■本研究是COVAG研究的扩展。我们比较了两种RAT,PanbioCOVID-19Ag快速测试(雅培)和SD生物传感器QSARS-CoV-2快速抗原测试(罗氏),针对新变体的箔上的RT-PCR。
■我们在2021年10月20日至2022年3月18日期间在诊断中心纳入了888名全体人员。检查了Ct值≤32的RT-PCR阳性样品中的SARS-CoV-2变体。
■雅培RAT和罗氏RAT的灵敏度分别为65%和67%,分别。对于两种RAT,较低的Ct值与较高的敏感性显著相关。对于Ct值≤25的样品,罗氏RAT和雅培RAT的敏感性分别为96%和95%,对于Ct值25-30,两者均为19%,对于Ct值≥30,它们分别为6%和2%,分别。与无症状参与者相比,RAT在有症状参与者中的敏感性明显更高(76%,77%,vs.29,31%,对于Abbott-RAT,罗氏RAT,分别)和由初级保健医师转诊的参与者(84,85%),而由于卫生部门的转诊(55,58%)或Corona-Warn-App的警告而寻求检测的参与者(49,49%)。在自我报告以前的COVID-19患者中,敏感性明显低于没有以前的COVID-19的患者:27%75%的罗氏RAT和27%与Abbott-RAT的73%。我们没有发现疫苗接种状态和敏感性之间的显著相关性。检测到Omicron变体的灵敏度为94%和92%,对雅培-RAT和罗氏-RAT的敏感性为80%和80%的δ变体,分别。这种差异归因于与Delta样品相比,O微米样品的Ct值较低。当针对Ct值进行调整时,多变量逻辑回归未显示Omicron和Delta之间的显著差异.在敏感度方面,我们发现野生型与Omicron和Delta变体之间没有显着差异,但与其他变体相比,对α变体的敏感性明显较低。总体特异性>99%。
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.