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Verification of Claimed Limit of Detection in Molecular Diagnostics
The Journal of Applied Laboratory Medicine
Limit of detection (LOD) is an important performance characteristic of clinical laboratory tests. Verification, as recommended by the CLSI EP17-A2 guideline, is done by testing a sample with a claimed LOD concentration. Claimed LOD is verified if the 95% CI for the population proportion, calculated from observed proportion of positive results, contains the expected detection rate of 95% (CLSI EP17-A2; Clin Chem 2004;50:732-40). Claimed LOD, verification sample concentration, and observed ratedoi:10.1373/jalm.2016.020735 pmid:33626838 fatcat:e3cynyexkja4bgi62xajqs7gaq