ArticlePloS one2017
Evaluation of two 4th generation point-of-care assays for the detection of Human Immunodeficiency Virus infection.
Article in PloS one, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
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Who cites it
13 citing papers in PubMed, 24 citations in OpenAlex.
- A randomized controlled trial evaluating combination detection of HIV in Malawian sexually transmitted infections clinics.Journal of the International AIDS Society · 2021Trial
- HIV rapid screening tests and self-tests: Be aware of differences in performance and cautious of vendors.EBioMedicine · 2018Trial
- Clinical diagnostic accuracy of the HIV rapid test ACCU-TELL anti-HIV 1 + 2 in sub-Saharan African region.BMC infectious diseases · 2025Article
- Stakeholder considerations on acceptability and implementation of a novel rapid test for acute HIV infection: A qualitative study in Indiana.PLOS global public health · 2025Article
- Performance evaluation of a novel RapiSafe HIV Ag/Ab combi rapid test for the detection of HIV antigen and antibodies.Frontiers in cellular and infection microbiology · 2025Article
- Stakeholder-engaged development of a rapid test for detection of acute HIV infection.Research square · 2024Article
- Laboratory-based evaluation of the 4th-generation AlereTM HIV Combo rapid point-of-care test.PloS one · 2024Article
- Flow-Cytometry Intracellular Detection and Quantification of HIV1 p24 Antigen and Immunocheckpoint Molecules in T Cells among HIV/AIDS Patients.HIV/AIDS (Auckland, N.Z.) · 2022Article
- Neurologic Complications of Acute HIV Infection.Current treatment options in infectious diseases · 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
- Diagnostic Performances of Three Rapid Diagnostic Tests for Detecting HIV Infections in Mali.Infectious diseases diagnosis & treatment · 2019Article
- 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
- Performance of the BioPlex 2200 HIV Ag-Ab assay for identifying acute HIV infection.Journal of clinical virology : the official publication of the Pan American Society for Clinical VirologyArticle
Corrections and comments
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Authors and funding
2 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundFourth generation assays detect simultaneously antibodies for HIV and the p24 antigen, identifying HIV infection earlier than previous generation tests. Previous studies have shown that the Alere Determine HIV-1/2 Combo has lower than anticipated performance in detecting antibodies for HIV and the p24 antigen. Furthermore, there are currently very few studies evaluating the performance of Standard Diagnostics BIOLINE HIV Ag/Ab Combo.
objectiveTo evaluate the performance of the Alere Determine HIV-1/2 Combo and the Standard Diagnostics BIOLINE HIV Ag/Ab Combo in a panel of frozen serum samples. STUDY
designThe testing panel included 133 previously frozen serum specimens from the UCLA Clinical Microbiology & Immunoserology laboratory. Reference testing included testing for HIV antibodies by a 3rd generation enzyme immunoassay followed by HIV RNA detection. Antibody negative and RNA positive sera were also tested by a laboratory 4th generation HIV Ab/Ag enzyme immunoassay.
resultsReference testing yielded 97 positives for HIV infection and 36 negative samples. Sensitivity of the Alere test was 95% (88-98%), while the SD Bioline sensitivity was 91% (83-96%). Both assays showed 100% (90-100%) specificity. No indeterminate or invalid results were recorded. Among 13 samples with acute infection (HIV RNA positive, HIV antibody negative), 12 were found positive by the first assay and 8 by the second. The antigen component of the Alere assay detected 10 acute samples, while the SD Bioline assay detected only one.
conclusionsBoth rapid assays showed very good overall performance in detecting HIV infection in frozen serum samples, but further improvements are required to improve the performance in acute infection.
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