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确保患者护理和公共卫生的诊断测试准确性 - 从EQA提供商的角度来看,扩大COVID-19测试规模

Veronica Restelli¹, Selvarani Vimalanathan¹, Mahfuza Sreya¹

¹Canadian Microbiology Proficiency Testing Program (CMPT), Department of Pathology and Laboratory Medicine, The University of British Columbia, Vancouver, British Columbia, Canada.

PLOS global public health

|December 6, 2023

概括

一个新的熟练测试计划改善了不列颠哥伦比亚省护理地点的SARS-CoV-2测试质量. 干预措施,包括培训,提高了分子和抗原检测方法的准确性,特别是对于新测试者.

科学领域:

临床微生物学临床微生物学
传染性疾病传染性疾病
公共卫生公共卫生

背景情况:

由于COVID-19大流行,需要迅速扩大SARS-CoV-2诊断测试的规模.
能力测试 (PT) 对于监测和确保诊断试验质量至关重要.
护理点测试 (POCT) 场所需要外部质量评估来保持测试准确性.

研究的目的:

在不列颠哥伦比亚省的POCT地点建立和评估SARS-CoV-2分子和抗原检测的新能力测试计划.
监测和提高各个卫生当局的COVID-19测试的质量和准确性.
识别和解决SARS-CoV-2检测方法的性能差距,特别是快速抗原检测 (RAD).

主要方法:

开发了一个PT计划,涉及每年6次向参与POCT地点运送SARS-CoV-2阳性和阴性样本.
最初的招生包括23个地点,在第一年内扩大到100多名参与者.
进行了根本原因分析,以调查绩效问题,随后进行了有针对性的干预措施,如加强培训,修订说明和视频资源.

主要成果:

核酸技术 (NAT) 站点始终表现出可接受的性能.
快速抗原检测 (RAD) 站点最初表现不佳,特别是弱阳性样本.
在干预后,测试准确性在所有地点显著提高,RAD性能接近NAT的性能.

结论:

实施的PT计划成功提高了POCT地点SARS-CoV-2测试的质量和准确性.
外部质量评估 (EQA) 对于维护公共健康和安全至关重要,特别是在认可实验室之外进行测试.
有针对性的培训和流程改进有效地解决了诊断测试中的性能缺陷.

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