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.

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.
Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Peter B. Luppa is member of the board of directors of INSTAND e.V., a non-profit organization, named as one of two EQA providers for Germany by the Deutsche Ärztekammer. Heinz Zeichhardt declares that he is co-chairman of the Joint Diagnostic Council of the Deutsche Vereinigung zur Bekaempfung der Viruskrankheiten e.V. (DVV e.V.) and Gesellschaft fuer Virologie (GfV e.V.) and is Advisor for the INSTAND External Quality Assessment (EQA) schemes in virus diagnostics. He is owner and managing director of IQVD GmbH - Institut fuer Qualitaetssicherung in der Virusdiagnostik, Berlin, and was majority owner and managing director of GBD Gesellschaft fuer Biotechnologische Diagnostik mbH, Berlin. He declares that he has no conflicts of interest with regard to the activities mentioned in relation to the publication. The other authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
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