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

J Clin Virol. 2020 Nov;132:104654. doi: 10.1016/j.jcv.2020.104654. Epub 2020 Sep 29.

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.

Keywords: Antigen test; Cell culture; Mass-screening; Point-of-care-testing; Sars CoV-2.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antigens, Viral / analysis*
  • Biosensing Techniques / methods*
  • COVID-19 / diagnosis*
  • COVID-19 Testing / methods*
  • Humans
  • Immunologic Tests
  • Mass Screening
  • Nasopharynx / virology
  • Nucleoproteins / analysis
  • Real-Time Polymerase Chain Reaction
  • SARS-CoV-2*
  • Sensitivity and Specificity
  • Viral Proteins / analysis

Substances

  • Antigens, Viral
  • Nucleoproteins
  • Viral Proteins