ArticlePloS one2022
Evaluating the field performance of multiple SARS-Cov-2 antigen rapid tests using nasopharyngeal swab samples.
Article in PloS one, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
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Who cites it
12 citing papers in PubMed, 18 citations in OpenAlex.
- The Performance of a Rapid Coronavirus Disease 2019 Antigen Test in Rural Gabon.The American journal of tropical medicine and hygiene · 2025Article
- SARS-CoV-2 Rapid Antigen Test Based on a New Anti-Nucleocapsid Protein Monoclonal Antibody: Development and Real-Time Validation.Microorganisms · 2023Article
- Rapid Antigen Tests during the COVID-19 Era in Korea and Their Implementation as a Detection Tool for Other Infectious Diseases.Bioengineering (Basel, Switzerland) · 2023Review
- Clinical Validation of GenBody COVID-19 Ag, Nasal and Nasopharyngeal Rapid Antigen Tests for Detection of SARS-CoV-2 in European Adult Population.Biomedicines · 2023Article
- Evaluation of immunoprotection against coronavirus disease 2019: Novel variants, vaccine inoculation, and complications.Journal of pharmaceutical analysis · 2023Review
- Direct Nasal Swab for Rapid Test and Saliva as an Alternative Biological Sample for RT-PCR in COVID-19 Diagnosis.Microbiology spectrum · 2022Article
- Enhancing Respiratory Disease Surveillance to Detect COVID-19 in Shelters for Displaced Persons, Thailand-Myanmar Border, 2020-2021.Emerging infectious diseases · 2022Review
- Identification of mutations in SARS-CoV-2 PCR primer regions.Scientific reports · 2022Article
- Performance Analysis of Self-Collected Nasal and Oral Swabs for Detection of SARS-CoV-2.Diagnostics (Basel, Switzerland) · 2022Article
- Field evaluation of COVID-19 rapid antigen test: Are rapid antigen tests less reliable among the elderly?World journal of clinical cases · 2022Article
- SARS-CoV-2 Antigen Testing Intervals: Twice or Thrice a Week?Diagnostics (Basel, Switzerland) · 2022Article
- Daily, self-test rapid antigen test to assess SARS-CoV-2 viability in de-isolation of patients with COVID-19.Frontiers in medicine · 2022Article
Corrections and comments
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Authors and funding
6 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The SARS-CoV-2 pandemic, which started in December 2019, has been posing significant challenges to the health care system worldwide. As the pandemic spreads with rapidly increasing number of positive cases, early diagnosis of infected patients is crucial to successfully limit the spread of the virus. Although the real-time reverse-transcription polymerase chain reaction (RT-qPCR) is the recommended laboratory method to diagnose COVID-19 infection, many factors such as availability of laboratory equipment, reagents and trained personnel affect the use of time-consuming molecular techniques. To facilitate on-the-spot diagnosis of COVID-19, SARS-CoV-2 rapid antigen tests were developed by several different manufacturers. The evaluation of such rapid tests is particularly important due to the recent unanimous agreement by the European Commission Member States on a recommendation setting out a framework for the use of antigen rapid tests that contains a list of the mutually recognized assays and the basis of independent validation protocols. To evaluate the on-field performance of ten commercially available SARS-CoV-2 antigen rapid tests (CLINITEST Rapid COVID-19 Antigen Test, GenBody COVID-19 Antigen Test, GENEDIA W COVID-19 Ag Test, Healgen Coronavirus Antigen Rapid Test, Humasis COVID-19 Ag Test, VivaDiag SARS-CoV-2 Ag Rapid Test, Helix i-SARS-CoV-2 Ag Rapid Test, Roche SARS-CoV-2 Rapid Antigen Test, Abbot COVID-19 Ag Rapid Test and Vazyme SARS-CoV-2 Antigen Detection Kit) and compare with RT-qPCR as a reference method, the Hungarian National Public Health Center provided 1,597 antigen rapid tests to the National Ambulance Service, COVID-testing trucks and two hospitals treating COVID-19 patients. Sensitivity, specificity and accuracy were determined by performing the rapid test directly from nasopharyngeal swab samples of symptomatic individuals. For strongly positive samples (Ct < 25) sensitivities ranged between 66.7% and 100%, while for positive samples (Ct < 30) they gave a maximum sensitivity of 87.5%. The specificity of the tests was ranging between 79% to 100%. The results presented here are of high importance to the European Commission and also help governmental decision-making regarding the application of the proper rapid tests for screening different at-risk populations. Nonetheless, SARS-Cov-2 rapid tests play an important role in early and on-the-spot diagnosis of potentially infected individuals.
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