Table 1.
Performance evaluations of point of care tests for Chlamydia trachomatis 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. 2015 [19] | Amsterdam, Netherlands | Gram stained urethral smear (2008-2009: including asymptomatic) | Urethral swab | APTIMA CT assay (Hologic, USA) | 7,185 “high risk” men at STI clinic, both symptomatic and asymptomatic | 83.8% (81.2–86.1%) | 74.1% (73.0–75.2%) | 31.7% (29.8–33.6%) | 97.0% (96.4%–97.4%) |
|
| |||||||||
| Bartelsman et al. 2015 [19] | Amsterdam, Netherlands | Gram stained urethral smear (2010-2011: only symptomatic) | Urethral swab | APTIMA CT assay (Hologic, USA) | 18,852 “high risk,” symptomatic men at STI clinic | 91.0% (89.5–92.3%) | 53.1% (51.8–54.4%) | 35.6% (34.1–37.1%) | 95.4% (94.6–96.1%) |
|
| |||||||||
| Pond et al. 2015 [20] | London, UK | Gram stained urethral smear | Urethral swab | BD Viper Qx System (BD, USA) | 208 symptomatic male patients (mean age 31 years) without NG at genitourinary medicine clinic |
93.7% (67.7–99.6%) |
N/A | 16.1% (9.6–25.5%) |
99.1% (94.5–99.9%) |
|
| |||||||||
| Gaydos et al. 2013 [21] | USA | Cepheid GeneXpert CT/NG (nucleic acid amplification test (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 | 98.7% (93.1–100%) | 99.4% (98.9–99.7%) | 88.6% | 99.9% |
|
| |||||||||
| 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 | 97.4% (91.0–99.7) | 99.6% (99.1–99.8%) | 91.6% | 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) | 1,722 sexually active females, symptomatic and asymptomatic, at OB-GYN, STD, teen, public health, or family planning clinics | 97.6% (91.5–99.7%) | 99.8% (99.5–100%) | 96.4% | 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 | 97.5% (91.4–99.7%) | 99.9% (99.6–100%) | 98.7% | 99.8% |
|
| |||||||||
| Ham et al. 2015 [22] | South Korea | aQcare Chlamydia TRF kit (lateral flow immunoassay (LFIA)) |
Endocervical and urethral swabs, urine overall results | AccuPower CT & NG Real-Time PCR Kit (Bioneer, Korea) | 340 women and 101 men, age 20–80, who visited a hospital for the evaluation of STD symptoms | 93.0% (88.0–96.3%) | 96.3% (94.6–97.5%) | 89.8% (85.0–93.0%) | 97.5% (95.8–98.7%) |
|
| |||||||||
| Ham et al. 2015 [22] | South Korea | aQcare Chlamydia TRF kit (LFIA) |
Endocervical and urethral swabs | AccuPower CT & NG Real-Time PCR Kit (Bioneer, Korea) | 8 urethral swabs and 340 endocervical swabs from women and men, age 20–80, who visited a hospital for the evaluation of STD symptoms | 93.8% (88.6–97.0%) | 96.8% (94.8–98.1%) | 91.9% Calculated by review authors |
97.6% Calculated by review authors |
|
| |||||||||
| Ham et al. 2015 [22] | South Korea | aQcare Chlamydia TRF kit (LFIA) |
Urine | AccuPower CT & NG Real-Time PCR Kit (Bioneer, Korea) | 93 men and women, age 20–80, who visited a hospital for the evaluation of STD symptoms | 88.2% (67.4–97.7%) | 94.7% (90.1–96.9%) | 79.0% Calculated by review authors |
97.3% Calculated by review authors |
|
| |||||||||
| Hurly et al. 2014 [23] | Port Vila, Vanuatu | Chlamydia Rapid Test, Diagnostics for the Real World (Signal Amplification System (SAS)) |
Urine | COBAS TaqMan Analyzer CT assay (Roche, USA) | 156 men, age 18+, at reproductive health clinic | 41.4% (23.5–61.1%) | 89.0% (82.2–93.8%) | 46.2% Calculated by review authors |
86.9% Calculated by review authors |
|
| |||||||||
| Hurly et al. 2014 [23] | Port Vila, Vanuatu | Chlamydia Rapid Test, Diagnostics for the Real World (SAS) |
Vaginal swab (self-collected) | COBAS TaqMan Analyzer CT assay (Roche, USA) | 223 women, age 18+, at reproductive health clinic, pregnant women not excluded | 74.2% (61.5–84.5%) | 95.7% (91.3–98.2%) | 86.8% Calculated by review authors |
90.6% Calculated by review authors |
|
| |||||||||
| van der Helm et al. 2012 [24] | Paramaribo, Suriname | Chlamydia Rapid Test, Diagnostics for the Real World (SAS) |
Vaginal swab (nurse-collected) | Aptima CT assay (Hologic, USA) | 912 women (median age 30 years) at either STI clinic or sexual health clinic | 41.2% (31.9–50.9%) | 96.4% (95.0–97.5%) | 59.2% (47.5–70.1%) | 92.9% (91.0–94.5%) |
|
| |||||||||
| van der Helm et al. 2012 [24] | Paramaribo, Suriname | Chlamydia Rapid Test, Diagnostics for the Real World (SAS) |
Vaginal swab (nurse-collected) | Aptima CT assay (Hologic, USA) | 159 women seeking STI care at STI clinic, “high risk” | 39.4% (24.0–56.6%) | 94.4% (89.3–97.5%) | 65.0% (42.7–83.2%) | 85.6% (79.0–90.7%) |
|
| |||||||||
| van der Helm et al. 2012 [24] | Paramaribo, Suriname | Chlamydia Rapid Test, Diagnostics for the Real World (SAS) |
Vaginal swab (nurse-collected) | Aptima CT assay (Hologic, USA) | 753 women at sexual health/family planning clinic, “low risk” | 42.0% (30.8–53.9%) | 96.8% (95.3–97.9%) | 56.9% (43.1–69.9%) | 94.3% (92.4–95.8%) |
|
| |||||||||
| Hurly et al. 2014 [23] | Port Vila, Vanuatu | ACON Chlamydia Rapid Test Device (immunoassay) |
Urine | COBAS TaqMan Analyzer CT assay (Roche, USA) | 133 men, age 18+, at reproductive health clinic | 43.8% (19.8–70.1%) | 98.3% (93.9–99.8%) | 77.8% Calculated by review authors | 92.7% Calculated by review authors |
|
| |||||||||
| Hurly et al. 2014 [23] | Port Vila, Vanuatu | ACON Chlamydia Rapid Test Device (immunoassay) |
Vaginal swab (self-collected) | COBAS TaqMan Analyzer CT assay (Roche, USA) | 75 women, age 18+, at reproductive health clinic, pregnant women not excluded | 66.7% (22.3–95.7%) | 91.3% (82.0–96.7%) |
40.0% Calculated by review authors |
96.9% Calculated by review authors |
|
| |||||||||
| Nuñez-Forero et al. 2016 [25] | Bogota, Colombia | ACON Chlamydia Rapid Test Device (immunoassay) |
Endocervical swab | COBAS AMPLICOR Analyzer CT/NG assay (Roche, USA) | 229 sexually active females, age 14–49, w/lower UTI symptoms (pregnant women excluded) | 22.7% (2.9–42.5%) | 100% (99.7–100%) | Not quantifiable (LR+) | 0.8 (LR−) |
|
| |||||||||
| 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, w/lower UTI symptoms (pregnant women excluded) | 30.5% (17.9–43.1%) | 99.8% (99.2–100%) | 131.8 (LR+) | 0.7 (LR−) |
|
| |||||||||
| Nuñez-Forero et al. 2016 [25] | Bogota, Colombia | QuickVue Chlamydia Rapid Test (immunoassay) |
Endocervical swab | COBAS AMPLICOR Analyzer CT/NG assay (Roche, USA) | 664 sexually active females, age 14–49, w/lower UTI symptoms (pregnant women excluded) | 37.7% (23.7–51.7%) | 99.4% (98.6–100%) | 57.6 (LR+) | 0.6 (LR−) |
|
| |||||||||
| Van Dommelen et al. 2010 [26] | Maastricht, Netherlands | QuickVue Chlamydia Rapid Test (immunoassay) |
Vaginal swab (self-collected) | COBAS AMPLICOR Analyzer CT/NG assay (Roche, USA) | 763 females, age 16+, at STI clinic | 25.0% (15.7–34.3%) | 99.7% (99.3–100%) | 91.3% | 91.5% |
|
| |||||||||
| Pond et al. 2015 [20] | London, UK | Automated Urine Flow Cytometry of first void urine | Urine | BD Viper Qx System (BD, USA) | 208 symptomatic male patients (mean age 31 years) without NG at genitourinary medicine clinic |
93.7% (67.7–99.6%) |
N/A | 28.3% (17.1–42.5%) |
99.3% (95.8–99.9%) |
|
| |||||||||
| Van Dommelen et al. 2010 [26] | Maastricht, Netherlands | Handilab-C (enzyme detection) |
Vaginal swab (self-collected) | COBAS AMPLICOR Analyzer CT/NG assay (Roche, USA) | 735 females, age 16+, at STI clinic | 22.5% (13.0–31.7%) | 88.9% (86.4–91.3%) | 90.4% | 4.8% |
|
| |||||||||
| Van Dommelen et al. 2010 [26] | Maastricht, Netherlands | Biorapid Chlamydia Ag test (antigen detection) |
Vaginal swab (self-collected) | COBAS AMPLICOR Analyzer CT/NG assay (Roche, USA) | 763 females, age 16+, at STI clinic | 17.1% (8.9–25.2%) | 93.7% (91.9–95.5%) | 24.6% | 90.4% |