Performance evaluation of a particle agglutination test for antibody to human immunodeficiency virus 1: comparison with enzyme immunoassay.

A performance evaluation of a particle agglutination test (PAT), manufactured by Fujirebio Inc., Japan (Serodia-HIV), for antibody to human immunodeficiency virus type-1 (anti-HIV-1) was carried out and compared with a currently available enzyme immunoassay (EIA), manufactured by Genetic Systems Corp., USA, (HIV-1/HIV-2 EIA). Testing 2,878 Indian donor and patient samples, both tests showed 100% sensitivity and comparable specificity (PAT: 99.8%; EIA: 99.7% among donor samples). We conclude that PAT is a specific and sensitive test for anti-HIV-1; it is simple to perform and does not require sophisticated equipment. Hence it is suitable for mass screening of blood donors in a developing country like India, especially in rural areas where presently no HIV-testing facilities are available.