Abstract
The availability of rapid and sensitive methods to diagnose syphilis facilitates screening of pregnant women, which is one of the most cost-effective health interventions available. We have evaluated two screening methods in Tanzania: an enzyme immunoassay (EIA), and a point-of-care test (POCT). We evaluated the performance of each test against the Treponema pallidum particle agglutination assay (TPPA) as the reference method, and the accessibility of testing in a rural district of Tanzania. The POCT was performed in the clinic on whole blood, while the other assays were performed on plasma in the laboratory. Samples were also tested by the rapid plasma Reagin (RPR) test. With TPPA as reference assay, the sensitivity and specificity of EIA were 95.3% and 97.8%, and of the POCT were 59.6% and 99.4% respectively. The sensitivity of the POCT and EIA for active syphilis cases (TPPA positive and RPR titer ≥1/8) were 82% and 100% respectively. Only 15% of antenatal clinic attenders in this district visited a health facility with a laboratory capable of performing the EIA. Although it is less sensitive than EIA, its greater accessibility, and the fact that treatment can be given on the same day, means that the use of POCT would result in a higher proportion of women with syphilis receiving treatment than with the EIA in this district of Tanzania.
Highlights
The prevalence of syphilis is high among pregnant women attending antenatal clinics in sub-Saharan Africa [1]
With Treponema pallidum particle agglutination assay (TPPA) as reference, the point-of-care test (POCT) had 11 false positive and 145 false negative results, giving a sensitivity of 59.6% (95% confidence interval CI: 54.3-64.7%) and specificity of 99.4% (Table 1)
Fifty out of 2099 samples tested by POCT had active syphilis, of which 41 were detected by POCT, giving a sensitivity of 82% (69.2%-90.2%) and specificity of 100%
Summary
The prevalence of syphilis is high among pregnant women attending antenatal clinics in sub-Saharan Africa [1]. Latent syphilis can only be diagnosed serologically Laboratory based assays such as the Treponema pallidum particle agglutination assay (TPPA) and rapid plasma reagin (RPR) test are widely used. Enzyme immunoassays (EIA) are recommended for syphilis screening in Europe [5]. They are easy to use, provide objective results, and are well adapted to high throughput laboratories; but they are more expensive than the other assays, require equipment (a plate washer and a plate reader), and as TPPA and RPR, require cold storage of consumables, which is a limiting factor for some settings [6,7]
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