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Objective: This is the first large-scale assessment of the implementation of HIV Rapid Test Quality Improvement Initiative in South Africa., Methods: We used a quasi-experimental one group post-test only design. The intervention implemented starting April 2014 comprised health-care worker training on quality assurance (QA) of HIV rapid testing and enrolment of the facilities in proficiency testing (PT), targeting 2,077 healthcare facilities in 32 high HIV burden districts. Following the intervention, two consecutive rounds of site assessments were undertaken. The first, conducted after a median of 7.5 months following the training, included 1,915 facilities that participated in the QA training, while the second, conducted after a median of one-year following the first-round assessment included 517 (27.0%) of the 1,915 facilities. In both assessments, the Stepwise-Process-for-Improving-the-quality-of-HIV-Rapid-Testing (SPI-RT) checklist was used to score facilities' performance in 7 domains: training, physical facility, safety, pre-testing, testing, post-testing and external quality assessment. Facilities' level of readiness for national certification was assessed., Result: Between 2016 and 2017, there were four PT cycles. PT participation increased from 32.4% (620/1,915) in 2016 to 91.5% (1,753/1,915) in 2017. In each PT cycle, PT results were returned by 76%-87% of facilities and a satisfactory result (>80%) was achieved by ≥95% of facilities. In the SPI-RT assessment, in round-one, 22.3% of facilities were close to or eligible for national certification-this significantly increased to 38.8% in round-two (P-value<0.001). The median SPI-RT score for the domains HIV pre-testing (83.3%) and post-testing (72.2%) remained the same between the two rounds. The median score for the testing domain increased by 5.6% (to 77.8%)., Conclusion: Facilities performance on the domains that are critical for accuracy of diagnosis (i.e. pre-testing, testing and post-testing) remained largely unchanged. This study provided several recommendations to improve QA implementation in South Africa, including the need to improve routine use of internal quality control for corrective actions., Competing Interests: The authors have declared that no competing interests exist.

Despite recent advances in ways to prevent transmission of HIV from a mother to her child during pregnancy, infants continue to be born and become infected with HIV, particularly in southern Africa where HIV prevalence is the highest in the world. In this region, emphasis has shifted from voluntary HIV counselling and testing to routine testing of women during pregnancy. There have also been proposals for mandatory testing. Could mandatory testing ever be an option, even in high-prevalence settings? Many previous examinations of mandatory testing have dealt with it in the context of low HIV prevalence and a well-resourced health care system. In this discussion, different assumptions are made. Within this context, where mandatory testing may be a strategy of last resort, the objections to it are reviewed. Special attention is paid in the discussion to the entrenched vulnerability of women in much of southern Africa and how this contributes to both HIV prevalence and ongoing challenges for preventing HIV transmission during pregnancy. While mandatory testing is ethically plausible, particularly when coupled with guaranteed access to treatment and care, the discussion argues that the moment to employ this strategy has not yet come. Many barriers remain for pregnant women in terms of access to testing, treatment and care, most acutely in the southern African setting, despite the presence of national and international human rights instruments aimed at empowering women and removing such barriers. While this situation persists, mandatory HIV testing during pregnancy cannot be justified.

Objectives: To establish whether the Determine (Abbott, Tokyo, Japan) HIV antibody test is suitable as an on-site rapid HIV test at primary health care centres by determining its sensitivity and specificity compared with the standard enzyme-linked immunoassay (ELISA) test., Design: Prospective field evaluation study of a rapid HIV test compared with an ELISA., Setting: KwaDabeka clinic and St Mary's Hospital, urban primary health care clinics in the Durban western metropolitan area., Subjects: Women attending antenatal clinics and those presenting at onset of labour., Outcome Measures: Performance of the rapid test versus conventional ELISA testing, sensitivity, specificity, feasibility of implementing the test at primary health care clinics, prevalence of HIV infection at study sites and its association with patient booking status., Results: A total of 323 specimens were tested from patients from two community clinics, KwaDabeka (N = 159) and St Mary's (N = 164). The overall HIV prevalence was 45.5%. There was a significant difference in HIV prevalence (P < 0.001) between KwaDabeka (35.2%) and St Mary's (55.5%). Of the participants 49.2% were from KwaDabeka clinic and 50.8% from St Mary's Hospital. Overall, HIV prevalence among unbooked participants was 43.0%, and among booked participants 46.3%. This was not statistically different (P = 0.612) between the two clinics. The rapid test showed a sensitivity and specificity of 100% when compared with a conventional diagnostic ELISA test., Conclusion: The Determine rapid HIV antibody test is sensitive, specific, easy to perform and provides a valuable method for HIV testing especially in settings with limited access to laboratory infrastructures and trained laboratory staff.