Evaluation of the analytical performance of six rapid diagnostic tests for the detection of HIV-1 and 2 in Lubumbashi, Democratic Republic of Congo

TL;DR

This study evaluates six rapid diagnostic tests for HIV in Lubumbashi, DRC, finding they meet WHO standards and recommending one as the best option.

Contribution

The study is the first in Lubumbashi to assess the analytical performance of HIV rapid diagnostic tests against WHO standards.

Findings

All six RDTs met WHO standards with 100% sensitivity and NPV, 99% specificity and PPV.

The Unigold RDT showed the highest detection limit and is recommended as the first-choice test.

No prior study in Lubumbashi had evaluated the quality of HIV rapid diagnostic tests.

Abstract

Human immunodeficiency virus (HIV) infection constitutes a major public health concern worldwide. According to UNAIDS estimates, Africa would be the most affected continent in the world, with around 25.7 million cases recorded, and the Democratic Republic of Congo (DRC) would be among the 22 countries in the world with the heavy burden of HIV. Screening constitutes an important lever in the prevention of this infection. In developing countries such as the DRC, rapid diagnostic tests (RDTs) are widely used in screening for HIV infection. Still, these RDTs might have a serious problem of analytical performance, which could compromise the prevention and medical management of HIV infection. To date, no study has been carried out in Lubumbashi to assess the quality of these RDTs. This study aimed to evaluate the analytical performance of RDTs used in Lubumbashi for the screening and diagnosis of HIV infection. A total of 200 serum samples (100 HIV positive samples and 100 HIV negative samples) were tested simultaneously by six locally used brands of RDTs and by the Liaison XL Murex assay used as a reference test. All six evaluated RDTs showed analytical performance in line with WHO standards, with a sensitivity and NPV of 100%, a specificity and PPV of 99% and a Kappa coefficient of 99%. The Unigold RDT mark, having presented a high detection limit, could be proposed as the RDT of first choice in HIV screening in Lubumbashi.