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Shionogi has collaborated with institutions to develop a panel of clinical isolates for laboratories to perform verification of unmodified
FDA-cleared tests according to the specifications set forth by the manufacturer, and well as validation that a laboratory-developed or modified FDA-cleared test method or instrument system delivers reliable results. The CLSI M52 document provides recommendations for verifying that such tests meet regulatory and quality assurance standards. Additional expert guidance on verification is provided in a toolkit developed by the Association of Public Health Laboratories.
Verification/Validation Isolates
Isolates Included in Available Cefiderocol Verification Panels
| LSI verification isolates for cefiderocol | CDC antimicrobial resistance isolate bank | |
|---|---|---|
| Escherichia coli | ||
| Enterobacter cloacae | ||
| Klebsiella pneumoniae | ||
| Proteus mirabilis | ||
| Serratia marcescens | ||
| Pseudomonas aeruginosa | ||
| Acinetobacter baumannii | ||
| Stenotrophomonas maltophilia |
CDC=US Centers for Disease Control and Prevention; LSI=Laboratory Specialists, Inc.
LSI Verification Isolates for Cefiderocol
This cefiderocol panel is available at no cost to the laboratory
CDC Antimicrobial Resistance Isolate Bank
This cefiderocol panel is available for only the cost of shipping
Reading Methods and Zone of Inhibition/MIC Results
How to Interpret Results for the LSI Cefiderocol Verification Panel
Cefiderocol MIC and zone results for both susceptible and nonsusceptible
Gram-negative isolates
Zone of Inhibition Results for LSI Cefiderocol Verification Isolates
Summary of disk diffusion results for Gram-negative isolates in the LSI verification isolate set
MIC Results for LSI Cefiderocol Verification Isolates
Summary of broth microdilution results for Gram-negative isolates in the LSI verification isolate set
General Antimicrobial Susceptibility Testing Guidance
Association of Public Health Laboratories Verification and Validation Toolkit
Expert guidance to help laboratories distinguish between validation and verification, determine when and how to perform each, and ensure new or modified test methods meet CLIA and other regulatory requirements
Abbreviations: CDC=US Centers for Disease Control and Prevention; CLIA=Clinical Laboratory Improvement Amendments; CLSI=Clinical and Laboratory Standards Institute; FDA=US Food and Drug Administration; LSI=Laboratory Specialists, Inc.