罗氏 cobas Liat SARS-CoV-2 & 流感 A/B 检测试剂在鼻腔样本中的临床性能。
Clinical Performance of the cobas Liat SARS-CoV-2 & Influenza A/B Assay in Nasal Samples.
机构信息
Division of Infectious Diseases, Department of Medicine, Tsukuba Medical Center Hospital, 1-3-1 Amakubo Tsukuba, Ibaraki, 305-8558, Japan.
Akashi Clinic of Internal Medicine, 3-1-63 Asahigaoka, Kashiwara, Osaka, 582-0026, Japan.
出版信息
Mol Diagn Ther. 2022 May;26(3):323-331. doi: 10.1007/s40291-022-00580-8. Epub 2022 Apr 7.
BACKGROUND AND OBJECTIVE
Point-of-care type molecular diagnostic tests have been used for detecting SARS-CoV-2, although their clinical utility with nasal samples has yet to be established. This study evaluated the clinical performance of the cobas Liat SARS-CoV-2 & Influenza A/B (Liat) assay in nasal samples.
METHODS
Nasal and nasopharyngeal samples were collected and were tested using the Liat, the cobas 6800 system and the cobas SARS-CoV-2 & Influenza A/B (cobas), and a method developed by National Institute of Infectious Diseases, Japan (NIID).
RESULTS
A total of 814 nasal samples were collected. The Liat assay was positive for SARS-CoV-2 in 113 (13.9%). The total, positive, and negative concordance rate between the Liat and cobas/NIID assays were 99.3%/98.4%, 99.1%/100%, and 99.3%/98.2%, respectively. Five samples were positive only using the Liat assay. Their Ct values ranged from 31.9 to 37.2. The Ct values of the Liat assay were significantly lower (p < 0.001) but were correlated (p < 0.001) with those of other molecular assays. In the participants who tested positive for SARS-CoV-2 on the Liat assay using nasopharyngeal samples, 88.2% of their nasal samples also tested positive using the Liat assay.
CONCLUSION
The Liat assay showed high concordance with other molecular assays in nasal samples. Some discordance occurred in samples with Ct values > 30 on the Liat assay.
背景与目的
即时检测型分子诊断检测已被用于检测 SARS-CoV-2，尽管其在鼻腔样本中的临床应用价值尚未得到证实。本研究评估了 cobas Liat SARS-CoV-2 & Influenza A/B（Liat）检测在鼻腔样本中的临床性能。
方法
采集鼻腔和鼻咽样本，使用 Liat、cobas 6800 系统和 cobas SARS-CoV-2 & Influenza A/B（cobas）以及日本国立传染病研究所（NIID）开发的方法进行检测。
结果
共采集 814 份鼻腔样本。Liat 检测对 SARS-CoV-2 的阳性率为 113（13.9%）。Liat 与 cobas/NIID 检测的总、阳性和阴性符合率分别为 99.3%/98.4%、99.1%/100%和 99.3%/98.2%。5 份样本仅使用 Liat 检测呈阳性。它们的 Ct 值范围为 31.9 至 37.2。Liat 检测的 Ct 值明显较低（p < 0.001），但与其他分子检测呈相关性（p < 0.001）。在使用鼻咽样本进行 Liat 检测对 SARS-CoV-2 呈阳性的参与者中，88.2%的鼻腔样本也使用 Liat 检测呈阳性。
结论
Liat 检测在鼻腔样本中与其他分子检测具有高度一致性。在 Liat 检测 Ct 值>30 的样本中存在一些不一致性。
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