Critical level and detection limit: performance measures for PCR-based assays.
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.
Markert-Hahn
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Boehringer Mannheim GmbH, Department of New Technologies LP-DNS, Penzberg, Germany. christine_markert-hahn@bmg.boehringer-mannheim.com
Berding
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Kuhn
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D015497:HIV-1 / Q000235:genetics / Q000302:isolation & purification*; D016174:Hepacivirus / Q000235:genetics / Q000302:isolation & purification*; D006526:Hepatitis C / Q000175:diagnosis; D006801:Humans; D012367:RNA, Viral / Q000097:blood; D020133:Reverse Transcriptase Polymerase Chain Reaction / Q000592:standards*; D012680:Sensitivity and Specificity; D012984:Software
D012367:RNA, Viral