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Titel:

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.

Dokumenttyp:
Journal Article
Autor(en):
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
Abstract:
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, expr...     »
Zeitschriftentitel:
J Clin Virol
Jahr:
2023
Band / Volume:
165
Volltext / DOI:
doi:10.1016/j.jcv.2023.105521
PubMed:
http://view.ncbi.nlm.nih.gov/pubmed/37302248
Print-ISSN:
1386-6532
TUM Einrichtung:
Institut für Klinische Chemie und Pathobiochemie (Prof. Ruland)
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