title: Evaluation of diagnostic accuracy, feasibility and client preference for rapid oral fluid-based diagnosis of HIV infection in rural India.
abstract: BACKGROUND
  Oral fluid-based rapid tests are promising for improving HIV diagnosis and screening. However, recent reports from the United States of false-positive results with the oral OraQuick ADVANCE HIV1/2 test have raised concerns about their performance in routine practice. We report a field evaluation of the diagnostic accuracy, client preference, and feasibility for the oral fluid-based OraQuick Rapid HIV1/2 test in a rural hospital in India.
  
  
  RESULTS
  A cross-sectional, hospital-based study was conducted in 450 consenting participants with suspected HIV infection in rural India. The objectives were to evaluate performance, client preference and feasibility of the OraQuick Rapid HIV-1/2 tests. Two Oraquick Rapid HIV1/2 tests (oral fluid and finger stick) were administered in parallel with confirmatory ELISA/Western Blot (reference standard). Pre- and post-test counseling and face to face interviews were conducted to determine client preference. Of the 450 participants, 146 were deemed to be HIV sero-positive using the reference standard (seropositivity rate of 32% (95% confidence interval [CI] 28%, 37%)). The OraQuick test on oral fluid specimens had better performance with a sensitivity of 100% (95% CI 98, 100) and a specificity of 100% (95% CI 99, 100), as compared to the OraQuick test on finger stick specimens with a sensitivity of 100% (95% CI 98, 100), and a specificity of 99.7% (95% CI 98.4, 99.9). The OraQuick oral fluid-based test was preferred by 87% of the participants for first time testing and 60% of the participants for repeat testing.
  
  
  CONCLUSIONS
  In a rural Indian hospital setting, the OraQuick Rapid- HIV1/2 test was found to be highly accurate. The oral fluid-based test performed marginally better than the finger stick test. The oral OraQuick test was highly preferred by participants. In the context of global efforts to scale-up HIV testing, our data suggest that oral fluid-based rapid HIV testing may work well in rural, resource-limited settings.
authors.affiliation: Immunodeficiency Service, Montreal Chest Institute, McGill University Health Center, Montreal, Canada. Nitika.Pai@mcgill.ca
authors.forename: Nitika
authors.initials: N
authors.lastname: Pant Pai
authors.forename: Rajnish
authors.initials: R
authors.lastname: Joshi
authors.forename: Sandeep
authors.initials: S
authors.lastname: Dogra
authors.forename: Bharati
authors.initials: B
authors.lastname: Taksande
authors.forename: S P
authors.initials: SP
authors.lastname: Kalantri
authors.forename: Madhukar
authors.initials: M
authors.lastname: Pai
authors.forename: Pratibha
authors.initials: P
authors.lastname: Narang
authors.forename: Jacqueline P
authors.initials: JP
authors.lastname: Tulsky
authors.forename: Arthur L
authors.initials: AL
authors.lastname: Reingold
mesh_terms: D015492:AIDS Serodiagnosis / Q000379:methods*; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003430:Cross-Sectional Studies; D005240:Feasibility Studies; D005260:Female; D015483:HIV Antibodies / Q000032:analysis*; D015658:HIV Infections / Q000175:diagnosis*; D006801:Humans; D007194:India; D008297:Male; D008875:Middle Aged; D057240:Patient Preference; D012424:Rural Population; D012463:Saliva / Q000276:immunology*; D055815:Young Adult
chemical_list: D015483:HIV Antibodies