Rapid HIV test kits perform well in South African clinical trial

March 2019 - A study led by Dr Simnikiwe Mayaphi of the University of Pretoria’s Department of Medical Virology has confirmed that so-called INSTI HIV self-test kits are as reliable as other HIV testing methods used in clinical settings in South Africa. HIV diagnosis forms a crucial part of the 90‐90‐90 strategy targeted by public health practitioners worldwide. The 90-90-90 strategy aims to diagnose 90% of all HIV‐infected individuals, have 90% of them on antiretroviral therapy (ART), and to have HIV viral load (VL) suppression in 90% of those receiving ART. Testing (and subsequent diagnosis) is an essential first step in this strategy.

Traditionally, HIV testing has relied upon laboratory testing procedures which have a high accuracy but are costly both in time and resources. In low-resource settings, such as rural Point of Care clinics, self-test or rapid HIV test kits are often used but these simpler tests offer lower sensitivity than typical laboratory tests. As a result, some HIV‐infected individuals are misdiagnosed by rapid tests, especially those with early HIV infection.

The research focused on the INSTI HIV‐1/‐2 Antibody Test (INSTI test), a Food and Drug Administration (FDA)‐approved rapid test. This easy to use test is used for the detection of HIV‐1 and HIV‐2 antibodies. It has been shown to have higher sensitivity for detection of these HIV‐specific antibodies compared to other rapid tests, even during early HIV infection.

The research was undertaken in 2016 at two antenatal clinics in Tshwane, one based in the Pretoria city centre and the other in Mamelodi. Potential participants were pregnant women who were seeking HIV testing during their first antenatal care visit.

Dr Sim Mayaphi, Department
of Medical Virology,
University of Pretoria

A total of 386 women were enrolled in the program and tested with both the INSTI test and existing rapid tests. 334 of these (86.5%) showed negative results on the screening rapid test, and 52 (13.5%) returned positive results on screening and confirmatory rapid tests. The INSTI test yielded the same results as other rapid tests in all of the participants.
To further confirm that the INSTI test was not returning any false negative tests, a laboratory test was performed for 290 of the participants who had negative rapid tests, and these tests yielded negative results for all of the women.

These results showed the excellent field performance of the INSTI test and highlight that this test can be implemented at South African clinics as a cost effective and accurate.

The study, published in the July 2019 issue of the Journal of Medical Virology, was partially funded by a South African Medical Research Council(SARMC) grant and was a collaboration with researchers from South Africa and the Unites States.

The original article is accessible here:

Simon Gear
Research News Africa