SynthesisEuropean journal of clinical investigation2022
Estimate false-negative RT-PCR rates for SARS-CoV-2. A systematic review and meta-analysis.
Synthesis in European journal of clinical investigation, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06047067 (BIOAEROSOL SAMPLING DEVICE), which is not on this map. Cited by 56 papers, 1 of them a synthesis that pooled it.
What it found
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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.
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.
BIOAEROSOL SAMPLING DEVICE (BSD) CLINICAL STUDY: Performance of Respiratory Pathogen Bioaerosol Sampling Device Compared to Matched Swab Sample With Molecular and Antigen Assays That Can Detect SARS-CoV-2 Phase II Validation
Who cites it
56 citing papers in PubMed, 1 synthesis or guideline pooled it, 113 citations in OpenAlex.
- Estimate false-negative RT-PCR rates for SARS-CoV-2. A systematic review and meta-analysis.European journal of clinical investigation · 2022Pooled it
- Optimising COVID-19 episode identification using serology and PCR/rapid antigen testing: insights from the BRACE trial.BMC infectious diseases · 2026Trial
- A comparative analysis of infection and mortality in reassessing africa's COVID-19 dynamic using time-varying tests.Communications medicine · 2026Article
- Advancing Point-of-Care Healthcare Diagnostics to Tackle Future Outbreaks and Pandemics: Nanotechnology-Driven Developments and Impact on Rapid Pathogen Detection.Environment & health (Washington, D.C.) · 2025Article
- Exploring the influence of vitamin C concentrations on the dynamics of RT-PCR assay reactions.Scientific reports · 2025Article
- A novel method for detecting SARS-CoV-2 IgM and IgG based on the gold immune chromatography assay.Scientific reports · 2025Article
- Article
- Comparative evaluation of GeneXpert and reverse transcription polymerase chain reaction for SARS-CoV-2 diagnosis: a retrospective study.Access microbiology · 2025Article
- Review
- ViralPrimer: a web server to monitor viral nucleic acid amplification tests' primer efficiency during pandemics, with emphasis on SARS-CoV-2 and Mpox.Bioinformatics (Oxford, England) · 2024Article
- Does coronavirus disease 2019 affect peripheral and central auditory systems? Matched group cross-sectional study and six-month follow up.The Journal of laryngology and otology · 2024Article
- Global COVID-19 Pandemic Outcomes: A Cross-Country Comparison Study of Policy Strategies.Integrative medicine (Encinitas, Calif.) · 2024Review
- Comparison of the Discrimination Performance of AI Scoring and the Brixia Score in Predicting COVID-19 Severity on Chest X-Ray Imaging: Diagnostic Accuracy Study.JMIR formative research · 2024Article
- Optimization of Screening Strategies for COVID-19: Scoping Review.JMIR public health and surveillance · 2024Article
- Effects of post-acute COVID-19 syndrome on cerebral white matter and emotional health among non-hospitalized individuals.Frontiers in neurology · 2024Article
- A droplet digital PCR method for the detection of scale drop disease virus in yellowfin seabream (Frontiers in microbiology · 2024Article
- Using SCENTinel® to predict SARS-CoV-2 infection: insights from a community sample during dominance of Delta and Omicron variants.Frontiers in public health · 2024Article
- The evaluation of a rapid microfluidic immunofluorescence antigen test in detecting the infectiousness of COVID-19 patients.BMC infectious diseases · 2023Article
- Performance of Reverse Transcription Loop-Mediated Isothermal Amplification (RT-LAMP) Targeting the RNA Polymerase Gene for the Direct Detection of SARS-CoV2 in Nasopharyngeal Swabs.International journal of molecular sciences · 2023Article
- TRACE-Omicron: Policy Counterfactuals to Inform Mitigation of COVID-19 Spread in the United States.Advanced theory and simulations · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundMolecular-based tests used to identify symptomatic or asymptomatic patients infected by SARS-CoV-2 are characterized by high specificity but scarce sensitivity, generating false-negative results. We aimed to estimate, through a systematic review of the literature, the rate of RT-PCR false negatives at initial testing for COVID-19.
methodsWe systematically searched Pubmed, Embase and CENTRAL as well as a list of reference literature. We included observational studies that collected samples from respiratory tract to detect SARS-CoV-2 RNA using RT-PCR, reporting the number of false-negative subjects and the number of final patients with a COVID-19 diagnosis. Reported rates of false negatives were pooled in a meta-analysis as appropriate. We assessed the risk of bias of included studies and graded the quality of evidence according to the GRADE method. All information in this article is current up to February 2021.
resultsWe included 32 studies, enrolling more than 18,000 patients infected by SARS-CoV-2. The overall false-negative rate was 0.12 (95%CI from 0.10 to 0.14) with very low certainty of evidence. The impact of misdiagnoses was estimated according to disease prevalence; a range between 2 and 58/1,000 subjects could be misdiagnosed with a disease prevalence of 10%, increasing to 290/1,000 misdiagnosed subjects with a disease prevalence of 50%.
conclusionsThis systematic review showed that up to 58% of COVID-19 patients may have initial false-negative RT-PCR results, suggesting the need to implement a correct diagnostic strategy to correctly identify suspected cases, thereby reducing false-negative results and decreasing the disease burden among the population.
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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.