ArticleJournal of clinical virology : the official publication of the Pan American Society for Clinical Virology2017
Performance evaluation of the FDA-approved Determine™ HIV-1/2 Ag/Ab Combo assay using plasma and whole blood specimens.
Article in Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
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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.
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Who cites it
9 citing papers in PubMed, 31 citations in OpenAlex.
- Fourth-Generation HIV Rapid Tests: Enhanced Sensitivity and Reduced Diagnostic Window for HIV-1 Primary Infection Screening.Journal of medical virology · 2024Article
- Performance evaluation of the MedMira reveal G4 LAB S/P and POC HIV antibody rapid screening tests using plasma and whole blood specimens.Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2020Article
- Performance evaluation of four point-of-care HIV tests using unprocessed specimens.Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2020Article
- Prospective Evaluation of HIV Testing Technologies in a Clinical Setting: Protocol for Project DETECT.JMIR research protocols · 2020Article
- 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
- Performance of the Alere Determine™ HIV-1/2 Ag/Ab Combo Rapid Test with algorithm-defined acute HIV-1 infection specimens.Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2018Article
- The Evolution of HIV Testing Continues.Sexually transmitted diseases · 2017Article
- Selecting an HIV Test: A Narrative Review for Clinicians and Researchers.Sexually transmitted diseases · 2017Review
Corrections and comments
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Authors and funding
9 authors at 5 institutions in 1 country.
Funding
Abstract
backgroundThe Determine™ HIV-1/2 Ag/Ab Combo (DC) rapid test can identify HIV-1 infection earlier than rapid antibody-only tests in plasma specimens.
objectivesWe compared the performance of DC with a laboratory-based antigen/antibody (Ag/Ab) combo assay in plasma and evaluated antigen reactivity in whole blood specimens. STUDY
designWe tested by DC 508 plasma specimens collected in a prospective study and 107 sequential plasma and simulated whole blood specimens from 20 seroconversion panels. Previous results using the ARCHITECT (ARC) Ag/Ab combo assay were compared to DC results. In seroconversion panels, the days from the first HIV1 RNA-positive test to first DC-reactive in plasma and whole blood was compared. McNemar's and Wilcoxon signed rank tests were used for statistical analysis.
resultsOf 415 HIV-positive samples, ARC detected 396 (95.4%) and DC 337 (81.2%) (p<0.0001). DC was reactive in 50.0% of ARC-reactive/MS-negative, 78.6% of ARC-reactive/MS-indeterminate, and 99.6% of ARC-reactive/MS-HIV-1-positive or -undifferentiated specimens. DC antigen reactivity was higher among ARC-reactive/MS-negative than MS-indeterminate samples. In 20 HIV-1 seroconversion panels, there was a significant difference between DC reactivity in plasma (91.1%) and whole blood (56.4%) (p<0.0001). DC with whole blood showed a significant delay in reactivity compared to plasma (p=0.008).
conclusionsIn plasma, DC was significantly less sensitive than an instrumented laboratory-based Ag/Ab combo assay. DC in plasma was significantly more sensitive compared to whole blood in early HIV-1 infections. With the U.S. laboratory-based diagnostic algorithm, DC as the first step would likely miss a high proportion of HIV-1 infections in early stages of seroconversion.
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