Evaluation of antenatal rapid human immunodeficiency virus testing in rural South Africa

Abstract

Introduction: South African guidelines recommend two rapid tests for diagnosing human immunodeficiency virus (HIV) using the serial HIV testing algorithm, but the accuracy and compliance to this algorithm is unknown in rural clinics. We evaluated the accuracy of HIV rapid testing and the time to receiving test results among pregnant women in rural KwaZulu-Natal (KZN).Method: We observed the accuracy of rapid HIV testing algorithms for 208 consenting antenatal patients accessing voluntary HIV testing services in nine rural primary healthcare (PHC) clinics in KZN. A PHC-based HIV counsellor obtained finger-prick whole blood from each participant to perform rapid testing using the Advanced Quality™ One Step anti-HIV (1&2) and/or ABON™ HIV 1/2/O Tri-Line HIV test. A research nurse obtained venous blood for an enzyme-linked immunosorbent assay (ELISA) HIV test, which is the gold standard diagnostic test. We recorded the time of receipt of HIV test results for each test.Results: Among 208 pregnant women with a mean age of 26 years, 72 women from nine rural PHC clinics were identified as HIV-positive by two rapid tests with an HIV-prevalence of 35% (95% Bayesian credibility intervals [BCI]: 28% – 41%). Of the 208 patients, 135 patients from six clinics were tested with the serial HIV testing algorithm. The estimated sensitivity and specificity for the 135 participants were 100% (95% confidence interval [CI]: 93% – 100%) and 99% (CI: 95% – 100%), respectively. The positive predictive value and negative predictive value were estimated at 98% (CI: 94% – 100%) and 95% (CI: 88% – 99%), respectively. All women received their HIV rapid test results within 20 min of testing. Test stock-out resulted in poor test availability at point-of-care, preventing performance of a second HIV test in three out of nine PHC clinics in rural KZN.Conclusion: Despite the poor compliance with national guidelines for HIV rapid testing services, HIV rapid test results provided to pregnant women in rural PHC clinics in KZN were generally accurate and timely. Test stock-out was shown to be one of the barriers to test availability in rural PHC clinics, resulting in poor compliance with guidelines. We recommend a compulsory confirmation HIV rapid test for all HIV-negative test results obtained from pregnant patients in rural and resource-limited settings.

Investigating the quality of HIV rapid testing practices in public antenatal health care facilities, South Africa

“…Consistent with our finding, evaluations by Jones et al [48] in 2019 on implementation of PMTCT policies (2013-2016) found that the highest proportions (around 60%) of facilities in rural SA reported no stock-outs of HIV test kits in the year before the survey [48]. However, contrary findings were reported by two studies in SA; a qualitative study [41] conducted in Durban, Cape Town and EC (2012-2013) and a survey [24] in rural PHC facilities in KZN (2015KZN ( -2016. These studies identified HIV test kits stockout as a major barrier which resulted in poor compliance with testing guidelines, with some testers having to adapt HIV rapid testing algorithms [24,41] or to refer clients to nearby facilities [41].…”

“…However, contrary findings were reported by two studies in SA; a qualitative study [41] conducted in Durban, Cape Town and EC (2012-2013) and a survey [24] in rural PHC facilities in KZN (2015KZN ( -2016. These studies identified HIV test kits stockout as a major barrier which resulted in poor compliance with testing guidelines, with some testers having to adapt HIV rapid testing algorithms [24,41] or to refer clients to nearby facilities [41]. Focused continuous quality improvement (CQI) interventions including technical on-site mentoring have shown to remarkably improve PMTCT data quality [42,43].…”

“…This underscores the need for sustaining universal uptake and good quality antenatal HIV testing. While challenges in the quality of HTS services have been recorded in SA [ 23 , 24 ], health facility service user satisfaction has been reported to be high (89.8%) [ 25 ]. To ensure the fidelity of routine HIV rapid testing, WHO recommends periodic site audits, external quality assurance (EQA) and re-testing of clients to verify HIV status before antiretroviral therapy (ART) initiation [ 26 ].…”

Testers’ compliance to the quality standards of HIV rapid testing services in Primary Health Care Facilities in Makete District, Tanzania

“…1,2 HIV rapid testing services allow people diagnosed with HIV to be linked appropriately and on timely manner to treatment and care services. 3,4 The World Health Organization (WHO) established quality standards for the implementation of HIV rapid testing ser-vices in order to ensure the quality of testing services. 5 Such standards include: personnel training and certification; physical facility (such as room, hand washing facilities, waste management equipment, light source, cabinets for storage of equipment's and registers); and safety practices (such as availability and use of PPEs, availability and use of job aids and SOPs for safety as well as hand washing during provision of services).…”