Field performance evaluation of dual rapid HIV and syphilis tests in three antenatal care clinics in Zambia

Abstract

This cross-sectional study of 3212 pregnant women assessed the field performance, acceptability, and feasibility of two dual HIV/syphilis rapid diagnostic tests, the Chembio DPP HIV-syphilis Assay and the SD Bioline HIV/syphilis Duo in antenatal clinics. Sensitivity and specificity for HIV and syphilis were calculated compared to the rapid Determine HIV-1/2 with Uni-Gold to confirm positive results for HIV and the Treponema pallidum particle agglutination assay for syphilis. RPR titers ≥1:4 were used to define active syphilis detection. Acceptability and feasibility were assessed using self-reported questionnaires. For Chembio, the HIV sensitivity was 90.6% (95%CI = 87.4, 93.0) and specificity was 97.2% (95%CI = 96.2, 97.8); syphilis sensitivity was 68.6% (95%CI = 61.9, 74.6) and specificity was 98.5% (95%CI = 97.8, 98.9). For SD Bioline, HIV sensitivity was 89.4% (95%CI = 86.1, 92.0) and specificity was 96.3% (95%CI = 95.3, 97.1); syphilis sensitivity was 66.2% (95%CI = 59.4, 72.4) and specificity was 97.2% (95%CI = 96.4, 97.9). Using the reference for active syphilis, syphilis sensitivity was 84.7% (95%CI = 76.1, 90.6) for Chembio and 81.6% (95%CI = 72.7, 88.1) for SD Bioline. Both rapid diagnostic tests were assessed as highly acceptable and feasible. In a field setting, the performance of both rapid diagnostic tests was comparable to other published field evaluations and each was rated highly acceptable and feasible. These findings can be used to guide further research and proposed scale up in antenatal clinic settings.

Facilitators and barriers to point-of-care testing for sexually transmitted infections in low- and middle-income countries: a scoping review

“…52.0% screened when tests supplies available Nkamba et al (2017) [ 57 ] TP Qualitative DRC, Zambia ANC (urban) Pregnant women, clinic administrators, and HCWs DRC: Alere Determine syphilis TP Zambia: SD Bioline Syphilis 3.0 Fingerprick blood Standalone project. POCT results determine treatment Testing and treatment at first ANC visit acceptable to both providers and patients – Althabe et al (2019) [ 58 ] TP Cluster RCT DRC, Zambia ANC (urban) Pregnant women DRC: Alere Determine Syphilis TP test Zambia: SD Bioline Syphilis 3.0 Fingerprick blood Integrated into routine care Intervention: 99.9% Control: 93.8% Behavioural components implemented with a compliance rate between 88 and 100% what was planned No stockouts of supplies for screening or treatment Kasaro et al (2019) [ 59 ] TP Field evaluation Zambia ANC (urban) Pregnant women SD BIOLINE HIV/Syphilis Duo Test Chembio Dual Path Platform HIV-Syphilis Assay Fingerprick blood Standalone project. No discussion of treatment 99.7% preferred the dual test over single tests Both dual RDTs received high and similar feasibility scores from staff Tinajeros et al (2017) [ 60 ] TP Mixed methods Bolivia ANC (urban) HCWs Clinical records of pregnant women – – – – – Garcia et al (2013) [ 61 ] ...…”

Sexually transmitted infections in pregnant women from sub-Saharan Africa

“… 13 , 14 , 15 As a result, these infections are still reported to cause adverse birth outcomes. 16 , 17 Recent studies in SSA have shown a high prevalence of curable STIs amongst pregnant women, and therefore the burden of STIs and HIV in SSA remains a significant threat to reproductive health. 18 , 19 , 20 Women infected with STIs can experience a variety of symptoms, including vaginal itching or irritation, vaginal discharge and dysuria, as well as more severe complications such as pelvic inflammatory disease and fallopian tube pathology.…”

Estimating syphilis seroprevalence among patients in a sexually transmitted infections clinic in Lilongwe, Malawi

“…21 In addition, other rapid tests have been developed that offer combined treponemal antibody and HIV antibody testing. 22,23 Although these types of rapid tests are not yet available in Malawi due to cost, the integration of both types of rapid test into one promises more accurate syphilis (and HIV) diagnosis in resource-limited settings.…”