Evaluation of the diagnostic performance of the Biosynex® Triplex HIV, HCV, HBsAg rapid diagnostic test under real-world conditions in Burkina Faso

Abstract

In resource-limited countries, approximately 95% of people with hepatitis B and C are unaware of their status. One of the reasons for this is the low accessibility of high-quality, low-cost diagnostic tools. The aim of this study was to evaluate the analytical performance of the Biosynex® Triplex HIV, HCV, HBsAg in Burkina Faso under real-life conditions. To this end, a diagnostic tool evaluation study was conducted between May and December 2021. It was conducted on people of all ages and pregnant women. From each consenting participant, 50 microliters of capillary blood were collected for testing with Biosynex® Triplex HIV, HCV, HBsAg. Approximately 7 mL of collected whole blood was then used to detect HBsAg, anti-HCV and anti-HIV antibodies using the Architect i1000SR (gold standard). Statistical analyses were used to determine the diagnostic performance of the test. A total of 500 specimens were analyzed. For HBsAg, the sensitivity (Se) was 83.33%, the specificity (Sp) was 99.78%, and the kappa coefficient (k) was 0.89. For anti-HCV, the Se was 40.74%, the Sp was 100% and the k was 0.57. For anti-HIV, the Se was 50%, the Sp was 100% and the k was 0.66. The evaluated test showed very good specificities for the detection of the 3 markers of infection. However, the low sensitivities obtained require improvement before use.