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Diagn Microbiol Infect Dis. 2019 Jul;94(3):213-217. doi: 10.1016/j.diagmicrobio.2018.12.018. Epub 2019 Jan 14.

A multisite implementation of a real-time polymerase chain reaction assay to predict ciprofloxacin susceptibility in Neisseria gonorrhoeae.

Author information

1
UCLA Jonathan and Karin Fielding School of Public Health, Department of Environmental Health Sciences, University of California, USA.
2
Los Angeles Department of Public Health, Public Health Laboratories, Los Angeles, CA, USA.
3
Social and Scientific Systems, Inc., Clinical Research and Biosciences Group, Silver Spring, MD, USA.
4
San Francisco Department of Public Health, San Francisco Public Health Laboratory, San Francisco, CA, USA.
5
Philadelphia Department of Public Health, Philadelphia Public Health Laboratory, Philadelphia, PA, USA.
6
Accelerate Diagnostics, Tucson, AZ, USA. Electronic address: rhumphries@axdx.com.
7
UCLA Division of Infectious Diseases, Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, CA, USA.

Abstract

There are no commercially available Food and Drug Administration-cleared rapid tests for Neisseria gonorrhoeae antimicrobial susceptibility testing. This study evaluated the performance of a laboratory-developed real-time polymerase chain reaction assay for genotyping the gyrA gene to determine antimicrobial susceptibility to ciprofloxacin. Validation and clinical performance of the gyrA assay were evaluated across 3 geographic locations (Los Angeles, San Francisco, Philadelphia). Following validation, clinical specimens were collected in Aptima Combo2® CT/NG transport medium from asymptomatic persons who tested positive for Neisseria gonorrhoeae and evaluated for assay percent reportable (i.e., proportion of N. gonorrhoeae-positive specimens that yielded a gyrA genotype). The percentage of gyrA genotyping results differed by laboratory and specimen type. The proportion of specimens that were reportable was best for urine/genital specimens (genotyped = 76.4% (95% confidence interval, 69.9-82%)) followed by rectal (genotyped = 67.2% (95% confidence interval, 63.4-70.6%)) and then pharyngeal specimens (genotyped = 36.1%, (95% confidence interval, 31.9-40.5%)). Overall, asymptomatic patients with N. gonorrhoeae yielded an interpretable genotype 57.2% (784/1370) of the time, of which 480 were wild-type gyrA, resulting in 61% (480/784) being potentially treatable with ciprofloxacin.

KEYWORDS:

Antibiotic resistance; Antimicrobial stewardship; Gonorrhea; Molecular surveillance

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