Evaluation of Commonly Used Rapid Test Kits and Serological Serial Testing Algorithm for Diagnosis of HIV-1 and 2 Antibodies in Port Harcourt, Nigeria

Abstract

Three diagnostic rapid test kits (Chembio HIV-1/2 Stat-Pak, Alere DetermineTM HIV-1/2, and Core HIV-1/2) for human immunodeficiency virus types 1 and 2 (HIV-1/2) antibodies detection were evaluated against a gold standard fourth generation ELISA (Dia-Pro). Hundred and seventy two serum samples were collected from Lulubriggs Health Center, University of Port Harcourt, Rivers State. All samples were tested for HIV-1/2 using the three rapid test (parallel algorithm and serial algorithm), and retested using the 4th generation ELISA. The results obtained were compared with those from the ELISA. The DetermineTM rapid strips had sensitivity of 66.7%, specificity of 100%, positive predictive value 100%, negative predictive value 89.4% and total agreement of 91.3%. Stat-pak and Core HIV-1/2 rapid strips both had sensitivity of 71.7%, specificity of 100%, positive predictive value 100%, and negative predictive value 90.7% and total agreement of 92.4%. Determine was mostly used by the participant laboratories 18 of 30 (60%). The performance evaluation of the testing algorithm showed that parallel algorithm is more accurate in comparison to serial algorithm. The result of this study reveals that most rapid test are less sensitive and the accuracy of serial testing algorithm is low, this implies that most acute HIV infection will be missed with rapid assay and false negative results will be reported as actual negative with serial algorithm.