Critical level and detection limit: performance measures for PCR-based assays.

J Virol Methods

Boehringer Mannheim GmbH, Department of New Technologies LP-DNS, Penzberg, Germany.

Published: October 1998

In clinical diagnostic work, sensitivity and specificity are key assay features. In this note we introduce two clinically relevant statistical assay performance measures, the critical level (CL), and the detection limit (DL) for the PCR-based assay. To allow for easy access to these characteristics a Windows-based program has been developed. The application of CL and DL by means of examples is described.

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http://dx.doi.org/10.1016/s0166-0934(98)00080-9DOI Listing

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