External quality assessment of molecular detection and variant typing of SARS-CoV-2 in European expert laboratories in 2023.

IF 6.1 2区 医学 Q1 MICROBIOLOGY
Journal of Clinical Microbiology Pub Date : 2025-04-09 Epub Date: 2025-03-14 DOI:10.1128/jcm.01538-24
Kim C Heimsch, Kamelia R Stanoeva, Ramona Mögling, Annette Kraus, Eeva K Broberg, Jan Felix Drexler, Chantal B E M Reusken, Adam Meijer, Christian Drosten, Victor M Corman
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引用次数: 0

Abstract

The COVID-19 pandemic highlighted the importance of laboratory preparedness. Regular monitoring of diagnostic tools via external quality assessments (EQAs) is key to maintaining robust public health response service. We hereby conducted a third SARS-CoV-2 EQA assessing the diagnostic capabilities of European expert public health laboratories. A 10 samples panel containing Alpha (used in previous EQA), BA.4, BA.5, and BQ.1.18 variants along with human seasonal coronaviruses and negative controls was produced and validated. Participants were invited by the European Centre for Disease Prevention and Control (ECDC) and asked to submit results and assay details via electronic forms. Thirty-eight laboratories from 31 European countries participated. Most (n = 32, 84%) identified all panel samples correctly and used in-house (11, 29%), commercial assays (22, 58%), or both (5, 13%). Compared to previous EQAs, correct detection of the SARS-CoV-2 samples in the panels increased: 8 (12%) in 2020, 45 (75%) in 2021, and 34 (90%) laboratories in 2023, respectively. The number of participants decreased to an average of one laboratory per country (range 1-3) compared to two (1-7) laboratories in both previous EQAs. The usage of commercial assays gradually increased in contrast to the usage of in-house or both approaches. The capacity for SARS-CoV-2 molecular diagnostics has markedly improved in Europe as evidenced by three consecutive EQAs carried out by expert public health laboratories. Routine monitoring of diagnostic and surveillance assays via EQAs remains key to maintaining rapid public health laboratory response systems.IMPORTANCEExternal quality assessments (EQAs) are crucial to ensure the reliability and consistency of diagnostic laboratories. They provide an objective framework for evaluating the performance of testing systems, enabling laboratories to identify weaknesses and implement improvements promptly. In the context of SARS-CoV-2, EQAs have become even more critical due to the high demand for accurate molecular diagnostics and the emergence of new variants. Accurate detection and typing of variants are especially essential for monitoring viral evolution. EQAs help standardize methodologies, ensuring that results across laboratories remain comparable and trustworthy. Moreover, they play a pivotal role in minimizing errors such as false positives or negatives. In this rapidly evolving landscape, regular EQAs are indispensable for maintaining high-quality standards in molecular diagnostics and variant surveillance. We demonstrate here that regular EQAs improve the molecular detection of SARS-CoV-2 in European laboratories.

2023年欧洲专家实验室SARS-CoV-2分子检测和变异分型外部质量评价
2019冠状病毒病大流行凸显了实验室准备的重要性。通过外部质量评估(eqa)对诊断工具进行定期监测是维持强有力的公共卫生应对服务的关键。兹开展第三次SARS-CoV-2 EQA,评估欧洲专家公共卫生实验室的诊断能力。制作并验证了包含Alpha(在以前的EQA中使用)、BA.4、BA.5和BQ.1.18变体以及人类季节性冠状病毒和阴性对照的10个样本面板。欧洲疾病预防和控制中心(ECDC)邀请与会者通过电子表格提交结果和化验细节。来自31个欧洲国家的38个实验室参与了研究。大多数(n = 32,84%)正确识别所有面板样本并使用内部(11.29%),商业分析(22.58%)或两者(5.13%)。与以往的eqa相比,面板中SARS-CoV-2样本的正确检测数量分别增加:2020年为8个(12%),2021年为45个(75%),2023年为34个(90%)。参与者的数量减少到平均每个国家一个实验室(范围1-3),而之前的两个eqa中有两个(1-7)个实验室。与内部或两种方法的使用相比,商业测定法的使用逐渐增加。公共卫生专家实验室连续三次开展的eqa证明,欧洲的SARS-CoV-2分子诊断能力已显著提高。通过eqa进行诊断和监测分析的常规监测仍然是维持快速公共卫生实验室反应系统的关键。重要性外部质量评估(eqa)对于确保诊断实验室的可靠性和一致性至关重要。它们为评估测试系统的性能提供了一个客观的框架,使实验室能够识别弱点并及时实施改进。在SARS-CoV-2的背景下,由于对准确分子诊断的高需求和新变体的出现,eqa变得更加重要。变异的准确检测和分型对于监测病毒进化尤为重要。eqa有助于标准化方法,确保跨实验室的结果保持可比性和可靠性。此外,它们在减少误报或误报等错误方面发挥着关键作用。在这种快速发展的环境中,定期的eqa对于保持分子诊断和变异监测的高质量标准是必不可少的。我们在这里证明,定期的eqa可以提高欧洲实验室对SARS-CoV-2的分子检测。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Journal of Clinical Microbiology
Journal of Clinical Microbiology 医学-微生物学
CiteScore
17.10
自引率
4.30%
发文量
347
审稿时长
3 months
期刊介绍: The Journal of Clinical Microbiology® disseminates the latest research concerning the laboratory diagnosis of human and animal infections, along with the laboratory's role in epidemiology and the management of infectious diseases.
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