Urgent need of rapid tests for SARS CoV-2 antigen detection: Evaluation of the SD-Biosensor antigen test for SARS-CoV-2

At the time of writing, FIND has listed four CE-marked SARSCoV-2 antigen tests. We evaluated the recently CE-approved rapid POCT SD-Biosensor for SARS-CoV-2 nucleoprotein detection in nasopharyngeal secretions from 330 patients admitted to the Emergency Room for a suspect of COVID-19 and travelers r...

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Bibliographic Details
Published in:Journal of clinical virology 2020-11, Vol.132, p.104654-104654, Article 104654
Main Authors: Cerutti, Francesco, Burdino, Elisa, Milia, Maria Grazia, Allice, Tiziano, Gregori, Gabriella, Bruzzone, Bianca, Ghisetti, Valeria
Format: Article
Language:English
Subjects:
Antigen test
Antigens, Viral - analysis
Biosensing Techniques - methods
Cell culture
COVID-19 - diagnosis
COVID-19 Testing - methods
Humans
Immunologic Tests
Mass Screening
Nasopharynx - virology
Nucleoproteins - analysis
Point-of-care-testing
Real-Time Polymerase Chain Reaction
SARS-CoV-2
Sensitivity and Specificity
Short Communication
Viral Proteins - analysis
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Summary:At the time of writing, FIND has listed four CE-marked SARSCoV-2 antigen tests. We evaluated the recently CE-approved rapid POCT SD-Biosensor for SARS-CoV-2 nucleoprotein detection in nasopharyngeal secretions from 330 patients admitted to the Emergency Room for a suspect of COVID-19 and travelers returning home from high risk countries. Sensitivity, specificity, accuracy, negative and predictive values were consistent with the use of the test to mass-screening for SARS-CoV-2 surveillance.
ISSN:1386-6532
1873-5967
DOI:10.1016/j.jcv.2020.104654