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.

Governance under the Covid-19 pandemic: comparative perspectives on Germany and Hungary

By adopting a comparative approach between different regime types, the paper concentrates on Germany and Hungary as case studies for the comparative analysis of the effects the pandemic has had on national governance in the two countries which most strongly represent the growing cleavage between the EU's liberal Western core and the illiberal Central-Eastern periphery. Methodologically the analysis follows the Most Different Systems Design and examines to what extent the Covid pandemic has functioned as a potential catalyser for the weakening of democratic governance in formerly solid democratic political systems and/or as an accelerator of democratic backsliding in hybrid regimes. For this purpose, the paper examines the process and the content of legislation passed domestically to contain the effects of the pandemic. The analysis shows that even under the stronger coordination of executive decision-making between the federal and regional government level, the foundations of legislative and judicial scrutiny remained resilient during the pandemic in Germany's multi-level polity, while in Hungary central government has used the pandemic to substantially expand its executive powers at the expense of legislative and judiciary powers.

Governance under the Covid-19 pandemic: comparative perspectives on Germany and Hungary : Special section "Democratic Health in the Corona Pandemic. The Corona Pandemic as a Trigger or Amplifier of Democratic Erosion?” Regieren unter der Covid-19 Pandemie: Vergleichende Perspektiven auf Deutschland und UngarnSonderausgabe „Demokratische Gesundheit in der Corona Pandemie: Die Corona Pandemie als Auslöser oder Verstärker demokratischer Erosion?"

By adopting a comparative approach between different regime types, the paper concentrates on Germany and Hungary as case studies for the comparative analysis of the effects the pandemic has had on national governance in the two countries which most strongly represent the growing cleavage between the EU's liberal Western core and the illiberal Central-Eastern periphery. Methodologically the analysis follows the Most Different Systems Design and examines to what extent the Covid pandemic has functioned as a potential catalyser for the weakening of democratic governance in formerly solid democratic political systems and/or as an accelerator of democratic backsliding in hybrid regimes. For this purpose, the paper examines the process and the content of legislation passed domestically to contain the effects of the pandemic. The analysis shows that even under the stronger coordination of executive decision-making between the federal and regional government level, the foundations of legislative and judicial scrutiny remained resilient during the pandemic in Germany's multi-level polity, while in Hungary central government has used the pandemic to substantially expand its executive powers at the expense of legislative and judiciary powers.