1. A multisite implementation of a real-time polymerase chain reaction assay to predict ciprofloxacin susceptibility in Neisseria gonorrhoeae
- Author
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Olivia Ellis, Peera Hemarajata, Romney M. Humphries, Kerry Buchs, Godfred Masinde, Akbar Shahkolahi, and Jeffrey D. Klausner
- Subjects
0301 basic medicine ,Microbiology (medical) ,Adult ,medicine.medical_specialty ,Time Factors ,Adolescent ,Genotype ,Genotyping Techniques ,030106 microbiology ,Gonorrhea ,Microbial Sensitivity Tests ,medicine.disease_cause ,Real-Time Polymerase Chain Reaction ,Asymptomatic ,Gastroenterology ,Article ,law.invention ,03 medical and health sciences ,Young Adult ,0302 clinical medicine ,law ,Ciprofloxacin ,Internal medicine ,Drug Resistance, Bacterial ,medicine ,Humans ,030212 general & internal medicine ,Genotyping ,Polymerase chain reaction ,Aged ,Philadelphia ,business.industry ,General Medicine ,Middle Aged ,medicine.disease ,Los Angeles ,Confidence interval ,Neisseria gonorrhoeae ,Anti-Bacterial Agents ,Infectious Diseases ,DNA Gyrase ,San Francisco ,medicine.symptom ,business ,medicine.drug - 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.
- Published
- 2018