Comparative evaluation of TRI-DOT Rapid HIV test with fourth-generation ELISA for the detection of human immunodeficiency virus.

This study evaluated the TRI-DOT Rapid HIV test for the early detection of human immunodeficiency virus (HIV) infection in comparison with a fourth-generation ELISA (Vironostika HIV Uniform II). Of 23,609 sera, seven (0.03%) gave discordant results. Six of these were reactive only by the fourth-generation assay and were p24 antigen-positive by VIDAS DUO, Western blot and qualitative RT-PCR tests. The remaining discordant serum was considered to be false-positive by the TRI-DOT assay, as it was negative by repeat ELISA and Western blot tests. The sensitivity and specificity of the TRI-DOT test were 99.48% and 99.99%, respectively, compared with the fourth-generation ELISA.