COMPREHENSIVE VERIFICATION SYSTEMS AND METHODS FOR ANALYZER-READ CLINICAL ASSAYS

摘要

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.