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. 2020 Nov:132:104654.
doi: 10.1016/j.jcv.2020.104654. Epub 2020 Sep 29.

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

Francesco Cerutti  1 , Elisa Burdino  1 , Maria Grazia Milia  1 , Tiziano Allice  1 , Gabriella Gregori  1 , Bianca Bruzzone  2 , Valeria Ghisetti  3
Affiliations

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

Francesco Cerutti et al. J Clin Virol. 2020 Nov.

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.

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Conflict of interest statement

The authors report no declarations of interest.

Figures

Fig. 1
Fig. 1
Mean Ct across viral genes values for SD-Biosensor antigen (R-Ag) positive and negative tests in studied samples. A subset of R-Ag negative/RT-PCR positive samples were subjected to viral cell culture with negative results after 21-days of incubation.
Fig. 2
Fig. 2
ROC curve of sensitivity and specificity of the SD-Biosensor antigen (R-Ag) test in studied samples.
See this image and copyright information in PMC

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