Leber Werner, Lammel Oliver, Siebenhofer Andrea, Redlberger-Fritz Monika, Panovska-Griffiths Jasmina, Czypionka Thomas
Centre for Primary Care, Wolfson Institute of Population Health, Barts School of Medicine and Dentistry, Queen Mary University of London, London, UK.
Practice Dr. Lammel, Ramsau am Dachstein, Austria.
EClinicalMedicine. 2021 Aug;38:101011. doi: 10.1016/j.eclinm.2021.101011. Epub 2021 Jul 13.
Testing for COVID-19 with quantitative reverse transcriptase-polymerase chain reaction (RT-PCR) may result in delayed detection of disease. Antigen detection via lateral flow testing (LFT) is faster and amenable to population-wide testing strategies. Our study assesses the diagnostic accuracy of LFT compared to RT-PCR on the same primarycare patients in Austria.
Patients with mild to moderate flu-like symptoms attending a general practice network in an Austrian district (October 22 to November 30, 2020) received clinical assessment including LFT. All suspected COVID-19 cases obtained additional RT-PCR and were divided into two groups: Group 1 (true reactive): suspected cases with reactive LFT and positive RT-PCR; and Group 2 (false non-reactive): suspected cases with a non-reactive LFT but positive RT-PCR.
Of the 2,562 symptomatic patients, 1,037 were suspected of COVID-19 and 826 (79.7%) patients tested RT-PCR positive. Among patients with positive RT-PCR, 788/826 tested LFT reactive (Group 1) and 38 (4.6%) non-reactive (Group 2). Overall sensitivity was 95.4% (95%CI: [94%,96.8%]), specificity 89.1% (95%CI: [86.3%, 91.9%]), positive predictive value 97.3% (95%CI:[95.9%, 98.7%]) and negative predictive value 82.5% (95%CI:[79.8%, 85.2%]). Reactive LFT and positive RT-PCR were positively correlated ( = 0.968,95CI=[0.952,0.985] and , 95%CI=[0.773,0.866]). Reactive LFT was negatively correlated with Ct-value and pre-test symptom duration ( = -0.1299, = 0.0043) while Ct-value was positively correlated with pre-test symptom duration ( = 0.3733), < 0.001).
We show that LFT is an accurate alternative to RT-PCR testing in primary care. We note the importance of administering LFT properly, here combined with clinical assessment in symptomatic patients.
Thomas Czypionka received funding from the European Union's Horizon 2020 Research and Innovation Programe under the grant agreement No 101016233 (PERISCOPE). No further funding was available for this study.
采用定量逆转录聚合酶链反应（RT-PCR）检测2019冠状病毒病（COVID-19）可能会导致疾病检测延迟。通过侧向流动检测（LFT）进行抗原检测速度更快，且适合大规模人群检测策略。我们的研究评估了在奥地利同一基层医疗患者中，LFT与RT-PCR相比的诊断准确性。
2020年10月22日至11月30日期间，在奥地利某地区一家全科医疗网络就诊的有轻至中度流感样症状的患者接受了包括LFT在内的临床评估。所有疑似COVID-19病例均进行了额外的RT-PCR检测，并分为两组：第1组（真正反应性）：LFT反应性且RT-PCR阳性的疑似病例；第2组（假阴性）：LFT无反应但RT-PCR阳性的疑似病例。
在2562名有症状的患者中，1037名疑似感染COVID-19，826名（79.7%）患者RT-PCR检测呈阳性。在RT-PCR检测呈阳性的患者中，788/826例LFT检测呈反应性（第1组），38例（4.6%）无反应（第2组）。总体敏感性为95.4%（95%CI：[94%，96.8%]），特异性为89.1%（95%CI：[86.3%，91.9%]），阳性预测值为97.3%（95%CI：[95.9%，98.7%]），阴性预测值为82.5%（9%CI：[79.8%，85.2%]）。LFT反应性与RT-PCR阳性呈正相关（r = 0.968，95%CI = [0.952，0.985]）。LFT反应性与Ct值（r = -0.1299，P = 0.0043）和检测前症状持续时间呈负相关，而Ct值与检测前症状持续时间呈正相关（r = 0.3733，P < 0.001）。
我们表明，在基层医疗中，LFT是RT-PCR检测的一种准确替代方法。我们指出了正确进行LFT检测的重要性，在此与有症状患者的临床评估相结合。
托马斯·齐皮翁卡获得了欧盟“地平线2020”研究与创新计划的资助，资助协议编号为101016233（PERISCOPE）。本研究没有其他可用资金。
