External Quality Assessment (EQA) scheme for serological diagnostic test for SARS-CoV-2 detection in Sicily Region (Italy), in the period 2020-2022.

IF 2.2 Q2 MEDICINE, GENERAL & INTERNAL
Diagnosis Pub Date : 2024-07-03 DOI:10.1515/dx-2024-0048
Francesca Di Gaudio, Giuseppina Brunacci, Annamaria Cucina, Vita Giaccone, Maria Raso, Anna Lundari, Antonio Cancilleri, Vito Buffa, Eleonora Russo, Sonya Vasto, Mario La Rocca, Sergio Indelicato
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引用次数: 0

Abstract

Objectives: Since December 2019, worldwide public health has been exposed to a severe acute respiratory syndrome caused by Coronavirus-2. Serological testing is necessary for retrospective assessment of seroprevalence rates, and the determination of vaccine response and duration of immunity. For this reason, it was necessary to introduce a panel of tests able to identify and quantify Covid-19 antibodies.

Methods: As a Regional Reference Centre, the CRQ Laboratory (Regional Laboratory for the Quality Control) developed and conducted an External Quality Assessment (EQA) panel of assays, to evaluate the quality of various methods, that were used by 288 Sicilian laboratories, previously authorized on behalf of the Public Health Service.

Results: The performance test was based on pooled samples with different levels of concentration of antibodies. 97 , 98, and 95 % of the participating laboratories tested all samples correctly in 2020, 2021, and 2022 respectively. The best performance was observed in the test of total Ig. The general performance of laboratories improved over the years.

Conclusions: The incorrect diagnosis had and could still have important implications on vaccination cycles. Only through the effort of laboratory professionals, and the extension of the EQA scheme, a better harmonization of methods, protocols, and thus results, to guarantee a better healthcare system, will be possible.

2020-2022 年期间意大利西西里大区检测 SARS-CoV-2 的血清诊断测试外部质量评估 (EQA) 计划。
目标:自 2019 年 12 月以来,全球公共卫生受到了由冠状病毒-2 引起的严重急性呼吸系统综合征的威胁。血清学检测是回顾性评估血清流行率、确定疫苗反应和免疫持续时间所必需的。因此,有必要引入一套能够识别和量化 Covid-19 抗体的检测方法:作为地区参考中心,CRQ 实验室(地区质量控制实验室)开发并实施了一套外部质量评估(EQA)检测方法,以评估各种方法的质量:性能测试基于不同抗体浓度水平的集合样本。2020年、2021年和2022年,分别有97%、98%和95%的参与实验室正确检测了所有样本。总 Ig 的检测结果最佳。多年来,实验室的总体表现有所改善:错误的诊断曾经并可能继续对疫苗接种周期产生重要影响。只有通过实验室专业人员的努力和 EQA 计划的扩展,才能更好地协调方法、规程和结果,从而保证更好的医疗保健系统。
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来源期刊
Diagnosis
Diagnosis MEDICINE, GENERAL & INTERNAL-
CiteScore
7.20
自引率
5.70%
发文量
41
期刊介绍: Diagnosis focuses on how diagnosis can be advanced, how it is taught, and how and why it can fail, leading to diagnostic errors. The journal welcomes both fundamental and applied works, improvement initiatives, opinions, and debates to encourage new thinking on improving this critical aspect of healthcare quality.  Topics: -Factors that promote diagnostic quality and safety -Clinical reasoning -Diagnostic errors in medicine -The factors that contribute to diagnostic error: human factors, cognitive issues, and system-related breakdowns -Improving the value of diagnosis – eliminating waste and unnecessary testing -How culture and removing blame promote awareness of diagnostic errors -Training and education related to clinical reasoning and diagnostic skills -Advances in laboratory testing and imaging that improve diagnostic capability -Local, national and international initiatives to reduce diagnostic error
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