Serological diagnostic for SARS-CoV-2: an experimental External Quality Assessment Scheme
| Autor: | Laura Sciacovelli, Andrea Padoan, Sandra Secchiero, Mario Plebani |
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| Rok vydání: | 2021 |
| Předmět: |
Scheme (programming language)
medicine.medical_specialty Coronavirus disease 2019 (COVID-19) Quality Assurance Health Care Computer science Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Clinical Biochemistry Medical laboratory serology Pilot Projects Antibodies Viral Sensitivity and Specificity Severity of Illness Index Antibodies External Quality Assessment Scheme Patient safety External quality assessment medicine Humans Medical physics Serologic Tests Viral computer.programming_language Retrospective Studies business.industry SARS-CoV-2 Biochemistry (medical) COVID-19 General Medicine Laboratory results Immunoglobulin A Health Care Immunoglobulin M Immunoglobulin G antibodies immunoglobulin business Quality Assurance Quality assurance computer |
| Zdroj: | Clinical chemistry and laboratory medicineReferences. 59(11) |
| ISSN: | 1437-4331 |
| Popis: | Objectives Numerous analytical systems, rapidly made available on the market throughout the SARS-CoV-2 pandemic, aim to detect COVID-19, and to continuously update and improve the same systems. Medical laboratory professionals have also developed in-house analytical procedures in order to satisfy the enormous volume of requests for tests. These developments have highlighted the need control the analytical procedures used in order to guarantee patient safety. The External Quality Assessment (EQA) Scheme, an important quality assurance tool, aims to guarantee high standard performance for laboratory and analytical procedures. The aim of the present study was to report on the results collected in an experimental EQA scheme for the serological diagnosis of SARS-CoV-2. Methods All qualitative results collected in the different EQA surveys were summarized in order to identify the percentage of laboratory results in relation to typology of antibodies, results and samples. Results A total of 4,867 data sets were collected. The analysis of EQA data made, demonstrates a better agreement among laboratories results for total Ig than single immunoglobulins (IgG, IgM, IgA) in the case samples positive for SARS-CoV-2, and a wide divergence between IgM results for positive samples (only 34.9% were correct). Results for negative controls and specificity controls demonstrated a better overall agreement than results for positive samples. Conclusions Working in collaboration with the IVD manufacturers, laboratory professionals must strive to achieve harmonization of results, and to develop well-defined protocols complying with the ISO 15189 requirements. |
| Databáze: | OpenAIRE |
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