Regulation of Laboratory Developed Tests

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Intra-assay reproducibility Scope of Reviews Molecular Microbiology-nucleic acid amplification assays Method Validation At least 3 authentic clinical samples or spiked clinical samples should be run in triplicate. If spiked, the three samples should include at least one concentration at or near the limit of detection. Also, if different instruments, platforms, models or technicians will be used to perform the assay, demonstrate the assay’s consistency across these variables.
Assay Verification Scope of Reviews Molecular Microbiology-nucleic acid amplification assays Method Validation Accuracy should be verified by conducting a randomized, blinded validation study where the assay results are compared to those of a gold standard or FDA or CLEP approved assay. Provide data from at least 30 positive samples and 10 negative samples. The samples should be authentic clinical specimens, but spiked samples are acceptable when clinical specimens are not available. If spiked samples are used, at least 10 samples should be close to the LOD (maximum, 10-fold above that level). If authentic clinical samples are used, at least 10 of the 30 positives should be weak positives, if the methods used allow for this determination. Include multiple different strains and specimens.
Page 1 and 2: Regulation of Laboratory Developed
Page 3 and 4: Wadsworth Center Clinical Laborator
Page 5 and 6: Part 58-1.10(g) of 10 NYCRR Assay A
Page 7 and 8: Assay Approval In the past 10 years
Page 9 and 10: Scope of Reviews Comprehensive Test
Page 11 and 12: Scope of Reviews Molecular Microbio
Page 19: Inter-assay reproducibility Scope o

Regulation of Laboratory Developed Tests

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