent and 150 μL of ALP solution) 901. An additional volume of washing buffer (e.g., 300 μL of washing buffer) can then be dispensed into the vessel 902. The same process used in the assay to remove unbound particles and resuspend the remainder (i.e., magnetizing the vessel (e.g., for 48 seconds), aspirating the fluid from the vessel, adding an additional 500 μL of washing buffer, and rapidly rotating and mixing the vessel to resuspend the contents) can then be carried out on the combined contents of the vessel 903. Next, check 904 is performed to determine whether this has been repeated more than once (which would be during assay 100, as shown in Figure 1), otherwise the unbound removal and resuspension process can be repeated. Otherwise, the fluid can be aspirated from the container 905 and prepared for the chemiluminescence reaction 906 by adding a substrate (e.g., 200 μL of substrate), mixing it at high speed, and allowing it to stand (e.g., 48 seconds). Finally, the container can be read with an illuminometer 907 to determine whether an unexpectedly high amount of light has been detected (indicating a failure in the washing process and an excess amount of ALP solution remaining in the container to react with the substrate (e.g., more than enough to react with the substrate and produce 20,000 RLU)). In addition, as with other diagnostic steps, the washing efficiency check step 2b can be performed in multiple containers (e.g., 10 containers) to provide additional data that can be used in determining whether there is a failure in the system.

[0073] If a failure is identified in the washing efficiency check step 2b, support resources (e.g., field service engineers) may be involved, or in some embodiments, one or more remedial steps may be performed to address the failure. For example, the arrangement of the positions of the washing wheel pick-and-place device (i.e., the device that transfers the reaction vessels to the washing wheel) relative to the in / out stations on the washing wheel may be checked. In addition, if this does not remediate the failure, one or more advanced diagnostic steps may be performed. For example, as shown in Figure 7, this may include performing a washing buffer volume check 2.1 using a camera. In some embodiments, this check 2.1 may be performed by using probes used to dispense a known amount (e.g., 200 μL) of washing buffer into a corresponding set of test vessels, using probes used to dispense washing buffer into the reaction vessels during the assay, then rotating those test vessels to a position on the washing wheel close to the camera (e.g., substrate dispensing position), imaging the vessels, and using the images to calculate the volume of washing buffer actually added to the vessels. This may include dispensing 200 μL of washing buffer into each of the five vessels using the QS probe (i.e., the probe used to add washing buffer to the reaction vessel at the QS position shown in Figure 3B), using the D1 probe (i.e., the probe used to add washing buffer to the reaction vessel at the D1 position shown in Figure 3B), and using the D2 probe (i.e., the probe used to add washing buffer to the reaction vessel at the D2 position shown in Figure 3B). If the captured image then indicates that the volume actually dispensed by one or more probes differs from what was expected, the process may proceed with one or more extended relief steps, such as replacing the washing dispensing syringe (i.e., probe) used to dispense washing buffer into the reaction vessel where the discrepancy was found.Alternatively, if the camera-based wash buffer volume check 2.1 fails to identify the root cause of the failure in the wash efficiency check 2b, an additional magnified diagnostic step 2.2 can be performed to check the residual volume using the camera.

[0074] In an embodiment where a failure in the washing efficiency check 2b leads to an enlarged diagnostic step 2.2 in which the residual volume is checked by a camera, it can be confirmed that this check 2.2 is used to confirm that the probe used to aspirate fluid from the reaction vessel during the assay is functioning as expected. This could include, for example, 1) using each of the probes (e.g., QS, D1, and D2 probes) to dispense a known amount of washing buffer (e.g., 500 μL of washing buffer) from a set of corresponding containers into each container in an assay (e.g., each probe may have a set of five corresponding containers); 2) rapidly rotating the containers at aspiration positions on the washing wheel corresponding to the probes used to dispense the washing buffer into those containers (e.g., moving a container into which the washing buffer has been dispensed by the QS probe to a first aspiration position, a container into which the washing buffer has been dispensed by the D1 probe to a second aspiration position, and a container into which the washing buffer has been dispensed by the D2 probe to a third aspiration position; alternatively, in an instrument where the reaction vessel can be dispensed with washing buffer and aspirationd at the same position, such containers may not be moved at all); 3) aspirating the fluid from the containers; and 4) rapidly rotating the containers to a camera position (i.e., a position on the washing wheel close to a digital camera) where images can be captured and used for volume calculations. If the volume calculation indicates a failure in suction (i.e., in some embodiments, any fluid that remains in the container after suction is treated as a failure in suction), one or more remediation steps may be performed to address the failure. These steps may include replacing the suction probe corresponding to the container where the failure was detected, ensuring that the suction probes corresponding to the container where the failure was detected are properly arranged at their reaction vessel stations, and / or replacing the peristaltic pump tube used by the suction probe to move the unbound liquid from the reaction vessel to the waste container.

[0075] Alternatively, if the residual volume check by camera 2.2 fails to identify the root cause of the failure in the washing efficiency check, in some embodiments, the diagnostic process, as shown in Figure 7, can proceed with an additional expanded diagnostic step of performing an aspiration probe carryover check 2.3. In embodiments where such an additional expanded diagnostic step exists, it can be performed, for example, by adding diagnostic ALP solution and washing buffer to each of several containers (e.g., adding 200 μL of diagnostic ALP solution and 200 μL of washing buffer to each of 10 containers), moving the containers to a position where fluid is aspirated from the reaction vessels to be washed between assays, aspirating the fluid, preparing the containers for the chemiluminescence reaction (e.g., adding substrate, high-speed rotation mixing, and warming, as described in the context of Figure 9), and then reading them with an illuminometer. If these illuminometer readings detect chemiluminescence, it can be treated as indicating a problem with the aspiration probe; otherwise, all ALP can be removed before being prepared for the chemiluminescence reaction, and various remedial measures can be taken. These may include replacing the suction probe, investigating the condition of the scrubbing tower which must clean the probe involved in the failed test, and / or replacing the pump used to dispense the scrubbing buffer. If these measures fail to address the root cause of the scrubbing efficiency check failure 2b, additional resources (such as a field service engineer who was informed of the failure, and the steps taken to diagnose and remedy the failure or its root cause) may be deployed. Alternatively, if the measures are successful, the process may proceed to the next diagnostic step 3b.

[0076] Referring here to the illuminance meter reagent volume check step 3b, this step can be used to evaluate the functionality of the instrument's reagent dispensing subsystem (i.e., components used to handle reagents during the assay, such as reagent pipettes and ultrasonic transducers). In some embodiments, this reagent volume check step 3b can be performed by preparing vessels for a chemiluminescent reaction by adding a predetermined volume of diagnostic ALP solution (e.g., 50 μL of ALP solution) to each of several containers (e.g., 10 containers) using a reagent pipette, adding a substrate (e.g., 200 μL of substrate), rotating and warming them at high speed as described in the context of Figure 9, and then using an illuminance meter to read the chemiluminescent light produced by the reaction of the substrate and ALP solution. If this reading does not match the expected amount of light based on the volume of ALP solution and substrate added to the container (e.g., within 10%), one or more remedy measures, such as aligning the reagent pipette with the reaction vessel and / or reagent pack, can be taken to address the discrepancy. If these measures are successful (or no discrepancies are detected), the process as shown in Figure 7 may proceed to the next diagnostic step 4b. Otherwise, one or more extended diagnostic steps may be performed to test and identify the root cause of the discrepancy, and if a root cause of the discrepancy can be identified, to remedy it.

[0077] If the illuminance meter reagent volume check 3b identifies a fault in the reagent dispensing subsystem, in some embodiments, one or more advanced diagnostic measures may be performed. As shown in Figure 7, these advanced diagnostic measures may include performing a camera reagent volume check 3.1, which in some embodiments may be performed in a similar manner to the previously described substrate volume check 1.2, but instead of dispensing a substrate, the camera reagent volume check 3.1 is preferably performed with a less expensive type of fluid, such as a wash buffer. That is, in a camera reagent volume check, a known volume of wash buffer can be dispensed into multiple containers using a reagent pipette (for example, 200 μL of wash buffer can be dispensed into each of five containers using a reagent pipette), and those containers can be imaged, and the volume of wash buffer in the image can be compared to the expected volume to determine whether there was an error in the operation of the reagent pipette. If this camera reagent volume check 3.1 identifies an error, various remedial measures may be taken to address it, such as replacing the syringe (i.e., reagent pipette) used for reagent dispensing, and / or replacing the motor used to generate the pressure difference for transporting the reagent from the reagent pack to the reagent pipette and from the reagent pipette to the reaction vessel (i.e., reagent dispensing motor). If these remedial activities are sufficient to address the root cause of the failure of the illuminance meter reagent volume check 3b, the diagnostic procedure may proceed to the next step 4b. Otherwise, additional extended diagnostic measures in the form of a reagent volume linearity check 3.2 may be performed.

[0078] In embodiments where a failure in the illuminance meter reagent volume check 3b leads to an extended diagnostic check performing a reagent volume linearity check 3.2, the reagent volume linearity check 3.2 may include adding various combinations of diagnostic ALP solution and washing buffer to various sets of containers, preparing them for a chemiluminescent reaction as described in the context of Figure 9, and then reading the light emitted from the containers using an illuminance meter. For example, in some embodiments, this may include adding 50 μL of ALP solution to 10 containers, adding 25 μL of ALP solution and 25 μL of washing buffer to 10 containers, adding 10 μL of ALP solution and 40 μL of washing buffer to 10 containers, then adding 200 μL of substrate to each container, and measuring the light produced by the reaction between ALP and substrate in each container. If, after performing a light measurement, there is a discrepancy between the measured light and what was expected based on the volume of ALP solution in various containers, this can be treated as an indicator of the root cause of a failure in the illuminometer reagent volume check, and one or more remedial measures may be taken to address it. These remedial measures may include checking the verticality of the reagent pipette, replacing the tip of the reagent pipette, and / or replacing the ultrasonic transducer. Alternatively, if the reagent volume linearity check 3.2 did not indicate the root cause of a failure in the illuminometer reagent volume check 3b, an additional extended diagnostic step may be performed in the form of a reagent pipette carryover check 3.3.

[0079] In embodiments where a failure in the illuminometer reagent volume check 3b leads to a reagent pipette carryover check 3.3, the reagent volume carryover check can be performed in a manner very similar to the previously considered aspiration probe carryover check 2.3. For example, in some embodiments, 50 μL of diagnostic ALP solution and washing buffer can be alternately added to each of 10 containers, and the containers can then be prepared for a chemiluminescent reaction by adding 200 μL of substrate, mixing them and allowing them to warm, and then reading the chemiluminescent light produced using an illuminometer. If the light measured by the illuminometer is greater than what was expected based on the volumes of ALP and substrate, this can be treated as an indicator of the root cause of the failure in the illuminometer reagent volume check 3b, and one or more remedy measures can be taken to address it. These remedy measures may include replacing the reagent pipette tip, checking the condition of the washing column, and / or replacing the washing dispensing pump. If these remedies fail to resolve the malfunction (or if the reagent pipette carryover check 3.3 does not indicate the root cause of the malfunction), additional resources (e.g., a field service engineer) may be called in to address the problem. Otherwise, if the remedies are successful in addressing the root cause of the malfunction in the illuminometer reagent volume check 3b, the diagnostic procedure may proceed with the illuminometer sample volume check 4b.

[0080] Referring here to the illuminometer sample volume check 4b, in some embodiments, the check may be used to evaluate the performance of the sample dispensing subsystem (i.e., components used within the instrument to transfer portions of a patient sample from a sample container to a reaction vessel, such as various sample pipettes and a sample dispensing motor that generates a pressure difference to aspirate and / or dispense portions of the sample into / from a container). This may be done by performing an activity that involves adding a predetermined volume of diagnostic ALP solution (e.g., 100 μL) to each of several containers (e.g., 10 containers) acting as sample containers using a reagent pipette. The illuminometer sample volume check 4b may also involve aliquoting a portion of the ALP solution (e.g., 50 μL) from each of the containers acting as sample containers to a container in another several containers acting as a reaction vessel using the instrument's sample precision pipette. Each of the vessels acting as reaction vessels can then be prepared for the chemiluminescent reaction previously described in the context of Figure 9 (i.e., substrate is added, then mixed, and warmed), and the light provided by the contents of the reaction vessel can be measured by an illuminometer. In the event of a discrepancy between the light detected by the illuminometer and the light expected based on the volume of ALP and substrate dispensed into the reaction vessel, this can be treated as a failure, and remedy measures such as checking the position of the sample precision pipette relative to the reaction vessel can be taken to try and address it. If these measures are successful, the diagnostic process shown in Figure 7 can continue, using the illuminometer, to check other pipettes (e.g., sample constant volume pipettes) that may be used to transfer portions of the patient sample from the sample vessel. Otherwise, one or more expanded diagnostic and remedy measures can be taken to identify and address the root cause of the illuminometer sample volume check failure.

[0081] As shown in Figure 7, in some embodiments, an extended diagnostic activity to identify the root cause of an illuminometer sample volume check failure may include a camera sample volume check 4.1. Such a camera sample volume check 4.1 may include using a reagent pipette to add a first volume of washing buffer to several containers that will serve as sample containers for the purpose of this test (e.g., adding 100 μL of washing buffer to each of five containers), using a sample precision pipette to aspirate a portion of the washing buffer (e.g., removing 30 μL of washing buffer from each of the containers acting as sample containers), and then imaging the containers to determine the actual volume of washing buffer remaining after aspiration (e.g., by measuring the distance between the bottom of the washing buffer meniscus and the base of the container and multiplying that distance by the cross-sectional area of ​​the container). In addition, in some embodiments, the camera sample volume check 4.1 may also dispense the washing buffer aspirated from the sample containers into a new container that will serve as a reaction vessel for this test. As an example, in some embodiments, in addition to (or instead of) aspirating the wash buffer from the sample container and imaging the sample container, the wash buffer (or a portion thereof) may be dispensed into a new container that is treated as a reaction vessel for the purpose of testing (either by itself or in combination with additional wash buffer aspirated from the sample container). For example, in some embodiments, for each container treated as a sample container for the purpose of testing, 25 μL of wash buffer may be dispensed into a first container acting as a reaction vessel, and 10 μL of wash buffer may be dispensed into a second container acting as a reaction vessel. In this type of embodiment, the image may capture each container acting as a reaction vessel after the wash buffer has been dispensed into it, and the image may capture the sample container after any additional wash buffer has been aspirated from it (and possibly thereafter).

[0082] Finally, the images captured as part of camera sample volume check 4.1 can be analyzed to determine the volume of washing buffer in the imaged container. These volumes can then be compared to the volume that should exist based on the amount of fluid aspirated and / or dispensed, and any discrepancy can be treated as indicating a potential root cause of failure in illuminometer sample volume check 4b. This can then be done by replacing the sample dispensing syringe on a precision pipette. And / or remedial actions may be triggered, such as contacting a field service engineer, informing them of the subsystem where the failure was detected, what the root cause of the failure appeared to be, and (if any) that remedial actions were attempted to address that root cause. Alternatively, if there is no discrepancy between the actual volume in the imaged container and the predicted volume, the diagnostic process as shown in Figure 7 may continue with additional extended diagnostic activities to continue searching for the root cause of the failure in the illuminometer sample volume check 4b.

[0083] As shown in Figure 7, in some embodiments that include an expanded diagnostic step that can be performed to determine the root cause of a failure in the illuminometer sample volume check 4b, these expanded diagnostic steps may include an illuminometer sample volume linearity check 4.2. The performance of this type of check 4.2 may be initiated using a reagent pipette to add a predetermined volume of diagnostic ALP solution to each of a plurality of containers acting as sample containers for this test (for example, adding 100 μL of ALP solution to each of 30 containers). A sample precision pipette may then be used to transfer a portion of its solution to containers acting as reaction vessels for the test, and a reagent pipette may be used to add washing buffer to those containers so that the total volume of liquid is the same in each of them, regardless of how much ALP solution was added by the sample precision pipette. For example, in some embodiments, ten reaction vessels can be filled with 50 μL of ALP solution, another ten can be filled with 25 μL of ALP solution and 25 μL of washing buffer, and the final ten can be filled with 10 μL of ALP solution and 40 μL of washing buffer. Then, after the appropriate amounts of ALP solution and washing buffer have been added to the vessels that will act as reaction vessels, those vessels can be prepared for the chemiluminescent reaction as described in the context of Figure 9, and an illuminometer can be used to measure the light emitted by the contents of those vessels. If this measured light does not match the amount of light expected based on the varying volumes of ALP solution in each of the vessels, this can be treated as indicating a potential root cause of failure in the illuminometer sample volume check, and remedy measures such as replacing the sample dispensing motor can be triggered. Alternatively, if no mismatch is present, an additional illuminometer sample dilution check 4.3 can be performed to attempt to identify the root cause of failure in the illuminometer sample volume check 4b.

[0084] In embodiments where this exists, the illuminometer sample dilution check 4.3 can be extended to the basic concept of transferring a fluid from a container acting as a sample container to a container acting as a reaction container by adding an intermediate container in which the fluid is diluted. Thus, the illuminometer sample dilution check 4.3 can begin using a reagent pipette to transfer a predetermined amount of ALP solution to multiple containers acting as sample containers for its test (for example, adding 100 μL of ALP solution to each of 20 containers). Then, varying amounts of washing buffer can be added to each of the multiple containers acting as dilution containers using a reagent pipette, and then, for each sample container, a portion of the ALP solution can be transferred to one of the dilution containers using a sample precision pipette in an amount corresponding to the previously added washing buffer. For example, in some embodiments, 10 dilution containers may be filled with 245 μL of washing buffer and 5 μL of ALP, and 10 dilution containers may be filled with 180 μL of washing buffer and 20 μL of ALP. Next, the dilution containers can be mixed, and a portion of the mixture from each container (e.g., 50 μL) can be transferred from each dilution container to the corresponding reaction container using a sample precision pipette. Each of the reaction containers can then be prepared for the chemiluminescent reaction shown in Figure 9, and the light emitted from the container can be measured using an illuminometer.

[0085] In the illuminometer sample dilution check 4.3, if the amount of light measured by the illuminometer does not match the expected light value based on the amount of ALP that must react with the substrate in the container (for example, in situations where 20x and 50x dilutions of ALP are produced, the expected light values ​​from these dilutions will be 1 / 20 and 1 / 50 of the undiluted signal), this can be treated as indicating the root cause of a failure in the illuminometer sample volume check. This can then be addressed by performing one or more remedial measures, such as checking whether the immersion height of the tip of the sample precision pipette differs from what is expected considering the instrument's design parameters. This information can then be used to address the problem (for example, by adjusting the operation of the sample precision pipette so that the immersion height matches the instrument's design parameters). Alternatively, it can be used to proceed with further remedial / diagnostic measures, such as calling a field service engineer if necessary and notifying that there appears to be a problem with the immersion height of the sample precision pipette or that there was a failure in the illuminometer sample volume check for which the root cause could not be properly identified. Ultimately, once the fault in the illuminance meter sample volume check 4b is resolved, the process of evaluating the operation of the remaining system of the instrument, if any, can proceed.

[0086] Referring here to the illuminometer sample constant volume check 5b, the step can be used to check the operation of the instrument's sample constant volume subsystem. In some embodiments, this can be performed in essentially the same manner as the illuminometer sample volume check 4b, except that the transfer of ALP from the sample container to the reaction vessel is performed using a sample constant volume pipette, except that the transfer is performed using a sample constant volume pipette. If the chemiluminescent light detected by the illuminometer in the reaction vessel does not match the expected light value based on the amount of ALP to be transferred, this can be treated as indicating a fault in the sample constant volume subsystem. This can then be used to avoid either investigating the level sensing function of the sample constant volume pipette and / or calling on additional support resources to address the detected fault using the sample constant volume syringe (i.e., pipette tip) or as a prelude. It can trigger one or more relief measures, such as exchanging items.

[0087] Various features of various embodiments may be combined in various combinations with one another, thereby obtaining further embodiments based on the principles of this disclosure.

[0088] Various modifications and changes to this disclosure will be apparent to those skilled in the art without departing from the scope and spirit of this disclosure, and it should be understood that the scope of this disclosure is not unduly limited to the exemplary embodiments described herein. Instead, the protection provided by any document relating to this document should be defined by the claims of that document, to the extent that any terms in the claims that are not expressly defined are given the broadest reasonable interpretation, as provided by a general dictionary.

[0089] For the purpose of understanding the claims set forth in this document, the following terms and phrases should be understood to have the following meanings:

[0090] When used in patent claims, the term “based on” should be understood to mean something that is determined, at least partially, by being indicated as “based on.” Anything that is determined entirely by this will be described as “exclusively based” to indicate that something must be determined entirely on something else.

[0091] Where used in the claims, “computer-readable medium” should be understood to mean any object, substance, or combination of objects or substances that can store data or instructions in a form that can be retrieved and / or processed by a device. Computer-readable medium should not be limited to any particular type or organization, but should be understood to include distributed and non-centralized systems, but they are storage objects of systems that are physically or logically arranged and located within defined and / or circumstantial physical and / or logical space. The “non-temporary” nature of “computer-readable medium” should be understood to be synonymous with the statement that “computer-readable medium” is “tangible,” and should be understood to exclude non-tangible transmission media such as vacuum that can transmit temporary electromagnetic carriers. Examples of “tangible” or “non-temporary” “computer-readable medium” include random-access memory (RAM), read-only memory (ROM), hard drives, and flash drives.

[0092] When used in the claims, “means for automatically diagnosing malfunctions in the operation of a machine” should be understood as a means + function form, as provided in § 112(f) of the U.S. Patent Act, where the function is “to automatically diagnosing malfunctions in the operation of a machine,” and the corresponding structure is a computer, as shown in Figure 6, configured to perform the process shown in Figure 7.

Claims

1. A method for operating laboratory equipment and diagnosing a malfunction in said laboratory equipment, wherein the method is: a) Performing an analytical step sequence for analyzing a biological sample, wherein the analytical step sequence includes adding an assay reagent to a reaction vessel, the assay reagent comprising paramagnetic particles and an antibody adapted to bind to the analyte. b) Performing a set of diagnostic steps to evaluate the operation of the laboratory equipment, wherein the set of diagnostic steps includes adding a diagnostic reagent to each container in a set of containers, and the diagnostic reagent contains paramagnetic particles and does not contain antibody components. The set of diagnostic steps includes, a) For each container in the set of containers, i) To prepare a test mixture by combining the diagnostic reagent added to the container with a portion of the washing buffer, ii) Exposing the test mixture to a magnetic field in the container, iii) Removing the container from the magnetic field, iv) After the container has been removed from the magnetic field, the test mixture contained in the container is mixed, b) Using a digital camera to capture one or more particle resuspension images, wherein each of the one or more particle resuspension images includes an image of the containers from the set of containers after the test mixture contained in the containers has been mixed, c) Perform a resuspension check using the one or more particle resuspension images mentioned above. Methods that include...

2. a) The assay reagent has paramagnetic particles of a first concentration, b) The diagnostic reagent has paramagnetic particles of a second concentration, c) The method according to claim 1, wherein the first concentration is lower than the second concentration.

3. a) The first concentration is 0.3 mg / mL to 2.0 mg / mL, b) The method according to claim 2, wherein the second concentration is 4.0 mg / mL.

4. For each container in the set of containers, the test mixture contained in the container is mixed. a) Moving the container to a high-speed rotating mixing position on the washing wheel, b) Mixing the test mixture contained in the container at high speed by rotation The method according to claim 1, including the method described in claim 1.

5. For each container in the set of containers, the test mixture contained within the container is mixed before the container is moved to the high-speed rotating mixing position on the washing wheel. a) Moving the container to the pipette position in the laboratory equipment, b) Using a reagent pipette, ultrasonically mix the test mixture contained in the container. The method according to claim 4, including the method described in claim 4.

6. A method for operating laboratory equipment and diagnosing a malfunction in said laboratory equipment, wherein the method is: a) Performing an analytical step sequence for analyzing a biological sample, wherein the analytical step sequence includes adding an assay reagent to a reaction vessel, the assay reagent comprising paramagnetic particles and an antibody adapted to bind to the analyte. b) Performing a set of diagnostic steps to evaluate the operation of the laboratory equipment, wherein the set of diagnostic steps includes adding a diagnostic reagent to each container in a set of containers, and the diagnostic reagent contains paramagnetic particles and does not contain antibody components. The set of diagnostic steps includes, a) For each of the containers in the set, before adding the diagnostic reagent to the container, the diagnostic reagent is ultrasonically mixed using an ultrasonic probe, b) Using a digital camera to capture one or more reagent resuspension images, wherein each of the one or more reagent resuspension images includes an image of the containers from the set of containers after the diagnostic reagent has been added to the containers, c) Perform a reagent resuspension check using one or more reagent resuspension images. Methods that include...

7. A non-temporary computer-readable medium storing data that can be used to configure a computer to operate a laboratory instrument comprising multiple subsystems and to perform a method for diagnosing a malfunction in the laboratory instrument, wherein the method a) Performing an analytical step sequence for analyzing a biological sample, wherein the analytical step sequence includes adding an assay reagent to a reaction vessel, the assay reagent comprising paramagnetic particles and an antibody adapted to bind to the analyte. b) Performing a set of diagnostic steps to evaluate the operation of the laboratory equipment, wherein the set of diagnostic steps includes adding a diagnostic reagent to each container in a set of containers, and the diagnostic reagent contains paramagnetic particles and does not contain antibody components. The set of diagnostic steps includes, a) For each container in the set of containers, i) To prepare a test mixture by combining the diagnostic reagent added to the container with a portion of the washing buffer, ii) Exposing the test mixture to a magnetic field in the container, iii) Removing the container from the magnetic field, iv) After removing the container from the magnetic field, the test mixture contained in the container is mixed, b) Using a digital camera to capture one or more particle resuspension images, wherein each of the one or more particle resuspension images includes an image of the containers from the set of containers after the test mixture contained in the containers has been mixed, c) Perform a resuspension check using the one or more particle resuspension images mentioned above. Non-temporary computer-readable media, including [specific examples of such media].

8. a) The assay reagent has paramagnetic particles of a first concentration, b) The diagnostic reagent has paramagnetic particles of a second concentration, c) The non-temporary computer-readable medium according to claim 7, wherein the first concentration is lower than the second concentration.

9. a) The first concentration is 0.3 mg / mL to 2.0 mg / mL, b) The non-temporary computer-readable medium according to claim 8, wherein the second concentration is 4.0 mg / mL.

10. Mixing the test mixture contained in each of the containers within the set of containers is: a) Moving the container to a high-speed rotating mixing position on the washing wheel, b) Mixing the test mixture contained in the container at high speed by rotation A non-temporary computer-readable medium according to claim 7, including the following:

11. Mixing the test mixture contained in each of the containers within the set of containers is: a) Moving the container to the pipette position in the laboratory equipment, b) Using a reagent pipette, ultrasonically mix the test mixture contained in the container. A non-temporary computer-readable medium according to claim 7, including the following:

12. A non-temporary computer-readable medium storing data that can be used to configure a computer to operate a laboratory instrument comprising multiple subsystems and to perform a method for diagnosing a malfunction in the laboratory instrument, wherein the method a) Performing an analytical step sequence for analyzing a biological sample, wherein the analytical step sequence includes adding an assay reagent to a reaction vessel, the assay reagent comprising paramagnetic particles and an antibody adapted to bind to the analyte. b) Performing a set of diagnostic steps to evaluate the operation of the laboratory equipment, wherein the set of diagnostic steps includes adding a diagnostic reagent to each container in a set of containers, and the diagnostic reagent contains paramagnetic particles and does not contain antibody components. The set of diagnostic steps includes, a) For each of the containers in the set, before adding the diagnostic reagent to the container, the diagnostic reagent is ultrasonically mixed using an ultrasonic probe, b) Using a digital camera to capture one or more reagent resuspension images, wherein each of the one or more reagent resuspension images includes an image of the containers from the set of containers after the diagnostic reagent has been added to the containers, c) Perform a reagent resuspension check using one or more reagent resuspension images. Non-temporary computer-readable media, including [specific examples of such media].

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