Abstract
BackgroundScreening pregnant women for HIV and syphilis is recommended by WHO in order to reduce mother-to-child transmission. We evaluated the field performance, feasibility, and acceptability of a dual rapid diagnostic test (RDT) for HIV and syphilis test in antenatal clinic settings in Nigeria.Methods and findingsParticipants were recruited at 12 antenatal clinic sites in three states of Nigeria. All consenting individuals were tested according to the national HIV testing algorithm, as well as a dual RDT, the SD BIOLINE HIV/Syphilis Duo Test (Alere, USA), in the clinic. To determine sensitivity, specificity and concordance, whole blood samples were obtained for repeat RDT performance in the laboratory, as well as reference tests for HIV and syphilis. Dual test acceptability and operational characteristics were assessed among participants and clinic staff.The prevalence of HIV among the 4,551 enrollees was 3.0% (138/4551) using the national clinic-based HIV testing algorithm. Positive and negative percent agreement of the HIV component of the dual RDT were 100.0% (95% CI 99.7–100.0) and 99.9% (95% CI 99.7–100.0) respectively, when compared with the national rapid testing algorithm. The prevalence of syphilis, using TPHA as the reference test, was low at 0.09% (4/4550). The sensitivity of the syphilis component of the dual RDT could not be calculated as no positive results were observed for patients that were positive for syphilis by TPHA. Each of the only four TPHA-positive specimens had RPR titers of 1:1 (neat), indicative of non-active syphilis. The specificity of the syphilis component of the dual RDT was 99.9% (95% CI 99.8–100.0).The dual RDT received favorable feasibility ratings among antenatal care clinic staff. Acceptability among study participants was high with most women reporting preference for rapid dual HIV/syphilis testing.ConclusionsThe SD BIOLINE HIV/Syphilis Duo Test showed a high overall diagnostic accuracy for HIV and a high specificity for syphilis diagnosis in antenatal clinic settings. This study adds to a growing body of evidence that supports the clinic-based use of dual tests for HIV and syphilis among pregnant women.
Highlights
The global burden of mother-to-child transmission of HIV/Syphilis Duo Test (HIV) and syphilis continues to disproportionately affect populations in low and middle-income countries and reflects access to quality antenatal care services that include HIV and syphilis testing and treatment
All consenting individuals were tested according to the national HIV testing algorithm, as well as a dual rapid diagnostic test (RDT), the SD BIOLINE HIV/Syphilis Duo Test (Alere, USA), in the clinic
The sensitivity of the syphilis component of the dual RDT could not be calculated as no positive results were observed for patients that were positive for syphilis by T. pallidum Hemagglutination assay (TPHA)
Summary
The global burden of mother-to-child transmission of HIV and syphilis continues to disproportionately affect populations in low and middle-income countries and reflects access to quality antenatal care services that include HIV and syphilis testing and treatment. Global and regional strategies and initiatives have been launched for dual elimination of mother-to-child transmission (EMTCT) of HIV and syphilis [1] [2] [3] [4], eleven countries have been validated for elimination to date [1], and a number of tools have been developed available to accelerate this [5]. Detection and timely intervention of pregnant women infected with HIV and/or syphilis are required services indicators for country validation of EMTCT [1]. There has been a limited decline in new pediatric HIV infections in Nigeria since 2009; 21% compared to the 60% average among the other Global Plan priority countries [6]. We evaluated the field performance, feasibility, and acceptability of a dual rapid diagnostic test (RDT) for HIV and syphilis test in antenatal clinic settings in Nigeria
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