Clinical Performance of the cobas Liat SARS-CoV-2 & Influenza A/B Assay in Nasal Samples.
Clinical Performance of the cobas Liat SARS-CoV-2 & Influenza A/B Assay in Nasal Samples.
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DOI：
10.1007/s40291-022-00580-8
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发表时间：
2022-05
影响因子：
4
通讯作者：
Suzuki H
中科院分区：
文献类型：
--
作者：
Akashi Y;Horie M;Kiyotaki J;Takeuchi Y;Togashi K;Adachi Y;Ueda A;Notake S;Nakamura K;Terada N;Kurihara Y;Kiyasu Y;Suzuki H
护理点型分子诊断测试已用于检测 SARS-CoV-2，但其在鼻腔样本中的临床应用尚未确定。本研究评估了 cobas Liat SARS-CoV-2 和 A/B 型流感 (Liat) 检测在鼻腔样本中的临床表现。收集鼻腔和鼻咽样本，并使用 Liat、cobas 6800 系统和 cobas SARS-CoV-2 和流感 A/B (cobas) 以及日本国家传染病研究所 (NIID) 开发的方法进行测试。总共收集了814份鼻腔样本。 Liat 检测结果显示 113 例 (13.9%) 的 SARS-CoV-2 呈阳性。 Liat 和 cobas/NIID 检测之间的总一致性、阳性一致性和阴性一致性分别为 99.3%/98.4%、99.1%/100% 和 99.3%/98.2%。仅使用 Liat 检测，五个样品呈阳性。它们的 Ct 值范围为 31.9 至 37.2。 Liat 测定的 Ct 值显着较低 (p < 0.001)，但与其他分子测定的 Ct 值相关 (p < 0.001)。在使用鼻咽样本进行 Liat 检测检测出 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。 Liat 检测结果与鼻腔样本中的其他分子检测结果高度一致。 Liat 检测中 Ct 值 > 30 的样品中出现了一些不一致。在线版本包含可在 10.1007/s40291-022-00580-8 获取的补充材料。
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. 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). 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. 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. The online version contains supplementary material available at 10.1007/s40291-022-00580-8.
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影响因子：
9.4
作者：
Lee RA;Herigon JC;Benedetti A;Pollock NR;Denkinger CM
通讯作者：
Denkinger CM
影响因子：
3.7
作者：
Mizoguchi M;Harada S;Okamoto K;Higurashi Y;Ikeda M;Moriya K
通讯作者：
Moriya K
影响因子：
9.4
作者：
Mostafa HH;Carroll KC;Hicken R;Berry GJ;Manji R;Smith E;Rakeman JL;Fowler RC;Leelawong M;Butler-Wu SM;Quintero D;Umali-Wilcox M;Kwiatkowski RW;Persing DH;Weir F;Loeffelholz MJ
通讯作者：
Loeffelholz MJ
影响因子：
4.6
作者：
Takeuchi Y;Akashi Y;Kato D;Kuwahara M;Muramatsu S;Ueda A;Notake S;Nakamura K;Ishikawa H;Suzuki H
通讯作者：
Suzuki H
影响因子：
9.4
作者：
Craney, Arryn R.;Velu, Priya D.;Westblade, Lars F.
通讯作者：
Westblade, Lars F.