Avocet Medical, Inc.

Beckman Coulter, Inc.

Benjamin G Meyer

Stephen Eliot Zweig

Thomas D Downey

Benjamin J Spink

John C Edson

Sameer Sharma

Gil Y Wong

A device and method for verifying correct performance of an optical clinical assay system is provided.

Verification device for optical clinical assay systems

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.

Comprehensive verification systems and methods for analyzer-read clinical assays

Strip holder

Test articles comprise a solid phase membrane having dry thromboplastin immobilized thereon or within. The thromboplastin is substantially free from substances which might cause aberrant functioning intermediate transition states as the thromboplastin is rehydrated with liquid sample. Coagulation neutral agents which facilitate rehydration of the dry thromboplastin are also provided on the solid phase membrane.

Test articles for performing dry reagent prothrombin time assays

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Saratoga, CA, United States of America

Benjamin G Meyer