Description
The BD Leucocount™ RBC control kit consists of red blood cell (RBC) Low and RBC High process controls intended for use with the BD Leucocount™ Kit to monitor the process for enumeration of residual leucocytes in leucoreduced RBC products, including dilution, staining, instrument setup, and white blood cell (WBC) enumeration. For In Vitro Diagnostic Use.
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Preparation and Storage
• Store vials upright, tightly capped, at 2° to 8°C when not in use.
• Unopened vials are stable until the expiration date indicated on each vial and on the Assay Values sheet when stored continuously at 2° to 8°C.
• Opened vials are stable for 30 days or 21 thermal cycles (uses), whichever comes first, when handled properly. A thermal cycle constitutes performing all steps once under Instructions for Use. In general, stability is limited by the number of times the vial is removed from the refrigerator, warmed, and mixed (defined as a use); by the time from first use; and by the decrease in volume with each use.
• Protect from freezing, from temperatures above 30°C, and from prolonged time at room temperature (18°-30°C).
• Follow exactly the steps under Instructions for Use.
- Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline—Third Edition. Wayne, PA: Clinical and Laboratory Standards Institute; 2005. CLSI document M29-A3.
- Center for Biologics Evaluation and Research. Recommendation and Licensure Requirements for Leukocyte-Reduced Blood Products. Rockville, MD: Food and Drug Administration. 1996.
- Centers for Disease Control. Perspectives in disease prevention and health promotion update: universal precautions for prevention of transmission of human immunodeficiency virus, hepatitis B virus, and other bloodborne pathogens in health-care settings. MMWR. 1988;37:377-388.
- Dumont LJ, Dzik WH, Rebulla P, Brandwein H. Practical guidelines for process validation and process control of white cell-reduced blood components: Report of the Biomedical Excellence for Safer Transfusion (BEST) Working Party of the International Society of Blood Transfusion (ISBT). Transfusion. 1996;36:11-20.
- Rebulla P, Porretti L, Bertolini F, et al. White cellreduced red cells prepared by filtration: a critical evaluation of current filters and methods for counting residual white blood cells. Transfusion. 1993:33:128-133.
- Vachula M, Simpson SJ, Martinson JA, er al. A flow cytometric method for counting very low levels of white cells in blood and blood components. Transfusion. 1993:33:262-267.
- Venglen-Tyler V, ed. Leukoreduction of RBC and platelet units. American Association of Blood Banks. 1996:722-725.
- Wenz B, Gurtlinger KF, O’Toole AM, Dugan EP. Preparation of granulocyte-poor red blood cells by microaggregate filtration: a simplified method to minimize febrile transfusion reactions. Vox Sang. 1980;39:282-287.
