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

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
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DOI:
10.1128/jcm.01136-20
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发表时间:
2020-08-01
影响因子:
9.4
通讯作者:
Aguero-Rosenfeld, Maria E.
Aguero-Rosenfeld, Maria E.
中科院分区:
医学2区
文献类型:
--
作者:
Basu, Atreyee;Zinger, Tatyana;Aguero-Rosenfeld, Maria E.

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最近出现的严重急性呼吸综合征冠状病毒2 (SARS-CoV-2)大流行给寻求可靠的实验室诊断确认的临床实验室带来了巨大挑战。在美国,危机的迅速发展导致紧急使用授权(EUA)促进了分子诊断分析的可用性,而不需要在FDA批准之前进行更严格的检查。我们的实验室目前使用两个实时逆转录pcr (RT-PCR)平台,Roche Cobas SARS-CoV2和Cepheid Xpert Xpress SARS-CoV-2。这两个平台的性能相当;然而,每个检测的运行时间分别为3.5小时和45分钟。为了寻找周转时间更短的平台,我们试图评估最近发布的雅培ID Now COVID-19检测,该检测能够在短短5分钟内产生阳性结果。我们在此介绍了用病毒转运介质运输的雅培ID Now COVID-19和造父变星Xpert Xpress SARS-CoV-2的鼻咽拭子对雅培ID Now和用造父变星病毒转运介质运输的鼻咽拭子对雅培ID Now的比较结果。无论采集方法和样本类型如何,在造父变星Xpert Xpress测试中,在病毒运输介质中使用鼻咽拭子检测为阳性的样本中,有三分之一的雅培ID Now COVID-19呈阴性,在使用干鼻拭子检测时为45%。
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.