ArticleInternational journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases2020
Evaluation of a novel antigen-based rapid detection test for the diagnosis of SARS-CoV-2 in respiratory samples.
Article in International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 217 papers, 13 of them syntheses 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.
A Clinical Performance Evaluation of the SARS-COV-2 Direct Antigen Rapid Test "DART"
Diagnostic Performance of an Antigen Test for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection (COVID-19)
Who cites it
217 citing papers in PubMed, 13 syntheses or guidelines pooled it, 402 citations in OpenAlex.
- Clinical accuracy of instrument-based SARS-CoV-2 antigen diagnostic tests: a systematic review and meta-analysis.Virology journal · 2024Pooled it
- Rapid, point-of-care antigen tests for diagnosis of SARS-CoV-2 infection.The Cochrane database of systematic reviews · 2022Pooled it
- Diagnostic performance of CO-RADS for COVID-19: a systematic review and meta-analysis.European radiology · 2022Pooled it
- Antigen Detection Tests for SARS-CoV-2: a systematic review and meta-analysis on real world data.Acta bio-medica : Atenei Parmensis · 2022Pooled it
- Accuracy of rapid point-of-care antigen-based diagnostics for SARS-CoV-2: An updated systematic review and meta-analysis with meta-regression analyzing influencing factors.PLoS medicine · 2022Pooled it
- Evaluation of the diagnostic accuracy of COVID-19 antigen tests: A systematic review and meta-analysis.Journal of the Chinese Medical Association : JCMA · 2021Pooled it
- Comparing the diagnostic accuracy of rapid antigen detection tests to real time polymerase chain reaction in the diagnosis of SARS-CoV-2 infection: A systematic review and meta-analysis.Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2021Pooled it
- A systematic review of the sensitivity and specificity of lateral flow devices in the detection of SARS-CoV-2.BMC infectious diseases · 2021Pooled it
- Accuracy of novel antigen rapid diagnostics for SARS-CoV-2: A living systematic review and meta-analysis.PLoS medicine · 2021Pooled it
- Recent advances in the diagnosis of COVID-19: a bird's eye view.Expert review of molecular diagnostics · 2021Pooled it
- Rapid, point-of-care antigen and molecular-based tests for diagnosis of SARS-CoV-2 infection.The Cochrane database of systematic reviews · 2021Pooled it
- A systematic review of the case findings, testing and management of COVID-19.F1000Research · 2021Pooled it
- Recommendations for use of antigenic tests in the diagnosis of acute SARS-CoV-2 infection in the second pandemic wave: attitude in different clinical settings.Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2020Guideline
- Trial
- Preemptive rapid antigen test as an emergency measure during coronavirus disease 2019 outbreaks.Frontiers in public health · 2026Article
- Evaluation of the Analytical Performance of the STANDARD Q COVID-19 Antigenic Test in Suspected COVID-19 Cases in Bobo-Dioulasso, Burkina Faso.BioMed research international · 2026Article
- Observational
- Advances in Virus Biorecognition and Detection Techniques for the Surveillance and Prevention of Infectious Diseases.Biosensors · 2025Review
- Developing, Characterizing, and Modeling CRISPR-Based Point-of-Use Pathogen Diagnostics.ACS synthetic biology · 2025Article
- Nanoplasmonic Biosensors: A Comprehensive Overview and Future Prospects.International journal of nanomedicine · 2025Review
157 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
11 authors at 3 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesIn the context of the coronavirus disease 2019 (COVID-19) pandemic, the development and validation of rapid and easy-to-perform diagnostic methods are of high priority. This study was performed to evaluate a novel rapid antigen detection test (RDT) for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in respiratory samples.
methodsThe fluorescence immunochromatographic SARS-CoV-2 antigen test (Bioeasy Biotechnology Co., Shenzhen, China) was evaluated using universal transport medium with nasopharyngeal (NP) and oropharyngeal (OP) swabs from suspected COVID-19 cases. Diagnostic accuracy was determined in comparison to SARS-CoV-2 real-time (RT)-PCR.
resultsA total of 127 samples were included; 82 were RT-PCR-positive. The median patient age was 38 years, 53.5% were male, and 93.7% were from the first week after symptom onset. Overall sensitivity and specificity were 93.9% (95% confidence interval 86.5-97.4%) and 100% (95% confidence interval 92.1-100%), respectively, with a diagnostic accuracy of 96.1% and Kappa coefficient of 0.9. Sensitivity was significantly higher in samples with high viral loads.
conclusionsThe RDT evaluated in this study showed a high sensitivity and specificity in samples mainly obtained during the first week of symptoms and with high viral loads, despite the use of a non-validated sample material. The assay has the potential to become an important tool for early diagnosis of SARS-CoV-2, particularly in situations with limited access to molecular methods.
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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.