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

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: Di Gaudio F.; Brunacci G.; Cucina A.; Giaccone V.; Raso M.; Lundari A.; Cancilleri A.; Buffa V.; Russo E.; Vasto S.; La Rocca M.; Indelicato S.
Contributors: Di Gaudio F.; Brunacci G.; Cucina A.; Giaccone V.; Raso M.; Lundari A.; Cancilleri A.; Buffa V.; Russo E.; Vasto S.; La Rocca M.; Indelicato S.
Publisher Information: WALTER DE GRUYTER GMBH
Publication Year: 2024
Collection: IRIS Università degli Studi di Palermo
Subject Terms: COVID-19; External Quality Assessment; SARS-CoV-2; serological test performance evaluation
Description: 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.
Document Type: article in journal/newspaper
Language: English
Relation: info:eu-repo/semantics/altIdentifier/pmid/38950285; info:eu-repo/semantics/altIdentifier/wos/WOS:001258992500001; numberofpages:8; journal:DIAGNOSIS; https://hdl.handle.net/10447/662401
DOI: 10.1515/dx-2024-0048
Availability: https://hdl.handle.net/10447/662401; https://doi.org/10.1515/dx-2024-0048
Rights: info:eu-repo/semantics/closedAccess
Accession Number: edsbas.5F468CB6
Database: BASE