Meta-analysis of the performance of a combined treponemal and non-treponemal rapid diagnostic test for syphilis and yaws.

26 May 2016
Marks, M; Yin, YP; Chen, XS; Castro, A; Causer, L; Guy, R; Wangnapi, R; Mitjà, O; Aziz, A; Castro, R; da Luz Martins Pereira, F; Taleo, F; Guinard, J; Bélec, L; Tun, Y; Bottomley, C; Ballard, RC; Mabey, DC;

Background. The human treponematoses are important causes of disease. Mother-to-child transmission of syphilis remains a major cause of stillbirth and neonatal death. There are also almost 100 000 cases of endemic treponemal disease reported annually, predominantly yaws. Rapid diagnostic tests (RDTs) would improve access to screening for these diseases. Most RDTs cannot distinguish current and previous infection. The Dual Path Platform (DPP) Syphilis Screen & Confirm test includes both a treponemal (T1) and nontreponemal (T2) component and may improve the accuracy of diagnosis.

Methods. We conducted a metaanalysis of published and unpublished evaluations of the DPP-RDT for the diagnosis of syphilis and yaws. We calculated the sensitivity, specificity, and overall agreement of the test compared with reference laboratory tests.

Results. Nine evaluations, including 7267 tests, were included. Sensitivity was higher in patients with higher titer rapid plasma reagin (≥1:16) for both the T1 (98.2% vs 90.1%, P < .0001) and the T2 component (98.2% vs 80.6%, P < .0001). Overall agreement between the DPP test and reference serology was 85.2% (84.4%–86.1%). Agreement was highest for high-titer active infection and lowest for past infection.

Conclusions. The RDT has good sensitivity and specificity of the treponemal and nontreponemal components both in cases of suspected syphilis and yaws, although the sensitivity is decreased at lower antibody titers.