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 />
Information Reviewed:<br />
•standard operating procedure manual (SOPM)<br />
•test requisitions and reports<br />
•pertinent literature references<br />
•summary <strong>of</strong> validation studies and supporting data<br />
•plans for carrying out pr<strong>of</strong>iciency testing
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