Development of an immunoassay for differentiating human immunodeficiency virus infections — from vaccine-induced immune response in Tiantan vaccine trials in China

ObjectiveTo develop a Rapid Flow-through assay for distinguishing replicating Tiantan vaccine-generated serological response from true HIV infection.Design and methodA Rapid Flow-through Test including gp41, gp36, sk1, sk2 and sk3 antigens was established and the performance of the assay was evaluated in clinical studies and compared with ELISA assay.ResultsSk1, sk2 and sk3 peptides performed at 100% specificity and slightly but not significantly different sensitivities between ELISA assay (92%, 76% and 41%) and Flow-through Test Kit (92%, 75% and 40%) in diagnosing HIV-1 infections. Of particular importance, Tiantan vaccine recipients that gave false-positive results in gp41 serodetection scored negative for sk1, sk2 and sk3 antibodies.ConclusionThe Rapid Flow-through Test could be a robust tool in both diagnosing HIV-1/2 infections and differentiating between vaccines induced immunity and immunity resulting from natural exposure, thus serving as potential implementation in HIV vaccine trials.

► We develop a Rapid Flow-through Test Kit for HIV diagnosis in HIV vaccine trials.
► Replicating Tiantan vaccine induced samples are evaluated by kit.
► The kit proves excellent specificity and well sensitivity.
► The novel kit serves as a potential implementation in HIV vaccine trials.