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 />
Summary <strong>of</strong> validation studies and results<br />
Data:<br />
•specificity<br />
•sensitivity (limit <strong>of</strong> detection)<br />
•reproducibility (inter- and intra-assay reproducibility)<br />
•accuracy verification<br />
Guidance is provided describing approaches that can be<br />
used to carry out these studies.
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