Objectives: This assessment in Brazil was to evaluate the performance of commercially available HIV rapid test (RT) against the gold standard testing and to establish a highly sensitive and specific RT algorithm for HIV diagnosis.
Design: A prospective, anonymous and unlinked study.
Methods: An evaluation of seven commercially available RT to compare their performance against the gold standard tests for Brazil. This includes two competing enzyme immunoassays plus a Western blot for confirmation. After informed consent, whole blood samples were collected from volunteers in voluntary counselling and testing sites (n = 400), antenatal clinics (n = 500) and from HIV-positive controls in AIDS treatment centres (n = 200). Two seroconversion panels, one HIV-1 subtype (B, B', C and F) panel and an operational assay performance evaluation were also part of the study parameters.
Results: For the seven RT the clinical sensitivity ranged from 97.74 to 100% and clinical specificity from 99.43 to 100%. However, only four RT were considered acceptable after full evaluation. The two EIA had a clinical sensitivity of 100% and clinical specificity of 99.32 and 99.66%. Two RT had the same performance on the seroconversions panels as the EIA. The operational assay performance evaluation for the RT indicated that Hexagon and Capillus could not be classified as simple assays.
Conclusion: We have provided evidence that RT assays can perform equally or better than EIA for the detection of HIV antibodies. The simplicity and rapidity of the RT warrants its utilization in an algorithm for a rapid diagnosis of HIV infection.