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UPDATE 2012 HIV

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Detection of Acute HIV Infection: A Field Evaluation of the Determine® HIV-1/2 Ag/Ab Combo Test

1. Nora E. Rosenberg1, 
2. Gift Kamanga5, 
3. Sam Phiri6, 
4. Dominic Nsona6,
5. Audrey Pettifor1, 
6. Sarah E. Rutstein2, 
7. Deborah Kamwendo5,3, 
8. Irving F. Hoffman3,
9. Maria Keating5,^a, 
10. Lillian B. Brown1,3, 
11. Beatrice Ndalama5, 
12. Susan A. Fiscus6,
13. Seth Congdon5, 
14. Myron S. Cohen1,3,4 and 
15. William C. Miller1,3

+Author Affiliations

1. ¹Department of Epidemiology
2. ²Department of Health Policy and Management
3. ³Department of Medicine
4. ⁴Department of Microbiology and Immunology, University of North Carolina, Chapel Hill; and the
5. ⁵UNC Project, Lilongwe, Malawi
6. ⁶Lighthouse Trust, Lilongwe, Malawi

1. Correspondence: Nora E. Rosenberg, MSPH, Department of Epidemiology, UNC-CH, Campus Box 7435, Chapel Hill, NC 27599-7435 (nora_rosenberg@unc.edu).

Abstract

ARTICLE

Background. Most human immunodeficiency virus (HIV) point-of-care tests detect antibodies (Ab) but not p24 antigen (Ag) or RNA. In the absence of antibodies, p24 antigen and RNA typically indicate acute HIV infection. We conducted a field evaluation of the Determine® HIV-1/2 Ag/Ab Combo rapid test (Combo RT).

Methods. The antigen portion of the Combo RT (for acute HIV infection) was compared with a Roche Monitor HIV RNA polymerase chain reaction assay. The antibody portion of Combo RT (for established HIV infection) was compared with rapid test algorithms. Participants were enrolled at a sexually transmitted infection clinic and HIV testing and counseling center in Lilongwe, Malawi. Rapid testing was conducted with parallel testing in the clinic and serial testing in the center. The Combo RT was performed in clinic participants with negative or discordant antibody results and in all center participants.

Results. Of the participants 838 were HIV negative, 163 had established HIV infection, and 8 had acute HIV infection. For detecting acute HIV infection, the antigen portion had a sensitivity of 0.000 and a specificity of 0.983. For detecting established HIV infection, the antibody portion had a sensitivity of 0.994 and a specificity of 0.992.

Conclusions. Combo RT displayed excellent performance for detecting established HIV infection and poor performance for detecting acute HIV infection. In this setting, Combo RT is no more useful than current algorithms.