Verification of Microbiology Tests - SWACM

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Verification of Unmodified FDA- • Accuracy Cleared Test – At least 20 specimens (mix of positive and negative) – Depends on reference method; ≥90% • Reproducibility – At least several members of 20-spec panel – Run in duplicate; rpt 2 nd run and 2 nd operator – Same or comparable results 6
Verification of Unmodified FDA- Cleared Test • Reportable range – Include positives (from 20-spec panel) with low and high values – Test should detect both weak and strong positives • Reference (normal) range – May use negative specimens (from 20-spec panel) – Values should be negative, or produce values below a cutoff – May use manufacturer’s reference range (pkg insert) if same patient population – May use published reference range Sources: Cumitech 31A; http://www.cms.hhs.gov/clia/downloads/6064bk.pdf. 7
Page 1 and 2: Verification of Microbiology Tests
Page 3 and 4: Definitions • Modified test: FDA-
Page 5: Verification Components • Accurac
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 and 20: Verification vs. Establishment of
Page 21 and 22: Verification Report • Summarize p
Page 23: Acknowledgments • Cumitech 31A co

Verification of Microbiology Tests - SWACM

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