Verification of Microbiology Tests - SWACM

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Verification of Unmodified FDA- Cleared Test • Verification specimen panel – Own patient specimens • Current test serves as reference method • Split and send to outside lab – Patient specimens from another lab (or vendor) – Old proficiency samples, QC or calibrators • Should be in appropriate matrix, and have analyte in clinically relevant concentrations – Spiked samples (own lab, or provided by vendor) • Appropriate matrix, and analyte in clinically relevant concentrations 10
Verification of Unmodified FDA- Cleared Test • Operators who would perform routine patient testing should perform verification study • Vendors often offer to perform/assist – OK only for fully automated test systems where inter-operator variability not an issue – Preferred assistance: free reagents/kits and data analysis (for complex systems that produce a lot of data, such as AST or serology platform), discrepant analysis 11
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 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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