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引用次数: 0
摘要
为了改进对 SARS-CoV-2 冠状病毒的检测和快速诊断,我们在 2020 年的一项前瞻性研究中评估了 ID NOW™ COVID-19 等温基因扩增技术与实验室常规使用的实时 PCR 技术(Diasorin)。由于该技术的灵敏度和特异性分别达到了令人满意的 98% 和 97.5%,因此我们建议在 2020-2021 年季节在急诊科和产科实施 SARS-CoV-2 冠状病毒检测,作为一种护理点检测(POCT),并评估其对临床和组织的影响。本文总结了所获得的结果,并强调了在急诊科实施这一策略的优势和局限性,尤其是在急诊科花费的时间、住院率、抗凝治疗和早期隔离患者方面,以及对产科的组织影响。基于这些经验,我们报告了在建立 POCT 时适用的法规限制,以及根据 NF EN ISO 22870 标准验证认证所需的步骤。
[Feedback on the detection of SARS-CoV-2 by the point-of-care testing].
In order to improve the detection and rapid diagnosis of the SARS-CoV-2 coronavirus, we evaluated the ID NOW™ COVID-19 isothermal gene amplification technique in parallel with the real-time PCR technique (Diasorin) routinely used in the laboratory during a prospective study in the 2020 season. As this technique showed satisfactory sensitivity and specificity of 98% and 97.5% respectively, we then proposed to implement the detection of SARS-CoV-2 coronavirus in the emergency department and maternity as a point-of-care test (POCT) for the 2020-2021 season and to evaluate its clinical and organizational impact. This article summarizes the results obtained and highlights the advantages and limitations of this strategy implemented in the emergency department, particularly in terms of time spent in the department, hospitalization rates, anticoagulant treatment and early isolation of patients, as well as the organizational impact on the maternity unit. Based on this experience, we report on the regulatory constraints that apply when setting up a POCT and the steps required to validate the accreditation in accordance with standard NF EN ISO 22870.