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
{"title":"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。","authors":"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","doi":"10.1515/dx-2024-0048","DOIUrl":null,"url":null,"abstract":"<p><strong>Objectives: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":11273,"journal":{"name":"Diagnosis","volume":null,"pages":null},"PeriodicalIF":2.2000,"publicationDate":"2024-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"External Quality Assessment (EQA) scheme for serological diagnostic test for SARS-CoV-2 detection in Sicily Region (Italy), in the period 2020-2022.\",\"authors\":\"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\",\"doi\":\"10.1515/dx-2024-0048\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objectives: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>\",\"PeriodicalId\":11273,\"journal\":{\"name\":\"Diagnosis\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":2.2000,\"publicationDate\":\"2024-07-03\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Diagnosis\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1515/dx-2024-0048\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"MEDICINE, GENERAL & INTERNAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Diagnosis","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1515/dx-2024-0048","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
External Quality Assessment (EQA) scheme for serological diagnostic test for SARS-CoV-2 detection in Sicily Region (Italy), in the period 2020-2022.
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.
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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