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Evaluation of multi-assay algorithms for identifying individuals with recent HIV infection: HPTN 071 (PopART)
Wendy Grant-McAuley1, Ethan Klock2, Oliver Laeyendecker2,3
1Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States of America.
Background:
Assays and multi-assay algorithms (MAAs) have been developed for population-level cross-sectional HIV incidence estimation. These algorithms use a combination of serologic and/or non-serologic biomarkers to assess the duration of infection. We evaluated the performance of four MAAs for individual-level recency assessments.
Methods:
Samples were obtained from 220 seroconverters (infected <1 year) and 4,396 non-seroconverters (infected >1 year) enrolled in an HIV prevention trial (HPTN 071 [PopART]); 28.6% of the seroconverters and 73.4% of the non-seroconverters had HIV viral loads ≤400 copies/mL. Samples were tested with two laboratory-based assays (LAg-Avidity, JHU BioRad-Avidity) and a point-of-care assay (rapid LAg). The four MAAs included different combinations of these assays and HIV viral load. Seroconverters on antiretroviral treatment (ART) were identified using a qualitative multi-drug assay.
Results:
The MAAs identified between 54 and 100 (25% to 46%) of the seroconverters as recently-infected. The false recent rate of the MAAs for infections >2 years duration ranged from 0.2%-1.3%. The MAAs classified different overlapping groups of individuals as recent vs. non-recent. Only 32 (15%) of the 220 seroconverters were classified as recent by all four MAAs. Viral suppression impacted the performance of the two LAg-based assays. LAg-Avidity assay values were also lower for seroconverters who were virally suppressed on ART compared to those with natural viral suppression.
Conclusions:
The four MAAs evaluated varied in sensitivity and specificity for identifying persons infected <1 year as recently infected and classified different groups of seroconverters as recently infected. Sensitivity was low for all four MAAs. These performance issues should be considered if these methods are used for individual-level recency assessments.
Insights
Four multi-assay algorithms (MAAs) for HIV recency testing showed low sensitivity in identifying recent infections. Performance issues were noted, especially with viral suppression, impacting individual-level assessments.
Area of Science:
- Biomarker analysis
- HIV diagnostics
- Epidemiological methods
Background:
- Multi-assay algorithms (MAAs) are used for population-level HIV incidence estimation.
- These algorithms combine biomarkers to determine infection duration.
- This study evaluates MAA performance for individual-level HIV recency assessments.
Purpose of the Study:
- To evaluate the performance of four multi-assay algorithms (MAAs) for individual-level HIV recency testing.
- To assess the accuracy of MAAs in identifying recent HIV infections (<1 year).
- To understand the impact of viral suppression on MAA performance.
Main Methods:
- Four MAAs were evaluated using samples from 220 recent HIV seroconverters and 4,396 non-seroconverters.
- Assays included laboratory-based (LAg-Avidity, JHU BioRad-Avidity) and point-of-care (rapid LAg) tests.
- HIV viral load and antiretroviral treatment (ART) status were also considered.
Main Results:
- MAAs identified 25%-46% of seroconverters as recently infected.
- False recent rates for infections >2 years ranged from 0.2%-1.3%.
- Low sensitivity was observed for all four MAAs, with only 15% of seroconverters classified as recent by all MAAs.
Conclusions:
- The four evaluated MAAs demonstrated variable sensitivity and specificity for individual HIV recency assessment.
- Performance issues, particularly low sensitivity, necessitate careful consideration for clinical use.
- Viral suppression significantly impacted the performance of LAg-based assays.
