A Prospective Evaluation of the Analytical Performance of GENECUBE(®) HQ SARS-CoV-2 and GENECUBE(®) FLU A/B.
A Prospective Evaluation of the Analytical Performance of GENECUBE(®) HQ SARS-CoV-2 and GENECUBE(®) FLU A/B.
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DOI：
10.1007/s40291-021-00535-5
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发表时间：
2021-07
影响因子：
4
通讯作者：
Suzuki H
中科院分区：
文献类型：
--
作者：
Kiyasu Y;Akashi Y;Sugiyama A;Takeuchi Y;Notake S;Naito A;Nakamura K;Ishikawa H;Suzuki H
分子检测是检测严重急性呼吸综合征冠状病毒2 （SARS-CoV-2）的主要方法。然而，由于检测时间长，无法一次对多个样品进行评估，其可及性受到限制。本研究评价了新开发的GENECUBE®HQ SARS-CoV-2和GENECUBE®FLU A/B快速分子检测方法的分析性能。这项前瞻性研究于2020年12月14日至2021年1月9日在聚合酶链反应（PCR）中心进行。用蜂群拭子从鼻咽采集样本。采用GENECUBE®系统和参考反转录(RT)-PCR进行分子检测，并比较两种检测结果。1065份样本中，81份（7.6%）经对照RT-PCR检测为SARS-CoV-2阳性。其中3例显示GENECUBE®HQ SARS-CoV-2与对照RT-PCR不一致；两种检测方法的总一致性、阳性和阴性样本分别为99.7%、100%和99.7%。所有不一致的病例均为GENECUBE®HQ SARS-CoV-2阳性，参考RT-PCR阴性。使用另一种SARS-CoV-2分子测定法在所有三个样本中检测到SARS-CoV-2。对于GENECUBE®FLU A/B，两项检测的总阳性和阴性样本的一致性分别为99.5%、100%和99.1%。GENECUBE®HQ SARS-CoV-2和GENECUBE®FLU A/B在检测SARS-CoV-2和流感病毒A/B方面表现出足够的分析性能。在线版本包含补充材料，可在10.1007/s40291-021-00535-5获得。
Molecular tests are the mainstay of detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). However, their accessibility can be limited by the long examination time and inability to evaluate multiple samples at once. This study evaluated the analytical performance of the newly developed rapid molecular assays GENECUBE® HQ SARS-CoV-2 and GENECUBE® FLU A/B. This prospective study was conducted between 14 December 2020 and 9 January 2021 at a polymerase chain reaction (PCR) center. Samples were collected from the nasopharynx with flocked swabs. Molecular tests were performed with the GENECUBE® system and reference reverse transcription (RT)-PCR, and the results of the two assays were compared. Among 1065 samples, 81 (7.6%) were positive for SARS-CoV-2 on the reference RT-PCR. Three showed discordance between GENECUBE® HQ SARS-CoV-2 and the reference RT-PCR; the total, positive, and negative samples of concordance for the two assays were 99.7%, 100%, and 99.7%, respectively. All discordant cases were positive with GENECUBE® HQ SARS-CoV-2 and negative with the reference RT-PCR. SARS-CoV-2 was detected in all three samples using another molecular assay for SARS-CoV-2. For GENECUBE® FLU A/B, the total, positive, and negative samples of concordance for the two assays were 99.5%, 100%, and 99.1%. The GENECUBE® HQ SARS-CoV-2 and GENECUBE® FLU A/B demonstrated sufficient analytical performance to detect SARS-CoV-2 and influenza virus A/B. The online version contains supplementary material available at 10.1007/s40291-021-00535-5.
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影响因子：
3
作者：
Morinaga, Yoshitomo;Suzuki, Hiromichi;Yanagihara, Katsunori
通讯作者：
Yanagihara, Katsunori
DOI：
10.1016/j.jmoldx.2020.11.007
发表时间：
2021-03
期刊：
The Journal of molecular diagnostics : JMD
影响因子：
--
作者：
Matsumura Y;Shimizu T;Noguchi T;Nakano S;Yamamoto M;Nagao M
通讯作者：
Nagao M
影响因子：
14.2
作者：
Pasomsub, E.;Watcharananan, S. P.;Phuphuakrat, A.
通讯作者：
Phuphuakrat, A.
影响因子：
2.2
作者：
Hayashi, Daisuke;Akashi, Yusaku;Imai, Hironori
通讯作者：
Imai, Hironori
影响因子：
3.7
作者：
Hida, Yukio;Uemura, Keiichi;Suzuki, Hiromichi
通讯作者：
Suzuki, Hiromichi