Diagnostic analyzer and quality control method

Abstract

A quality control method for a diagnostic analyzer includes performing a quality control test or a plurality of sample tests; determining, with a controller, that a quality control test result or a plurality of sample test results is outside of a threshold; monitoring, with the controller, one or more mechanical devices of the diagnostic analyzer; receiving, by the controller, an error code indicative of an error in a mechanical device of the one or more mechanical devices; and initiating a calibration procedure in response to the quality control test result or the plurality of sample test results being outside of the threshold and receiving the error code. Other apparatuses and methods are disclosed.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 948,754, filed December 16, 2019, entitled “DIAGNOSTIC ANALYZERS AND QUALITY CONTROL METHODS,” the disclosure of which is hereby incorporated by reference in its entirety for all purposes. Technical Field

[0003] Embodiments of the present disclosure relate to apparatus and methods suitable for providing quality control in a diagnostic analyzer. Background Art

[0004] In medical testing and processing, diagnostic analyzers (immunoassay instruments, clinical diagnostic analyzers, in vitro analyzers, and the like) can be used to test the concentration of one or more components (e.g., one or more analytes or (one or more) other components) contained in a biological sample, such as, for example, blood or components thereof, such as serum or plasma, urine, sputum, saliva, cerebrospinal fluid, and the like. Such diagnostic analyzers can be complex and may perform hundreds or even thousands of diagnostic tests (hereinafter referred to as "sample tests") on samples per day. In order to ensure that the results of the sample tests generated by the diagnostic analyzer are valid, a series of repeated quality control tests (hereinafter referred to as "repeated QC tests") can often be performed on the sample using carefully prepared quality control samples to produce the expected results.

[0005] If one of the repeat QC tests produces an unexpected result, the diagnostic analyzer may be considered "out of control." That is, the diagnostic analyzer is operating unacceptably and all sample test results produced by that diagnostic analyzer since the last successful repeat QC test may be questionable and, therefore, may have to be discarded or possibly rerun.

[0006] Therefore, apparatus and methods are sought that can improve quality control in diagnostic analyzers. Summary of the Invention

[0007] According to a first aspect, a quality control method for a diagnostic analyzer is provided. The quality control method includes performing a quality control test or a plurality of sample tests; determining, with a controller, that a quality control test result or a plurality of sample test results are outside a threshold; monitoring, with the controller, one or more mechanical devices of the diagnostic analyzer; receiving, by the controller, an error code indicating an error in a mechanical device of the one or more mechanical devices; and initiating a calibration procedure in response to the quality control test result or the plurality of sample test results being outside a threshold and receiving the error code.

[0008] According to a second aspect, a diagnostic analyzer is provided. The diagnostic analyzer includes a controller configured to perform a quality control test or a plurality of sample tests; determine that a quality control test result or the plurality of sample test results is outside a threshold; monitor one or more mechanical devices of the diagnostic analyzer; receive an error code indicating an error in a mechanical device of the one or more mechanical devices; and, in response to the quality control test result or the plurality of sample test results being outside a threshold and receiving the error code, initiate a calibration procedure.

[0009] According to a third aspect, a quality control method is provided. The quality control method includes performing a quality control test; determining, with a controller, that a variance in the quality control test is outside a threshold; monitoring, with the controller, one or more mechanical devices of a diagnostic analyzer; receiving, by the controller, an error code indicating an error in a mechanical device of the one or more mechanical devices; and initiating, by the controller, a calibration procedure in response to the variance in the quality control test being outside the threshold and receiving the error code.

[0010] Still other aspects, features, and advantages of the present disclosure may be readily apparent from the detailed description of the following diagrammatic representations of a plurality of example embodiments. The present disclosure may also be capable of different embodiments, and its several details may be modified in various respects. Therefore, the present disclosure covers all modifications, equivalents, and alternatives falling within the scope of the claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] Figure 1 A flow chart illustrating actions taken when an operator of a diagnostic analyzer according to the prior art notices high variance in a quality control test or a series of sample tests.

[0012] Figure 2 A schematic block diagram of a diagnostic analyzer according to one or more embodiments of the present disclosure is illustrated.

[0013] Figure 3 A detailed schematic block diagram of a diagnostic analyzer according to one or more embodiments of the present disclosure is illustrated.

[0014] Figure 4 A flow chart describing a method of operating a diagnostic analyzer according to one or more embodiments of the present disclosure is illustrated.

[0015] Figure 5 A flow chart describing another method of operating a diagnostic analyzer according to one or more embodiments of the present disclosure is illustrated. DETAILED DESCRIPTION

[0016] Diagnostic analyzers can rely on quality control (QC) testing to ensure that diagnostic test results produced by the diagnostic analyzer are valid. QC testing can involve testing a QC sample in the diagnostic analyzer and comparing the QC sample test results to expected results for that QC sample. In some embodiments, QC testing can include performing multiple tests using a repeat QC sample. The QC sample can contain a particular concentration of a chemical being tested (e.g., an analyte) and, if the diagnostic analyzer is operating properly, will cause the diagnostic analyzer to output expected test results. If the diagnostic analyzer does not produce expected test results in response to the QC testing, the diagnostic analyzer can be considered to be "out of control" and all test results produced by the diagnostic analyzer since the last successful QC test can be called into question. For example, if there is a high variance in the QC testing, then the diagnostic analyzer can be considered to be out of control. Conventional methods of operating a diagnostic analyzer provide that, when a determination is made that the diagnostic analyzer is out of control, a service agent is called into the lab to repair the diagnostic analyzer.

[0017] Reference is now made to Figure 1 which illustrates a flowchart of a prior art method 100 of operating a diagnostic analyzer. First, in block 102, an operator of the diagnostic analyzer detects that a variance in QC testing is outside of a threshold. For example, the diagnostic analyzer can periodically perform QC testing (e.g., repeat QC testing) to ensure the integrity of the diagnostic analyzer and the variance in these QC tests can be outside of a threshold. In response to the variance in QC testing being outside of a threshold in block 102, the operator can perform a new QC test on the diagnostic analyzer in block 104. The new QC test can be of the same type as the QC test performed in block 102 to arrive at the result.

[0018] If, after performing the new QC test in block 104, the variance in QC testing is within the threshold, then processing continues to block 106, where the problem with the diagnostic analyzer is resolved. For example, after performing the new QC test, when the variance in QC testing is within the threshold, the operator of the diagnostic analyzer can be confident that the diagnostic analyzer is operating properly. If running the new QC test in block 104 causes the variance in QC testing to remain outside of the threshold, then processing continues to block 108, where the problem with the diagnostic analyzer is not resolved. In block 108, the diagnostic analyzer can be out of control.

[0019] If the variance in the QC is outside the threshold after running the new QC test in block 104, the user contacts a service agent, as described in block 110. For example, the service agent may be a representative of the manufacturer of the diagnostic analyzer. In block 112, the service agent visits the location of the diagnostic analyzer to service the diagnostic analyzer and evaluate and possibly realign and / or recalibrate the diagnostic analyzer. In block 114, a subsequent QC test is performed on the diagnostic analyzer. The subsequent QC test may be of the same type as the QC test performed in block 104.

[0020] In block 116, the problem with the diagnostic analyzer is resolved. For example, after performing subsequent QC tests, the variance of the QC tests is within a threshold. Therefore, the alignment and / or recalibration performed by the service agent resolved the problem with the diagnostic analyzer. If, after running subsequent QC tests in block 114, the variance of the QC tests remains outside the threshold, processing continues to block 118, where the problem with the diagnostic analyzer is not resolved. The service agent can evaluate other factors to determine whether other factors are causing the problem with the diagnostic analyzer.

[0021] exist Figure 1 In method 100, a service agent visits the diagnostic analyzer's site to perform the aforementioned realignment and / or recalibration of the diagnostic analyzer. While the service agent is en route and at the diagnostic analyzer's site, the diagnostic analyzer may not be operating properly and may be unable to perform one or more diagnostic tests. Consequently, diagnostic testing may be significantly delayed. This delay may result in test samples having to be sent to another diagnostic analyzer, which is time-consuming and expensive.

[0022] In view of the foregoing, one or more embodiments of the present disclosure provide a quality control method and apparatus that is configured and operable to detect when a diagnostic analyzer is not operating properly. The method and apparatus can initiate an alignment and / or calibration procedure that can be performed in the absence of a service agent at the diagnostic analyzer. The method and apparatus can analyze sample test results and / or QC test results (e.g., copy QC test results) performed by the diagnostic analyzer. For example, the method and apparatus can compare the test results from the sample test with the expected test results to determine whether the diagnostic analyzer is operating properly. In other embodiments, the variance in the QC test can be analyzed to determine whether the variance in the QC test is outside a threshold. Analysis of the sample test results and / or the variance in the QC test can indicate that the diagnostic analyzer is not operating properly or that the diagnostic analyzer is out of control.

[0023] According to one or more embodiments of the present disclosure, once the controller of the diagnostic analyzer has determined that an error exists, it can automatically prompt the operator of the diagnostic analyzer to perform one or more calibration procedures. In some embodiments, the one or more calibration procedures may include one or more automated calibration procedures. In other embodiments, the one or more calibration procedures may be performed by the user of the diagnostic analyzer. Thus, the controller can prompt the user to initiate the one or more calibration procedures, which can be performed even when a service agent is not present at the diagnostic analyzer. Thus, the one or more calibration procedures save time and reduce costs.

[0024] Will refer to Figures 2 to 5 These and other aspects and features of embodiments of the present disclosure are described.

[0025] Now refer to Figure 2 , which illustrates a block diagram of a diagnostic analyzer 200 according to one or more embodiments. The diagnostic analyzer 200 may include a controller 202, a testing device 204, and a user interface 206. The diagnostic analyzer 200 may be configured to perform one or more diagnostic tests and / or analyses on a biological sample, as described herein.

[0026] The controller 202 may include a memory 208 (e.g., RAM, ROM, or other device) configured to store programming instructions, test results, and / or other information / data. In some embodiments, the controller 202 may be separate from the testing device 204. For example, the controller 202 may be integrated into a laboratory information system (LIS). The controller 202 may include a processor 210 configured to execute program instructions stored in the memory 208. The processor 210 may also be configured to communicate with one or more devices within the diagnostic analyzer 200. In some embodiments, the processor 210 may be configured to communicate with devices external to the diagnostic analyzer (not shown), such as a computer server, a computer workstation, and the LIS. The processor 210 may be or may include a central processing unit (CPU), a microprocessor, and / or the like.

[0027] Memory 208 may store an error detection module 212, which may be programming instructions that, when executed by processor 210, cause processor 210 to monitor test device 204. Error detection module 212 may also cause processor 210, or a program executed by processor 210, to identify errors, such as errors with components of test device 204. Other programming instructions stored in memory 208 may cause processor 210 to operate diagnostic analyzer 200, including test device 204, as described herein.

[0028] The testing device 204 can be configured to perform analysis on different sample types, such as patient samples and QC samples. The testing device 204 can be controlled by instructions transmitted by the processor 210. In addition, test results from the analysis can be transmitted from the testing device 204 to the processor 210. The program executed by the processor 210 can analyze the test results, which can be used to determine the operating status of the diagnostic analyzer 200, as described herein.

[0029] The test apparatus 204 may include one or more sensors 214 that may monitor one or more devices within the test apparatus 204. For example, the one or more sensors 214 may monitor electronic devices, mechanical devices, and other devices within the test apparatus 204. The one or more sensors 214 and / or the processor 210 may generate an error code that identifies an error with a component (such as a defective motor) or an error with a process performed by the test apparatus 204. The one or more sensors 214 and / or the processor 210 may identify the cause of the error, such as a misaligned component caused by a component crash within the test apparatus 204.

[0030] In some embodiments, one or more mechanical devices may include one or more encoders that may be configured to monitor the position of one or more mechanical devices and / or movable devices. For example, one or more encoders may generate data identifying the position of one or more movable devices and / or mechanical devices within the test apparatus 204. One or more sensors 214, in conjunction with the controller 202, may generate data (such as an error code) indicating an error in the position of the encoder and / or alignment of the movable device. In some embodiments, one or more mechanical devices or electrical devices may include one or more Hall effect sensors. In some embodiments, one or more Hall effect sensors may be configured to monitor the position of one or more movable devices and / or one or more mechanical devices. One or more sensors 214, in conjunction with the controller 202, may detect an error in the Hall effect sensor.

[0031] In some embodiments, the one or more mechanical or electrical devices may include one or more motors within the test apparatus 204 that can move the one or more movable devices. The one or more sensors 214, in conjunction with the controller 202, can generate data (such as an error code) indicating an error with the motor. The error code associated with the motor detected by the one or more sensors 214 can indicate a short circuit associated with the motor and / or an undervoltage condition associated with the motor.

[0032] In some embodiments, one or more sensors 214, in conjunction with controller 202, can generate data (such as an error code) indicating an error with the movable device. In some embodiments, the error code can indicate a crash of the movable device. In some embodiments, the movable device can be a pipette, and the error code can indicate a crash of the pipette, as described herein.

[0033] In some embodiments, the one or more mechanical devices may include a suction device. The one or more sensors 214, in conjunction with the controller 202, may generate data (such as an error code) indicating an error with the suction device. The error code may indicate that the pressure associated with the suction device is outside a threshold, or that the average pressure associated with the suction device is outside a threshold.

[0034] The one or more sensors 214 may also include a thermometer, a barcode reader, a barometer, and / or other sensors. The one or more sensors 214 may be internal and / or external to the test device 204 and may be configured to provide various measurements related to the operation of the diagnostic analyzer 200. These measurements may include, but are not limited to, the internal temperature of the test device 204, the internal vibration level of the test device 204, the humidity level, and the atmospheric pressure. Other measurements / data related to the operation of the diagnostic analyzer 200 may be provided.

[0035] As described above, the error detection module 212 can be configured to analyze data generated by the one or more sensors 214. In addition, the error detection module 212 can analyze the results of tests performed by the testing device 204. For example, the error detection module 212 can determine whether one or more sensors 214 have detected an error. The error detection module 212 can also analyze the variance of patient sample test results and / or QC tests to determine whether the diagnostic analyzer 200 is operating properly. If the diagnostic analyzer 200 is not operating properly, the controller 202 can initiate a process to correct the operation of the diagnostic analyzer 200, as described herein.

[0036] The diagnostic analyzer 200 may also include an imaging device 218 that can capture images of items being tested by the test device 204. For example, the imaging device 218 can capture images of a sample, a sample container, and / or a barcode label affixed to the sample container. The imaging device 218 can also capture images of other items.

[0037] The user interface 206 may include one or more devices that enable a user of the diagnostic analyzer 200 to input data into the diagnostic analyzer 200, such as into the processor 210. The user interface 206 may also enable the diagnostic analyzer 200 to communicate data and information to the user. In some embodiments, the user interface 206 may include a monitor 206A, such as a computer monitor, a keyboard 206B, and / or a computer mouse 206C.

[0038] right Figure 3 Reference is made to the accompanying diagram, which illustrates a block diagram of a more detailed embodiment of a diagnostic analyzer 200. The diagnostic analyzer 200 can analyze a sample, such as a sample 320S, located within a sample container 320. In some embodiments, the sample 320S can be a QC sample having a precise and known concentration of an analyte that can be used to calibrate the diagnostic analyzer 200. In some embodiments, the sample 320S can be a sample from a patient (e.g., a biological sample), wherein the diagnostic analyzer 200 determines the concentration of one or more analytes located in the sample 320S.

[0039] Diagnostic analyzer 200 may include a driver 322 electrically coupled between controller 202 and various components of test device 204. For example, driver 322 may receive signals from processor 210 instructing various components within test device 204 to move to certain positions. Driver 322 may also transmit signals from test device 204 to controller 202 indicating one or more operating conditions of test device 204. In some embodiments, driver 322 or components thereof may be implemented in controller 202.

[0040] The driver 322 may include a suction control module 324 and a position control module 326. The driver 322 may include other modules and components. The suction control module 324 may control one or more suction processes performed by the test device 204. In some embodiments, the suction control module 324 may receive data generated by one or more sensors that monitor the suction process. The position control module 326 may control one or more motors that move one or more movable devices within the test device 204. In some embodiments, the position control module 326 may receive data generated by one or more sensors that monitor the movement of one or more movable devices. The one or more sensors may include a Hall effect sensor and a position encoder. Other sensors may be included in the test device 204.

[0041] The testing device 204 can include a pipette 328 having a removable pipette tip 328T attached thereto. The testing device 204 can be operated to move the pipette tip 328T and the sample container 320 closer together. The testing device 204 can then move the pipette tip 328T into the sample container 320 to aspirate the sample 320S. The pipette 328 can also be used in a similar manner to dispense liquid into the sample container 320.

[0042] The testing device 204 may include one or more motors that move the pipette 328 to a specific location, such as near the sample container 320. Motors may also be used to move other movable devices within the testing device 204. Figure 3 In the embodiment depicted in FIG, the testing device 204 includes a motor 330 configured to move a pipette 328 in a plane defined by an x-axis and a y-axis, wherein the y-axis enters the paper. In some embodiments, the motor 330 can move a movable member 332 coupled between the motor 330 and the pipette 328. The testing device 204 can also include a z-motor 330Z configured to move the pipette 328 in a z-direction, such as into and out of the sample container 320. The motor 330 and the z-motor 330Z can receive signals from the position control module 326 that cause the motor 330 and the z-motor 330Z to move the pipette 328 to a specific position.

[0043] The testing device 204 can include a pump 336 operated by a motor 338, where the motor 338 can be operated by instructions provided by the aspiration control module 324. During aspiration and dispense, the pump 336 can induce pressure in a conduit 340 between the pump 336 and the pipette 328. In some embodiments, the pump 336 can be used to aspirate liquid from and dispense liquid into the sample container 320.

[0044] The test device 204 may include one or more sensors that provide a status of the test device 204. For example, the one or more sensors may provide data to the processor 210 that indicates a status of one or more mechanical and / or electrical components associated with the one or more sensors. In some embodiments, the one or more sensors may include one or more encoders. In some embodiments, the one or more encoders monitor the position of one or more mechanical devices in the test device 204. Figure 3In the embodiment depicted in FIG, the testing device 204 includes a first encoder 344A and a second encoder 344B. The first encoder 344A can provide data regarding the vertical position (e.g., along the z-axis) of the pipette 328. The second encoder 344B can provide data regarding the position of the pipette 328 in the XY plane. The first encoder 344A can include a sensor that provides data indicating a possible error in the first encoder 344A. The second encoder 344B can also include a sensor that provides data indicating a possible error in the second encoder 344B. For example, the sensor can indicate that the first encoder 344A and the second encoder 344B are not correctly positioned, or that the data provided by the first encoder 344A and the second encoder 344B are incorrect.

[0045] In some embodiments, first encoder 344A and second encoder 344B may be sensors that, in conjunction with controller 202 or other devices, diagnose errors in motor 330 and / or z-motor 330Z. For example, first encoder 344A and second encoder 344B may provide position data for pipette 328. This position data may be compared to expected position data, such as data stored or provided by position control module 326, to determine whether motor 330 and / or z-motor 330Z are misaligned. For example, position control module 326 may move pipette 328 to a known position within test device 204. If pipette 328, first encoder 344A, and second encoder 344B are properly aligned and operating, the data provided by first encoder 344A and second encoder 344B should match the known position within test device 204.

[0046] Diagnostic analyzer 200 may include a motor sensor 346A that senses one or more parameters of z-motor 330Z and transmits a signal indicative of the one or more parameters. In some embodiments, the signal is an error code. Motor sensor 346A may measure the current entering the z-motor and / or the voltage at the z-motor. If motor sensor 346A does not measure the current entering the z-motor, motor sensor 346A may generate a signal (e.g., an error code) indicating that the z-motor has an open circuit error. In some embodiments, motor sensor 346A may transmit the signal indicative of the current to error detection module 212 (or other device), where error detection module 212 determines that an open circuit condition or a high current condition exists in z-motor 330Z. If motor sensor 346A measures a voltage at the z-motor below a predetermined threshold, motor sensor 346A may generate a signal indicating a short circuit or undervoltage condition within z-motor 330Z. In some embodiments, motor sensor 346A may generate an error code that identifies the specific error detected by motor sensor 346A. In other embodiments, the error code may be generated by error detection module 212. Motor sensor 346B can detect similar error(s) and / or parameters of motor 330. Motor sensor 346B can be similar or identical to motor sensor 346A. Motor sensor 346A and motor sensor 346B can detect other errors of the motor.

[0047] The diagnostic analyzer 200 can include one or more Hall effect sensors that can be configured to sense the position of one or more removable devices, such as a pipette 328. An embodiment of the Hall effect sensor 348 includes a coil that can be attached to a location within the diagnostic analyzer. The removable device can have a magnet positioned thereon. When the magnet passes near the Hall effect sensor 348, the interaction between the magnet and the coil generates an electrical current that can be detected by a detector, such as a detector within the position control module 326. Thus, the Hall effect sensor 348 provides data regarding the position of the removable device within the test device 204.

[0048] The Hall effect sensor 348 may have an associated error sensor 350. The error sensor 350, in conjunction with the controller 202, can detect one or more errors with the Hall effect sensor 348 and can generate one or more error codes in response to the detection of an error. In some embodiments, the error sensor 350 can detect an open circuit in a coil within the Hall effect sensor 348. In some embodiments, the error sensor 350 can detect a short circuit in the coil. In some embodiments, the position control module 326 can move the pipette 328 close to the Hall effect sensor 348 so that the Hall effect sensor 348 generates a signal indicating that the pipette 328 is close to the Hall effect sensor 348. In the event that the Hall effect sensor 348 does not generate such a signal, the diagnostic analyzer 200 can flag an error with the Hall effect sensor 348. Other error detection devices and methods may be used. The Hall effect sensor 348 or other Hall effect sensors may be located in other locations within the test device 204 to detect the position of other movable devices.

[0049] The testing device 204 may include a suction device, Figure 3 In the embodiment depicted in , the aspiration device includes a pump 336 and a conduit 340. The testing device 204 may include a pressure sensor 354 configured to measure the pressure in the conduit 340, which may indicate the operating state of the aspiration device. For example, during aspiration and / or dispensing, the pressure sensor 354 may measure the pressure in the conduit 340. The pressure sensor 354 may transmit a signal indicating that the pressure in the conduit 340 is above a predetermined pressure, below a predetermined pressure, and / or outside a predetermined pressure range. In some embodiments, an error may be detected in response to the average pressure measured in the conduit 340 being above a predetermined pressure, below a predetermined pressure, and / or outside a predetermined pressure range. For example, a low pressure in the conduit 340 may indicate a leak between the pump 336 and the pipette 328. A high pressure in the conduit 340 may indicate a blockage in the conduit 340 and / or the pipette 328.

[0050] Monitor 206A can display the status of diagnostic analyzer 200. For example, during operation of diagnostic analyzer 200, monitor 206A can display data generated by one or more sensors and / or error detection module 212. If an error code is detected, monitor 206A can display the error code. Monitor 206A can also display instructions prompting a user of diagnostic analyzer 200 to initiate a calibration procedure. For example, initiating the calibration procedure can include providing instructions to the user to perform the calibration procedure. The instructions can also include procedures to be performed by the user to complete the calibration procedure. The calibration procedure can include an alignment procedure.

[0051] Now Figure 4 For additional reference, Figure 4 is a flow chart describing an embodiment of a quality control method 400 for the diagnostic analyzer 200. The method 400 may be performed at least in part by the controller 202. For example, instructions for performing at least a portion of the method 400 may be stored in the memory 208 and executed on the processor 210.

[0052] In block 402, a quality control (QC) test or multiple sample tests are performed. For example, the controller 202 may store a moving average of the sample test results. In some embodiments, the controller may calculate the variance of the QC test. In some embodiments, performing the QC test may include testing one or more QC samples. In some embodiments, performing the QC test may include testing replicate QC samples. In block 404, the quality control test result or the multiple sample test results are determined to be outside a threshold. In some embodiments, the variance in the QC test is determined to be outside a threshold. In some embodiments, a test result is outside a threshold if it is outside a range, which may have an upper threshold and a lower threshold. A test result is considered outside a threshold if it is above the upper threshold or below the lower threshold. In the case of a single threshold, whether a test result is outside a threshold depends on whether the threshold is an upper or lower limit. A value above the upper limit is considered outside a threshold, and a value below the lower limit is considered outside a threshold.

[0053] The QC sample may include a known concentration of the analyte. Thus, when the QC sample is tested, if the diagnostic analyzer 200 is operating normally, the test result will be a known concentration. Similarly, if the diagnostic analyzer 200 is operating normally, the variance of the QC test will be within a threshold.

[0054] In some embodiments, in block 404, the diagnostic analyzer 200 may analyze multiple sample tests to determine whether the results of the sample tests are drifting toward a threshold. For example, a normal sample test result may be between a first threshold and a second threshold, below a threshold, or above a threshold. Multiple sample test results may be analyzed to determine whether the test results are approaching a threshold. For example, a moving average of the test results may be analyzed to determine whether the moving average is approaching a threshold, which may indicate an error in the diagnostic analyzer 200. In some embodiments, outliers and / or abnormal test results are not included in the moving average analysis. In some embodiments, a sharp change in the moving average of the test results may indicate an error in the diagnostic analyzer 200.

[0055] In block 406, one or more mechanical devices of the diagnostic analyzer 200 are monitored. The mechanical devices may include, among other mechanical devices, the mechanical devices described above. For example, motors, Hall effect sensors 348, pipettes 328, encoders 344A-344B, pumps 336, and / or other devices may be monitored. In block 408, the controller 202 may receive and / or generate an error code indicating an error in the mechanical device or process in one or more mechanical devices.

[0056] In block 410, in response to a quality control test result or a plurality of sample test results being outside a threshold and the generation or receipt of an error code, a calibration procedure is initiated. In some embodiments, in response to a variance in a QC test being outside a threshold and the generation of an error code, a calibration procedure is initiated. In some embodiments, initiating the calibration procedure may include prompting a user of the diagnostic analyzer 200 to initiate or execute the calibration procedure. For example, the processor 210 may output a prompt via the monitor 206A instructing the user to execute the calibration procedure. In some embodiments, initiating the calibration procedure may include instructing the user about a procedure for executing the calibration procedure. For example, calibration instructions may be provided on the monitor 206A. In some embodiments, initiating the calibration procedure includes causing the diagnostic analyzer 200 to execute an automatic calibration procedure. For example, the processor 210 may execute instructions stored in the memory 208 that cause the mechanical and / or electronic devices within the diagnostic analyzer 200 to execute an automatic calibration procedure as described herein.

[0057] Several calibration procedures can be performed in the diagnostic analyzer 200. In some embodiments, the calibration procedure can include aligning the encoder or calibrating the encoder's output in response to an error code indicating an encoder error. Referring to the first encoder 344A, calibration may be required after an error code indicating that the pipette 328 has crashed or another removable device has crashed is generated. In some embodiments, calibration of the pipette 328 includes moving the pipette 328 to a predetermined position. For example, instructions can be transmitted from the processor 210 to the position control module 326, which instructions instruct the position control module 326 to move the pipette 328 to a predetermined position. Data about the position of the pipette 328 can be transmitted to the position control module 326 from at least one of the first encoder 344A or the second encoder 344B. The position data provided by at least one of the first encoder 344A or the second encoder 344B should match the predetermined position of the pipette 328.

[0058] In the event that the predetermined position of the pipette 328 does not match the data provided by at least one of the first encoder 344A or the second encoder 344B, a calibration procedure may be performed. In some embodiments, the calibration procedure may be automatically performed by the diagnostic analyzer 200 (e.g., by the controller 202). In some embodiments, the calibration procedure may be performed by a user in response to instructions provided by the controller 202. During the automated calibration procedure, the controller 202 and / or the position control module 326 may internally offset the data provided by at least one of the first encoder 344A or the second encoder 344B to match the data corresponding to the predetermined position of the pipette 328. In another embodiment, the user may adjust at least one of the first encoder 344A or the second encoder 344B until the data provided thereby matches the data corresponding to the predetermined position of the pipette 328.

[0059] The Hall Effect Sensor 348 is Figure 3 . The error sensor 350 and / or the position control module 326 can generate an error code indicating an error with the Hall effect sensor 348. In some embodiments, the position control module 326 can move the pipette 328 past the Hall effect sensor 348, which will cause the Hall effect sensor 348 to generate a signal. If the Hall effect sensor 348 does not generate a signal, an error code indicating an error with the Hall effect sensor 348 can be generated. A calibration procedure can be performed by moving the pipette 328 between positions within the test device 204 to determine whether the Hall effect sensor 348 has moved and should be realigned. Realignment can involve physically moving the Hall effect sensor 348 to the correct position.

[0060] In some embodiments, the calibration procedure can include testing the Hall effect sensor 348. For example, the error sensor 350 can measure the impedance (e.g., resistance) of the coil in the Hall effect sensor 348. This calibration procedure can be performed automatically by the controller 202 or manually by a user. The error sensor 350 can measure a high impedance, which indicates an open circuit in the Hall effect sensor 348. The error sensor 350 can also measure a very low impedance, which indicates a short circuit in the Hall effect sensor 348.

[0061] A calibration routine of at least one of the first encoder 344A or the second encoder 344B and the Hall effect sensor 348 can align the pipette 328. For example, the calibration routine ensures that the data generated by the first encoder 344A, the second encoder 344B, and the Hall effect sensor 348 provide accurate data of the position of the pipette 328. These calibration routines can be performed in response to an error code indicating a crash of a removable device (e.g., the pipette 328) within the testing device 204.

[0062] In some embodiments, a crash of one or more movable devices within the diagnostic analyzer 200 can be detected by measuring the current flowing to and / or the voltage at a motor coupled to the movable device. When a movable device crashes, the motor coupled to the movable device may suddenly draw a large amount of current and / or experience a sudden change in voltage. A sudden increase in current and / or a change in voltage at the motor 330 or z-motor 330Z may indicate that the movable device coupled to the motor 330 or z-motor 330Z has encountered an object that is preventing or obstructing the movement of the movable device. For example, if the motor sensor 346A senses an increase in current and / or a change in voltage at the z-motor 330Z, the error detection module 212 may determine that the pipette 328 has encountered an obstruction. Similarly, if the motor sensor 346B senses an increase in current and / or a change in voltage at the motor 330, the error detection module 212 may determine that the pipette 328 or movable member 332 has encountered an obstruction. If the error detection module 212 detects a crash, the error detection module 212 may instruct the processor 210 to initiate a calibration procedure. After encountering an obstacle, the alignment of the movable device may become offset, which may be corrected by calibration and / or alignment. The calibration procedure may include aligning at least one of the first encoder 344A, the second encoder 344B, or the Hall effect sensor 348, as described herein.

[0063] In some embodiments, the error detection module 212 may determine that the z-motor 330Z and / or the motor 330 has an overcurrent condition (e.g., a short circuit) or an overvoltage condition. In such a situation, the error detection module 212 may instruct the processor 210 to notify the operator that an object is preventing the pipette 328 or one of the movable members 332 from moving. The processor 210 may instruct the operator to remove the obstruction and perform a calibration procedure as described above. The calibration procedure may include aligning at least one of the first encoder 344A, the second encoder 344B, or the Hall effect sensor 348, as described herein.

[0064] In some embodiments, pressure sensor 354 can sense errors associated with aspiration and / or dispensing. For example, during the aspiration and dispensing process, pressure sensor 354 can measure the pressure in conduit 340, which can be the same as the pressure in pump 336 and / or pipette 328. In some embodiments, error detection module 212 can identify an error if the pressure sensed by pressure sensor 354 is outside a threshold. For example, if the pressure sensed by pressure sensor 354 during aspiration is greater than a first threshold, error detection module 212 can indicate a blockage in the aspiration system. Error detection module 212 can also indicate that pump 336 is pumping too hard and can instruct processor 210 to calibrate the pressure of pump 336. If the pressure sensed by pressure sensor 354 during aspiration is less than a second threshold, error detection module 212 can indicate a leak in the aspiration system. Error detection module 212 can also indicate that pump 336 is pumping too soft and can instruct processor 210 to calibrate the pressure of pump 336.

[0065] After the calibration procedure, a subsequent QC test can be performed to determine whether the diagnostic analyzer 200 is operating properly. In some embodiments, the error detection module 212 can determine whether the QC test results are within a threshold. In some embodiments, the error detection module 212 can determine whether the variance in the QC test is within a threshold, indicating that the diagnostic analyzer 200 is operating properly. If the results of the subsequent QC test indicate that the diagnostic analyzer 200 is not operating properly, the user of the diagnostic analyzer can contact a service agent to perform other procedures on the diagnostic analyzer 200.

[0066] Now Figure 5 Reference is now made to a flowchart illustrating a method 500 for operating a diagnostic analyzer (e.g., diagnostic analyzer 200). Method 500 includes, at block 502, performing a quality control test. The method includes, at block 504, determining, by a controller (e.g., controller 202), that a variance in the quality control test is outside a threshold. Method 500 includes, at block 506, monitoring, by the controller, one or more mechanical devices of the diagnostic analyzer. Method 500 includes, at block 508, receiving, by the controller, an error code indicating an error in one of the one or more mechanical devices. Method 500 includes, at block 510, in response to the variance in the quality control test being outside the threshold and receiving the error code, initiating, by the controller, a calibration procedure.

[0067] Although specific devices and methods have been shown herein by way of example embodiments, it should be understood that other and different embodiments are possible. This disclosure is intended to cover all modifications, equivalents, and alternatives falling within the scope of the following claims.

Claims

1. A quality control method for a diagnostic analyzer, comprising: Perform quality control testing or multiple sample testing using quality control samples; determining, using a controller, that a quality control test result or a plurality of sample test results are outside a threshold; monitoring one or more mechanical devices of the diagnostic analyzer with the controller; receiving, by the controller, an error code indicative of an error in a mechanical device of the one or more mechanical devices; and In response to a quality control test result or the plurality of sample test results being outside of a threshold and receiving an error code, initiating a calibration procedure, The one or more mechanical devices include one or more motors, and wherein the error code indicates an error with the one or more motors. 2 . The method of claim 1 , wherein determining, with the controller, that a result of a quality control test is outside a threshold comprises determining, with the controller, that a variance in the quality control test is outside a threshold.

3. The method of claim 1 , wherein the diagnostic analyzer comprises one or more encoders, wherein the one or more encoders are configured to monitor the position of the one or more mechanical devices, and wherein the error code indicates an error in the position of the one or more mechanical devices.

4. The method of claim 1 , wherein the diagnostic analyzer comprises one or more Hall effect sensors, wherein the one or more Hall effect sensors are configured to monitor the position of the one or more mechanical devices, and wherein the error code indicates an error in the position of the one or more mechanical devices. The method of claim 1 , wherein the error of the one or more electric machines indicates a high current condition associated with the one or more electric machines. The method of claim 1 , wherein the error of the one or more motors indicates an undervoltage condition of the one or more motors.

7. The method of claim 1, wherein the one or more mechanical devices include one or more removable devices, and wherein the error code indicates a crash of the one or more removable devices. The method of claim 7 , wherein the one or more movable devices are pipettes.

9. The method of claim 1, wherein the one or more mechanical devices include a suction device, and wherein the error code indicates that a pressure associated with the suction device is outside a threshold.

10. The method of claim 1, wherein initiating the calibration procedure comprises prompting a user to initiate the calibration procedure. The method of claim 1 , wherein initiating the calibration procedure comprises providing instructions to a user to perform the calibration procedure.

12. The method of claim 1, wherein initiating a calibration procedure comprises causing the diagnostic analyzer to perform an automatic calibration procedure.

13. The method of claim 1, wherein the diagnostic analyzer includes an encoder, and wherein the calibration procedure includes aligning the encoder.

14. The method of claim 1, wherein the diagnostic analyzer includes a motor, and wherein the calibration procedure includes at least one of measuring current to the motor or measuring voltage at the motor.

15. The method of claim 1, wherein the diagnostic analyzer includes one or more Hall effect sensors, and wherein the calibration procedure includes aligning the one or more Hall effect sensors.

16. The method of claim 1, wherein the diagnostic analyzer comprises one or more movable devices, and wherein the calibration procedure comprises aligning the one or more movable devices.

17. The method of claim 16, wherein the one or more movable devices are pipettes, and wherein the calibration procedure comprises aligning the pipettes.

18. The method of claim 1, wherein the diagnostic analyzer includes an aspiration device, and wherein the calibration procedure includes measuring a pressure associated with the aspiration device.

19. The method of claim 1, wherein determining that a plurality of sample test results are outside a threshold comprises determining that a moving average of the plurality of sample test results is outside the threshold.

20. A diagnostic analyzer comprising: The controller is configured as: Perform quality control testing or multiple sample testing using quality control samples; Determining that quality control test results or multiple sample test results are outside of threshold values; monitoring one or more mechanical devices of the diagnostic analyzer; receiving an error code indicative of an error in a mechanical device of the one or more mechanical devices; and In response to the quality control test result or the plurality of sample test results being outside a threshold and receiving the error code, initiating a calibration procedure, The one or more mechanical devices include one or more motors, and wherein the error code indicates an error with the one or more motors.

21. A method of operating a diagnostic analyzer, comprising: Perform quality control testing using quality control samples; determining, with a controller, that a variance in the quality control test is outside a threshold; monitoring one or more mechanical devices of the diagnostic analyzer with the controller; receiving, by the controller, an error code indicative of an error in a mechanical device of the one or more mechanical devices; and initiating, by the controller, a calibration procedure in response to a variance in the quality control test being outside a threshold and receiving the error code, The one or more mechanical devices include one or more motors, and wherein the error code indicates an error with the one or more motors.

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