LeukoSure Enumeration Kit, 200 Tests, CE, IVD

The LeukoSure Enumeration Kit is comprised of a set of reagents used to prepare and enumerate white blood cells in leukoreduced red blood cell and platelet products by flow cytometry. The LeukoSure Enumeration Kit is configured to utilize the sensitivity of flow cytometry to enumerate residual leukocytes at the levels necessary to ensure the quality control of leukoreduced blood.

The enumeration method depends upon mixing a known volume (100 μL) of LeukoSure Fluorospheres with an identical volume of sample to be tested. After analysis the absolute count for the specimen is calculated. This represents the absolute number of leukocytes in the specimen.

The specimen is lysed and permeabilized using the LeukoSure Lyse Reagent to eliminate RBCs and prepare the cells for subsequent addition of the LeukoSure Stain Reagent which contains propidium iodide and RNAse (enzyme used to remove ribonucleic acid, or RNA). In the absence of RNA, propidium iodide binds only to double stranded deoxyribonucleic acid (DNA) so that nucleated cells in the sample emit fluorescence in proportion to their DNA content. The flow cytometer measures the fluorescence from each stained cell as it passes through the laser beam. Since mature platelets and red blood cells do not contain DNA, the stained cells represent the leukocyte component of the blood.