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Evaluation of the Clinical Performances of a Point of Care Analyzer Enabling Pre-transfusion ABOD Group Ultimate Verification at the Patient Bedside

Francis Corazza · 2020
ClinicalTrials.gov · Datasets · License: Public Domain · 2020
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ABO-incompatible red blood cell transfusions still represent an important hazard in transfusion medicine. Therefore, some countries have introduced a systematic bedside ABO agglutination test checking that the right blood is given to the right patient. However, this strategy is entirely manual, requires an extremely time-consuming learning program and relies on a subjective interpretation of agglutination on ABO test cards (for example Biorad, Diagast). The ULB spinoff Antigon developed a prototype device on the basis of a technology developed in the Translational research laboratory of CHU-Brugmann, ULB. This device is specifically dedicated to perform a "near patient" control of the blood group of the patient and of the blood bag just before transfusion, and to control that the right blood bag is given to the right patient by cross-checking their identifications. The principle of the assay relies on an agglutination and filtration in a disk including anti A,B and D antibodies. The goal of this study is to validate the analytical performances of this device (phase A) and to validate the clinical performances of this device (phase B).
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