Verification of Microbiology Tests - SWACM

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Modified Tests and LDTs—Number of Specimens to Test • Cumitech 31A: recommended number of specimens – ≥ 50 positive specimens – ≥ 100 negative specimens – Rationale: scientifically justified, and laboratories performing LDTs or modified tests have resources to perform larger studies – Number of samples may depend on extent of modification – This is a recommendation. Neither CLIA nor CAP specify number of specimens Source: Cumitech 31A 20
Verification Report • Summarize performance—did it meet your acceptance criteria (as defined in a verification protocol) • Attach raw data • Director (or designee) must sign the report, documenting that the test does indeed perform as per manufacturer’s specifications • Keep report for life of assay, plus 2 years 21
Page 1 and 2: Verification of Microbiology Tests
Page 3 and 4: Definitions • Modified test: FDA-
Page 5 and 6: Verification Components • Accurac
Page 7: Verification of Unmodified FDA- Cle
Page 11 and 12: Verification of Unmodified FDA- Cle
Page 13 and 14: Verification of AST • At least 30
Page 15 and 16: Modified Tests and Laboratory- Deve
Page 17 and 18: Modification Examples • Change in
Page 19: Verification vs. Establishment of
Page 23: Acknowledgments • Cumitech 31A co

Verification of Microbiology Tests - SWACM

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