1. Urgent need of rapid tests for SARS CoV-2 antigen detection: Evaluation of the SD-Biosensor antigen test for SARS-CoV-2
- Author
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Valeria Ghisetti, Tiziano Allice, Elisa Burdino, Gabriella Gregori, Maria Grazia Milia, Francesco Cerutti, and Bianca Bruzzone
- Subjects
0301 basic medicine ,2019-20 coronavirus outbreak ,Coronavirus disease 2019 (COVID-19) ,Short Communication ,Point-of-care testing ,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ,030106 microbiology ,Biosensing Techniques ,Immunologic Tests ,Real-Time Polymerase Chain Reaction ,Sensitivity and Specificity ,Viral Proteins ,03 medical and health sciences ,Mass-screening ,COVID-19 Testing ,0302 clinical medicine ,Antigen ,Antigen Test ,Nasopharynx ,Virology ,Humans ,Mass Screening ,Medicine ,030212 general & internal medicine ,Antigens, Viral ,Mass screening ,cell culture ,SARS-CoV-2 ,business.industry ,COVID-19 ,Antigen test ,Sars CoV-2 ,Predictive value ,Nucleoproteins ,Infectious Diseases ,Point-of-care-testing ,business - Abstract
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.
- Published
- 2020
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