Università degli Studi di Milano, Milano, Italy.
Università degli Studi di Milano, Milano, Italy; Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milano, Italy.
Diagn Microbiol Infect Dis. 2022 Apr;102(4):115635. doi: 10.1016/j.diagmicrobio.2022.115635. Epub 2022 Jan 16.
Use of antigen tests for the diagnosis of COVID-19 has become widespread. The aim of this study was to evaluate the diagnostic accuracy of the nasopharyngeal rapid antigen diagnostic (RAD) immunoassay LumiraDx UK in an Emergency Department (ED). All patients admitted to our ED between November 11 and December 8, 2020, and had both a RAD test and a real-time-reverse-transcription-polymerase-chain-reaction (RT-PCR) test were enrolled. RAD was considered as the index test and RT-PCR test was used as the reference standard. Sensitivity, specificity, negative and positive predictive values, and likelihood ratios were calculated with the 95% confidence interval. The sensitivity and specificity of RAD were 34.2% and 92.3%. Positive and negative likelihood ratios were 4.4 and 0.71. Our results demonstrate that the diagnostic accuracy of the LumiraDx RAD test is too low for routine use as a diagnostic method in the ED.
抗原检测在 COVID-19 的诊断中已得到广泛应用。本研究旨在评估鼻咽部快速抗原诊断(RAD)免疫测定 LumiraDx UK 在急诊科(ED)的诊断准确性。2020 年 11 月 11 日至 12 月 8 日期间,所有收入我院 ED 的患者均进行了 RAD 检测和实时逆转录-聚合酶链反应(RT-PCR)检测。RAD 检测被视为指标检测,而 RT-PCR 检测被作为参考标准。采用 95%置信区间计算敏感度、特异度、阴性和阳性预测值以及似然比。RAD 的敏感度和特异度分别为 34.2%和 92.3%。阳性和阴性似然比分别为 4.4 和 0.71。我们的结果表明,LumiraDx RAD 检测的诊断准确性过低,不适合在 ED 常规用作诊断方法。