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      Cartridge Kit

      BD FACSPresto™ Cartridge Kit

      (CE_IVD)
      Product Details
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      BD FACSPresto™
      Human
      CD4 Monitoring
      CE_IVD


      Description

      The BD FACSPresto Cartridge kit is designed for venous and capillary finger-stick whole blood application. It comes with 100 cartridges (657681) and Finger-stick sample collection kit for 100 samples which has 100 BD CAL Lancets, 100 Alcohol Swabs packets, 100 Cotton Gauze packets and 100 Band Aids. The BD FACSPresto CD4/Hb Cartridge is a single use reagent cartridge to be used with the BD FACSPresto™ System for performing the direct quantification and enumeration of CD4 absolute count, CD4 percentage of lymphocytes, and determination of hemoglobin concentration in normal and HIV positive patients, in conjunction with other laboratory and clinical findings.

      Preparation And Storage

      Store the cartridge: • In its original foil pouch. Do not use the cartridge if the pouch has been opened for more than 30 minutes. • At 4°C–31°C (39°F–88°F). • In 10%–95% non-condensing humidity. • Until the expiration date. Do not use the cartridge after the expiration date on the package. Incubate the cartridge at 10°C–40°C (50°F–104°F).

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      655495 Rev. 1
      Citations & References
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      Development References (29)

      1. Bernard A, Boumsell L, Hill C. Joint report of the first international workshop on human leucocyte differentiation antigens by the investigators of the participating laboratories. In: Bernard A, Boumsell L, Dausset J, Milstein C, Schlossman SF, ed. Leucocyte Typing. New York, NY: Springer-Verlag; 1984:9-108.
      2. Bernstein ID, Self S. Joint report of the Myeloid Section of the Second International Workshop on Human Leukocyte Differentiation Antigens. In: Reinherz EL, Haynes BF, Nadler LM, Bernstein ID, ed. Leukocyte Typing II: Human Myeloid and Hematopoietic Cells. New York, NY: Springer-Verlag; 1986:1-25.
      3. Clinical and Laboratory Standards Institute. 2005. (Biology).
      4. Clinical and Laboratory Standards Institute. 2008. (Biology).
      5. Dalgleish AG, Beverley PC, Clapham PR, Crawford DH, Greaves MF, Weiss RA. The CD4 (T4) antigen is an essential component of the receptor for the AIDS retrovirus.. Nature. 312(5996):763-7. (Biology). View Reference
      6. Engleman EG, Benike CJ, Glickman E, Evans RL. Antibodies to membrane structures that distinguish suppressor/cytotoxic and helper T lymphocyte subpopulations block the mixed leukocyte reaction in man. J Exp Med. 1981; 154(1):193-198. (Biology). View Reference
      7. Evans RL, Wall DW, Platsoucas CD, et al. Thymus-dependent membrane antigens in man: inhibition of cell-mediated lympholysis by monoclonal antibodies to TH2 antigen. Proc Natl Acad Sci U S A. 1981; 78(1):544-548. (Biology). View Reference
      8. Fahey JL, Taylor JM, Detels R, et al. The prognostic value of cellular and serologic markers in infection with human immunodeficiency virus type 1. N Engl J Med. 1990; 322:166-172. (Biology).
      9. Firnhaber C, Smeaton L, Saukila N, et al. Comparisons of anemia, thrombocytopenia, and neutropenia at initiation of HIV antiretroviral therapy in Africa, Asia, and the Americas. Int J Infect Dis. 2010; 14:e1088-1092. (Biology).
      10. Giorgi J, Hultin L. Lymphocyte subset alterations and immunophenotyping by flow cytometry in HIV disease. Clin Immunol Newslett. 1990; 10(4):55-61. (Biology).
      11. Giorgi JV. Lymphocyte subset measurements: significance in clinical medicine. In: Rose NR, Friedman H, Fahey JL, ed. Manual of Clinical Laboratory Immunology. 3rd ed.. Washington, DC: American Society for Microbiology; 1986:236-246.
      12. Goyert SM, Ferrero E. Biochemical analysis of myeloid antigens and cDNA expression of gp55 (CD14). In: McMichael AJ. A.J. McMichael .. et al., ed. Leucocyte typing III : white cell differentiation antigens. Oxford New York: Oxford University Press; 1987:613-619.
      13. Henry DH, Beall GN, Benson CA, et al. Recombinant human erythropoietin in the treatment of anemia associated with human immunodeficiency virus (HIV) infection and zidovudine therapy. Overview of four clinical trials. Ann Intern Med. 1992; 117:739-748. (Biology).
      14. Kotzin BL, Benike CJ, Engleman EG. Induction of immunoglobulin-secreting cells in the allogeneic mixed leukocyte reaction: regulation by helper and suppressor lymphocyte subsets in man. J Immunol. 1981; 127(9):931-935. (Biology). View Reference
      15. Ledbetter JA, Evans RL, Lipinski M, Cunningham-Rundles C, Good RA, Herzenberg LA. Evolutionary conservation of surface molecules that distinguish T lymphocyte helper/inducer and cytotoxic/suppressor subpopulations in mouse and man. J Exp Med. 1981; 153(2):310-323. (Biology). View Reference
      16. Lehmann HP, Henry JB. Henry, J, ed. Clinical Diagnosis and Management Diagnosis, Twentieth Edition. Philadelphia: WB Saunders Company; 2001:1426-1441.
      17. Levine AM, Berhane K, Masri-Lavine L, et al. Prevalence and correlates of anemia in a large cohort of HIV-infected women: Women's Interagency HIV Study. J Acquir Immune Defic Syndr. 2001; 26:28-35. (Biology).
      18. Lewis DE, Puck JM, Babcock GF, Rich RR. Disproportionate expansion of a minor T cell subset in patients with lymphadenopathy syndrome and acquired immunodeficiency syndrome.. J Infect Dis. 1985; 151(3):555-9. (Biology). View Reference
      19. McEnroe RJ, Burritt, MF, Powers DM, et al. Interference Testing in Clinical Chemistry; Approved Guideline- Second Edition CLSI document EP7-A2. Wayne, PA: Clinical and Laboratory Standards Institute; 2005.
      20. Ohno T, Kanoh T, Suzuki T, et al. Comparative analysis of lymphocyte phenotypes between carriers of human immunodeficiency virus (HIV) and adult patients with primary immunodeficiency using two-color immunofluorescence flow cytometry.. Tohoku J Exp Med. 1988; 154(2):157-72. (Biology). View Reference
      21. Reichert T, DeBruyere M, Deneys V, et al. Lymphocyte subset reference ranges in adult Caucasians. Clin Immunol Immunopathol. 1991; 60(2):190-208. (Biology). View Reference
      22. Rose LM, Ginsberg AH, Rothstein TL, Ledbetter JA, Clark EA. Selective loss of a subset of T helper cells in active multiple sclerosis.. Proc Natl Acad Sci USA. 1985; 82(21):7389-93. (Biology). View Reference
      23. Schmidt RE. Monoclonal antibodies for diagnosis of immunodeficiencies. Blut. 1989; 59:200-206. (Biology).
      24. Schwinzer R. Cluster Report: CD45/CD45R. In: Knapp W. W. Knapp .. et al., ed. Leucocyte typing IV : white cell differentiation antigens. Oxford New York: Oxford University Press; 1989:628-634.
      25. Serra HM, Krowka JF, Ledbetter JA, Pilarski LM. Loss of CD45R (Lp220) represents a post-thymic T cell differentiation event.. J Immunol. 1988; 140(5):1435-41. (Biology). View Reference
      26. Siegel JD, Rhinehart E, Jackson M, Chiarello L. Healthcare Infection Control Practices Advisory Committee. Available: http://www.cdc.gov/ ncidod/dhqp/pdf/isolation2007.pdf .
      27. Sobel RA, Hafler DA, Castro EE, Morimoto C, Weiner HL. The 2H4 (CD45R) antigen is selectively decreased in multiple sclerosis lesions.. J Immunol. 1988; 140(7):2210-4. (Biology). View Reference
      28. Stites DP, Casavant CH, McHugh TM, et al. Flow cytometric analysis of lymphocyte phenotypes in AIDS using monoclonal antibodies and simultaneous dual immunofluorescence.. Clin Immunol Immunopathol. 1986; 38(2):161-77. (Biology). View Reference
      29. Zeh C, Amornkul PN, Inzaule S, et al. Populationbased biochemistry, immunologic and hematological reference values for adolescents and young adults in a rural population in western Kenya. PLOS One. 2011; 6:43840. (Biology).
      View All (29) View Less
      655495 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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