BD Biosciences’ BD IMAGN™ system has received clearance by the US Food and Drug Administration for analysis of leucoreduced blood products, such as platelet and red cell concentrates. The compact, automated, benchtop cytometer has a blood bank, application-specific software, and reagents.
The presence of leucocytes, or white blood cells (WBCs), in blood and platelet products has been shown to be associated with an increased incidence of transfusion reactions in recipient patients. These reactions can range from mild fever to more severe responses, such as respiratory distress. Leucoreduction, removing WBCs using various processing techniques, requires a method such as the BD IMAGN system to evaluate the amount of residual WBCs remaining in a blood product.
The BD IMAGN residual WBC (rWBC) assay measures any rWBC concentrations in leucoreduced products, and rWBC measurement is used in the quality control of the various leucoreduction processes. In vitro diagnostic tests currently available for measuring residual WBCs include the BD LeucoCOUNT™ assay, an automated or manual flow cytometer-based assay test, and a laborious microscopic test based on Nageotte counting. The new BD IMAGN system was designed to fill the gap in the current technology spectrum.
The BD IMAGN system is currently available for sale in various countries in Europe and the Asian-Pacific Rim. The launch to the United States blood bank market is pending completion of an ongoing process validation.
