Verification of Microbiology Tests - SWACM

More documents

Recommendations

Info

Test Verification • What about blood culture system – Sensitivity, specificity, reportable & reference ranges are not applicable – Seeded bottles • At least 20 representative isolates spiked at low CFU • Detection of all isolates within expected time – Parallel study • Collection of both bottle sets; compare both systems 14
Modified Tests and Laboratory- Developed Tests (LDTs) 15
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: Verification of AST • At least 30
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

Create successful ePaper yourself

Delete template?

Save as template?