文摘
The aim of this study was to evaluate the performance of two antibody enzyme-linked immunosorbent assays (ELISAs) [Vironostika Uni-Form II plus O and Enzygnost® anti-HIV-1/2 Plus], and two antigen/antibody combination ELISAs [Murex and Vironostika HIV Uni-Form II] for use in an alternative confirmatory HIV diagnostic testing strategy in Dar es Salaam, Tanzania. Altogether, 1380 serum samples were included. All ELISA reactive samples were tested using the Inno-Lia antibody assay and discrepant samples were tested on the Innotest p24 antigen assay. Three hundred and one (21.8 % ) samples were confirmed HIV-1 antibody positive by Inno-Lia including 27/508 (5.3 % ) from blood donors, 65/511 (12.7 % ) from pregnant women and 209/361 (57.9 % ) from hospital patients. The sensitivity at initial testing was 100 % (95 % CI; 98.8–100 % ) for all assays except Vironostika Uni-Form II plus O (99.7 % ; 95 % CI; 98.2–99.9 % ) which showed one false negative sample at initial testing but 100 % sensitivity after repeat testing. The final specificity at repeat testing was 100 % (95 % CI; 99.7–100 % ) for Enzygnost® anti-HIV-1/2 Plus, 99.4 % (95 % CI; 98.8–99.8 % ) for each of the antigen/antibody combination ELISAs and 97.9 % (95 % CI; 96.8–98.6 % ) for Vironostika plus O ELISA. An alternative confirmatory HIV testing strategy based on initial testing on any of the two antigen/antibody assays followed by testing of reactive samples on the Enzygnost® anti-HIV-1/2 Plus assay gave 100 % specificity (95 % CI; 99.7–100 % ).