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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.

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


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.


Antibiotic resistance; Antimicrobial stewardship; Gonorrhea; Molecular surveillance

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