Comparison of Detection Limits of Fourth- and Fifth-Generation Combination HIV Antigen-Antibody, p24 Antigen, and Viral Load Assays on Diverse HIV Isolates

Author:

Stone Mars12ORCID,Bainbridge John34,Sanchez Ana M.34,Keating Sheila M.12,Pappas Andrea34,Rountree Wes34,Todd Chris34,Bakkour Sonia12,Manak Mark5ORCID,Peel Sheila A.6,Coombs Robert W.7,Ramos Eric M.7,Shriver M. Kathleen8,Contestable Paul9,Nair Sangeetha Vijaysri10,Wilson David H.11,Stengelin Martin12,Murphy Gary13,Hewlett Indira14,Denny Thomas N.34,Busch Michael P.12

Affiliation:

1. Blood Systems Research Institute, San Francisco, California, USA

2. Department of Laboratory Medicine, University of California, San Francisco, California, USA

3. Duke Human Vaccine Institute, Duke University Medical Center, Durham, North Carolina, USA

4. Department of Medicine, Duke University Medical Center, Durham, North Carolina, USA

5. Henry M. Jackson Foundation, Silver Spring, Maryland, USA

6. MHRP, Walter Reed Army Institute of Research (WRAIR), Silver Spring, Maryland, USA

7. Department of Laboratory Medicine, University of Washington, Seattle, Washington, USA

8. Bio-Rad Laboratories, Redmond, Washington, USA

9. Ortho Clinical Diagnostics, Rochester, New York, USA

10. Hologic, Inc., San Diego, California, USA

11. Quanterix, Lexington, Massachusetts, USA

12. MesoScale Discovery, Rockville, Maryland, USA

13. Public Health England, London, United Kingdom

14. Center for Biologic Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA), Bethesda, Maryland, USA

Abstract

Detection of acute HIV infection is critical for HIV public health and diagnostics. Clinical fourth-generation antigen (Ag)/antibody (Ab) combination (combo) and p24 Ag immunoassays have enhanced detection of acute infection compared to Ab-alone assays but require ongoing evaluation with currently circulating diverse subtypes.

Funder

HHS | National Institutes of Health

AIDS Clinical Trials Group

University of Washington

Publisher

American Society for Microbiology

Subject

Microbiology (medical)

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