Evaluation of two indigenous rapid and two ELISA assays for the diagnosis of HIV infection India.

Purpose: Human immunodeficiency virus (HIV) diagnostic tests are being used extensively in India. However, the evaluation data on these assays are very limited. The present study evaluates indigenous HIV test kits manufactured in India. Materials and Methods: A total of 200 characterised specimens were assayed with Comb AIDS - RS Advantage HIV 1+2 Immunodot Test, Enzaids HIV 1+2 ELISA test, Enzaids Duet HIV Antigen+antibody ELISA test and Signal HIV Flow Through HIV 1+2 test kits. Performance characteristics of these assays were calculated. Results: Sensitivity, specificity, positive predictive value, negative predictive value and efficiency of all the assays were 100% except for Signal HIV Flow Through HIV 1+2 test kit. The specificity, positive predictive value and efficiency of the Signal HIV Flow Through HIV 1+2 test kit were 98.9%, 98.9% and 99.4%, respectively. The Enzaids Duet HIV kit was found to be extremely sensitive in detecting p24 Ag with the sensitivity of 1.5 pg/mL. Conclusions: To conclude, selection of better diagnostic assay is very much important to resolve discrepancies in HIV diagnosis. All these assays under evaluation in this report have got excellent performance characteristics and much suitable to use in serial testing algorithms in use for resources limited settings.

Serologic evidence of quality improvement of domestic HIV-antibody detecting ELISA kits / 中国输血杂志

Objective To investigate the quality of current domestic HIV antibody detecting kits and to assure the credibility of experimental results.Methods The sensitivity and specificity of three kinds of domestic HIV antibody detection ELISA kits made in three different years were evaluated and compared by testing the serum panel from National AIDS Reference Laboratory.Results The sensitivity of kits produced by three domestic manufacturers in 2001 is significantly better than the kits produced in 1998 and 1999.The false negative rates were apparently decreasing.Conclusions The quality of domestic HIV antibody detecting kits has been improving steadily.The sensitivity of double antigen sandwich ELISA assay is apparently better than the indirect ELISA assay.