The versatility of external quality assessment for the surveillance of laboratory and


Journal

Clinical chemistry and laboratory medicine
ISSN: 1437-4331
Titre abrégé: Clin Chem Lab Med
Pays: Germany
ID NLM: 9806306

Informations de publication

Date de publication:
27 09 2021
Historique:
received: 31 03 2021
accepted: 21 06 2021
pubmed: 30 6 2021
medline: 15 9 2021
entrez: 29 6 2021
Statut: epublish

Résumé

External quality assessment (EQA) schemes provide information on individual and general analytical performance of participating laboratories and test systems. The aim of this study was to investigate the use and performance of SARS-CoV-2 virus genome detection systems in Austrian laboratories and their preparedness to face challenges associated with the pandemic. Seven samples were selected to evaluate performance and estimate variability of reported results. Notably, a dilution series was included in the panel as a measure of reproducibility and sensitivity. Several performance criteria were evaluated for individual participants as well as in the cohort of all participants. A total of 109 laboratories participated and used 134 platforms, including 67 different combinations of extraction and PCR platforms and corresponding reagents. There were no false positives and 10 (1.2%) false negative results, including nine in the weakly positive sample ( Beyond providing certification for participating laboratories, EQA provides the opportunity for participants to evaluate their performance against others so that they may improve operating procedures and test systems. Well-selected EQA samples offer additional inferences to be made about assay sensitivity and reproducibility, which have practical applications.

Identifiants

pubmed: 34187131
pii: cclm-2021-0604
doi: 10.1515/cclm-2021-0604
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

1735-1744

Informations de copyright

© 2021 Christoph Buchta et al., published by De Gruyter, Berlin/Boston.

Références

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Auteurs

Christoph Buchta (C)

Austrian Association for Quality Assurance and Standardization of Medical and Diagnostic Tests (ÖQUASTA), Vienna, Austria.

Jeremy V Camp (JV)

Center for Virology, Medical University of Vienna, Vienna, Austria.

Jovana Jovanovic (J)

Austrian Association for Quality Assurance and Standardization of Medical and Diagnostic Tests (ÖQUASTA), Vienna, Austria.

Peter Chiba (P)

Austrian Association for Quality Assurance and Standardization of Medical and Diagnostic Tests (ÖQUASTA), Vienna, Austria.

Elisabeth Puchhammer-Stöckl (E)

Center for Virology, Medical University of Vienna, Vienna, Austria.

Maximilian Mayerhofer (M)

Armament and Defence Technology Agency, NBC & Environmental Protection Technology Division, Vienna, Austria.

Helga Plicka (H)

Armament and Defence Technology Agency, NBC & Environmental Protection Technology Division, Vienna, Austria.

Alexander Lercher (A)

CeMM Research Center for Molecular Medicine of the Austrian Academy of Sciences, Vienna, Austria.

Alexandra M Popa (AM)

CeMM Research Center for Molecular Medicine of the Austrian Academy of Sciences, Vienna, Austria.

Lukas Endler (L)

CeMM Research Center for Molecular Medicine of the Austrian Academy of Sciences, Vienna, Austria.

Andreas Bergthaler (A)

CeMM Research Center for Molecular Medicine of the Austrian Academy of Sciences, Vienna, Austria.

Wolfgang Huf (W)

Karl Landsteiner Institute for Clinical Risk Management, Vienna, Austria.

Bernhard Benka (B)

Federal Ministry of Social Affairs, Health, Care and Consumer Protection, Vienna, Austria.

Vincent Delatour (V)

Laboratoire National de Métrologie et d'Essais (LNE), Paris, France.

Mathias M Müller (MM)

Austrian Association for Quality Assurance and Standardization of Medical and Diagnostic Tests (ÖQUASTA), Vienna, Austria.

Andrea Griesmacher (A)

Austrian Association for Quality Assurance and Standardization of Medical and Diagnostic Tests (ÖQUASTA), Vienna, Austria.

Stephan W Aberle (SW)

Center for Virology, Medical University of Vienna, Vienna, Austria.

Irene Görzer (I)

Austrian Association for Quality Assurance and Standardization of Medical and Diagnostic Tests (ÖQUASTA), Vienna, Austria.
Center for Virology, Medical University of Vienna, Vienna, Austria.

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