SynthesisPloS one2016
Evaluation of a Rapid Point of Care Test for Detecting Acute and Established HIV Infection, and Examining the Role of Study Quality on Diagnostic Accuracy: A Bayesian Meta-Analysis.
Synthesis in PloS one, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.
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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.
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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
17 citing papers in PubMed.
- The fourth generation AlereJournal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2017Trial
- Developing and evaluating a novel rapid test for recent HIV-1 infection: comparison with commercial LAg-EIA assays.Journal of clinical microbiology · 2026Article
- Who declines "opt-out" HIV/HCV testing? Experience of an internal medicine resident continuity clinic serving a predominantly Black adult population in South Carolina.Journal of the National Medical Association · 2024Article
- Predicting, Diagnosing, and Treating Acute and Early HIV Infection in a Public Sector Facility in Eswatini.Journal of acquired immune deficiency syndromes (1999) · 2021Article
- Optimization of Case Definitions for Sensitivity as a Preventive Strategy-A Modelling Exemplified with Rapid Diagnostic Test-Based Prevention of Sexual HIV Transmission.Diagnostics (Basel, Switzerland) · 2021Article
- Evaluating Point-of-Care Nucleic Acid Tests in Adult Human Immunodeficiency Virus Diagnostic Strategies: A Côte d'Ivoire Modeling Analysis.Open forum infectious diseases · 2021Article
- 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
- Diagnostics as Prevention - A Rapid Testing-Based Strategy of Sex Workers against Sexual HIV Exposure.European journal of microbiology & immunology · 2018Article
- HIV prevention strategies and risk of infection: a model-based analysis.Epidemiology and infection · 2018Article
- Evaluation of Blood-Based Antibody Rapid Testing for HIV Early Therapy: A Meta-Analysis of the Evidence.Frontiers in immunology · 2018Article
- Human anti-HIV IgM detection by the OraQuickPeerJ · 2018Article
- Primary HIV Infection: Clinical Presentation, Testing, and Treatment.Current infectious disease reports · 2017Review
- The accuracy of HIV rapid testing in integrated bio-behavioral surveys of men who have sex with men across 5 Provinces in South Africa.Medicine · 2017Article
- Clinical and public health implications of acute and early HIV detection and treatment: a scoping review.Journal of the International AIDS Society · 2017Article
- Improving the Quality of Diagnostic Studies Evaluating Point of Care Tests for Acute HIV Infections: Problems and Recommendations.Diagnostics (Basel, Switzerland) · 2017Article
- Evaluation of two 4th generation point-of-care assays for the detection of Human Immunodeficiency Virus infection.PloS one · 2017Article
Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionFourth generation (Ag/Ab combination) point of care HIV tests like the FDA-approved Determine HIV1/2 Ag/Ab Combo test offer the promise of timely detection of acute HIV infection, relevant in the context of HIV control. However, a synthesis of their performance has not yet been done. In this meta-analysis we not only assessed device performance but also evaluated the role of study quality on diagnostic accuracy.
methodsTwo independent reviewers searched seven databases, including conferences and bibliographies, and independently extracted data from 17 studies. Study quality was assessed with QUADAS-2. Data on sensitivity and specificity (overall, antigen, and antibody) were pooled using a Bayesian hierarchical random effects meta-analysis model. Subgroups were analyzed by blood samples (serum/plasma vs. whole blood) and study designs (case-control vs. cross-sectional).
resultsThe overall specificity of the Determine Combo test was 99.1%, 95% credible interval (CrI) [97.3-99.8]. The overall pooled sensitivity for the device was at 88.5%, 95% [80.1-93.4]. When the components of the test were analyzed separately, the pooled specificities were 99.7%, 95% CrI [96.8-100] and 99.6%, 95% CrI [99.0-99.8], for the antigen and antibody components, respectively. Pooled sensitivity of the antibody component was 97.3%, 95% CrI [60.7-99.9], and pooled sensitivity for the antigen component was found to be 12.3%, 95% (CrI) [1.1-44.2]. No significant differences were found between subgroups by blood sample or study design. However, it was noted that many studies restricted their study sample to p24 antigen or RNA positive specimens, which may have led to underestimation of overall test performance. Detection bias, selection (spectrum) bias, incorporation bias, and verification bias impaired study quality.
conclusionsAlthough the specificity of all test components was high, antigenic sensitivity will merit from an improvement. Besides the accuracy of the device itself, study quality, also impacts the performance of the test. These factors must be kept in mind in future evaluations of an improved device, relevant for global scale up and implementation.
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