Publicly available accuracy measures of Determine Syphilis TP point-of-care test
| Location | Study design | Study sample | Sample type used with POC test | Reference standard | Sensitivity (95% CI) | Specificity (95% CI) |
|---|---|---|---|---|---|---|
| *Performance characteristics were obtained from the same study using two different reference standards. | ||||||
| †Performance characteristics were calculated for three different readers. | ||||||
| ‡Calculated using diagti commands in Stata version 9 (StataCorp LP, College Station, Texas, USA). | ||||||
| CI, confidence interval; ELISA, enzyme-linked immunosorbent assay; FTA-ABS, fluorescent treponemal antibody; RPR, rapid plasma reagin; STI, sexually transmitted infection; TB, tuberculosis; TPHA, Treponema pallidum haemagglutination assay; TPPA, Treponema pallidum particle agglutination assay; VDRL, venereal diseases research laboratory. | ||||||
| Bolivia (present study) | Prospective | 8889 pregnant women | Whole blood from finger-stick | RPR, positives confirmed by TPPA | 91.8 (88.4 to 94.5) | 98.5 (98.2 to 98.8) |
| Brazil*†5 | Retrospective | 250 TPHA+; 300 TPHA− | Stored serum | TPHA only | 97.6 (94.6 to 98.8) | 97.3 (94.6 to 98.6) |
| 98.4 (95.6 to 99.4) | 95.7 (92.9 to 97.7) | |||||
| 95.6 (93.2 to 96.2) | 96.3 (93.4 to 98.3) | |||||
| Brazil*†5 | Retrospective | 195 VDRL and TPHA+; 300 VDRL and TPHA− | Stored serum | VDRL and TPHA | 97.9 (94.4 to 99.2) | 97.3 (94.6 to 98.6) |
| 98.5 (95.1 to 99.4) | 95.7 (92.9 to 97.7) | |||||
| 96.9 (93.6 to 98.9) | 96.3 (93.4 to 98.3) | |||||
| Brazil6 | Retrospective | 63 syphilis cases; 24 with other STD; 38 syphilis seronegative | Serum | Clinical evaluation, VDRL, FTA-ABS, TPHA, and ELISA | 93.7 (84.4 to 97.9) | 95.2 (86.4 to 98.7) |
| WHO SDI multi-country evaluation7 | Retrospective | 399 TPHA or TPPA+; 390 TPHA or TPPA− | Stored serum | TPHA or TPPA | 97.2 (95.6 to 98.8) | 94.1 (91.8 to 96.4) |
| Vietnam8 | Prospective | 291 participants: 71 syphilis cases; 92 negative cases; 128 potential cross reacting (by hepatitis A and B, HIV, malaria, pregnancy, syphilis, TB and high risk of STI acquisition) | Venous whole blood, plasma and serum | RPR confirmed by ELISA (FTA-ABS used to resolve discordant confirmatory results) | 100 (95.0 to 100.0)‡ | 98.6 (96.0 to 99.7) |