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Tests zur Detektion einer Infektion mit SARS-CoV-2 (neuartiges Coronavirus) sowie zum Nachweis von Antikörpern gehören zu den sog. In-vitro-Diagnostika (IVD). Das erstmalige Inverkehrbringen von In-vitro-Diagnostika auf dem deutschen Markt ist nach §§ 25 und 30 Medizinproduktegesetz (MPG) anzeig...epflichtig. Das DIMDI betreibt dafür die Datenbank "In-vitro-Diagnostika-Anzeigen (MPIVDA)", in welcher demnach auch Daten von "Corona-Tests" von den anzeigepflichtigen deutschen Herstellern und Bevollmächtigten bzw. Einführern erfasst werden.more
To meet the need for laboratory diagnosis to be integrated in community care, the new 2022 Update describes point-of-care tests that can be performed both in district laboratories and peripheral healthcare facilities by non-specialist staff. Also included are recently developed self-tests.