Related Experiment Video
Updated: May 1, 2026
Comprehensive & Cost Effective Laboratory Monitoring of HIV/AIDS: an African Role Model
Published on: October 31, 2010
Multi-centre evaluation of the Determine HIV Combo assay when used for point of care testing in a high risk
Damian P Conway1, Martin Holt2, Anna McNulty3
1The Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia.
Insights
The Determine HIV Combo (DHC) assay showed moderate sensitivity for early HIV detection. The antibody component was effective, but the antigen component did not improve point-of-care testing performance in high-risk populations.
Area of Science:
- Infectious Diseases
- Diagnostic Medicine
- Public Health
Background:
- Determine HIV Combo (DHC) is a novel point-of-care assay for HIV detection.
- It aims to improve early HIV infection diagnosis by detecting both antibodies and antigens.
- This study evaluated DHC performance in Sydney sexual health clinics.
Purpose of the Study:
- To assess the performance of the DHC assay in a real-world clinical setting.
- To compare DHC with conventional laboratory HIV testing methods.
- To evaluate DHC's effectiveness in detecting early HIV infections.
Main Methods:
- A multi-center evaluation of 3,190 specimens from gay and bisexual men.
- Comparison of DHC results with laboratory-based serology, including fourth-generation immunoassay, HIV antibody, p24 antigen, and Western blot tests.
- Definition of early infection as HIV acquired within the last six months.
Main Results:
- Overall DHC sensitivity was 87.2%, with antibody sensitivity at 94.4% and antigen sensitivity at 0%.
- In early HIV infections, DHC sensitivity was 66.7%, with all positive cases detected by the antibody component.
- The DHC antigen component did not detect any of the nine HIV p24 antigen-positive specimens and contributed to false positives.
Conclusions:
- The DHC antibody component shows promise for detecting early HIV infections.
- The DHC antigen component did not enhance point-of-care HIV testing performance in this high-risk population.
- Further research may be needed to optimize antigen detection in point-of-care HIV assays.
Background:
Determine HIV Combo (DHC) is the first point of care assay designed to increase sensitivity in early infection by detecting both HIV antibody and antigen. We conducted a large multi-centre evaluation of DHC performance in Sydney sexual health clinics.
Methods:
We compared DHC performance (overall, by test component and in early infection) with conventional laboratory HIV serology (fourth generation screening immunoassay, supplementary HIV antibody, p24 antigen and Western blot tests) when testing gay and bisexual men attending four clinic sites. Early infection was defined as either acute or recent HIV infection acquired within the last six months.
Results:
Of 3,190 evaluation specimens, 39 were confirmed as HIV-positive (12 with early infection) and 3,133 were HIV-negative by reference testing. DHC sensitivity was 87.2% overall and 94.4% and 0% for the antibody and antigen components, respectively. Sensitivity in early infection was 66.7% (all DHC antibody reactive) and the DHC antigen component detected none of nine HIV p24 antigen positive specimens. Median HIV RNA was higher in false negative than true positive cases (238,025 vs. 37,591 copies/ml; p = 0.022). Specificity overall was 99.4% with the antigen component contributing to 33% of false positives.
Conclusions:
The DHC antibody component detected two thirds of those with early infection, while the DHC antigen component did not enhance performance during point of care HIV testing in a high risk clinic-based population.
