Objectives This study aimed to evaluate the immunochromatographic coronavirus disease 2019 (COVID-19) speed antigen test (BioSpeedia, France) as an antigen point-of-care test (AgPOCT) to detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection at the paediatric emergency department of the University Hospital of Saint-Etienne in France. Methods Between 15 January and 28 May, 2021, children presenting with respiratory symptoms compatible with COVID-19 infection (symptomatic group) or those requiring hospitalization for any reason (asymptomatic group) were included prospectively and received a nasopharyngeal aspiration to carry out both AgPOCT and quantitative reverse transcription (RT) PCR (RT-qPCR) tests, with the latter being used as the reference standard, for the diagnosis of SARS-CoV-2 infection. Results Among the 1009 enrolled children, we obtained a result from both techniques for 990: 33 (3.3%) tested positive with AgPOCT and 46 (4.6%) with RT-qPCR. The overall sensitivity and specificity of the AgPOCT were 69.6% (95% confidence interval (CI), 54.3–82.3) and 99.9% (95% CI, 99.4–100), respectively, compared with the RT-qPCR. Sensitivity increased to 82.9% (95% CI, 66.4–93.4) in symptomatic children. The mean cycle threshold value was significantly lower in positive samples for AgPOCT than in negative samples in the overall population and in both the symptomatic and asymptomatic groups. Discussion The use of the COVID-19 speed antigen test at the bedside in the emergency department has satisfactory performance for diagnosing SARS-CoV-2 infection in symptomatic children.
【저자키워드】 COVID-19, sensitivity, POCT, paediatric, Diagnosis test, 【초록키워드】 coronavirus disease, SARS-CoV-2, coronavirus, Hospitalization, SARS-COV-2 infection, children, Infection, Antigen, RT-qPCR, PCR, Asymptomatic, Sensitivity and specificity, nasopharyngeal, symptomatic, France, reverse transcription, university, Quantitative, immunochromatographic, reference standard, Cycle threshold value, acute respiratory syndrome, 95% CI, 95% confidence interval, respiratory symptom, diagnosing, positive, significantly lower, positive sample, AgPOCT, objective, negative sample, Result, enrolled, tested, detect, evaluate, groups, presenting, Antigen point-of-care test, diagnosis of SARS-CoV-2, symptomatic and asymptomatic, with COVID-19, 【제목키워드】 SARS-CoV-2, point-of-care, Prospective, antigenic, immunochromatographic test,