Performance evaluation of the FDA-approved Determine™ HIV-1/2 Ag/Ab Combo assay using plasma and whole blood specimens |
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| Institution: | 1. Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, GA, United States;2. New York City Department of Health & Mental Hygiene, New York City, NY, United States;3. San Francisco Department of Public Health, San Francisco, CA, United States;4. University of North Carolina, Chapel Hill, NC, United States;5. ICF International, Atlanta, GA, United States;1. Laboratory of Viral Hepatitis, Oswaldo Cruz Institute, FIOCRUZ, Rio de Janeiro, Brazil;2. Laboratory of Tecnhological Development of Virology, Oswaldo Cruz Institute, FIOCRUZ, Rio de Janeiro, Brazil;3. Hepatology Division, Clementino Fraga Filho University Hospital, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil;4. Medicine Faculty, Federal University of Tocantins, Palmas, Brazil;5. Institute of Psychiatry, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil;6. Institute of Communication and Scientific Information & Technology for Health, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil;7. Department of Community & Family Health, Federal University of Bahia, Salvador, Brazil;8. Department of Biochemistry and Pharmacy, Federal University of Mato Grosso do Sul, Campo Grande, MS, Brazil;1. The Kirby Institute, University of New South Wales, Sydney, NSW 2052, Australia;2. Sydney Sexual Health Centre, Sydney Hospital, Sydney, NSW 2000, Australia;3. NSW State Reference Laboratory for HIV, St Vincent’s Hospital, Darlinghurst, NSW 2010, Australia;4. St Vincent’s Centre for Applied Medical Research, University of New South Wales, Sydney, NSW 2052, Australia;5. School of Public Health and Community Medicine, University of New South Wales, Sydney, NSW 2052, Australia;6. Western Sydney Sexual Health Centre, Western Sydney Local Health District, NSW 2150, Australia;7. The Marie Bashir Institute for Infectious Diseases, University of Sydney, NSW 2145, Australia;8. Northern Sydney Sexual Health Service, Royal North Shore Hospital, St Leonards, NSW 2065, Australia;9. Sydney Medical School, University of Sydney, NSW 2006, Australia;10. Albion Centre, Surry Hills, NSW 2010, Australia;11. ACON, Surry Hills, Sydney, NSW 2010, Australia;12. Centre for Social Research in Health, University of New South Wales, Sydney, NSW 2052, Australia;13. RPA Sexual Health, Community Health, Sydney LHD, Camperdown, Sydney, NSW 2050, Australia;14. Central Clinical School, Sydney Medical School, University of Sydney, Sydney, NSW 2006, Australia;15. Kirketon Road Centre, PO Box 22, Kings Cross, NSW 1340, Australia;p. Australian Research Centre in Sex, Health and Society, La Trobe University, Melbourne, VIC 3000, Australia;1. Centers for Disease Control and Prevention, Atlanta, GA, USA;2. Bio-Rad Laboratories, Redmond, WA, USA;3. Wadsworth Center, New York State Department of Health, Albany, NY, USA;1. Central Institute for Blood Transfusion and Immunology, University Hospital, Innsbruck, Austria;2. Banc de Sang I Teixits, Barcelona, Spain;3. DRK Blutspendedienst West, Hagen, Germany;4. Department of Transfusion Medicine, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand;5. Roche Diagnostics, Penzberg, Germany;6. Labor Schottdorf MVZ GmbH, Abt RIA, Augsburg, Germany |
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| Abstract: | BackgroundThe Determine™ HIV-1/2 Ag/Ab Combo (DC) rapid test can identify HIV-1 infection earlier than rapid antibody-only tests in plasma specimens.ObjectivesWe compared the performance of DC with a laboratory-based antigen/antibody (Ag/Ab) combo assay in plasma and evaluated antigen reactivity in whole blood specimens.Study designWe tested by DC 508 plasma specimens collected in a prospective study and 107 sequential plasma and simulated whole blood specimens from 20 seroconversion panels. Previous results using the ARCHITECT (ARC) Ag/Ab combo assay were compared to DC results. In seroconversion panels, the days from the first HIV1 RNA-positive test to first DC-reactive in plasma and whole blood was compared. McNemar’s and Wilcoxon signed rank tests were used for statistical analysis.ResultsOf 415 HIV-positive samples, ARC detected 396 (95.4%) and DC 337 (81.2%) (p < 0.0001). DC was reactive in 50.0% of ARC-reactive/MS-negative, 78.6% of ARC-reactive/MS-indeterminate, and 99.6% of ARC-reactive/MS-HIV-1-positive or −undifferentiated specimens. DC antigen reactivity was higher among ARC-reactive/MS-negative than MS-indeterminate samples. In 20 HIV-1 seroconversion panels, there was a significant difference between DC reactivity in plasma (91.1%) and whole blood (56.4%) (p < 0.0001). DC with whole blood showed a significant delay in reactivity compared to plasma (p = 0.008).ConclusionsIn plasma, DC was significantly less sensitive than an instrumented laboratory-based Ag/Ab combo assay. DC in plasma was significantly more sensitive compared to whole blood in early HIV-1 infections. With the U.S. laboratory-based diagnostic algorithm, DC as the first step would likely miss a high proportion of HIV-1 infections in early stages of seroconversion. |
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| Keywords: | HIV diagnostics Rapid test Antigen-antibody detection |
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