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.
Keywords: COVID19; Point-of-care testing; Rapid antigen detection test; Rt-pcr; Sars-cov-2.
【저자키워드】 SARS-CoV-2, COVID19, RT-PCR, point-of-care testing, rapid antigen detection test, 【초록키워드】 SARS-CoV-2, cross-sectional, diagnostic, Diagnosis, risk, Symptom, RT-PCR, reverse transcription polymerase chain reaction, polymerase chain reaction, sensitivity, specificity, Health, cross-sectional study, Asymptomatic, Rapid test, Sensitivity and specificity, cycle threshold, Rapid, France, sensitivity analysis, Informed consent, General population, antigen detection, Ag-RDT, university, Clinical practice, RT-PCR test, Analysis, bioMérieux, Abbott, Health Organization, Chain Reaction, Bordeaux, World Health Organization, student, 95% CI, reaction, 95% confidence interval, All participants, asymptomatic subjects, chain, antigenic, Secondary objectives, lack, evaluate, recruited, addition, question, subjects, stratified, All participant, offered, Secondary objective, 【제목키워드】 COVID-19, rapid antigenic test,