title: Evaluation of two indigenous rapid and two ELISA assays for the diagnosis of HIV infection India.
abstract: OBJECTIVE
  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.
  
  
  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.
authors.affiliation: Infectious Diseases Laboratory, YRG Centre for AIDS Research and Education (YRG CARE), Voluntary Health Services Hospital Campus, Taramani, Chennai, India.
authors.forename: H S
authors.initials: HS
authors.lastname: Iqbal
authors.forename: S
authors.initials: S
authors.lastname: Solomon
authors.forename: K G
authors.initials: KG
authors.lastname: Murugavel
authors.forename: S S
authors.initials: SS
authors.lastname: Solomon
authors.forename: P
authors.initials: P
authors.lastname: Balakrishnan
mesh_terms: D019411:Clinical Laboratory Techniques / Q000379:methods*; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods; D015658:HIV Infections / Q000175:diagnosis*; D015497:HIV-1 / Q000276:immunology*; D006801:Humans; D007194:India; D011237:Predictive Value of Tests; D012680:Sensitivity and Specificity; D013997:Time Factors