ArticleJournal of clinical microbiology2014
Poor performance of the determine HIV-1/2 Ag/Ab combo fourth-generation rapid test for detection of acute infections in a National Household Survey in Swaziland.
Article in Journal of clinical microbiology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
32 citing papers in PubMed, 2 syntheses or guidelines pooled it, 57 citations in OpenAlex.
- Pooled it
- Field accuracy of fourth-generation rapid diagnostic tests for acute HIV-1: a systematic review.AIDS (London, England) · 2015Pooled it
- HIV rapid screening tests and self-tests: Be aware of differences in performance and cautious of vendors.EBioMedicine · 2018Trial
- The fourth generation AlereJournal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2017Trial
- Feasibility, Acceptability, and Test Performance of Point-of-Care Nucleic Acid Tests for HIV Testing and Viral Load Monitoring in the United States: Prospective Longitudinal Mixed-Methods Study.JMIR research protocols · 2026Article
- Immunomagnetic Sample Preparation Targeting Host- and Viral-Derived Antigens for HIV-1 Isolation from Limited Plasma Volumes.Analytical chemistry · 2026Article
- A luminescence-based point-of-care HIV viral load test for antiretroviral therapy monitoring.Lab on a chip · 2025Article
- DETECTION OF NEW HIV CASES UNDER EPIDEMIC CONTROL - WHEN IS IT THE RIGHT TIME TO REVIEW HIV TESTING ALGORITHMS FOR COUNTRIES NEARING THE 95-95-95 MILESTONES? CASE STUDY -BOTSWANA.African journal of infectious diseases · 2025Article
- Rapid tests should be used with caution for HIV-1 primary infection screening.Medical microbiology and immunology · 2024Article
- Laboratory-based evaluation of the 4th-generation AlereTM HIV Combo rapid point-of-care test.PloS one · 2024Article
- Go Where the Virus Is: An HIV Micro-epidemic Control Approach to Stop HIV Transmission.Global health, science and practice · 2020Article
- Comparative multi-assay evaluation of Determine™ HIV-1/2 Ag/Ab Combo rapid diagnostic tests in acute and chronic HIV infection.Medical microbiology and immunology · 2020Article
- Challenges of HIV diagnosis and management in the context of pre-exposure prophylaxis (PrEP), post-exposure prophylaxis (PEP), test and start and acute HIV infection: a scoping review.Journal of the International AIDS Society · 2019Article
- Field Validation of Limiting-Antigen Avidity Enzyme Immunoassay to Estimate HIV-1 Incidence in Cross-Sectional Survey in Swaziland.AIDS research and human retroviruses · 2019Article
- Rapid HIV Antigen-Antibody Assays and Detection of Acute HIV Infection in Sub-Saharan Africa.The American journal of tropical medicine and hygiene · 2019Article
- p24 revisited: a landscape review of antigen detection for early HIV diagnosis.AIDS (London, England) · 2018Review
- Comparison of Detection Limits of Fourth- and Fifth-Generation Combination HIV Antigen-Antibody, p24 Antigen, and Viral Load Assays on Diverse HIV Isolates.Journal of clinical microbiology · 2018Article
- No Time to Delay! Fiebig Stages and Referral in Acute HIV infection: Seattle Primary Infection Program Experience.AIDS research and human retroviruses · 2018Observational
- Evaluation of HIV-1 rapid tests and identification of alternative testing algorithms for use in Uganda.BMC infectious diseases · 2018Article
- Point-of-care diagnostics to improve maternal and neonatal health in low-resource settings.Lab on a chip · 2017Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
19 authors at 5 institutions in 3 countries.
Funding
Abstract
Fourth-generation HIV rapid tests (RTs) claim to detect both p24 antigen (Ag) and HIV antibodies (Ab) for early identification of acute infections, important for targeting prevention and reducing HIV transmission. In a nationally representative household survey in Swaziland, 18,172 adults, age 18 to 49 years, received home-based HIV rapid testing in 2010 and 2011. Of the 18,172 individuals, 5,822 (32.0%) were Ab positive (Ab(+)) by the Determine HIV-1/2 Ab/Ab combo test, and 5,789 (99.4%) of those were confirmed to be reactive in the Uni-Gold test. Determine combo identified 12 individuals as having acute infections (Ag(+)/Ab negative [Ab(-)]); however, none had detectable HIV-1 RNA and 8 of 12 remained HIV negative at their 6-week follow-up visit (4 were lost to follow-up). All RT-nonreactive samples were pooled and tested by nucleic acid amplification testing (NAAT) to identify acute infections. NAAT identified 13 (0.1%) of the 12,338 HIV antibody-negative specimens as HIV RNA positive, with RNA levels ranging from 300 to >10,000,000 copies/ml. However, none of them were Ag(+) by Determine combo. Follow-up testing of 12 of the 13 NAAT-positive individuals at 6 months demonstrated 12 seroconversions (1 individual was lost to follow-up). Therefore, the Determine combo test had a sensitivity of 0% (95% confidence interval, 0 to 28) and positive predictive value of 0% for the detection of acute infections. The ability of the 4th-generation Determine combo to detect antigen was very poor in Swaziland. Thus, the Determine combo test does not add any value to the current testing algorithm; rather, it adds additional costs and complexity to HIV diagnosis. The detection of acute HIV infections may need to rely on other testing strategies.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.