tetano
Editor, Senior Moderator
J Med Virol
. 2021 Feb 21.
doi: 10.1002/jmv.26896. Online ahead of print.
High performance of a novel antigen detection test on nasopharyngeal specimens for diagnosing SARS-CoV-2 infection
L Courtellemont[SUP] 1 [/SUP], J Guinard[SUP] 1 [/SUP], C Guillaume[SUP] 1 [/SUP], S Giach?[SUP] 2 [/SUP], V Rzepecki[SUP] 2 [/SUP], A Seve[SUP] 2 [/SUP], C Gubavu[SUP] 2 [/SUP], K Baud[SUP] 2 [/SUP], C Le Helloco[SUP] 2 [/SUP], G N Cassuto[SUP] 3 [/SUP], G Pialoux[SUP] 4 [/SUP], L Hocqueloux[SUP] 2 [/SUP], T Prazuck[SUP] 2 [/SUP]
Affiliations
Abstract
Introduction: The SARS-CoV-2 pandemic has become a major public health issue worldwide. Developing and evaluating rapid and easy-to-perform diagnostic tests is a high priority. The current study was designed to assess the diagnostic performance of an antigen-based rapid detection test (COVID-VIRO?) in a real-life setting.
Methods: Two nasopharyngeal specimens of symptomatic or asymptomatic adult patients hospitalized in the Infectious Diseases Department or voluntarily accessing the COVID-19 Screening Department of the Regional Hospital of Orl?ans, France, were concurrently collected. The diagnostic specificity and sensitivity of COVID VIRO? results were compared to those of real-time reverse transcriptase quantitative polymerase chain reaction (RT-qPCR) results. A subset of patients underwent an additional oropharyngeal and/or saliva swab for rapid testing.
Results: A total of 121 patients confirmed to be infected and 127 patients having no evidence of recent or ongoing infection were enrolled for a total of 248 nasopharyngeal swab specimens. Overall, the COVID-VIRO? sensitivity was 96.7% (IC: 93.5%-99.9%). In asymptomatic patients, symptomatic patients having symptoms for more than 4 days and those with an RT-qPCR cycle threshold value ≥32, the sensitivities were 100%, 95.8% and 91.9%, respectively. The concordance between RT-qPCR and COVID VIRO? rapid test results was 100% for the 127 patients with no SARS-CoV-2 infection.
Conclusion: The COVID-VIRO? test had 100% specificity and a sensitivity greater than 95%, which are better than the recommendations set forth by the WHO (specificity ≥97-100%, sensitivity ≥80%). These rapid tests may be particularly useful for large-scale screening in emergency departments, low-resource settings and airports. This article is protected by copyright. All rights reserved.
Keywords: Chromatographic techniques < Research and Analysis Methods; Local infection/Replication/Spread < Pathogenesis; SARS coronavirus < Virus classification.
. 2021 Feb 21.
doi: 10.1002/jmv.26896. Online ahead of print.
High performance of a novel antigen detection test on nasopharyngeal specimens for diagnosing SARS-CoV-2 infection
L Courtellemont[SUP] 1 [/SUP], J Guinard[SUP] 1 [/SUP], C Guillaume[SUP] 1 [/SUP], S Giach?[SUP] 2 [/SUP], V Rzepecki[SUP] 2 [/SUP], A Seve[SUP] 2 [/SUP], C Gubavu[SUP] 2 [/SUP], K Baud[SUP] 2 [/SUP], C Le Helloco[SUP] 2 [/SUP], G N Cassuto[SUP] 3 [/SUP], G Pialoux[SUP] 4 [/SUP], L Hocqueloux[SUP] 2 [/SUP], T Prazuck[SUP] 2 [/SUP]
Affiliations
- PMID: 33615487
- DOI: 10.1002/jmv.26896
Abstract
Introduction: The SARS-CoV-2 pandemic has become a major public health issue worldwide. Developing and evaluating rapid and easy-to-perform diagnostic tests is a high priority. The current study was designed to assess the diagnostic performance of an antigen-based rapid detection test (COVID-VIRO?) in a real-life setting.
Methods: Two nasopharyngeal specimens of symptomatic or asymptomatic adult patients hospitalized in the Infectious Diseases Department or voluntarily accessing the COVID-19 Screening Department of the Regional Hospital of Orl?ans, France, were concurrently collected. The diagnostic specificity and sensitivity of COVID VIRO? results were compared to those of real-time reverse transcriptase quantitative polymerase chain reaction (RT-qPCR) results. A subset of patients underwent an additional oropharyngeal and/or saliva swab for rapid testing.
Results: A total of 121 patients confirmed to be infected and 127 patients having no evidence of recent or ongoing infection were enrolled for a total of 248 nasopharyngeal swab specimens. Overall, the COVID-VIRO? sensitivity was 96.7% (IC: 93.5%-99.9%). In asymptomatic patients, symptomatic patients having symptoms for more than 4 days and those with an RT-qPCR cycle threshold value ≥32, the sensitivities were 100%, 95.8% and 91.9%, respectively. The concordance between RT-qPCR and COVID VIRO? rapid test results was 100% for the 127 patients with no SARS-CoV-2 infection.
Conclusion: The COVID-VIRO? test had 100% specificity and a sensitivity greater than 95%, which are better than the recommendations set forth by the WHO (specificity ≥97-100%, sensitivity ≥80%). These rapid tests may be particularly useful for large-scale screening in emergency departments, low-resource settings and airports. This article is protected by copyright. All rights reserved.
Keywords: Chromatographic techniques < Research and Analysis Methods; Local infection/Replication/Spread < Pathogenesis; SARS coronavirus < Virus classification.