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 />
Data needs to be submitted that demonstrates the<br />
analytical and clinical validity <strong>of</strong> the assay.<br />
•Analytical validity means the ability <strong>of</strong> the assay to meet<br />
technical performance specifications<br />
•Clinical validity means the proven ability <strong>of</strong> an assay to<br />
reliably identify a specific condition in a test subject.
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