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 />
Procedure:<br />
• detailed step-by-step protocol<br />
•specimen collection, processing, storage, rejection criteria<br />
•sources <strong>of</strong> reagents and equipment<br />
•description <strong>of</strong> controls<br />
•interpretation <strong>of</strong> results<br />
•technical limitations <strong>of</strong> the assay<br />
•steps taken to minimize amplicon contamination
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