title: Evaluation of HIV/AIDS diagnostics kits and formulation of a testing strategy for Pakistan.
abstract: BACKGROUND
  Rapid diagnosis of HIV/AIDS enables the development of prevention and treatment programmes but accurate, reliable and cost effective testing strategies should be used for testing of HIV/AIDS from a large population.
  
  
  OBJECTIVE
  To evaluate the performance and effectiveness of three assays for the diagnosis of HIV in comparison with Western blot and to formulate an alternative cost-effective confirmatory approach for HIV diagnosis.
  
  
  METHODS
  472 specimens (serum) from a Pakistani population were evaluated. Two rapid HIV testing kits (Capillus, SD Bioline) and one ELISA (Vironostika Ag/Ab) kit were used to detect HIV. Results were compared with Western blot against which sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of all HIV assays were assessed.
  
  
  RESULTS
  280/472 (59.3%) of the samples were positive for antibodies against purified HIV-1 viral proteins. The sensitivity of SD Bioline and Vironostika ELISA was 100% (95% CI; 98-100) while that of anti-HIV Capillus™ kit was 94.6% (95% CI; 91-96.8). The specificity of the Vironostika ELISA and anti-HIV Capillus™ kit was 100% (95% CI; 97-100) while specificity of SD Bioline was 98.4% (95% CI; 95-99). PPV was 100% (95% CI; 98-100%) for the anti-HIV Capillus™ and Vironostika ELISA and 98.9% (95% CI; 96-99%) for SD Bioline. NPV for SD Bioline and Vironostika ELISA was 100% (95% CI; 98-100%) and 92.7% for anti-HIV Capillus™ (95% CI; 88-96%).
  
  
  CONCLUSIONS
  The sensitivity and specificity of all three kits were satisfactory compared to Western blot and could be used for effective diagnosis of HIV/AIDS in Pakistani population.
authors.affiliation: National HIV/STI Referral Laboratory, National AIDS Control Programme, Ministry of Health, Government of Pakistan, Pakistan. usman.waheed07@gmail.com
authors.forename: Usman
authors.initials: U
authors.lastname: Waheed
authors.forename: Khizar
authors.initials: K
authors.lastname: Hayat
authors.forename: Bashir
authors.initials: B
authors.lastname: Ahmad
authors.forename: Yasir
authors.initials: Y
authors.lastname: Waheed
authors.forename: Hasan Abbas
authors.initials: HA
authors.lastname: Zaheer
mesh_terms: D000163:Acquired Immunodeficiency Syndrome / Q000175:diagnosis*; D000293:Adolescent; D000328:Adult; D015153:Blotting, Western; D002648:Child; D002675:Child, Preschool; D003362:Cost-Benefit Analysis; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D015483:HIV Antibodies / Q000032:analysis*; D015497:HIV-1 / Q000302:isolation & purification*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010154:Pakistan; D011237:Predictive Value of Tests; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013997:Time Factors; D055815:Young Adult
chemical_list: D015483:HIV Antibodies; D011933:Reagent Kits, Diagnostic