title: Suitability of simple human immunodeficiency virus rapid tests in clinical trials in community-based clinic settings.
abstract: The suitability and accuracy of using simple human immunodeficiency virus (HIV) rapid (SR) tests in community-based clinics in northwest Tanzania were determined to assess eligibility for participation in clinical trials. The HIV rapid and ELISA test results for 789 women aged 16 to 54 who were screened for two clinical trials of HIV prevention were compared. Women were offered voluntary HIV counseling and testing (VCT) at screening; those who accepted were tested with the Abbott Determine and Trinity Biotech Capillus SR tests in parallel. The results were confirmed by two parallel HIV enzyme-linked immunosorbent assay (ELISA) tests (Abbott Murex HIV Ag/Ab combination and Vironostika Uniform II HIV Ag/Ab) to determine eligibility. Positive samples for any of the four assays were confirmed by a line immunoassay and p24 testing. The parallel SR tests had high concordance (96.2%) with the parallel ELISA algorithm. The sensitivities of the SR tests were 98.6% for Capillus (95% confidence interval [CI], 95.1 to 99.8%), 99.3% for Determine (95% CI, 96.2 to 100%), and 98.6% for the parallel SR (95% CI, 95.1 to 99.8%). The specificities were 99.7% for Capillus (95% CI, 98.9 to 100%), 99.7% for Determine (95% CI, 98.9 to 100%), and 100% for the parallel SR (95% CI, 99.4 to 100%). SR tests are suitable for use in community-based clinical research settings to assess eligibility both for trial participation and for the provision of on-site VCT services.
authors.affiliation: London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, United Kingdom. Dean.Everett@Liverpool.ac.uk
authors.forename: Dean B
authors.initials: DB
authors.lastname: Everett
authors.forename: Kathy
authors.initials: K
authors.lastname: Baisley
authors.forename: John
authors.initials: J
authors.lastname: Changalucha
authors.forename: Andrew
authors.initials: A
authors.lastname: Vallely
authors.forename: Deborah
authors.initials: D
authors.lastname: Watson-Jones
authors.forename: Claire
authors.initials: C
authors.lastname: Cook
authors.forename: Louise
authors.initials: L
authors.lastname: Knight
authors.forename: David A
authors.initials: DA
authors.lastname: Ross
authors.forename: Kokugonza
authors.initials: K
authors.lastname: Mugeye
authors.forename: Sheena
authors.initials: S
authors.lastname: McCormack
authors.forename: Charles J
authors.initials: CJ
authors.lastname: Lacey
authors.forename: Ute
authors.initials: U
authors.lastname: Jentsch
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Hayes
mesh_terms: D015492:AIDS Serodiagnosis / Q000379:methods; D000293:Adolescent; D000328:Adult; D000818:Animals; D005260:Female; D006678:HIV / Q000302:isolation & purification*; D015658:HIV Infections / Q000175:diagnosis*; D006801:Humans; D008403:Mass Screening / Q000379:methods; D008875:Middle Aged; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D013636:Tanzania; D055815:Young Adult
chemical_list: D011933:Reagent Kits, Diagnostic