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O15.4 Field Performance of the Alere Determine HIV Combo Assay in a Large Australian Multi-Centre Study in a Sexual Health Clinic Setting
  1. D P Conway1,
  2. M Holt2,
  3. A McNulty3,4,
  4. D L Couldwell5,6,
  5. D E Smith7,3,
  6. S C Davies8,
  7. P Cunningham9,10,
  8. P Keen1,
  9. R Guy1
  1. 1The Kirby Institute, University of New South UK, Sydney NSW 2052, Australia
  2. 2National Centre in HIV Social Research, University of New South UK, Sydney NSW 2052, Australia
  3. 3School of Public Health and Community Medicine, University of New South UK, Sydney NSW 2052, Australia
  4. 4Sydney Sexual Health Centre, Sydney Hospital, Sydney NSW 2000, Australia
  5. 5Western Sydney Sexual Health Centre, Western Sydney Local Health District, NSW, Australia
  6. 6Sydney Emerging Infections and Biosecurity Institute, University of Sydney, NSW, Australia
  7. 7Albion Centre, Surry Hills NSW 2010, Australia
  8. 8North Shore Sexual Health Service, Royal North Shore Hospital, St Leonards NSW 2065, Australia
  9. 9St Vincent’s Centre for Applied Medical Research, University of New South UK, Sydney NSW 2052, Australia
  10. 10NSW State Reference Laboratory for HIV, St Vincent’s Hospital, Darlinghurst NSW 2010, Australia

Abstract

Background Rapid HIV testing has been available to gay and other men who have sex with men (MSM) overseas for many years. Alere’s Determine HIV Combo ‘fourth generation’ rapid test containing antibody and antigen components is now available in Australia, but field performance data for this assay are limited.

Methods From September 2011, MSM attending four Sydney public sexual health clinics were offered rapid HIV testing using the Determine HIV Combo and also had sexually transmissible infection screening and conventional HIV serology. Rapid test sensitivity, specificity, and positive and negative predictive values (PPV, NPV) were calculated by comparing results to reference tests (Abbott Architect HIV Ag/Ab Combo, Biorad Genscreen HIV antigen and HIV Western blot).

Results In 15 months, 1716 men had 2043 rapid tests performed with four invalid rapid tests (0.2%) excluded from analysis. Of 34 men confirmed as HIV-positive by national HIV case definitions, 29 had reactive rapid tests (sensitivity = 85.3%, 95% CI: 68.2–94.5). With 29 true reactive rapid tests from a total of 44 reactive tests, PPV overall was 65.9% (50.0–79.1). Of five men with false non-reactive tests, four were seroconvertors. Rapid tests were non-reactive in 1990 out of 2005 cases where laboratory HIV testing was negative; hence, overall specificity was 99.3% (95% CI: 98.7–99.6) and NPV was 99.8% (99.4–99.9). Of 15 men with false reactive rapid tests, four had non-specific reactivity on HIV Western blot. Specificity and NPV for the antibody component was 99.5% (99.0–99.7) and 99.9% (99.6–100.0) and for the antigen component was 99.8% (99.4–99.9) and 99.6% (99.1–99.8), respectively.

Conclusion Antibody and antigen component specificity was consistent with the rapid test package insert; whereas sensitivity was lower, notably in those with recent infections. Hence, identifying patients at risk of recent infection is vital so that conventional laboratory serology is performed. A formal assessment of test performance in seroconvertors is warranted.

  • Field performance
  • Rapid HIV testing
  • Sexual health clinic

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