Regulation of Laboratory Developed Tests

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Scope of Reviews Molecular Microbiology-nucleic acid amplification assays Method Validation Assay Verification (cont.) For quantitative assays, provide data across the full range of concentrations likely to be encountered in clinical samples. Multiplex assays (especially those with multiple sample types) can present a difficult situation for the design of a validation study, since it can be a large and expensive endeavor to assay 40 samples (30positive and 10 negative) for each analyte in each specimen type. Samples can be spiked with multiple organisms, so as to reduce the number of samples required. We may be contacted for guidance prior to the submission of a package with multiplex analysis having four or more simultaneous targets.
Scope of Reviews Molecular Microbiology-nucleic acid amplification assays Method Validation Additional Guidance Provided •Broad range sequencing to identify bacteria, mycobacteria, or fungi •Subtyping using nucleic acid sequencing and comparisons to sequence databases •Prognostic viral typing assays
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 and 20: Inter-assay reproducibility Scope o
Page 21: Assay Verification Scope of Reviews

Regulation of Laboratory Developed Tests

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