External Quality Assessment (EQA) scheme for serological diagnostic test for SARS-CoV-2 detection in Sicily Region (Italy), in the period 2020–2022
Author:
Di Gaudio Francesca12ORCID, Brunacci Giuseppina2, Cucina Annamaria2ORCID, Giaccone Vita2, Raso Maria2, Lundari Anna2, Cancilleri Antonio2, Buffa Vito2, Russo Eleonora3ORCID, Vasto Sonya4, La Rocca Mario5, Indelicato Sergio2
Affiliation:
1. PROMISE , 18998 University of Palermo , Palermo , Italy 2. Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello, Chromatography and Mass Spectrometry Section , Quality Control and Chemical Risk (CQRC) , Palermo , Italy 3. Human Anatomy Section, Department of Experimental Biomedicine and Clinical Neurosciences , 18998 University of Palermo Palermo , Italy 4. Department of Biological, Chemical and Pharmaceutical Sciences and Technologies , 18998 University of Palermo , Palermo , Italy 5. Assessorato Regionale Della Salute , Dipartimento per la Pianificazione Strategica , Palermo , Italy
Abstract
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.
Publisher
Walter de Gruyter GmbH
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