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雅培 ID Now COVID-19 快速核酸扩增检测试剂使用鼻咽拭子和干鼻拭子在纽约市学术机构中运输的病毒运输介质的性能。

Performance of Abbott ID Now COVID-19 Rapid Nucleic Acid Amplification Test Using Nasopharyngeal Swabs Transported in Viral Transport Media and Dry Nasal Swabs in a New York City Academic Institution.

机构信息

NYU Grossman School of Medicine, Department of Pathology, New York, New York, USA.

NYU Langone Health, Tisch Hospital, New York, New York, USA.

出版信息

J Clin Microbiol. 2020 Jul 23;58(8). doi: 10.1128/JCM.01136-20.

Abstract

The recent emergence of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has posed formidable challenges for clinical laboratories seeking reliable laboratory diagnostic confirmation. The swift advance of the crisis in the United States has led to Emergency Use Authorization (EUA) facilitating the availability of molecular diagnostic assays without the more rigorous examination to which tests are normally subjected prior to FDA approval. Our laboratory currently uses two real-time reverse transcription-PCR (RT-PCR) platforms, the Roche Cobas SARS-CoV2 and the Cepheid Xpert Xpress SARS-CoV-2. The two platforms demonstrate comparable performances; however, the run times for each assay are 3.5 h and 45 min, respectively. In search for a platform with a shorter turnaround time, we sought to evaluate the recently released Abbott ID Now COVID-19 assay, which is capable of producing positive results in as little as 5 min. We present here the results of comparisons between Abbott ID Now COVID-19 and Cepheid Xpert Xpress SARS-CoV-2 using nasopharyngeal swabs transported in viral transport media and comparisons between Abbott ID Now COVID-19 and Cepheid Xpert Xpress SARS-CoV-2 using nasopharyngeal swabs transported in viral transport media for Cepheid and dry nasal swabs for Abbott ID Now. Regardless of method of collection and sample type, Abbott ID Now COVID-19 had negative results in a third of the samples that tested positive by Cepheid Xpert Xpress when using nasopharyngeal swabs in viral transport media and 45% when using dry nasal swabs.

摘要

严重急性呼吸综合征冠状病毒 2(SARS-CoV-2)大流行的最近出现给寻求可靠实验室诊断确认的临床实验室带来了巨大挑战。美国危机的迅速发展导致紧急使用授权(EUA)促进了分子诊断检测的可用性,而这些检测通常在获得 FDA 批准之前不会接受更严格的检查。我们的实验室目前使用两种实时逆转录聚合酶链反应(RT-PCR)平台,罗氏 Cobas SARS-CoV2 和 Cepheid Xpert Xpress SARS-CoV-2。这两个平台表现出相当的性能;然而,每个检测的运行时间分别为 3.5 小时和 45 分钟。为了寻找一个具有更短周转时间的平台,我们试图评估最近发布的 Abbott ID Now COVID-19 检测,它能够在 5 分钟内产生阳性结果。我们在此介绍使用运送于病毒运输介质的鼻咽拭子的 Abbott ID Now COVID-19 与 Cepheid Xpert Xpress SARS-CoV-2 之间的比较结果,以及使用运送于病毒运输介质的鼻咽拭子的 Abbott ID Now COVID-19 与 Cepheid Xpert Xpress SARS-CoV-2 之间的比较结果和 Abbott ID Now 的干鼻拭子。无论采集方法和样本类型如何,使用病毒运输介质中的鼻咽拭子时,Abbott ID Now COVID-19 在 Cepheid Xpert Xpress 检测为阳性的三分之一样本中结果为阴性,而使用干鼻拭子时为 45%。

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本文引用的文献

1
Comparison of Cepheid Xpert Xpress and Abbott ID Now to Roche cobas for the Rapid Detection of SARS-CoV-2.
J Clin Virol. 2020 Jul;128:104428. doi: 10.1016/j.jcv.2020.104428. Epub 2020 May 13.
2
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J Clin Microbiol. 2020 Jul 23;58(8). doi: 10.1128/JCM.00926-20.
6
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J Clin Microbiol. 2020 Jul 23;58(8). doi: 10.1128/JCM.00783-20.
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Emerging SARS-CoV-2 mutation hot spots include a novel RNA-dependent-RNA polymerase variant.
J Transl Med. 2020 Apr 22;18(1):179. doi: 10.1186/s12967-020-02344-6.
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Diagnostic Testing for Severe Acute Respiratory Syndrome-Related Coronavirus 2: A Narrative Review.
Ann Intern Med. 2020 Jun 2;172(11):726-734. doi: 10.7326/M20-1301. Epub 2020 Apr 13.

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