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Accuracy of COVID-19 rapid antigenic tests compared to RT-PCR in a student population: The StudyCov study.
Ferté, Thomas; Ramel, Viviane; Cazanave, Charles; Lafon, Marie-Edith; Bébéar, Cécile; Malvy, Denis; Georges-Walryck, Agnès; Dehail, Patrick.
  • Ferté T; Univ. Bordeaux ISPED, Inserm Bordeaux Population Health Research Center UMR 1219, Inria BSO, team SISTM, F-33000 Bordeaux, France. Electronic address: thomas.ferte@u-bordeaux.fr.
  • Ramel V; Bordeaux Population Health Research Center, Inserm U1219, Université de Bordeaux, 146 rue Léo Saignat, 33076, F-33000, Bordeaux, France; Agence régionale de santé Nouvelle-Aquitaine, 103 bis rue de Belleville, F-33000 Bordeaux, France.
  • Cazanave C; CHU de Bordeaux, Place Amélie Raba Léon, F-33000 Bordeaux, France; Université de Bordeaux, EA 3671, F-33000 Bordeaux, France.
  • Lafon ME; CHU de Bordeaux, Place Amélie Raba Léon, F-33000 Bordeaux, France; de Bordeaux, UMR CNRS 5234, F-33000 Bordeaux, France.
  • Bébéar C; CHU de Bordeaux, Place Amélie Raba Léon, F-33000 Bordeaux, France; Université de Bordeaux, EA 3671, F-33000 Bordeaux, France.
  • Malvy D; Bordeaux Population Health Research Center, Inserm U1219, Université de Bordeaux, 146 rue Léo Saignat, 33076, F-33000, Bordeaux, France; CHU de Bordeaux, Place Amélie Raba Léon, F-33000 Bordeaux, France.
  • Georges-Walryck A; CHU de Bordeaux, Place Amélie Raba Léon, F-33000 Bordeaux, France.
  • Dehail P; Bordeaux Population Health Research Center, Inserm U1219, Université de Bordeaux, 146 rue Léo Saignat, 33076, F-33000, Bordeaux, France; Agence régionale de santé Nouvelle-Aquitaine, 103 bis rue de Belleville, F-33000 Bordeaux, France; CHU de Bordeaux, Place Amélie Raba Léon, F-33000 Bordeaux, Franc
J Clin Virol ; 141: 104878, 2021 Aug.
Article in English | MEDLINE | ID: covidwho-1253161
ABSTRACT

OBJECTIVE:

There is a lack of data evaluating performance of antigenic test (AT) for SARS-CoV-2 diagnosis (Ag-RDT) in clinical practice, especially in asymptomatic subjects. The main objective of this study was to evaluate the diagnostic performance of AT compared to Reverse Transcription Polymerase Chain Reaction (RT-PCR) for SARS-CoV-2 diagnosis.

METHODS:

StudyCov is a monocentric cross-sectional study. A SARS-CoV-2 screening facility was set up in the Bordeaux University health campus from October 28th to November 20th 2020. Students willing to have a RT-PCR test (ARGENE SARS-CoV-2 R-GENE, BioMérieux, France) for SARS-CoV-2 diagnosis were also offered the Abbott Panbio™ SARS-CoV-2 antigenic rapid test. All participants attending the screening facility with an AT in addition to RT-PCR and having signed an informed consent were included in the study. The main objective was to assess performance of AT as compared with RT-PCR in the recruited population. Secondary objectives dealt with the analysis of the main objective stratified by current symptoms and risk exposure. A sensitivity analysis with different RT-PCR cycle thresholds was included.

RESULTS:

RT-PCR and AT results were available for 692 subjects. Overall sensitivity and specificity of AT tests were respectively 63.5% (95% confidence interval (CI) 49.0 - 76.4) and 100% (95% CI 99.4 - 100). In the asymptomatic sub-group, they were respectively 35.0% (95% CI 15.4% - 59.2%) and 100% (95% CI 99.3 - 100).

CONCLUSIONS:

This study shows the poor sensitivity of AT in asymptomatic subjects, specificity being however excellent. The performance results fall below the World Health Organization recommendation of 80% sensitivity and question using AT in general population, especially when asymptomatic.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Type of study: Diagnostic study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal: J Clin Virol Journal subject: Virology Year: 2021 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Type of study: Diagnostic study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal: J Clin Virol Journal subject: Virology Year: 2021 Document Type: Article