Assay verification control for an automated analytical system

Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving antigen-antibody binding – specific binding protein...

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422 63, 422 64, 435 783, 435 794, 435962, 435967, 436 43, 436132, 436518, 436526, 436533, 436534, 436536, 436538, 436539, 436541, 436805, G01N 3353, G01N 33538, G01N 33546, G01N 3500

Patent

active

056353642

ABSTRACT:
A method for verifying that an assay methodology is properly performed, that assay reagents employed possess the necessary potency for accurately performing such assay methodology, and whether or not test samples or assay reagents have been tampered with or are adulterated, is described. The method is performed by employing an assay verification sample, comprising a positive analyte component and the test sample under analysis, wherein the assay verification sample is analyzed employing the same assay reagents and essentially the same assay methodology employed to analyze the test sample. The method is particularly useful for performing heterogeneous immunoassays on an automated continuous and random access analytical system.

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