Regulation of Laboratory Developed Tests
Regulation of Laboratory Developed Tests
Regulation of Laboratory Developed Tests
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Assay Verification<br />
Scope <strong>of</strong> Reviews<br />
Molecular Microbiology-nucleic acid amplification assays<br />
Method Validation<br />
Accuracy should be verified by conducting a randomized, blinded validation<br />
study where the assay results are compared to those <strong>of</strong> a gold standard or<br />
FDA or CLEP approved assay.<br />
Provide data from at least 30 positive samples and 10 negative samples. The<br />
samples should be authentic clinical specimens, but spiked samples are<br />
acceptable when clinical specimens are not available.<br />
If spiked samples are used, at least 10 samples should be close to the LOD<br />
(maximum, 10-fold above that level).<br />
If authentic clinical samples are used, at least 10 <strong>of</strong> the 30 positives should<br />
be weak positives, if the methods used allow for this determination. Include<br />
multiple different strains and specimens.
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