Regulation of Laboratory Developed Tests
Regulation of Laboratory Developed Tests
Regulation of Laboratory Developed Tests
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Inter-assay reproducibility<br />
Scope <strong>of</strong> Reviews<br />
Molecular Microbiology-nucleic acid amplification assays<br />
Method Validation<br />
At least 3 authentic clinical samples or spiked clinical samples<br />
should be run on three different days.<br />
If spiked, the three samples should include one concentration at<br />
or near the limit <strong>of</strong> detection.<br />
Alternatively, a single positive control run repeatedly over many<br />
days (15 or more) may be used.
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