Reply to Humphries and Simner, "Verification Is an Integral Part of Antimicrobial Susceptibility Test Quality Assurance," and Wojewoda et al., "College of American Pathologists (CAP) Microbiology Committee Perspective: the Need for Verification Studies"

James E Kirby^{1

2}, Thea Brennan-Krohn^{3

2

4}, Kenneth P Smith^{3

2}

Affiliations

¹ Department of Pathology, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA jekirby@bidmc.harvard.edu.
² Harvard Medical School, Boston, Massachusetts, USA.
³ Department of Pathology, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.
⁴ Division of Infectious Diseases, Boston Children's Hospital, Boston, Massachusetts, USA.

James E Kirby et al. J Clin Microbiol. 2020.

. 2020 Mar 25;58(4):e02062-19.

doi: 10.1128/JCM.02062-19. Print 2020 Mar 25.

James E Kirby^{1

2}, Thea Brennan-Krohn^{3

2

4}, Kenneth P Smith^{3

2}

¹ Department of Pathology, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA jekirby@bidmc.harvard.edu.
² Harvard Medical School, Boston, Massachusetts, USA.
³ Department of Pathology, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.
⁴ Division of Infectious Diseases, Boston Children's Hospital, Boston, Massachusetts, USA.

No abstract available

References

1. Kirby JE, Brennan-Krohn T, Smith KP. 2019. Bringing antimicrobial susceptibility testing for new drugs into the clinical laboratory: removing obstacles in our fight against multidrug-resistant pathogens. J Clin Microbiol 57:e01270-19. doi:10.1128/JCM.01270-19. - DOI - PMC - PubMed
1. Bonett DG, Price RM. 2006. Confidence intervals for a ratio of binomial proportions based on paired data. Stat Med 25:3039–3047. doi:10.1002/sim.2440. - DOI - PubMed
1. Clark RB, Lewisnski ML, Loeffelholtz MJ, Tibbets RJ. 2009. Cumitech 31A. Verification and validation of procedures in the clinical microbiology laboratory. Coordinating ed, Sharp SE.ASM Press, Washington, DC.
1. CLSI. 2015. Verification of commercial microbial identification and antimicrobial susceptibility testing systems, 1st ed CLSI guideline M52 Clinical and Laboratory Standards Institute, Wayne, PA.
1. US Food and Drug Administration. 2009. Class II special controls guidance document: antimicrobial susceptibility test (AST) systems. FDA, Washington, DC: https://www.fda.gov/regulatory-information/search-fda-guidance-documents.... Accessed 27 July 2019.