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      Plasma Count Kit
      Product Details
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      BD™
      Human
      Flow cytometry
      CE_IVD


      Description

      The BD Plasma Count kit is intended for in vitro diagnostic use to identify and enumerate residual leucocytes (rWBCs), red blood cells (rRBCs), and platelets (rPLTs) in fresh human plasma, using flow cytometry.

      Preparation And Storage

      • Store the BD Plasma Count kit at 2° to 8° C. Do not use after the expiration date shown on the label.

      • Avoid unnecessary exposure of the reagents to light.

      • The BD Trucount tubes are packaged in two foil pouches. Each pouch contains 25 tubes and desiccant. Store BD Trucount tubes in their original foil pouch at 2° to 25° C. To avoid potential condensation, open the pouch only after it has reached room temperature and carefully reseal the pouch immediately after removing a tube. Examine the desiccant each time you open the pouch. If the desiccant has turned from blue to lavender, discard the remaining tubes. Use tubes within 1 hour after removal from the foil pouch. Once the pouch has been opened, the tubes are stable for 1 month. Do not use beyond the expiration date indicated on the packaging.

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      338331 Rev. 1
      Citations & References
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      Development References (27)

      1. Bundesgesundheitsbl- Gesundheitsforsch-Gesundheitsschutz. 2000:555–589.
      2. Centers for Disease Control. Update: universal precautions for prevention of transmission of human immunodeficiency virus, hepatitis B virus, and other bloodborne pathogens in healthcare settings. MMWR. 1988; 37:377-388. (Biology).
      3. Clinical Applications of Flow Cytometry: Quality Assurance and Immunophenotyping of Lymphocytes: Approved Guideline. H42-A2. 2007. (Biology).
      4. Council of Europe Publishing. 2004.
      5. Dzik S. Counting Low Numbers of Leukocytes in Leukoreduced Blood Components. Infusion Therapy and Transfusion Medicine. 1999; 26:62–65. (Biology).
      6. Feng R, Shimazaki C, Inaba T, et al. CD34+/CD41a+ cells best predict platelet recovery after autologous peripheral blood stem cell transplantation. Bone Marrow Transplant. 1998; 21:1217-1222. (Biology).
      7. Frey B, Furrer M, Wettstein M, Minder U. Quanti cation of residual red blood cells in platelet concentrates and fresh frozen plasma by flow cytometry. Infusion Therapy and Transfusion Medicine. 2001; 28:53. (Biology).
      8. Gahmberg CG, Jokinen M, Andersson LC. Expression of the major sialoglycoprotein (glycophorin) on erythroid cells in human bone marrow. Blood. 1978; 52:379-387. (Biology).
      9. Heiden M, Seitz R. Quality of therapeutic plasmarequirements for marketing authorization. Thromb Res. 2002; 107:47-51. (Biology).
      10. ICH SC. Q2A: Text on Validation of Analytical Procedures Presented at the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. (Biology).
      11. ICH SC. Q2B: Validation of Analytical Procedures Presented at the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. (Biology).
      12. Jennings LK, Ashmun RA, Wang WC, Dockter ME. Analysis of human platelet glycoproteins IIb-IIIa and Glanzmann's thrombasthenia in whole blood by flow cytometry.. Blood. 1986; 68(1):173-9. (Biology). View Reference
      13. Jilma-Stohlawetz P, Marsik C, Horvath M, Siegmeth H, Hocker P, Jilma B. A new ow cytometric method for simultaneous measurement of residual platelets and RBCs in plasma: validation and application for QC. Transfusion. 2001; 41(1):87–92. (Biology).
      14. Krailadsiri P, Seghatchian J. Residual red cell and platelet content in WBC-reduced plasma measured by a novel ow cytometric method. Transfusion and Apheresis Science. 2001; 24:279–286. (Biology).
      15. Lambrecht B, Spengler HP, Bauerfeind U, Mohr H. Simultaneous quantitation of contaminating leukocytes, erythrocytes, and platelets in fresh frozen plasma in a single tube assay by flow cytometry. Infusion Therapy and Transfusion Medicine. 2001; 52–53. (Biology).
      16. Lee LG, Chen CH, Chiu LA. Thiazole orange: a new dye for reticulocyte analysis. Cytometry. 1986; 7(6):508-517. (Biology).
      17. Linneweber J, Chow TW, Takano T, et al. Direct detection of red blood cell fragments: a new ow cytometric method to evaluate hemolysis in blood pumps. Asaio J. 2001; 47(5):533-536. (Biology).
      18. NCCLS document. 2001. (Biology).
      19. Pichler J, Printz D, Scharner D, Trbojevic D, Siekmann J, Fritsch G. Improved ow cytometric method to enumerate residual cells: minimal linear detection limits for platelets, erythrocytes, and leukocytes. Cytometry. 2002; 50(4):231-237. (Biology).
      20. Preliminary Evaluation of Quantitative Clinical Laboratory Methods; Approved Guideline— Second Edition. NCCLS document EP10-A2. 2002. (Biology).
      21. Rogers CE, Bradley MS, Palsson BO, Koller MR. Flow cytometric analysis of human bone marrow perfusion cultures: erythroid development and relationship with burst-forming units-erythroid. Exp Hematol. 1996; 24(5):597-604. (Biology). View Reference
      22. Terstappen LW, Loken MR. Five-dimensional ow cytometry as a new approach for blood and bone marrow differentials. Cytometry. 1988; 9(6):548-556. (Biology).
      23. Vowells S, Cadden M, Wagner C, Nuñez R. Quality of therapeutic plasmarequirements for marketing authorization. Detection and Enumeration of Residual White Blood Cells in Leucoreduced Red Blood Cell and Platelet Products Using the LeucoCOUNT Kit. 1998. (Biology).
      24. Wise GE, Oakford LX, Dzandu JK. Ultrastructure of a transmembrane glycoprotein, glycophorin A. Tissue & Cell. 1988; 20:219-227. (Biology).
      25. de Haas M, von dem Borne A. CD41/CD61 Workshop Panel report. In: Knapp W. W. Knapp .. et al., ed. Leucocyte typing IV : white cell differentiation antigens. Oxford New York: Oxford University Press; 1989:643-645.
      26. de Vries E, De Bruin-Versteeg S, Comans-Bitter WM, et al. Correction for erythroid cell contamination in microassay for immunophenotyping of neonatal lymphocytes. Arch Dis Child Fetal Neonatal Ed. 1999; 80:226-229. (Biology).
      27. von dem Borne AEGKr, Modderman PW, Admiraal LG, Nieuwenhuis, HK. Platelet antibodies, the overall results. In: Knapp W. W. Knapp .. et al., ed. Leucocyte typing IV : white cell differentiation antigens. Oxford New York: Oxford University Press; 1989:951-966.
      View All (27) View Less
      338331 Rev. 1

      Please refer to Support Documents for Quality Certificates

      Global - Refer to manufacturer's instructions for use and related User Manuals and Technical data sheets before using this products as described

      Comparisons, where applicable, are made against older BD Technology, manual methods or are general performance claims.  Comparisons are not made against non-BD technologies, unless otherwise noted.

      For In Vitro Diagnostic Use.

       

      23-22942-00

      Documents are subject to revision without notice. Please verify you have the correct revision of the document, and always refer back to BD's eIFU website for the latest and most up to date information.

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