Table 2.
Performance evaluations of point of care tests for Neisseria gonorrhoeae from 2010 to 2015.
| Study authors and year | Location | Test used | Sample type | Reference test | Sample size and population | Sensitivity (95% CI) | Specificity (95% CI) | Positive predictive value (95% CI) or LR+ | Negative predictive value (95% CI) or LR− |
|---|---|---|---|---|---|---|---|---|---|
| Bartelsman et al. 2014 [27] | Amsterdam, Netherlands | Gram stained urethral or cervical smear (2008-2009) |
Urethral and cervical swabs | Culture | 10,952 “high risk” men and women attending STI clinic, symptomatic and asymptomatic | 87.2% (83.3–90.4%) | 99.9% (99.8–100%) | 97.0% (94.5–98.5%) | 99.6% (99.4%–99.7%) |
|
| |||||||||
| Bartelsman et al. 2014 [27] | Amsterdam, Netherlands | Gram stained urethral or cervical smear (2010-2011) |
Urethral and cervical swabs | Culture | 11,755 “high risk” men and women attending STI clinic, only symptomatic | 84.8% (82.3–87.1%) | 99.8% (99.7–99.9%) | 97.7% (96.3–98.6%) | 98.8% (98.5–99.0%) |
|
| |||||||||
| Bartelsman et al. 2014 [27] | Amsterdam, Netherlands | Gram stained cervical smear (2008-2009) |
Cervical swab | Culture | 3767 “high risk” women attending STI clinic, symptomatic and asymptomatic | 32.0% (19.5–46.7%) | 100% (99.9–100%) | 100% (82.9–100%) | 99.1% (98.7–99.4%) |
|
| |||||||||
| Bartelsman et al. 2014 [27] | Amsterdam, Netherlands | Gram stained cervical smear (2010-2011) |
Cervical swab | Culture | 4530 “high risk” women attending STI clinic, only symptomatic | 23.1% (16.1–31.3%) | 99.9% (99.8–100%) | 90.9% (75.7–98.1%) | 98.7% (97.3–98.2%) |
|
| |||||||||
| Bartelsman et al. 2014 [27] | Amsterdam, Netherlands | Gram stained urethral smear (2008-2009) |
Urethral swab | Culture | 7185 “high risk” men attending STI clinic, symptomatic and asymptomatic | 95.9% (93.1–97.8%) | 99.9% (99.7–99.9%) | 96.8% (94.2–98.5%) | 99.8% (99.7–99.9%) |
|
| |||||||||
| Bartelsman et al. 2014 [27] | Amsterdam, Netherlands | Gram stained urethral smear (2010-2011) |
Urethral swab | Culture | 7225 “high risk” men attending STI clinic, only symptomatic | 95.4% (93.7–96.8%) | 99.8% (99.6–99.9%) | 98.0% (96.7–98.9%) | 99.5% (99.3–99.6%) |
|
| |||||||||
| Gaydos et al. 2013 [21] | USA | Cepheid GeneXpert CT/NG (NAAT) |
Vaginal swab (self-collected) | Aptima Combo 2 assay (Hologic, USA) & ProbeTec ET System (BD, USA) | 1,722 sexually active females, symptomatic and asymptomatic, at OB-GYN, STD, teen, public health, or family planning clinics | 100% (87.3–100%) | 99.9% (99.6–100%) | 91.7% | 100% |
|
| |||||||||
| Gaydos et al. 2013 [21] | USA | Cepheid GeneXpert CT/NG (NAAT) |
Endocervical swab | Aptima Combo 2 assay (Hologic, USA) & ProbeTec ET System (BD, USA) | 1,722 sexually active females, symptomatic and asymptomatic, at OB-GYN, STD, teen, public health, or family planning clinics | 100% (87.3–100%) | 100% (99.8–100%) | 100% | 100% |
|
| |||||||||
| Gaydos et al. 2013 [21] | USA | Cepheid GeneXpert CT/NG (NAAT) |
Urine | Aptima Combo 2 assay (Hologic, USA) & ProbeTec ET System (BD, USA) | 1,722 sexually active females, symptomatic and asymptomatic, at OB-GYN, STD, teen, public health, or family planning clinics | 95.6% (78.1–99.9%) | 99.9% (99.7–100%) | 95.6% | 99.9% |
|
| |||||||||
| Gaydos et al. 2013 [21] | USA | Cepheid GeneXpert CT/NG (NAAT) |
Urine | Aptima Combo 2 assay (Hologic, USA) & ProbeTec ET System (BD, USA) | 1,387 sexually active males, symptomatic and asymptomatic, at OB-GYN, STD, teen, public health, or family planning clinics |
98.0% (89.4–99.9%) | 99.9% (99.6–100%) | 98.0% | 99.9% |
|
| |||||||||
| Nuñez-Forero et al. 2016 [25] | Bogota, Colombia | ACON CT/NG Duo test (immunoassay) |
Endocervical swab | COBAS AMPLICOR Analyzer CT/NG assay (Roche, USA) | 491 sexually active females, age 14–49, symptomatic (pregnant women excluded) |
12.5% (0–41.7%) | 99.8% (99.3–100%) | 60.4 (LR+) | 0.4 (LR−) |
|
| |||||||||
| Nuñez-Forero et al. 2016 [25] | Bogota, Colombia | ACON NG individual test (immunoassay) |
Endocervical swab | COBAS AMPLICOR Analyzer CT/NG assay (Roche, USA) | 773 sexually active females, age 14–49, asymptomatic (pregnant women excluded) | Not quantifiable (no true positives) | 97.2% (96–98.5%) | Not quantifiable (LR+) | Not quantifiable (LR−) |
|
| |||||||||
| Samarawickrama et al. 2014 [28] | London, UK | BioStar Optical ImmunoAssay | Urine | Aptima Combo 2 assay (Hologic, USA) | 52 men, age 18+, attending sexual health clinic | 100% (57–100%) | 98% (98–100%) | 83% (44–97%) | 100% (92–100%) |
|
| |||||||||
| Samarawickrama et al. 2014 [28] | London, UK | BioStar Optical ImmunoAssay | Urine | Microscopy | 33 men, age 18+, attending sexual health clinic | 100% (51–100%) | 93% (78–98%) | 67% (30–90%) | 100% (88–100%) |
|
| |||||||||
| Samarawickrama et al. 2014 [28] | London, UK | BioStar Optical ImmunoAssay | Urine | Culture | 32 men, age 18+, attending sexual health clinic | 100% (51–100%) | 93% (77–98%) | 67% (30–90%) | 100% (87–100%) |