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Diagnostic analyzer and quality control method

A quality control method, a technique for diagnostic analysis, applied in the field of diagnostic analyzers and quality control, capable of solving problems such as reruns, discards, questionable sample test results, etc.

Pending Publication Date: 2022-07-15
SIEMENS HEALTHCARE DIAGNOSTICS INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

That is, the diagnostic analyzer is operating unacceptably, and all sample test results produced by the diagnostic analyzer since the last successful repeat QC test may be questionable, and therefore may have to be discarded or possibly re-tested. run

Method used

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  • Diagnostic analyzer and quality control method
  • Diagnostic analyzer and quality control method
  • Diagnostic analyzer and quality control method

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Embodiment Construction

[0016] Diagnostic analyzers may rely on quality control (QC) testing to ensure that the diagnostic test results produced by the diagnostic analyzer are valid. QC testing may involve testing a QC sample in a diagnostic analyzer and comparing the QC sample test results to the expected results for that QC sample. In some embodiments, QC testing can include performing multiple tests using replicate QC samples. A QC sample can contain a specific concentration of the chemical being tested (eg, an analyte) and, if the diagnostic analyzer is operating normally, will cause the diagnostic analyzer to output the expected test result. A diagnostic analyzer may be considered "out of control" if it does not produce the expected test results in response to a QC test, and all test results produced by the diagnostic analyzer since the last successful QC test may be question. For example, if there is high variance in a QC test, then the diagnostic analyzer may be considered out of control. A...

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Abstract

A quality control method for a diagnostic analyzer includes performing a quality control test or a plurality of sample tests; determining, with the controller, that the quality control test result or the plurality of sample test results are outside a threshold; monitoring the 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 a calibration program in response to the quality control test result or the plurality of sample test results being outside the threshold and receiving an error code. Other apparatus and methods are disclosed.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS [0002] This application claims the benefit of US Provisional Patent Application No. 62 / 948,754, filed December 16, 2019, entitled "DIAGNOSTIC ANALYZERS AND QUALITYCONTROL 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 technique [0004] In medical testing and processing, diagnostic analyzers (immunoassays, clinical diagnostic analyzers, in vitro analyzers, and the like) can be used to test one or more components (eg, one or more components) contained within a biological sample concentration of an analyte or other component(s) such as, for example, blood or components thereof, such as serum or plasma, urine, sputum, saliva, cerebrospinal fluid, and the like. Such diagnostic analyzers may be complex, and...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N1/10G01N31/00
CPCG01N35/00623G01N35/00693G01N35/1011G01N2035/0494G01N2035/0475G01N35/1016G16H10/40G16H40/40
Inventor M·艾哈迈德
Owner SIEMENS HEALTHCARE DIAGNOSTICS INC