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快速适应并持续评估 SARS-CoV-2 包膜基因(E 基因)实时 RT-PCR 检测以支持医院检测需求激增。

Rapid adaptation and continuous performance evaluation of SARS-CoV-2 envelope gene (E-gene) real-time RT-PCR assays to support the hospital surge in test demand.

机构信息

Department of Microbiology, Prince of Wales Hospital, Hong Kong, China.

出版信息

J Med Virol. 2021 Mar;93(3):1824-1827. doi: 10.1002/jmv.26660. Epub 2020 Nov 22.

Abstract

We describe the timely adaption of both published WHO E-gene protocol and commercially available LightMix Modular E-gene assay to the test platform (ABI 7900 Fast real-time analyzer and TaqMan Fast One-step Virus Master Mix) available in an accredited tertiary hospital laboratory with an on-going evaluation to ensure the provision of quality service within the time constraint. The LightMix Modular E-gene was slightly more sensitive when compared to the WHO E-gene, both analytically and diagnostically. The assay was recommended for screening of SARS-CoV-2 infection. With the availability of technically competent staff through continuous training, the provision of round-the-clock service is feasible despite the test is of high complexity. The thermal cycling duration of the adapted LightMix E-gene and WHO E-gene is shortened by half and one hour respectively and allows the number of runs to double when 24-h round-the-clock service is provided. An increase in testing capacity could support surges in testing demand, which is essential to control the current SARS-CoV-2 pandemic, to prevent potential overwhelming of the healthcare system, and to optimize utilization of the isolation beds.

摘要

我们及时对已发布的世卫组织 E 基因检测协议和市售 LightMix 模块化 E 基因检测试剂盒进行了适配,使其适用于我们认证的三级医院实验室所具备的检测平台(ABI 7900 Fast 实时分析仪和 TaqMan Fast One-step Virus Master Mix),同时持续开展评估工作,以确保在时间限制内提供高质量的服务。LightMix 模块化 E 基因检测试剂盒在分析和诊断方面的灵敏度均略高于世卫组织 E 基因检测试剂盒。建议将该检测试剂盒用于筛查 SARS-CoV-2 感染。通过持续培训确保技术人员具备相应能力,即使检测具有高度复杂性,也能够实现 24 小时不间断服务。经过适配的 LightMix E 基因和世卫组织 E 基因检测的热循环时间分别缩短了一半和一个小时,并且在提供 24 小时不间断服务时,运行次数可增加一倍。增加检测能力可以支持检测需求的激增,这对于控制当前的 SARS-CoV-2 大流行、防止医疗系统潜在的超负荷运转以及优化隔离床位的使用至关重要。

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