Observational studyClinical infectious diseases : an official publication of the Infectious Diseases Society of America2017
Analysis of False-Negative Human Immunodeficiency Virus Rapid Tests Performed on Oral Fluid in 3 International Clinical Research Studies.
Observational study in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis 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
15 citing papers in PubMed, 1 synthesis or guideline pooled it, 23 citations in OpenAlex.
- Influence of Combination Antiretroviral Therapy on HIV-1 Serological Responses and Their Implications: A Systematic Review and Meta-Analysis.Frontiers in immunology · 2022Pooled it
- Altered Antibody Responses in Persons Infected with HIV-1 While Using Preexposure Prophylaxis.AIDS research and human retroviruses · 2021Trial
- HIV Self-Testing Increases HIV Testing Frequency in High-Risk Men Who Have Sex With Men: A Randomized Controlled Trial.Journal of acquired immune deficiency syndromes (1999) · 2018Trial
- Biomedical and Behavioral Outcomes of Keep It Up!: An eHealth HIV Prevention Program RCT.American journal of preventive medicine · 2018Trial
- Highlighting and addressing barriers to widespread adaptation of HIV self-testing in the United States.Expert review of molecular diagnostics · 2023Review
- PrEP use and unmet PrEP-need among men who have sex with men in London prior to the implementation of a national PrEP programme, a cross-sectional study from June to August 2019.BMC public health · 2022Article
- Poststudy Point-of-Care Oral Fluid Testing in Human Immunodeficiency Virus-1 Vaccinees.Open forum infectious diseases · 2021Article
- Combination prevention and HIV: a cross-sectional community survey of gay and bisexual men in London, October to December 2016.Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin · 2019Article
- HIV Testing and Sexual Health Among Black African Men and Women in London, United Kingdom.JAMA network open · 2019Article
- Intersectional Stigma and Multi-Level Barriers to HIV Testing Among Foreign-Born Black Men From the Caribbean.Frontiers in public health · 2019Review
- Assessment of HIV prevalence among MSM in Tokyo using self-collected dried blood spots delivered through the postal service.BMC infectious diseases · 2018Article
- No Time to Delay! Fiebig Stages and Referral in Acute HIV infection: Seattle Primary Infection Program Experience.AIDS research and human retroviruses · 2018Observational
- Selecting an HIV Test: A Narrative Review for Clinicians and Researchers.Sexually transmitted diseases · 2017Review
- Primary HIV Infection: Clinical Presentation, Testing, and Treatment.Current infectious disease reports · 2017Review
- Point-of-Care Testing for Infectious Diseases: Past, Present, and Future.Journal of clinical microbiology · 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
13 authors at 2 institutions in 2 countries.
Funding
Abstract
BACKGROUND.: The OraQuick Advance Rapid HIV-1/2 Test is a point-of-care test capable of detecting human immunodeficiency virus (HIV)-specific antibodies in blood and oral fluid. To understand test performance and factors contributing to false-negative results in longitudinal studies, we examined results of participants enrolled in the Botswana TDF/FTC Oral HIV Prophylaxis Trial, the Bangkok Tenofovir Study, and the Bangkok MSM Cohort Study, 3 separate clinical studies of high-risk, HIV-negative persons conducted in Botswana and Thailand. METHODS.: In a retrospective observational analysis, we compared oral fluid OraQuick (OFOQ) results among participants becoming HIV infected to results obtained retrospectively using enzyme immunoassay and nucleic acid amplification tests on stored specimens. We categorized negative OFOQ results as true-negative or false-negative relative to nucleic acid amplification test and/or enzyme immunoassay, and determined the delay in OFOQ conversion relative to the estimated time of infection. We used log-binomial regression and generalized estimating equations to examine the association between false-negative results and participant, clinical, and testing-site factors. RESULTS.: Two-hundred thirty-three false-negative OFOQ results occurred in 80 of 287 seroconverting individuals. Estimated OFOQ conversion delay ranged from 14.5 to 547.5 (median, 98.5) days. Delayed OFOQ conversion was associated with clinical site and test operator (P < .05), preexposure prophylaxis (P = .01), low plasma viral load (P < .02), and time to kit expiration (P < .01). Participant age, sex, and HIV subtype were not associated with false-negative results. Long OFOQ conversion delay time was associated with antiretroviral exposure and low plasma viral load. CONCLUSIONS.: Failure of OFOQ to detect HIV-1 infection was frequent and multifactorial in origin. In longitudinal trials, negative oral fluid results should be confirmed via testing of blood samples.
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.