Data from studies evaluating the performance of Chlamydia trachomatis antigen detection POCT
| Study/year/location | Test evaluated | Specimen | Reference assay | Sample size/population (% CT prevalence) | Sensitivity (95% CI)* | Specificity (95% CI)* | PPV | NPV |
| Bandea et al (2009)23 USA | BioStar Optical Immunoassay | Cervical swab | Abbott ligase chain reaction | 261 female adolescents (16%) | 59.4% | 98.4% | – | – |
| Hurly et al (2014)10 Vanuatu | Acon Chlamydia Rapid Test | Vaginal swab | Roche Cobas TaqMan PCR assay | 75 women Reproductive clinic | 66.7% (22.3% to 95.7%) | 91.3% (82.0% to 96.7%) | 40% | 96.9% |
| Acon Chlamydia Rapid Test | Urine | Roche Cobas TaqMan PCR assay | 133 men Reproductive clinic | 43.8% (19.8% to 70.1%) | 98.3% (93.9% to 99.8%) | 77.8% | 92.7% | |
| DRW Chlamydia Rapid Test | Vaginal swab | Roche Cobas TaqMan PCR assay | 223 women Reproductive clinic | 74.2% (61.5% to 84.5%) | 95.7% (91.3% to 98.2%) | 86.8% | 90.6% | |
| DRW Chlamydia Rapid Test | Urine | Roche Cobas TaqMan PCR assay | 156 men Reproductive clinic | 41.4% (23.5% to 61.1%) | 89.0% (82.2% to 93.8%) | 46.2% | 86.9% | |
| Michel et al (2009)28 Philippines | HandiLab-C | Vaginal swab | Abbott m2000 PCR assay | 231 women (17%) | 17.9% | 90.6% | 28% | 85% |
| Nadala et al (2009)25 UK | DRW Chlamydia Rapid Test | Urine | Roche Cobas TaqMan PCR assay | 1211 men GUM clinic (9.1%) | 82.6% (74.1% to 89.2%) | 98.5% (97.5% to 99.1%) | 84.1% | 98.3% |
| Sabidó et al (2009)27 Guatemala | Chlamydia Test Card | Endocervical swab | Roche Amplicor PCR assay | 276 women STI clinic (9.8%) | 63.0% | 99.6% | 94% | 96% |
| Saison et al (2007)24 Philippines | Clearview Chlamydia Test | Vaginal swabs | Roche Amplicor PCR assay | 333 women STI clinic (18.3%) | 31.1 | 95.2 | 59% | 86% |
| Cervical swabs | 822 women STI clinic (19.3%) | 53.5% | 99.1% | 93% | 90% | |||
| DRW Chlamydia Rapid Test | Vaginal swabs | Roche Amplicor PCR assay | 1129 women STI clinic and OB/Gyn clinic (12.9%) | 76.7% | 99.6% | 91.8% | 96.6% | |
| van der Helm et al (2012)26 Suriname | DRW Chlamydia Rapid Test | Vaginal swab | Hologic Aptima assay | 912 women STI/sexual health clinic (9.2%–20.8%) | 41.2% (31.9% to 50.9%) | 96.4% (95.0% to 97.5%) | 59.2% | 92.9% |
| van Dommelen et al (2010)22 Netherlands | QuickVue Chlamydia Rapid Test | Vaginal swab, self-collected | Roche Cobas Amplicor PCR assay | 737 women STI clinic (11%) | 27.3% | 99.7% | 91.3% | 92.2% |
| HandiLab-C | Vaginal swab, self-collected | Roche Cobas Amplicor PCR assay | 378 women STI clinic (11%) | 11.6% | 91.9% | 15.6% | 89.0% | |
| BioRapid Chlamydia Antigen Test | Vaginal swab, self-collected | Roche Cobas Amplicor PCR assay | 737 women STI clinic (11%) | 17.3% | 93.5% | 24.6% | 90.4% | |
| Wisniewski et al (2008)11 UK | DRW Chlamydia Rapid Test | Urine—urine cup | Roche Amplicor PCR assay | 534 men STI clinic (6.4%) | 47% (30% to 64%) | 98.8% (97.9% to 99.8%) | – | – |
| Urine—FirstBurst sample | 82% (70% to 95%) | 98.8% (97.9% to 99.8%) | – | – | ||||
| Yin et al (2006)8 China | Clearview Chlamydia Rapid Test | Vaginal swab | Roche Amplicor PCR assay | 1497 women STI clinic (13%) | 32.8% (26.5% to 39.9%) | 99.2% (98.4% to 99.6%) | 85.7% | 90.5% |
| Cervical swabs | 49.7% (42.6% to 56.9%) | 97.9% (96.9% to 98.6%) | 78.4% | 92.8% | ||||
| Additional studies identified in second systematic review (Herbst de Cortina et al 4) | ||||||||
| Ham et al (2015)21 South Korea | aQcare Chlamydia kit | Cervical swab | AccuPower CT and NG/RT PCR assay | 348 women (27.8%) | 93.8% (88.6% to 97.0%) | 96.8% (94.8% to 98.1%) | 91.9% | 97.6% |
| aQcare Chlamydia kit | Urine | AccuPower CT and NG/RT PCR assay | 93 men and women (18.3%) | 88.2% (67.4% to 97.7%) | 94.7% (90.1% to 96.9%) | 78.9% | 97.3% | |
| Nuñez-Forero et al (2016)20 Colombia | Acon Chlamydia Rapid Test | Cervical swab | Roche Cobas Amplicor PCR assay | 229 women with lower UTI symptoms | 22.7% (2.9% to 42.5%) | 100% (99.7% to 100%) | – | – |
| Acon Chlamydia/Gonorrhoea Rapid Test | Cervical swab | Roche Cobas Amplicor PCR assay | 491 women with lower UTI symptoms | 30.5% (17.9% to 43.1%) | 99.8% (99.2% to 100%) | – | – | |
| QuickVue Chlamydia Rapid Test | Cervical swab | Roche Cobas Amplicor PCR assay | 664 women with lower UTI symptoms | 37.7% (23.7% to 51.7%) | 99.4% (98.6% to 100%) | – | – | |
| Near-patient molecular assays | ||||||||
| Gaydos et al (2013)12 USA | Cepheid GeneXpert CT/NG | Vaginal swab, self-collected | Hologic Aptima and BD ProbeTec assays | 1772 women and 1387 men STI, OB/Gyn, teen, family planning clinics | 98.7% (93.1% to 100%) | 99.4% (98.9 to 99.7) | 88.6% | 99.9% |
| Cervical swab | 97.4% (91.0% to 99.7%) | 99.6% (99.1% to 99.8%) | 91.6% | 99.9% | ||||
| Urine—female | 97.6% (91.5% to 99.7%) | 99.8% (99.5% to 100%) | 96.4% | 99.9% | ||||
| Urine—male | 97.5% (91.4% to 99.7%) | 99.9% (99.6% to 100%) | 98.7% | 99.8% | ||||
| Goldenberg et al (2012)13 UK | Cepheid GeneXpert CT/NG | Rectal swab | Hologic Aptima assay | 409 men (10.5%) | 86.0% (72.1% to 94.7%) | 99.2% (97.6% to 99.8%) | 92.5% | 98.4% |
*95% CIs are shown when available.
NPV, negative predictive value; POCT, point-of-care test; PPV, positive predictive value; UTI, urinary tract infection.