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

Author:

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

Publisher

Elsevier BV

Subject

Infectious Diseases,Virology

Reference27 articles.

1. REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU, 2017.

2. Point-of-care testing (POCT): current techniques and future perspectives;Luppa;Trends Analyt. Chem,2011

3. WHO COVID-19: Case definitions: Updated in Public Health Surveillance For COVID-19, Published 16 December 2020,2020

4. Recommendations For National SARS-CoV-2 Testing Strategies and Diagnostic capacities, Interim guidance. 25 June 2021,2021

5. Point-of-care testing-The key in the battle against SARS-CoV-2 pandemic;Iliescu;Micromachines (Basel),2021

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