title: Programmatic evaluation of a combined antigen and antibody test for rapid HIV diagnosis in a community and sexual health clinic screening programme.
abstract: BACKGROUND
  A substantial proportion of HIV-infected individuals in the UK are unaware of their status and late presentations continue, especially in low prevalence areas. Fourth generation antigen/antibody rapid test kits could facilitate earlier diagnosis of HIV in non-clinical settings but lack data on performance under programmatic conditions.
  
  
  RESULTS
  We evaluated the performance of Determine HIV-1/2 Ag/Ab Combo Test (Determine Combo), a rapid test with indicators for both HIV antibodies and p24 antigen, in participants recruited from community outreach and hospital-based sexual health clinics. HIV infection was confirmed using laboratory enzyme-linked immunosorbent assay (EIA), Line Immuno Assay (LIA) and quantitative polymerase chain reaction (PCR). In total, 953 people underwent HIV testing. HIV antibody (Ab) prevalence was 1.8% (17/953). Four false positive rapid tests were identified: two antibody and two p24 antigen (Ag) reactions. Of participants diagnosed as HIV Ab positive, 2/17 (12%) were recent seroconverters based on clinical history and HIV antibody avidity test results. However, none of these were detected by the p24 antigen component of the rapid test kit. There were no other true positive p24 Ag tests.
  
  
  CONCLUSIONS
  These data lend support to an increasing body of evidence suggesting that 4th generation rapid HIV tests have little additional benefit over 3rd generation HIV kits for routine screening in low prevalence settings and have high rates of false positives. In order to optimally combine community-based case-finding among hard-to-reach groups with reliable and early diagnosis 3rd generation kits should be primarily used with laboratory testing of individuals thought to be at risk of acute HIV infection. A more reliable point of care diagnostic is required for the accurate detection of acute HIV infection under programmatic conditions.
authors: Liverpool School of Tropical Medicine, Liverpool, United Kingdom. miriamt@liverpool.ac.uk
authors: Miriam
authors: M
authors: Taegtmeyer
authors: Peter
authors: P
authors: MacPherson
authors: Kathy
authors: K
authors: Jones
authors: Mark
authors: M
authors: Hopkins
authors: Jay
authors: J
authors: Moorcroft
authors: David G
authors: DG
authors: Lalloo
authors: Anu
authors: A
authors: Chawla
mesh_terms: D000328:Adult; D019937:Diagnostic Techniques and Procedures; D005260:Female; D015483:HIV Antibodies / Q000276:immunology*; D015488:HIV Antigens / Q000276:immunology*; D015658:HIV Infections / Q000175:diagnosis* / Q000276:immunology*; D006268:Health Facilities; D006801:Humans; D008297:Male; D008403:Mass Screening; D012111:Residence Characteristics; D012307:Risk Factors; D055815:Young Adult
chemical_list: D015483:HIV Antibodies; D015488:HIV Antigens