Performance of OraQuick Advance® Rapid HIV-1/2 Antibody Test for detection of antibodies in oral fluid and serum/plasma in HIV-1 + subjects carrying different HIV-1 subtypes and recombinant variants

Background: Rapid, simple, low-cost, sensitive, and specific tests are needed to detect antibodies to all HIV-1 subtypes, especially in developing countries. Objective: To evaluate the performance of a rapid diagnostic test for detection of HIV-1/2 antibodies in oral fluids and sera/plasma from subjects from geographic areas infected with different HIV-1 variants. Study design: OraQuick Rapid HIV-1/2 Diagnostic Test was evaluated in sera and oral fluids from 100 subjects from Spain and South-America. It was also assessed in 56 plasma and 39 oral fluid specimens from 56 Africans carrying HIV-1 non-B subtypes or inter-subtype recombinants defined by phylogenetic analysis at pol and gp41 coding regions. All patients were previously diagnosed as HIV-1 positive by serological tests (Abbott AxSYM HIV-1/2; Western Blot HIV-1/HIV-2 and Pepti-LAV, BIO-RAD). Results: OraQuick provided positive results in all 156 serum/plasma specimens regardless of the infecting HIV-1 subtype, and in 136/139 (97.8%) oral fluids. The three oral specimens (2.2%) that yielded false-negative results by OraQuick were taken from one subtype B-infected Spaniard and from two subtype D-infected Africans. The last two were also negative by Pepti-LAV using plasma samples. Ten additional sera and 32 oral fluids from HIV-negative individuals yielded negative results by OraQuick. This rapid test showed good sensitivity for detecting anti-HIV-1 antibodies in oral fluids and in serum/plasma specimens from subjects carrying different HIV-1 subtypes and recombinant variants. Conclusion: OraQuick demonstrated its utility for detecting infections due to HIV-1 subtypes and recombinants common in developing countries. (C) 2009 Elsevier B.V. All rights reserved.