Sexually transmitted infections · 2010
Positive predictive value of the Becton Dickinson VIPER system and the ProbeTec GC Q x assay, in extracted mode, for detection of Neisseria gonorrhoeae.
Оценочное исследованиеСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Pope Cassie F, Hay Phillip, Alexander Sarah, Capaldi Kay, Dave Jayshree, Sadiq S Tariq, Ison Catherine A, Planche Timothy
Аннотация
OBJECTIVES: Performance of the new Becton Dickinson ProbeTec GC Q(x) assay on the BD VIPER platform was evaluated to ascertain whether confirmatory testing is required in our clinical setting.
METHODS: Positive predictive value (PPV) was determined by comparison with culture and a confirmatory nucleic acid amplification test (NAAT)-based Neisseria gonorrhoeae assay from genital and extragenital samples (rectal and pharyngeal) collected from a genitourinary medicine (GUM) clinic.
RESULTS: Among 14,223 clinical genital samples, 149 (1.0%) specimens were positive using the ProbeTec GC Q(x) assay, automated on the VIPER platform; 141 of these were confirmed by either culture or a real-time PCR targeting two gonococcal-specific targets (PPV 94.6%; 95% CI 90% to 98%). Among 840 pharyngeal samples, 26 (3.1%) were positive by the ProbeTec GC Q(x) assay; 13 were confirmed (PPV 50%; 95% CI 30% to 70%). Among 593 rectal samples, 17 tested positive by the ProbeTec GC Q(x) assay; all were confirmed (PPV 100%; 95% CI 80% to 100%).
CONCLUSIONS: The lower 95% CI of the PPV for the ProbeTec GC Q(x) assay for genital specimens was >90% in this GUM clinic population, and therefore confirmatory testing for genital specimens is not required. Confirmatory testing of pharyngeal and rectal samples should continue in line with national guidelines.
METHODS: Positive predictive value (PPV) was determined by comparison with culture and a confirmatory nucleic acid amplification test (NAAT)-based Neisseria gonorrhoeae assay from genital and extragenital samples (rectal and pharyngeal) collected from a genitourinary medicine (GUM) clinic.
RESULTS: Among 14,223 clinical genital samples, 149 (1.0%) specimens were positive using the ProbeTec GC Q(x) assay, automated on the VIPER platform; 141 of these were confirmed by either culture or a real-time PCR targeting two gonococcal-specific targets (PPV 94.6%; 95% CI 90% to 98%). Among 840 pharyngeal samples, 26 (3.1%) were positive by the ProbeTec GC Q(x) assay; 13 were confirmed (PPV 50%; 95% CI 30% to 70%). Among 593 rectal samples, 17 tested positive by the ProbeTec GC Q(x) assay; all were confirmed (PPV 100%; 95% CI 80% to 100%).
CONCLUSIONS: The lower 95% CI of the PPV for the ProbeTec GC Q(x) assay for genital specimens was >90% in this GUM clinic population, and therefore confirmatory testing for genital specimens is not required. Confirmatory testing of pharyngeal and rectal samples should continue in line with national guidelines.