ReviewJournal of clinical microbiology2018
Rapid Antigen Tests for Influenza: Rationale and Significance of the FDA Reclassification.
Review in Journal of clinical microbiology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers.
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
34 citing papers in PubMed, 80 citations in OpenAlex.
- Analytical comparison of over-the-counter multiplex tests for influenza A, influenza B, and SARS-CoV-2.Microbiology spectrum · 2026Article
- How to identify respiratory pathogens in primary health care - a review on the benefits, prospects and pitfalls in using point of care tests.Infection · 2025Review
- Patterns in Prescribing and Dispensing Influenza Antivirals Among Adults With Influenza Presenting to Urgent Care and Emergency Department Settings: VISION Network, 2023-2024.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Article
- Key Insights into Respiratory Virus Testing: Sensitivity and Clinical Implications.Microorganisms · 2025Review
- Development and Implementation of Informational Toolkits to Address Inequities in COVID-19 Testing.Health equity · 2025Article
- Comparative Evaluation of Three Rapid Influenza Diagnostic Tests for Detection of Influenza A and B Viruses Using RT-PCR as Reference Method.Journal of medical virology · 2025Article
- At-home testing for respiratory viruses: a minireview of the current landscape.Journal of clinical microbiology · 2024Review
- Lateral Flow Biosensor for On-Site Multiplex Detection of Viruses Based on One-Step Reverse Transcription and Strand Displacement Amplification.Biosensors · 2024Article
- Application of Nanopore Sequencing in the Diagnosis and Treatment of Pulmonary Infections.Molecular diagnosis & therapy · 2023Review
- Taiwanese Guidelines for Molecular Point-of-Care Testing for Influenza in Emergency Medicine From the New Diagnostic Technology Team of the Taiwan Society of Emergency Medicine.Journal of acute medicine · 2023Article
- Recent development of microfluidics-based platforms for respiratory virus detection.Biomicrofluidics · 2023Article
- The convergent evolution of influenza A virus: Implications, therapeutic strategies and what we need to know.Current research in microbial sciences · 2023Article
- What is the true place of the SARS-CoV-2 rapid point-of-care antigen test in the hospital setting? Lessons learned from real life.Journal of medical virology · 2022Article
- Diagnostic Accuracy of an At-Home, Rapid Self-test for Influenza: Prospective Comparative Accuracy Study.JMIR public health and surveillance · 2022Article
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- Factors Influencing Frequency of Pediatric Clinically Distinguishable Influenza: A 2 Season Case-Control Study.Clinical medicine insights. Pediatrics · 2022Article
- Influenza A, Influenza B, and SARS-CoV-2 Similarities and Differences - A Focus on Diagnosis.Frontiers in microbiology · 2022Review
- Multicenter Technical Validation of 30 Rapid Antigen Tests for the Detection of SARS-CoV-2 (VALIDATE).Microorganisms · 2021Article
- Influenza Management During the COVID-19 Pandemic: A Review of Recent Innovations in Antiviral Therapy and Relevance to Primary Care Practice.Mayo Clinic proceedings. Innovations, quality & outcomes · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Rapid antigen tests for influenza, here referred to as rapid influenza diagnostic tests (RIDTs), have been widely used for the diagnosis of influenza since their introduction in the 1990s due to their ease of use, rapid results, and suitability for point of care (POC) testing. However, issues related to the diagnostic sensitivity of these assays have been known for decades, and these issues gained greater attention following reports of their poor performance during the 2009 influenza A(H1N1) pandemic. In turn, significant concerns arose about the consequences of false-negative results, which could pose significant risks to both individual patient care and to public health efforts. In response to these concerns, the FDA convened an advisory panel in June 2013 to discuss options to improve the regulation of the performance of RIDTs. A proposed order was published on 22 May 2014, and the final order published on 12 January 2017, reclassifying RIDTs from class I to class II medical devices, with additional requirements to comply with four new special controls. This reclassification is a landmark achievement in the regulation of diagnostic devices for infectious diseases and has important consequences for the future of diagnostic influenza testing with commercial tests, warranting the prompt attention of clinical laboratories, health care systems, and health care providers.
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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.