Diagnostic accuracy of HIV test kits, Genscreen Ultra and Bioelisa

Abstract

Purpose: Genetic diversities in different countries affect the performance of HIV test kits. Therefore, WHO recommends evaluation of every HIV test kit in countries' context before its use. Therefore, this study aimed to evaluate the performance of Genscreen ULTRA HIV Ag-Ab and Bioelisa.

Materials and methods: The study had used 400 characterized plasma samples obtained from CDC Atlanta bio-bank derived from Africa, USA, and Thailand.

Results: Diagnostic performance of both test kits under evaluation was assessed at 95% CI. Genscreen ULTRA HIV Ag-Ab had sensitivity and negative predictive value of 99.5% [95% CI, 97.2-99.9] and the specificity and positive predictive value of 98.5% [95% CI, 95.7-99.7]. Bioelisa HIV test kit had exhibited sensitivity and negative predictive value of 99% [95% CI, 96.4-99.7] and specificity and positive predictive value of 98.5% [95% CI, 95.7-99.7]. Both test kits were able to detect almost all samples with HIV-2, dual infections, and seroconversion.

Conclusion: Both the test kits were highly sensitive and specific in detecting HIV. However, there are still few samples containing HIV antibody which were not identified by both kits. Therefore, additional screening measures should be done in using these assays for blood transfusion and organ transplantation. In addition, the study can be used as a reference by other African countries.

Keywords: ELISA; positive predictive; sensitivity; specificity; validation.