title: Limitations of rapid HIV-1 tests during screening for trials in Uganda: diagnostic test accuracy study.
abstract: OBJECTIVE
  To evaluate the limitations of rapid tests for HIV-1.
  
  
  METHODS
  Diagnostic test accuracy study.
  
  
  METHODS
  Rural Rakai, Uganda.
  
  
  METHODS
  1517 males aged 15-49 screened for trials of circumcision for HIV prevention.
  
  
  METHODS
  Sensitivity, specificity, negative predictive values, and positive predictive values of an algorithm using three rapid tests for HIV, compared with the results of enzyme immunoassay and western blotting as the optimal methods.
  
  
  RESULTS
  Rapid test results were evaluated by enzyme immunoassay and western blotting. Sensitivity was 97.7%. Among 639 samples where the strength of positive bands was coded if the sample showed positivity for HIV, the algorithm had low specificity (94.1%) and a low positive predictive value (74.0%). Exclusion of 37 samples (5.8%) with a weak positive band improved the specificity (99.6%) and positive predictive value (97.7%).
  
  
  CONCLUSIONS
  Weak positive bands on rapid tests for HIV should be confirmed by enzyme immunoassay and western blotting before disclosing the diagnosis. Programmes using rapid tests routinely should use standard serological assays for quality control. Trial registration Clinical Trials NCT00425984.
authors.affiliation: Johns Hopkins University, Bloomberg School of Public Health, Baltimore, MD 21205, USA. rgray@jhsph.edu
authors.forename: Ronald H
authors.initials: RH
authors.lastname: Gray
authors.forename: Fredrick
authors.initials: F
authors.lastname: Makumbi
authors.forename: David
authors.initials: D
authors.lastname: Serwadda
authors.forename: Tom
authors.initials: T
authors.lastname: Lutalo
authors.forename: Fred
authors.initials: F
authors.lastname: Nalugoda
authors.forename: Pius
authors.initials: P
authors.lastname: Opendi
authors.forename: Godfrey
authors.initials: G
authors.lastname: Kigozi
authors.forename: Steven J
authors.initials: SJ
authors.lastname: Reynolds
authors.forename: Nelson K
authors.initials: NK
authors.lastname: Sewankambo
authors.forename: Maria J
authors.initials: MJ
authors.lastname: Wawer
mesh_terms: D000293:Adolescent; D000328:Adult; D015153:Blotting, Western; D002944:Circumcision, Male; D004797:Enzyme-Linked Immunosorbent Assay; D015658:HIV Infections / Q000175:diagnosis*; D015497:HIV-1; D006801:Humans; D008297:Male; D008875:Middle Aged; D012680:Sensitivity and Specificity; D014454:Uganda