Published values for sensitivities and specificities of gonorrhoea, chlamydia, trichomoniasis, and HSV-2 diagnostics used in the trials
| Trial and test | Sex | Gold standard | Se (%) | Sp (%) | Population | Reference |
|---|---|---|---|---|---|---|
| *The specificity was not reported. We assumed it was 100%. | ||||||
| F = female, M = male, NG = gonorrhoea, CT = chlamydia, TV = trichomoniasis, HSV-2 = herpes simplex virus type 2, LCR = ligase chain reaction, PCR = polymerase chain reaction, EIA = enzyme immunoassay; MOMP = major outer membrane protein; ANC = antenatal clinic, Se = sensitivity, Sp = specificity, Ob-gyn = obstetrical/gynaecology patients, CSW = commercial sex workers, nr = not reported. | ||||||
| Rakai and Masaka: LCR on urine for CT | F | Gen-Probe (endocervical) /EIA (endocervical) /LCR (urine) | 98.4 | 100 | Ob-gyn | 29 |
| F | EIA (endocervical)/ culture (endocervical) / PCR (endocervical)/ LCR (urine) | 77.8 | 100 | CSW | 30 | |
| F | EIA (endocervical)/ culture (endocervical)/ PCR (urine)/ LCR (urine) | 75 | 100 | STD clinic | 31 | |
| F | LCR (urine)/ LCR (cervical)/ DFA (cervical) | 95 | nr | STD clinic | 32 | |
| Mean | F | 86.6 | 100 | |||
| Rakai and Masaka: LCR on urine for CT | M | LCR (urine)/ EIA (urethral)/ PCR (urethral)/ culture (urethral) | 100 | 100 | STD clinic | 30 |
| M | EIA (urethral)/ culture (urtheral)/ PCR (urine)/ LCR (urine) | 75 | 100 | STD clinic | 31 | |
| Mean | M | 87.5 | 100 | |||
| Mwanza: EIA on endocervical swab for CT | F | Gen-Probe (endocervical) /EIA (endocervical) /LCR (urine) | 50 | 100 | Ob-gyn | 29 |
| F | EIA (endocervical)/ culture (endocervical) / PCR (endocervical)/ LCR (urine) | 22.2 | 100 | CSW | 30 | |
| F | EIA (endocervical)/ culture (endocervical)/ PCR (urine)/ LCR (urine) | 58 | 100 | STD clinic | 31 | |
| F | LCR (urine)/ LCR (cervical)/ DFA (cervical) | 65 | nr | STD clinic | 32 | |
| Mean | F | 48.8 | 100 | |||
| Mwanza: EIA on urethral swab for CT | M | LCR (urine)/ EIA (urethral)/ PCR (urethral)/ culture (urethral) | 82.6 | 100 | STD clinic | 30 |
| M | EIA (urethral)/ culture (urethral)/ PCR (urine)/ LCR (urine) | 58 | 100 | STD clinic | 31 | |
| Mean | M | 70.3 | 100 | |||
| Rakai and Masaka: LCR on urine for NG | F | LCR (urine)/ MOMP-LCR (urine)/ culture (endocervical) | 50 | 100 | STD clinic | 21 |
| F | LCR (urine)/ Pilin-LCR (urine)/ Culture (endocervical) | 94.7 | 100 | STD clinic | 33 | |
| F | Culture (endocervical)/ Pilin and protein-1 LCR (urine) | 91.7 | 100 | STD clinic | 34 | |
| F | Pilin and protein1-LCR (urine)/ LCR (endocervical)/ culture (endocervical) | 94.6 | 100 | STD clinic | 35 | |
| F | PCR (urine)/ LCR (urine)/ culture (endocervical) | 88.2 | 100 | Adolescent clinic | 36 | |
| Mean | F | 83.8 | 100 | |||
| Rakai and Masaka: LCR on urine for NG | M | LCR (urine)/ MOMP-LCR (urine)/ culture (urethral) | 88.9 | 100 | STD clinic | 21 |
| Mwanza: culture on endocervical swab for NG | F | LCR (urine)/ MOMP-LCR (urine)/ Culture (endocervical) | 50 | 100 | STD clinic | 21 |
| F | LCR (urine)/ Pilin-LCR (urine)/ Culture (endocervical) | 84.2 | 100 | STD clinic | 33 | |
| F | Culture (endocervical)/ Pilin and protein-1 LCR (urine) | 58.3 | 100 | STD clinic | 34 | |
| F | Pilin and protein1-LCR (urine)/ LCR (endocervical)/ culture (endocervical) | 96.4 | 100 | STD clinic | 35 | |
| F | PCR (urine)/ LCR (urine)/ culture (endocervical) | 82.3 | 98.9 | Adolescent clinic | 36 | |
| Mean | F | 74.2 | 99.8 | |||
| Mwanza: Gram stain on urethral smear for NG | M | LCR (urine)/ MOMP-LCR (urine)/ culture (urethral) | 83.3 | nr* | STD clinic | 21 |
| Rakai: InPouchTV on vaginal swab for TV | F | InPouch Culture (vaginal)/ Diamond’s culture (vaginal)/ wet mount (vaginal) | 88.3 | 100 | ANC | 37 |
| F | PCR (vaginal)/ InPouchTV culture (vaginal)/ wet mount (vaginal) | 69.7 | 100 | Army medical clinic | 38 | |
| Mean | F | 79 | 100 | |||
| Mwanza: Wet mount microscopy on vaginal swab for TV | F | InPouch Culture (vaginal)/ Diamond’s culture (vaginal)/ wet mount (vaginal) | 85.3 | 99.5 | ANC | 37 |
| F | PCR (vaginal)/ InPouchTV culture (vaginal)/ wet mount (vaginal) | 36.4 | 100 | Army medical clinic | 38 | |
| Mean | F | 60.9 | 99.8 | |||
| Rakai: CDC assay for HSV-2 | F/M | Western blot | 92 | 100 | 16 | |
| Mwanza and Masaka: Monoclonal antibody blocking assay for HSV-2 | F/M | Western blot | 91 | 93 | Rural African population | 17 |