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 />
Standard Operating Procedure Manual<br />
Overview <strong>of</strong> the Assay<br />
• an overview describing the scientific basis <strong>of</strong> the test and<br />
an explanation <strong>of</strong> the assay<br />
• target gene or region being amplified with the location <strong>of</strong><br />
primers and probes<br />
• oligonucleotide list with sequences<br />
• target population <strong>of</strong> the assay and clinical validity
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