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Serological diagnostic for SARS-CoV-2: an experimental External Quality Assessment Scheme.
Sciacovelli, Laura; Padoan, Andrea; Secchiero, Sandra; Plebani, Mario.
  • Sciacovelli L; Centre of Biomedical Research for Quality in Laboratory Medicine, Department of Laboratory Medicine, University Hospital of Padua, Padua, Italy.
  • Padoan A; Department of Medicine DIMED, University of Padua, Padua, Italy.
  • Secchiero S; Department of Medicine DIMED, University of Padua, Padua, Italy.
  • Plebani M; Centre of Biomedical Research for Quality in Laboratory Medicine, Department of Laboratory Medicine, University Hospital of Padua, Padua, Italy.
Clin Chem Lab Med ; 59(11): 1878-1884, 2021 10 26.
Article in English | MEDLINE | ID: covidwho-1341521
ABSTRACT

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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Serologic Tests / SARS-CoV-2 / COVID-19 / Antibodies, Viral Type of study: Diagnostic study / Observational study / Prognostic study / Qualitative research Limits: Humans Language: English Journal: Clin Chem Lab Med Journal subject: Chemistry, Clinical / Laboratory Techniques and procedures Year: 2021 Document Type: Article Affiliation country: Cclm-2021-0662

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Serologic Tests / SARS-CoV-2 / COVID-19 / Antibodies, Viral Type of study: Diagnostic study / Observational study / Prognostic study / Qualitative research Limits: Humans Language: English Journal: Clin Chem Lab Med Journal subject: Chemistry, Clinical / Laboratory Techniques and procedures Year: 2021 Document Type: Article Affiliation country: Cclm-2021-0662