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 />
Guidance on use and preparation <strong>of</strong> controls<br />
Description <strong>of</strong> the types <strong>of</strong> controls that need to be included:<br />
•positive lysis/extraction control<br />
•negative lysis/extraction control<br />
•inhibition control<br />
•reagent contamination control
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