Wertenauer Christoph, Dressel Alexander, Wieland Eberhard, Wertenauer Hans-Jörg, Braitmaier Helmine, Straub Anna, Helfert Stefan, Lützner Nicolas, März Winfried
Medical Clinic V, Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany.
Hausärzte am Schillerplatz, Stuttgart, Germany.
Front Med (Lausanne). 2024 Apr 16;11:1352633. doi: 10.3389/fmed.2024.1352633. eCollection 2024.
This study is the extension of the COVAG study. We compared two RATs, the Panbio COVID-19 Ag Rapid Test (Abbott) and the SD Biosensor Q SARS-CoV-2 Rapid Antigen Test (Roche), against RT-PCR on the foil of new variants.
We included 888 all-comers at a diagnostic center between October 20, 2021, and March 18, 2022. RT-PCR-positive samples with a Ct value ≤32 were examined for SARS-CoV-2 variants.
The sensitivity of the Abbott-RAT and Roche-RAT were 65 and 67%, respectively. For both RATs, lower Ct values were significantly correlated with higher sensitivity. For samples with Ct values ≤25, the sensitivities of the Roche-RAT and of the Abbott-RAT were 96 and 95%, for Ct values 25-30 both were 19%, and for Ct values ≥30 they were 6 and 2%, respectively. The RATs had substantially higher sensitivities in symptomatic than asymptomatic participants (76, 77%, vs. 29, 31%, for Abbott-RAT, Roche-RAT, respectively) and in participants referred to testing by their primary care physician (84, 85%) compared to participants who sought testing due to referral by the health department (55, 58%) or a warning by the Corona-Warn-App (49, 49%). In persons with self-reported previous COVID-19 sensitivities were markedly lower than in patients without previous COVID-19: 27% vs. 75% for Roche-RAT and 27% vs. 73% for Abbott-RAT. We did not find significant correlation between vaccination status and sensitivity. The Omicron variant was detected with a sensitivity of 94 and 92%, the delta variant with a sensitivity of 80 and 80% for Abbott-RAT and Roche-RAT, respectively. This difference is attributable to the lower Ct values of the Omicron samples compared to the Delta samples. When adjusted for the Ct value, a multivariate logistic regression did not show a significant difference between Omicron and Delta. In terms of sensitivity, we found no significant difference between the wild-type and the Omicron and Delta variants, but a significantly lower sensitivity to the alpha variant compared to the other variants.The specificities were > 99% overall.
本研究是COVAG研究的扩展。我们比较了两种快速抗原检测（RAT），即Panbio新冠病毒抗原快速检测（雅培）和SD生物传感器Q SARS-CoV-2快速抗原检测（罗氏），与针对新变种病毒的逆转录聚合酶链反应（RT-PCR）检测在新变种病毒样本上的表现。
我们纳入了2021年10月20日至2022年3月18日期间在一个诊断中心的888名前来就诊者。对逆转录聚合酶链反应检测呈阳性且Ct值≤32的样本进行SARS-CoV-2变种病毒检测。
雅培快速抗原检测和罗氏快速抗原检测的灵敏度分别为65%和67%。对于这两种快速抗原检测，较低的Ct值与较高的灵敏度显著相关。对于Ct值≤25的样本，罗氏快速抗原检测和雅培快速抗原检测的灵敏度分别为96%和95%；对于Ct值为25 - 30的样本，两者均为19%；对于Ct值≥30的样本，分别为6%和2%。快速抗原检测在有症状参与者中的灵敏度显著高于无症状参与者（雅培快速抗原检测分别为76%和77%，罗氏快速抗原检测分别为29%和31%），在由初级保健医生转诊来进行检测的参与者中的灵敏度（84%和85%）高于因卫生部门转诊（55%和58%）或新冠预警应用程序提示（49%和49%）而前来检测的参与者。在自我报告曾感染过新冠病毒的人群中，检测灵敏度明显低于未曾感染过新冠病毒的患者：罗氏快速抗原检测分别为27%和75%，雅培快速抗原检测分别为27%和73%。我们未发现疫苗接种状态与检测灵敏度之间存在显著相关性。奥密克戎变种病毒的检测灵敏度，雅培快速抗原检测为94%，罗氏快速抗原检测为92%；德尔塔变种病毒的检测灵敏度，雅培快速抗原检测和罗氏快速抗原检测均为80%。这种差异归因于奥密克戎样本的Ct值低于德尔塔样本。在对Ct值进行调整后，多因素逻辑回归分析显示奥密克戎和德尔塔变种病毒之间无显著差异。在灵敏度方面，我们发现野生型与奥密克戎和德尔塔变种病毒之间无显著差异，但与其他变种病毒相比，对阿尔法变种病毒的检测灵敏度显著较低。总体特异性均>99%。
