ArticleVirology journal2021
False negative rate of COVID-19 PCR testing: a discordant testing analysis.
Article in Virology journal, 2021. 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 104 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
104 citing papers in PubMed, 1 synthesis or guideline pooled it, 216 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
- Monitoring the 2023 Omicron waves in Morocco: Trends in incidence, variants, and testing disparities.IJID regions · 2026Article
- An Oscillating-Flow Microfluidic PCR Method for Rapid and Flexible Detection of Periodontal Pathogens.Sensors (Basel, Switzerland) · 2026Article
- Toward Safer Diagnoses: A SEIPS-Based Narrative Review of Diagnostic Errors.Diagnostics (Basel, Switzerland) · 2026Review
- Endogenous Biomarkers Analysis and False-Negative Results for SARSCov2 Using two Commercial RT-PCR Diagnostic Kits.Iranian journal of pathology · 2026Article
- Chest CT as a diagnostic tool for COVID-19 in resource-limited Countries : Diagnostic accuracy of chest CT for COVID-19 pneumonia in a resource-limited Gaza cohort: a retrospective study of 252 patients.Emergency radiology · 2025Article
- Analysis of the SEIR mean-field model in dynamic networks under intervention.Infectious Disease Modelling · 2025Article
- Nucleocapsid Antibodies as an Optimal Serological Marker of SARS-CoV-2 Infection: A Longitudinal Study at the Thomayer University Hospital.Journal of clinical laboratory analysis · 2025Article
- Comparative analysis of frequentist, Bayesian, and machine learning models for predicting SARS-CoV-2 PCR positivity.Frontiers in artificial intelligence · 2025Article
- COMPARISON OF ABBOTT REAL TIME SARS-COV-2 ASSAY AND LIFERIVER NOVEL CORONAVIRUS REAL TIME MULTIPLEX KIT FOR THE RT-PCR BASED DETECTION OF SARS-COV-2 FROM NASOPHARYNGEAL SWABS.Acta clinica Croatica · 2024Article
- Microfluidic Immunoarray for Point-of-Care Detection of Cytokines in COVID-19 Patients.ACS omega · 2024Article
- Global COVID-19 Pandemic Outcomes: A Cross-Country Comparison Study of Policy Strategies.Integrative medicine (Encinitas, Calif.) · 2024Review
- Enhancing Disease Classification with Deep Learning: a Two-Stage Optimization Approach for Monkeypox and Similar Skin Lesion Diseases.Journal of imaging informatics in medicine · 2024Article
- An augmentation aided concise CNN based architecture for COVID-19 diagnosis in real time.Scientific reports · 2024Article
- The Incidence of Pulmonary Embolism in Hospitalized Non-ICU Patients with COVID-19 during the First Wave: A Multicenter Retrospective Cohort Study in the Netherlands.Journal of vascular research · 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
- Faradaic Impedimetric Immunosensor for Label-Free Point-of-Care Detection of COVID-19 Antibodies Using Gold-Interdigitated Electrode Array.Biosensors · 2023Article
- Can Nitazoxanide and/or other anti-viral medications be a solution to long COVID? Case report with a brief literature review.Clinical case reports · 2023Article
- The Diagnostic Performance of Various Clinical Specimens for the Detection of COVID-19: A Meta-Analysis of RT-PCR Studies.Diagnostics (Basel, Switzerland) · 2023Review
- A microfluidic biosensor architecture for the rapid detection of COVID-19.Analytica chimica acta · 2023Article
44 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 6 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundCOVID-19 is diagnosed via detection of SARS-CoV-2 RNA using real time reverse-transcriptase polymerase chain reaction (rtRT-PCR). Performance of many SARS-CoV-2 rtRT-PCR assays is not entirely known due to the lack of a gold standard. We sought to evaluate the false negative rate (FNR) and sensitivity of our laboratory-developed SARS-CoV-2 rtRT-PCR targeting the envelope (E) and RNA-dependent RNA-polymerase (RdRp) genes.
methodsSARS-CoV-2 rtRT-PCR results at the Public Health Laboratory (Alberta, Canada) from January 21 to April 18, 2020 were reviewed to identify patients with an initial negative rtRT-PCR followed by a positive result on repeat testing within 14 days (defined as discordant results). Negative samples from these discordant specimens were re-tested using three alternate rtRT-PCR assays (targeting the E gene and N1/N2 regions of the nucleocapsid genes) to assess for false negative (FN) results.
resultsDuring the time period specified, 95,919 patients (100,001 samples) were tested for SARS-CoV-2. Of these, 49 patients were found to have discordant results including 49 positive and 52 negative swabs. Repeat testing of 52 negative swabs found five FNs (from five separate patients). Assuming 100% specificity of the diagnostic assay, the FNR and sensitivity in this group of patients with discordant testing was 9.3% (95% CI 1.5-17.0%) and 90.7% (95% CI 82.6-98.9%) respectively.
conclusionsStudies to understand the FNR of routinely used assays are important to confirm adequate clinical performance. In this study, most FN results were due to low amounts of SARS-CoV-2 virus concentrations in patients with multiple specimens collected during different stages of infection. Post-test clinical evaluation of each patient is advised to ensure that rtRT-PCR results are not the only factor in excluding COVID-19.
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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.