Design of external quality assessment (EQA) schemes and definition of the roles of their providers in future epidemics

Author:

Buchta Christoph1,Zeichhardt Heinz2,Aberle Stephan w.3,Camp Jeremy V3,Görzer Irene3,Weseslindtner Lukas3,Puchhammer-Stöckl E´lisabeth3,Huf Wolfgang4,Benka Bernhard5,Allerberger Franz5,Mielke Martin6,Griesmacher Andrea1,Müller Mathias M1,Schellenberg Ingo2,Kammel Martin7

Affiliation:

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

2. INSTAND e.V. Society for Promoting Quality Assurance in Medical Laboratories, Düsseldorf, Germany

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

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

5. Austrian Agency for Health and Food Safety (AGES), Vienna, Austria

6. Robert Koch-Institute, Department for Infectious Diseases, Berlin, Germany

7. IQVD GmbH, Institut für Qualitätssicherung in der Virusdiagnostik, Berlin, Germany

Abstract

Abstract Background The accuracy of individual test results affects the reliability of epidemiological indicators during pandemics. Therefore, the performance of test facilities and test systems must be continuously monitored. In this respect, external quality assessment (EQA) schemes are unique data sources, and their providers may serve as valuable contact for non-EQA inquiries on technical-analytical topics. However, the epidemiological importance of EQA during pandemics has not yet been evaluated. Methods Seventeen publications on SARS-CoV-2 virus genome detection EQA schemes were evaluated for their content of information which was aggregated and classified as “relevant”, “conditionally relevant” or “imperceptibly relevant” for the quality of public health microbiology. The effort required to report on any missing information was estimated. Extra-EQA services of EQA providers were also assessed for their epidemiological relevance. Findings Publications contained six to nine of the ten information criteria classified as relevant for public health microbiology. The effort required to report missing information appeared low. Information classified as epidemiologically conditionally relevant was collected only from dedicated EQA rounds. Extra-EQA services from EQA providers seemed particularly important in times of a pandemic. Interpretation Professional operation of non-EQA services and competent design of EQA schemes by their providers ensure that test facilities receive the best possible support during pandemics and that relevant information on the performance of infection diagnostics is made available. The importance of EQA for public health emergency response is therefore evident. Funding None.

Publisher

Research Square Platform LLC

Reference54 articles.

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2. https://www.who.int/director-general/speeches/detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19---16-march-2020 (accessed September 04, 2022)

3. Mathieu E, Rodés–Guirao L, et al. "Coronavirus Pandemic (COVID–19)". Retrieved from: https://ourworldindata.org/coronavirus;Ritchie H,2022

4. Mercer T, Almond N, Chain P et al. A roadmap to better COVID-19 testing from the Coronavirus Standards Working Group. https://www.researchgate.net/publication/356371245_A_roadmap_to_better_COVID-19_testing_from_the_Coronavirus_Standards_Working_Group publication details to be added after provision by journal

5. International Organization for Standardization. Conformity assessment - general requirements for proficiency testing. ISO/IEC 17043:2010 ISO, Geneva, 2010.

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