title: Multi-centre field evaluation of the performance of the Trinity Biotech Uni-Gold HIV 1/2 rapid test as a first-line screening assay for gay and bisexual men compared with 4th generation laboratory immunoassays.
abstract: The Trinity Biotech Uni-Gold HIV test (Uni-Gold) is often used as a supplementary rapid test in testing algorithms.
  
  
  
  To evaluate the operational performance of the Uni-Gold as a first-line screening test among gay and bisexual men (GBM) in a setting where 4th generation HIV laboratory assays are routinely used.
  
  
  
  We compared the performance of Uni-Gold with conventional HIV serology conducted in parallel among GBM attending 22 testing sites. Sensitivity was calculated separately for acute and established infection, defined using 4th generation screening Ag/Ab immunoassay (EIA) and Western blot results. Previous HIV testing history and results of supplementary 3rd generation HIV Ab EIA, and p24 antigen EIA were used to further characterise cases of acute infection.
  
  
  
  Of 10,793 specimens tested with Uni-Gold and conventional serology, 94 (0.90%, 95%CI:0.70-1.07) were confirmed as HIV-positive by conventional serology, and 37 (39.4%) were classified as acute infection. Uni-Gold sensitivity was 81.9% overall (77/94, 95%CI:72.6-89.1); 56.8% for acute infection (21/37, 95%CI:39.5-72.9) and 98.2% for established infection (56/57, 95%CI:90.6-100.0). Of 17 false non-reactive Uni-Gold results, 16 were acute infections, and of these seven were p24 antigen reactive but antibody negative. Uni-Gold specificity was 99.9% (10,692/10,699, 95%CI:99.9-100.0), PPV was 91.7% (95%CI:83.6-96.6) and NPV was 99.8% (95%CI:99.7-99.9), respectively.
  
  
  
  In this population, Uni-Gold had good specificity and sensitivity was high for established infections when compared to 4th generation laboratory assays, however sensitivity was lower in acute infections. Where rapid tests are used in populations with a high proportion of acute infections, additional testing strategies are needed to detect acute infections.
authors.affiliation: The Kirby Institute, University of New South Wales, Sydney, NSW 2052, Australia. Electronic address: pkeen@kirby.unsw.edu.au.
authors.forename: P
authors.initials: P
authors.lastname: Keen
authors.affiliation: The Kirby Institute, University of New South Wales, Sydney, NSW 2052, Australia; Sydney Sexual Health Centre, Sydney Hospital, Sydney, NSW 2000, Australia.
authors.forename: D P
authors.initials: DP
authors.lastname: Conway
authors.affiliation: NSW State Reference Laboratory for HIV, St Vincent's Hospital, Darlinghurst, NSW 2010, Australia; St Vincent's Centre for Applied Medical Research, University of New South Wales, Sydney, NSW 2052, Australia.
authors.forename: P
authors.initials: P
authors.lastname: Cunningham
authors.affiliation: Sydney Sexual Health Centre, Sydney Hospital, Sydney, NSW 2000, Australia; School of Public Health and Community Medicine, University of New South Wales, Sydney, NSW 2052, Australia.
authors.forename: A
authors.initials: A
authors.lastname: McNulty
authors.affiliation: Western Sydney Sexual Health Centre, Western Sydney Local Health District, NSW 2150, Australia; The Marie Bashir Institute for Infectious Diseases, University of Sydney, NSW 2145, Australia.
authors.forename: D L
authors.initials: DL
authors.lastname: Couldwell
authors.affiliation: Northern Sydney Sexual Health Service, Royal North Shore Hospital, St Leonards, NSW 2065, Australia; Sydney Medical School, University of Sydney, NSW 2006, Australia.
authors.forename: S C
authors.initials: SC
authors.lastname: Davies
authors.affiliation: School of Public Health and Community Medicine, University of New South Wales, Sydney, NSW 2052, Australia; Albion Centre, Surry Hills, NSW 2010, Australia.
authors.forename: D E
authors.initials: DE
authors.lastname: Smith
authors.affiliation: ACON, Surry Hills, Sydney, NSW 2010, Australia.
authors.forename: J
authors.initials: J
authors.lastname: Gray
authors.affiliation: Centre for Social Research in Health, University of New South Wales, Sydney, NSW 2052, Australia.
authors.forename: M
authors.initials: M
authors.lastname: Holt
authors.affiliation: The Kirby Institute, University of New South Wales, Sydney, NSW 2052, Australia; RPA Sexual Health, Community Health, Sydney LHD, Camperdown, Sydney, NSW 2050, Australia; Central Clinical School, Sydney Medical School, University of Sydney, Sydney, NSW 2006, Australia.
authors.forename: C C
authors.initials: CC
authors.lastname: O'Connor
authors.affiliation: The Kirby Institute, University of New South Wales, Sydney, NSW 2052, Australia; Kirketon Road Centre, PO Box 22, Kings Cross, NSW 1340, Australia.
authors.forename: P
authors.initials: P
authors.lastname: Read
authors.affiliation: The Kirby Institute, University of New South Wales, Sydney, NSW 2052, Australia.
authors.forename: D
authors.initials: D
authors.lastname: Callander
authors.affiliation: The Kirby Institute, University of New South Wales, Sydney, NSW 2052, Australia; Australian Research Centre in Sex, Health and Society, La Trobe University, Melbourne, VIC 3000, Australia.
authors.forename: G
authors.initials: G
authors.lastname: Prestage
authors.affiliation: The Kirby Institute, University of New South Wales, Sydney, NSW 2052, Australia.
authors.forename: R
authors.initials: R
authors.lastname: Guy
mesh_terms: D000293:Adolescent; D000328:Adult; D003951:Diagnostic Errors; D005260:Female; D015658:HIV Infections / Q000175:diagnosis*; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D008297:Male; D008403:Mass Screening / Q000379:methods*; D012680:Sensitivity and Specificity; D000072339:Sexual and Gender Minorities; D013997:Time Factors; D055815:Young Adult
keywords: 3rd generation immunoassay; 4th generation immunoassay; Acute HIV infection; Performance; Rapid HIV test; p24 antigen