Evaluation of five simple rapid HIV assays for use with national HIV test algorithm in Brazil
Background: Since 2006, the Department of STD, AIDS and Viral Hepatitis (D DST AIDS/HV, Brazil Ministry of Health Surveillance Secretariat) has been using a test algorithm that relies only on rapid testing for the diagnosis of HIV infection in special situations (i.e. occupational exposure, pregnant women without prenatal care, etc.). Because Brazil has unique viral subtypes, test performance must be validated in Brazil. This multi-center study was conducted as part of a D DST AIDS/HV evaluation to assess diagnostic testing performance of five rapid tests-all available, but not yet approved for use in Brazil-against a panel of diverse Brazilian specimens.
Methods: We evaluated the following tests: VIKIA® HIV 1/2 ; Rapid Check HIV 1 & 2, HIV-1/2 3.0 Strip Test Bioeasy, Labtest HIV, Teste Rápido HIV 1/2 - Bio-Manguinhos. After informed consent, whole blood was obtained from patients enrolled in five clinic centers from distinct regions of Brazil. Results of rapid test assays were analyzed using a reference standard that defined HIV infection using a dual-immunoassay (4th/3rd generation) + Western blot.
Results: Among 972 samples, 143 (14.9%) were confirmed HIV antibody positive, while 829 were negative. For the five tests evaluated, clinical sensitivity ranged from 99.3 to 100% and clinical specificity was 100% for all tests. Three tests met all the performance requirements from D DST AIDS/HV (clinical sensitivity = 100%): VIKIA® HIV 1/2; Rapid Check HIV 1 & 2, HIV-1/2 3.0 Strip Test Bioeasy. All tests were easy to perform and scored well on an operational assay performance evaluation.
Conclusion: Of the tests evaluated, three showed performance equivalent to the reference tests on samples of whole blood and were approved for use according with the national test algorithm.
L.R. Motta1, A.C. Vanni1, L.G.A. Borges1, S.K. Kato1,2,3, R.D. Sperhacke1, R.M.M. Ribeiro4, L.A. Inocêncio4, HIV Rapid Test Evaluation Group
1Universidade de Caxias do Sul, Laboratório de Pesquisa em HIV/AIDS, Caxias do Sul, Brazil, 2Pontifícia Universidade Católica do Rio Grande do Sul, Departamento de Estatística, Porto Alegre, Brazil, 3Fundação Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, Brazil, 4Brazil Ministry of Health Surveillance Secretariat, Deparment of STD, AIDS and Viral Hepatitis, Brasília, Brazil