COMPREHENSIVE VERIFICATION SYSTEMS AND METHODS FOR ANALYZER-READ CLINICAL ASSAYS
First Claim
1. A method for verifying accurate performance of an analyzer system which electronically interrogates a chemical test element, said method comprising:
- providing a test element with an environmental degradation indicator;
observing the environmental degradation indicator to confirm that the test element has not degraded; and
confirming correct operation of the analyzer based on interrogation of a verification device by the analyzer;
wherein accurate performance of both the analyzer and the test element of the analyzer system is found based on non-degradation of the test element and accurate operation of the analyzer.
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Accused Products
Abstract
The present invention provides improved systems and methods for verifying accurate test performance of monitoring systems, particularly for point-of-care service. Such monitoring systems typically include a test element containing the test reagent(s), and an electronic analyzer device. A blood or other patient sample is applied to the test element, which is introduced to the analyzer. As the reaction proceeds, the analyzer stores the data and outputs the testing result. Accuracy in the result is dependent upon proper functioning of both the test element and the analyzer. The systems of the present invention provide indicators to evaluate the integrity of the test elements and a verification device to evaluate the performance of the analyzer. Such systems may be provided as kits with instructions for use.
34 Citations
24 Claims
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1. A method for verifying accurate performance of an analyzer system which electronically interrogates a chemical test element, said method comprising:
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providing a test element with an environmental degradation indicator;
observing the environmental degradation indicator to confirm that the test element has not degraded; and
confirming correct operation of the analyzer based on interrogation of a verification device by the analyzer;
wherein accurate performance of both the analyzer and the test element of the analyzer system is found based on non-degradation of the test element and accurate operation of the analyzer. - View Dependent Claims (2, 3, 4, 5, 6)
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7. A kit for use with an electronic analyzer system comprising:
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a chemical test element having an environmental degradation indicator; and
instructions for use setting forth the following method for verifying performance of the analyzer system which electronically interrogates the test element;
observing the environmental degradation indicator to confirm that the test element has not degraded; and
confirming correct operation of the analyzer based on interrogation of a verification device by the analyzer;
wherein accurate performance of both the analyzer and the test element of the analyzer system is found based on non-degradation of the test element and accurate operation of the analyzer. - View Dependent Claims (8, 9, 10, 11, 12, 13, 14)
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15. A kit comprising:
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an analyzer which receives and electronically interrogates a chemical test element; and
instructions for use setting forth the following method for verifying performance of an analyzer system which electronically interrogates the test element;
observing the environmental degradation indicator to confirm that the test element has not degraded; and
confirming correct operation of the analyzer based on interrogation of a verification device by the analyzer;
wherein accurate performance of both the analyzer and the test element of the analyzer system is found based on non-degradation of the test element and accurate operation of the analyzer. - View Dependent Claims (16, 17, 18, 19, 20, 21, 22)
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23. An electronic analyzer device which receives and electronically interrogates a chemical test element comprising:
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means to automatically assess the state of an environmental degradation indicator associated with the chemical test element; and
means to electronically verify the proper function of the electronic analyzer device, whereby accurate performance of both the analyzer device and the test element is found based on non-degradation of the test element and accurate operation of the analyzer.
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24. A method for verifying accurate performance of an analyzer system which electronically interrogates a chemical test element, said method comprising:
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providing an electronic verification device configured to be introduced to the analyzer and to test and/or calibrate the analyzer;
introducing the verification device into the analyzer;
confirming correct operation of the analyzer based on interrogation of the verification device by the analyzer;
providing a test element with an environmental degradation indicator;
introducing the test element with the degradation indicator into the analyzer;
observing response from analyzer to confirm that the test element has not degraded;
wherein accurate performance of both the analyzer and the test element of the analyzer system is found based on non-degradation of the test element and accurate operation of the analyzer.
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Specification