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Classification of "Near-patient" and "Point-of-Care" SARS-CoV-2 Nucleic Acid Amplification Test Systems and a first approach to evaluate their analytical independence of operator activities.
Buchta, Christoph; Zeichhardt, Heinz; Badrick, Tony; Coucke, Wim; Wojtalewicz, Nathalie; Griesmacher, Andrea; Aberle, Stephan W; Schellenberg, Ingo; Jacobs, Ellis; Nordin, Gunnar; Schweiger, Christian; Schwenoha, Karin; Luppa, Peter B; Gassner, Ulrich M; Wagner, Thomas; Kammel, Martin.
Afiliación
  • Buchta C; Austrian Association for Quality Assurance and Standardization of Medical and Diagnostic Tests (ÖQUASTA), Austria. Electronic address: christoph.buchta@oequasta.at.
  • Zeichhardt H; INSTAND e.V. Society for Promoting Quality Assurance in Medical Laboratories, Düsseldorf, Germany; IQVD GmbH, Institut für Qualitätssicherung in der Virusdiagnostik, Berlin, Germany; GBD Gesellschaft für Biotechnologische Diagnostik mbH, Berlin, Germany.
  • Badrick T; Royal College of Pathologists of Australasia Quality Assurance Programs, St Leonards, Sydney, Australia.
  • Coucke W; Sciensano, Brussels, Belgium.
  • Wojtalewicz N; INSTAND e.V. Society for Promoting Quality Assurance in Medical Laboratories, Düsseldorf, Germany.
  • Griesmacher A; Austrian Association for Quality Assurance and Standardization of Medical and Diagnostic Tests (ÖQUASTA), Austria.
  • Aberle SW; Center for Virology, Medical University of Vienna, Vienna, Austria.
  • Schellenberg I; INSTAND e.V. Society for Promoting Quality Assurance in Medical Laboratories, Düsseldorf, Germany.
  • Jacobs E; EJ Clinical Consulting, LLC, Teaneck, NJ, USA.
  • Nordin G; Equalis AB, Uppsala, Sweden.
  • Schweiger C; Clinical Institute of Laboratory Medicine, Medical University of Vienna, Vienna, Austria.
  • Schwenoha K; QMD Services GmbH Vienna, Austria.
  • Luppa PB; INSTAND e.V. Society for Promoting Quality Assurance in Medical Laboratories, Düsseldorf, Germany; Institut für Klinische Chemie und Pathobiochemie, Klinikum rechts der Isar der Technischen Universität München, Germany.
  • Gassner UM; Institute of Medical Device Law, Faculty of Law, University of Augsburg, Germany.
  • Wagner T; Department of Blood Group Serology and Transfusion Medicine, Medical University of Graz, Austria.
  • Kammel M; INSTAND e.V. Society for Promoting Quality Assurance in Medical Laboratories, Düsseldorf, Germany; IQVD GmbH, Institut für Qualitätssicherung in der Virusdiagnostik, Berlin, Germany; GBD Gesellschaft für Biotechnologische Diagnostik mbH, Berlin, Germany.
J Clin Virol ; 165: 105521, 2023 08.
Article en En | MEDLINE | ID: mdl-37302248
BACKGROUND: European legislation defines as "near-patient testing" (NPT) what is popularly and in other legislations specified as "point-of-care testing" (POCT). Systems intended for NPT/POCT use must be characterized by independence from operator activities during the analytic procedure. However, tools for evaluating this are lacking. We hypothesized that the variability of measurement results obtained from identical samples with a larger number of identical devices by different operators, expressed as the method-specific reproducibility of measurement results reported in External Quality Assessment (EQA) schemes, is an indicator for this characteristic. MATERIALS AND METHODS: Legal frameworks in the EU, the USA and Australia were evaluated about their requirements for NPT/POCT. EQA reproducibility of seven SARS-CoV-2-NAAT systems, all but one designated as "POCT", was calculated from variabilities in Ct values obtained from the respective device types in three different EQA schemes for virus genome detection. RESULTS: A matrix for characterizing test systems based on their technical complexity and the required operator competence was derived from requirements of the European In Vitro Diagnostic Regulation (IVDR) 2017/746. Good EQA reproducibility of the measurement results of the test systems investigated implies that different users in different locations have no recognizable influence on their measurement results. CONCLUSION: The fundamental suitability of test systems for NPT/POCT use according to IVDR can be easily verified using the evaluation matrix presented. EQA reproducibility is a specific characteristic indicating independence from operator activities of NPT/POCT assays. EQA reproducibility of other systems than those investigated here remains to be determined.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: SARS-CoV-2 / COVID-19 Tipo de estudio: Diagnostic_studies Límite: Humans Idioma: En Revista: J Clin Virol Asunto de la revista: VIROLOGIA Año: 2023 Tipo del documento: Article Pais de publicación: Países Bajos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: SARS-CoV-2 / COVID-19 Tipo de estudio: Diagnostic_studies Límite: Humans Idioma: En Revista: J Clin Virol Asunto de la revista: VIROLOGIA Año: 2023 Tipo del documento: Article Pais de publicación: Países Bajos