Regulation of Laboratory Developed Tests
Regulation of Laboratory Developed Tests
Regulation of Laboratory Developed Tests
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Scope <strong>of</strong> Reviews<br />
Molecular Microbiology-nucleic acid amplification assays<br />
Method Validation<br />
Assay Verification (cont.)<br />
For quantitative assays, provide data across the full range <strong>of</strong><br />
concentrations likely to be encountered in clinical samples.<br />
Multiplex assays (especially those with multiple sample types) can<br />
present a difficult situation for the design <strong>of</strong> a validation study,<br />
since it can be a large and expensive endeavor to assay 40 samples<br />
(30positive and 10 negative) for each analyte in each specimen type.<br />
Samples can be spiked with multiple organisms, so as to reduce the<br />
number <strong>of</strong> samples required. We may be contacted for guidance<br />
prior to the submission <strong>of</strong> a package with multiplex analysis having<br />
four or more simultaneous targets.
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