Arbaciauskaite Skaiste, Babakhani Pouya, Sandetskaya Natalia, Vitkus Dalius, Jancoriene Ligita, Karosiene Dovile, Karciauskaite Dovile, Zablockiene Birute, Kuhlmeier Dirk
Department of Diagnostics, Fraunhofer Institute for Cell Therapy and Immunology IZI, Perlickstraße 1, 04103 Leipzig, Germany.
Institute of Cell Biology and Neurobiology, Charité-Universitätsmedizin Berlin, Charitéplatz 1, 10117 Berlin, Germany.
Diagnostics (Basel). 2022 Mar 22;12(4):775. doi: 10.3390/diagnostics12040775.
We assessed the viability of self-sampled gargle water direct RT-LAMP (LAMP) for detecting SARS-CoV-2 infections by estimating its sensitivity with respect to the gold standard indirect RT-PCR of paired oro-nasopharyngeal swab samples. We also assessed the impact of symptom onset to test time (STT)-i.e., symptom days at sampling, on LAMP. In addition, we appraised the viability of gargle water self-sampling versus oro-nasopharyngeal swab sampling, by comparing paired indirect RT-PCR results. 202 oro-nasopharyngeal swab and paired self-sampled gargle water samples were collected from hospital patients with COVID-19 associated symptoms. LAMP, indirect and direct RT-PCR were performed on all gargle water samples, and indirect RT-PCR was performed on all oro-nasopharyngeal samples. LAMP presented a sensitivity of 80.8% (95% CI: 70.8-90.8%) for sample pairs with sub-25 Ct oro-nasopharyngeal indirect RT-PCR results, and 77.6% (66.2-89.1%) sensitivity for sub-30 Ct samples with STT ≤ 7 days. STT, independently of Ct value, correlated negatively with LAMP performance. 80.7% agreement was observed between gargle water and oro-nasopharyngeal indirect RT-PCR results. In conclusion, LAMP presents an acceptable sensitivity for low Ct and low STT samples. Gargle water may be considered as a viable sampling method, and LAMP as a screening method, especially for symptomatic persons with low STT values.
我们通过估计自采样漱口水直接逆转录环介导等温扩增法（LAMP）相对于配对口咽拭子样本的金标准间接逆转录聚合酶链反应（RT-PCR）的敏感性，来评估其检测严重急性呼吸综合征冠状病毒2（SARS-CoV-2）感染的可行性。我们还评估了症状出现至检测时间（STT），即采样时的症状天数，对LAMP的影响。此外，我们通过比较配对的间接RT-PCR结果，评估了漱口水自采样与口咽拭子采样的可行性。从有新型冠状病毒肺炎相关症状的住院患者中收集了202份口咽拭子及配对的自采样漱口水样本。对所有漱口水样本进行LAMP、间接和直接RT-PCR检测，对所有口咽样本进行间接RT-PCR检测。对于口咽间接RT-PCR结果Ct值低于25的样本对，LAMP的敏感性为80.8%（95%置信区间：70.8 - 90.8%）；对于STT≤7天、Ct值低于30的样本，敏感性为77.6%（66.2 - 89.1%）。独立于Ct值之外，STT与LAMP性能呈负相关。漱口水与口咽间接RT-PCR结果之间的一致性为80.7%。总之，LAMP对低Ct值和低STT值的样本具有可接受的敏感性。漱口水可被视为一种可行的采样方法，而LAMP可作为一种筛查方法，尤其适用于STT值较低的有症状者。
