Study characteristics and performance of point-of-care tests (POCTs) for Neisseria gonorrhoeae
| Country | Study population | Symptoms (%) | Sex | Sample size (n) | POCT brand name | Gold standard | Gonorrhoea prevalence (%) | Specimen type | Time to result/ (# steps) | Sensitivity % (95% CI) | Specificity % (95% CI) | PPV % (95% CI) | NPV % (95% CI) | Reference |
| Benin | Sex workers | 5.4 | F | 1084 | GC check (PATH) | NAAT Amplicor CT/NG (Roche, location not specified) | 4.6 | Cervical swab/ vaginal swab | 25 min (five steps) | 70 (55 to 82)/ 54 (37 to 71) | 97 (96 to 98)/ 98 (97 to 99) | 55 (50 to 76)/ 61 (42 to 76) | 98.7 (98 to 99)*/ 97.7 (96 to 99)* | Alary et al 20 |
| Brazil | STI clinic attendees | High risk† | F | 326 | Biostar GC (OIA) (ThermoFisher Scientific) | Culture Modified Thayer-Martin | 15.0 | Cervical swab | 25–40 min (seven steps) | 60 (46 to 74) | 89 (86 to 94) | 56 (42 to 69) | 92.6 (89.5 to 95.7) | Benzaken et al 21 |
| Columbia | Sexually active 14–49 years, pregnant women excluded | 100 | F | 491 | ACON NG Duo test ImmunoAssay | Cobas Amplicor (Roche) | 1.4 | Endocervical swab | 12.5 (0 to 41.7) | 99.8 (99.3 to 100) | 60.4 | 0.4 | Nunez-Forero et al 25 | |
| Sexually active 14–49 years, pregnant women excluded | 100 | F | 773 | ACON NG Individual test ImmunoAssay | Cobas Amplicor (Roche) | 1.4 | Endocervical swab | No information | Not quantifiable | 97.2 (96 to 98.5) | Not quantifiable | Not quantifiable | Nunez-Forero et al 25 | |
| UK | Sexual health clinic attendees | 67 | M | 52 | Biostar OIA GC (Biostar) | Aptima Combo 2 assay | 10 | Urine | No information | 100 (57 to 100) | 98 (98 to 100) | 83 (44 to 97) | 100 (92 to 100) | Samarawickrama et al 22 |
| Sexual health clinic attendees | 67 | M | 33 | Biostar OIA GC (Biostar) | Microscopy | 12 | Urine | No information | 100 (51 to 100) | 93 (78 to 98) | 67 (30 to 90) | 100 (88 to 100) | Samarawickrama et al 22 | |
| Sexual health clinic attendees | 67 | M | 32 | Biostar OIA GC (Biostar) | Culture | 13 | Urine | No information | 100 (51 to 100) | 93 (77 to 98) | 67 (30 to 90) | 100 (87 to 100) | Samarawickrama et al 22 | |
| Japan | Urology department | 100 | M | 58 | Binax Now Gonorrhoea Test (Inverness) | Culture Thayer-Martin | 58.6 | Urine | 25 min (six steps) | 94 (80 to 99)* | 96 (79 to 100)* | 97* (84 to 100)* | 92 (75 to 98) | Suzuki et al 23 |
| USA | STD, OBGYN, teen, public health or family planning clinics | 27 | F | 1722 | GeneXpert CT/NG (Cepheid) | NAAT Aptima Combo 2 assay and ProbeTec ET system | 1.3 | Vaginal swab (self- collected)/ endocervical swab | 90 min (three steps) | 100 (87.3 to 100)/ 100 (87.3 to 100) | 99.9 (99.6 to 100)/ 100 (99.8 to 100) | 91.7/ 100 | 100/ 100 | Gaydos et al 24 |
| STD, OBGYN, teen, public health or family planning clinics | 27 | F | 1722 | GeneXpert CT/NG (Cepheid) | NAAT Aptima Combo 2 assay and ProbeTec ET system | 1.3 | Urine | 90 min (three steps) | 95.6 (78.1 to 99.9) | 99.9 (99.7 to 100) | 95.6 | 99.9 | Gaydos et al 24 | |
| STD, OBGYN, teen, public health or family planning clinics | 27 | M | 1387 | GeneXpert CT/NG (Cepheid) | NAAT Aptima Combo 2 assay and ProbeTec ET system | 3.6 | Urine | 90 min (three steps) | 98.0 (88.4 to 99.9) | 99.9 (99.6 to 100) | 98.0 | 99.9 | Gaydos et al 24 |
↵*Calculated by author (Watchirs-Smith).17
†Referred by sexual partner or symptomatic.
F, female; M, male; NAAT, nucleic acid amplification technology; NPV, negative predictive value; OBGYN, obstetrics/gynaecology clinics; OIA, optical immunoassay; PPV, positive predictive value.