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新型基于等温扩增的新冠病毒诊断方法雅培ID NOW与逆转录聚合酶链反应的比较。

Comparison of Abbott ID NOW, a novel isothermal amplification based COVID-19 diagnostic method with RTPCR.

作者信息

Srivastava Smriti, Singh Parul, Malhotra Rajesh, Mathur Purva

机构信息

Department of Microbiology, Jai Prakash Narayan Apex Trauma Centre, All India Institute of Medical Sciences, New Delhi, India.

Department of Orthopaedics, All India Institute of Medical Sciences New Delhi, India.

出版信息

J Virol Methods. 2022 Jun;304:114521. doi: 10.1016/j.jviromet.2022.114521. Epub 2022 Mar 9.

Abstract

BACKGROUND

The emergent crisis of the COVID-19 pandemic has posed enormous challenges for clinical laboratories to speed up diagnostics. The current reference standard for the diagnosis of COVID-19 is real time reverse transcriptase PCR on various platforms. However, even with automation, the turnaround time is huge enough to keep up with ever increasing numbers of patients. With increasing surge of COVID cases we need rapid diagnostic tests with good sensitivity and specificity.

OBJECTIVES

Comparison between Abbott ID NOW COVID-19 and real time reverse transcriptase PCR as a reference method.

MATERIALS AND METHODS

Specimens from seventy-two individuals were obtained over a period of two months which were processed for ID NOW and RTPCR at a dedicated COVID-19 centre of AIIMS. Dry nasal swabs were used for ID NOW while nasopharyngeal swabs along with throat swab were used for RTPCR. Among the participants, 15 were healthcare workers. Mild COVID was seen in 36 participants, moderate in 19 and severe in 9. Eight participants had non COVID illness.

RESULTS

From the given samples, we observed that ID NOW has a sensitivity of 93.22% (55/59) specificity 100% (13/13), PPV 100% (55/55) and NPV 76.47% (13/17).

CONCLUSION

ID NOW is a convenient, rapid molecular test which makes it suitable for both in laboratory use and as a point of care test. It can be a rapid rule-in test for COVID-19. Negative results, however, have to be interpreted as per the context.

摘要

背景

新型冠状病毒肺炎(COVID-19)大流行引发的紧急危机给临床实验室加快诊断带来了巨大挑战。目前,COVID-19诊断的参考标准是在各种平台上进行实时逆转录聚合酶链反应(RT-PCR)。然而,即使采用自动化操作,周转时间仍然很长,难以满足不断增加的患者数量需求。随着COVID病例的激增,我们需要具有良好敏感性和特异性的快速诊断测试。

目的

比较雅培ID NOW COVID-19检测与作为参考方法的实时逆转录聚合酶链反应(RT-PCR)。

材料与方法

在两个月的时间内,从72名个体采集样本,并在全印医学科学研究所(AIIMS)的一个专门的COVID-19中心对样本进行ID NOW和RT-PCR检测。ID NOW检测使用干燥鼻拭子,而RT-PCR检测使用鼻咽拭子和咽拭子。参与者中有15名医护人员。36名参与者患有轻度COVID,19名患有中度COVID,9名患有重度COVID。8名参与者患有非COVID疾病。

结果

从给定样本中,我们观察到ID NOW的敏感性为93.22%(55/59),特异性为100%(13/13),阳性预测值为100%(55/55),阴性预测值为76.47%(13/17)。

结论

ID NOW是一种便捷、快速的分子检测方法,适用于实验室检测和即时检测。它可以作为COVID-19的快速确诊检测方法。然而,阴性结果必须根据具体情况进行解读。

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