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 />
Sensitivity (limit <strong>of</strong> detection)<br />
Data from a dilution series <strong>of</strong> a known concentration <strong>of</strong> the target<br />
(preferably whole organism) that is spiked into negative clinical samples<br />
for each matrix being validated.<br />
Perform 3 separate extractions <strong>of</strong> this dilution series and test in<br />
duplicate.<br />
The dilution series must encompass six dilutions including one below the<br />
limit <strong>of</strong> detection <strong>of</strong> the assay.<br />
If the LOD is determined to be >100 gene copies, linearity data must<br />
be provided.
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