Aboud S., Urassa W., Lyamuya E., Mhalu F., Biberfeld G.
Department of Microbiology and Immunology, Muhimbili University College of Health Sciences, P.O. Box 65001, Dar es Salaam, Tanzania; Swedish Institute for Infectious Disease Control and Microbiology, Tumorbiology Centre, Karolinska Institute, Nobels väg 18, SE-171 82 Solna, Stockholm, Sweden
Aboud, S., Department of Microbiology and Immunology, Muhimbili University College of Health Sciences, P.O. Box 65001, Dar es Salaam, Tanzania; Urassa, W., Department of Microbiology and Immunology, Muhimbili University College of Health Sciences, P.O. Box 65001, Dar es Salaam, Tanzania; Lyamuya, E., Department of Microbiology and Immunology, Muhimbili University College of Health Sciences, P.O. Box 65001, Dar es Salaam, Tanzania; Mhalu, F., Department of Microbiology and Immunology, Muhimbili University College of Health Sciences, P.O. Box 65001, Dar es Salaam, Tanzania; Biberfeld, G., Swedish Institute for Infectious Disease Control and Microbiology, Tumorbiology Centre, Karolinska Institute, Nobels väg 18, SE-171 82 Solna, Stockholm, Sweden
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%). © 2006 Elsevier B.V. All rights reserved.
antigen p24; Human immunodeficiency virus antibody; Human immunodeficiency virus antigen; antigen antibody complex; antigen binding; article; blood donor; blood sampling; clinical article; confidence interval; diagnostic test; enzyme linked immunosorbent assay; false negative result; female; hospital patient; human; Human immunodeficiency virus; Human immunodeficiency virus 1; Human immunodeficiency virus 2; Human immunodeficiency virus infection; immunoassay; pregnant woman; priority journal; sensitivity analysis; sensitivity and specificity; Tanzania; AIDS Serodiagnosis; Enzyme-Linked Immunosorbent Assay; HIV Antibodies; HIV Core Protein p24; HIV-1; HIV-2; Humans; Sensitivity and Specificity; Human immunodeficiency virus 1; Murex