Analytical Validation and Stability Studies for Basophil Activation Test to Meet IVDR Certification.
Basophil Activation Tests (BAT) have gained increasing importance in the field of allergy. We hypothesize a thorough assay validation study meeting CLIA requirements is possible and performed analytical and stability studies with Flow CAST BAT assay, to achieve the new EU-IVDR compliance.
Source: Journal of Allergy and Clinical Immunology - Category: Allergy & Immunology Authors: Collin Shaw, Dominik Vogt, Anna Melone, Martina Berchtold, Christina Bauer, Michele Romano, Michael Schneider, Christian-Benedikt Gerhold, Michael Gerspach, Thomas Schuster Source Type: research