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10.1016/j.jcv.2021.104878

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suck abstract from ncbi


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pmid34134035      J+Clin+Virol 2021 ; 141 (ä): 104878
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  • Accuracy of COVID-19 rapid antigenic tests compared to RT-PCR in a student population: The StudyCov study #MMPMID34134035
  • Ferte T; Ramel V; Cazanave C; Lafon ME; Bebear C; Malvy D; Georges-Walryck A; Dehail P
  • J Clin Virol 2021[Aug]; 141 (ä): 104878 PMID34134035show ga
  • 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, BioMerieux, 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.
  • |*COVID-19[MESH]
  • |COVID-19 Testing[MESH]
  • |Cross-Sectional Studies[MESH]
  • |Humans[MESH]
  • |Reverse Transcriptase Polymerase Chain Reaction[MESH]
  • |SARS-CoV-2[MESH]
  • |Sensitivity and Specificity[MESH]


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