Verification of Microbiology Tests - SWACM

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Test Verification • Accuracy, reproducibility, reportable and reference range best describe a diagnostic test • What about an identification test, or AST – Organism identification test – AST • Accuracy (species, genus) and reproducibility • Accuracy, reproducibility • Reportable range = both sensitive and resistant strains 12
Verification of AST • At least 30 isolates per panel • Acceptance criteria – If reference method is not used, no very major errors – Less than 5% major errors (one test S or R, other test opposite result) – Overall essential agreement (+/- 1 twofold dilution) and categorical agreement (SIR) ≥90% Source: Cumitech 31A 13
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: Verification of Unmodified FDA- Cle
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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