ArticleThe Journal of infectious diseases2012
Detection of acute HIV infection: a field evaluation of the determine® HIV-1/2 Ag/Ab combo test.
Article in The Journal of infectious diseases, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 61 papers, 3 of them syntheses that pooled it.
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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.
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Who cites it
61 citing papers in PubMed, 3 syntheses or guidelines pooled it, 125 citations in OpenAlex.
- Systematic review of the performance and clinical utility of point of care HIV-1 RNA testing for diagnosis and care.PloS one · 2019Pooled it
- Pooled it
- Field accuracy of fourth-generation rapid diagnostic tests for acute HIV-1: a systematic review.AIDS (London, England) · 2015Pooled it
- Human Immunodeficiency Virus (HIV)-1 Transmission Among Persons With Acute HIV-1 Infection in Malawi: Demographic, Behavioral, and Phylogenetic Relationships.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2019Trial
- 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
- 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
- Clinical diagnostic accuracy of the HIV rapid test ACCU-TELL anti-HIV 1 + 2 in sub-Saharan African region.BMC infectious diseases · 2025Article
- A comparative analysis of the different HIV testing techniques used in Zambia: data from a clinical performance study.BMC research notes · 2025Article
- Evaluation of a point-of-care rapid HIV antibody test with insights into acute HIV symptomatology in a population with low prevalence.Journal of clinical microbiology · 2024Article
- Preferences for HIV Testing Services and HIV Self-Testing Distribution Among Migrant Gay, Bisexual, and Other Men Who Have Sex With Men in Australia.Frontiers in medicine · 2022Article
- Evaluation of serological assays for the diagnosis of HIV infection in adults.South African family practice : official journal of the South African Academy of Family Practice/Primary Care · 2021Article
- Economic evaluation of alternative testing regimes and settings to detect undiagnosed HIV in Australia.BMC health services research · 2021Article
- 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
- Rapid HIV Antigen-Antibody Assays and Detection of Acute HIV Infection in Sub-Saharan Africa.The American journal of tropical medicine and hygiene · 2019Article
- Nanoparticle-based assay for detection of S100P mRNA using surface-enhanced Raman spectroscopy.Journal of biomedical optics · 2019Article
- Diagnostic Performances of Three Rapid Diagnostic Tests for Detecting HIV Infections in Mali.Infectious diseases diagnosis & treatment · 2019Article
- p24 revisited: a landscape review of antigen detection for early HIV diagnosis.AIDS (London, England) · 2018Review
1 more citing papers are in PubMed but not listed here.
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Authors and funding
15 authors at 3 institutions in 2 countries.
Funding
Abstract
backgroundMost 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).
methodsThe 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.
resultsOf 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.
conclusionsCombo 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.
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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.