Verification of Microbiology Tests - SWACM

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<strong>Verification</strong> • Confirm that test performs as per manufacturer’s specifications – What Any FDA cleared/approved diagnostic, identification, or antibiotic susc test – When A new test procedure, or different manufacturer – How Several analyses using at least 20 specimens. With a well designed panel, these analyses can be completed in a couple days 4
<strong>Verification</strong> Components • Accuracy (CAP requires sensitivity and specificity) • Reproducibility • Reportable range • Reference (normal) range • Other test characteristics, as applicable (precision, analytical measurement range) 5
Page 1 and 2: Verification of Microbiology Tests
Page 3: Definitions • Modified test: FDA-
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 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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