Laboratory evaluation of three dual rapid diagnostic tests for HIV and syphilis in China and Nigeria

AbstractObjectiveTo determine the laboratory-based performance and operational characteristics of three dual rapid diagnostic tests (RDTs) for testing HIV and syphilis.MethodsThree dual RDTs (SD Bioline, Chembio, and MedMira) were evaluated using 1514 serum specimens archived at laboratories or collected from clinics in China and Nigeria to determine sensitivity and specificity, with 95% confidence intervals. Concordance of testing results read by two technicians, stability of testing results read at two time points, and test operation characteristics were also assessed.ResultsAll three of the evaluated RDTs gave excellent performance with a combined sensitivity ranging from 99.0%–99.6% for HIV and 98.3%–99.0% for syphilis, and a combined specificity ranging from 97.9%–99.0% for HIV and 97.2%–99.6% for syphilis. Concordance of testing results between two technicians and stability of testing results read within and one hour past the recommended reading period showed excellent agreement, with Kappa greater than or equal to 0.98.ConclusionsAll the tests were found to be very or fairly easy to use and easy to interpret the results. Further evaluations of these dual RDTs with whole blood in field settings, and more studies on the implication of introduction of these tests in HIV and syphilis control programs are needed

Mapping health service coverage inequalities in Africa: a scoping review protocol

Introduction Addressing inequities in health service coverage is a global priority, especially with the resurgence of interest in universal health coverage. However, in Africa, which has the lowest health service coverage index, there is limited information on the progress of countries in addressing inequalities related to health services. Thus, we seek to map the evidence on inequalities in health service coverage in Africa.Methods and analysis We will conduct a scoping review following the Joanna Briggs Institute Manual for Evidence Synthesis. We preregistered this protocol with the Open Science Framework on 26 July 2022 (https://osf.io/zd5bt). We will consider any empirical research that assesses inequalities in relation to services for reproductive, maternal, newborn and child health (eg, family planning), infectious diseases (eg, tuberculosis treatment) and non-communicable diseases (eg, cervical cancer screening) in Africa. We will search MEDLINE, Embase, Web of Science, CINAHL, PsycINFO and Cochrane Library from their inception onwards. We will also hand-search Google and Global Index Medicus, and screen reference lists of relevant studies. We will evaluate studies for eligibility and extract data from included studies using pre-piloted and standardised forms. We will further extract a core set of health service coverage indicators, which are disaggregated by place of residence, race/ethnicity/culture, occupation, gender, religion, education, socioeconomic status and social capital plus equity stratifiers. We will summarise data using a narrative approach involving thematic syntheses and descriptive statistics. We will report our findings according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist.Ethics and dissemination Ethical approval is not required as primary data will not be collected. This work will contribute to identifying knowledge gaps in the evidence of inequalities in health service coverage in Africa, and propose strategies that could help overcome current challenges. We will disseminate our findings to knowledge users through a publication in a peer-reviewed journal and organisation of workshops

Clinic-based evaluation study of the diagnostic accuracy of a dual rapid test for the screening of HIV and syphilis in pregnant women in Nigeria

<div><p>Background</p><p>Screening 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.</p><p>Methods and findings</p><p>Participants 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.</p><p>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).</p><p>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.</p><p>Conclusions</p><p>The 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.</p></div

Summary of diagnostic accuracy results.

<p>Summary of diagnostic accuracy results.</p

Operational feasibility of dual HIV-syphilis rapid diagnostic test among ANC clinic staff by site.

<p>Operational feasibility of dual HIV-syphilis rapid diagnostic test among ANC clinic staff by site.</p

Workflow used for laboratory processing of specimens.

<p>Workflow used for laboratory processing of specimens.</p

Concordance for HIV and syphilis diagnosis by the SD BIOLINE HIV/Syphilis Duo test when conducted in laboratory and field settings.

<p>Concordance for HIV and syphilis diagnosis by the SD BIOLINE HIV/Syphilis Duo test when conducted in laboratory and field settings.</p

Characteristics of study participants, including their age, gestation length and the time required to reach the ANC clinic from home.

<p>Characteristics of study participants, including their age, gestation length and the time required to reach the ANC clinic from home.</p