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Chapter 5.18 : Evaluation and Verification of Antimicrobial Susceptibility Test Systems

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Evaluation and Verification of Antimicrobial Susceptibility Test Systems, Page 1 of 2

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Abstract:

A wide variety of antimicrobial susceptibility test (AST) systems are available to clinical microbiologists. This procedure provides guidance on evaluating and choosing a system or method appropriate for your laboratory. The primary focus should be on determination of the systems’ capabilities, assessment of costs and work flow, and examination of performance data. A procedure for analyzing results generated from evaluating a new system in comparison with those generated from a reference system is described.

Citation: Leber A. 2016. Evaluation and Verification of Antimicrobial Susceptibility Test Systems, p 5.18.1-5.18.12. In Clinical Microbiology Procedures Handbook, Fourth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555818814.ch5.18
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References

/content/book/10.1128/9781555818814.chap5.18
1. CLIA Subpart K- Quality Systems for Non-waived Testing. Section 493.1253. Standard: Establishment and Verification of Performance Specifications. (wwwn.cdc.gov/clia/regs/subpart_k.aspx)
2. CLSI. 2015. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically, 10th ed. Approved standard M07-A10. CLSI, Wayne, PA.
3. CLSI. 2015. Performance Standards for Antimicrobial Disk Susceptibility, 12th ed. Approved standard M02-A12. CLSI, Wayne, PA
4. CLSI. 2015. Performance Standards for Antimicrobial Susceptibility Testing, 25th ed. Approved standard M100-S25. CLSI, Wayne, PA.
5. Food and Drug Administration. Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems. Food and Drug Administration, Rockville, MD. (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Guidance-Documents/ucm080564.htm) Last updated 17 July 2015.
6. Patel J., Sharp S, Novak-Weekley S. 2013. Verification of antimicrobial susceptibility testing methods: a practical approach. Clin Microbiol Newsletter 35:103109.
7. Clark RB, Lewinski MA, Loeffelholz MJ, Thibbetts RJ. 2009. Cumitech 31A, Verification and validation of procedures in the clinical microbiology laboratory. Coordinating ed, Sharp SE. ASM Press, Washington, DC.
8. Munro S, Mulder RM, Farnham SM, Grinius B. 2010. Evaluating antimicrobial susceptibility test systems. In Garcia LS (ed), Clinical Microbiology Procedures Handbook, 3 ed. ASM Press, Washington, DC.
9. CLSI. 2015. Verification of Commercial Microbial Identification and Antimicrobial Susceptibility Testing Systems. 1st ed. CLSI guideline M52. CLSI, Wayne, PA.
10. Jorgensen JH, Ferraro MJ. 2009. Antimicrobial susceptibility testing: a review of general principles and contemporary practices. Clin Infect Dis 49:17491755.
11. Karlowsky JA, Richter SS. 2015. Antimicrobial Susceptibility Testing Systems, p 1274–1285. In Jorgensen JH, Pfaller MA, Carroll KC, Funke G, Landry ML, Richter SS, Warnock DW (ed), Manual of Clinical Microbiology, 11th ed. ASM Press, Washington, DC.
12. Livermore DM, Winstanley TG, Shannon KP. 2001. Interpretive reading: recognizing the unusual and inferring resistance mechanisms from resistance phenotypes. J Antimicrob Chemother 48(S1):87102.

Tables

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Citation: Leber A. 2016. Evaluation and Verification of Antimicrobial Susceptibility Test Systems, p 5.18.1-5.18.12. In Clinical Microbiology Procedures Handbook, Fourth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555818814.ch5.18
Generic image for table
Susceptibility category errors

Susceptibility category errors

Citation: Leber A. 2016. Evaluation and Verification of Antimicrobial Susceptibility Test Systems, p 5.18.1-5.18.12. In Clinical Microbiology Procedures Handbook, Fourth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555818814.ch5.18
Generic image for table
Gentamicin: XYZ system compared with CLSI broth microdilution reference MIC method

Gentamicin: XYZ system compared with CLSI broth microdilution reference MIC method

Citation: Leber A. 2016. Evaluation and Verification of Antimicrobial Susceptibility Test Systems, p 5.18.1-5.18.12. In Clinical Microbiology Procedures Handbook, Fourth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555818814.ch5.18
Generic image for table
Correlation table for XYZ system compared with CLSI broth microdilution reference MIC method

Correlation table for XYZ system compared with CLSI broth microdilution reference MIC method

Citation: Leber A. 2016. Evaluation and Verification of Antimicrobial Susceptibility Test Systems, p 5.18.1-5.18.12. In Clinical Microbiology Procedures Handbook, Fourth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555818814.ch5.18

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