DONOR TESTING
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Required Tests:
| ABO/Rh | | Manufacturer: | Diagast, Loos, France | | Test Name: | Blood Grouping Reagents (for the Olympus® PK® Systems) | | License: | U.S. License No. 1744 |
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| Alternate ABO/Rh | | Manufacturer: | Biotest Medical Diagnostics, Dreieich, Germany | | Test Name: | Erytype S ABD+Rev. A1,B (for the TANGO) | | License: | U.S. License No. 1702 |
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| Alternate Syphilis Serology: RPR | | Manufacturer: | Arlington Scientific Inc., Springville, UT | | Test Name: | RPR Card Test for Syphilis | | List Number: | 900500 |
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| Antibody Screen | | Manufacturer: | Biotest Medical Diagnostics, Dreieich, Germany | | Test Name: | Solidscreen II (for the TANGO) | | License: | U.S. License No. 1702 |
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| Anti-HBc ChLIA | | Manufacturer: | Abbott Laboratories, Abbott Park, IL | | Test Name: | Abbott PRISM® HBcore, Hepatitis B Virus Core Antigen (E.coli, Recombinant) | | License: | U.S. License No. 43 | | List Number: | 6E66 |
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| Anti-HCV ChLIA | | Manufacturer: | Abbott Laboratories, Abbott Park, IL | | Test Name: | Abbott PRISM® HCV, Hepatitis C Virus Encoded Antigens (Recombinant c100-3, HCr43, NS5) | | License: | U.S. License No. 43 | | List Number: | 6D18 |
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| Anti-HIV-1/HIV-2 EIA | | Manufacturer: | Abbott Laboratories, Abbott Park, IL | | Test Name: | Human Immunodeficiency Virus Types 1 and 2 (E.Coli, B. Megaterium, Recombination Antigen) HIVABTM HIV-1/HIV-2 (rDNA) EIA | | License: | U.S. License No. 43 | | List Number: | 3A77 |
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| Anti-HTLV-I/HTLV-II ChLIA | | Manufacturer: | Abbott Laboratories, Abbott Park, IL | | Test Name: | Abbott PRISM® HTLV-I/HTLV-II, Human T-Lymphotropic Virus Types I and II | | License: | U.S. License No. 43 | | List Number: | 6E50 |
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| HBsAg ChLIA | | Manufacturer: | Abbott Laboratories, Abbott Park, IL | | Test Name: | Abbott PRISM® HBsAg, Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal IgM) | | License: | U.S. License No. 43 | | List Number: | 6D19 |
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| Nucleic Acid Testing (NAT) West Nile Virus (WNV) (Pooled testing for blood and plasma donors; individual testing for selected donors as required by the FDA) | | Manufacturer: | Roche Diagnostics, Branchburg, NJ | | Test Name: | cobas® TaqScreen West Nile Virus Test | | License: | U.S. License No. 1636 |
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| Nucleic Acid Testing using the cobas TaqScreen MPX Test (Pooled testing for blood and plasma donors; individual testing for selected donors as required by the FDA) | | Manufacturer: | Roche Diagnostics, Branchburg, NJ | | Test Name: | cobas® TaqScreen MPx Test | | License: | U.S. License No. 163 |
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| Syphilis Serology: MHA TP Screen | | Manufacturer: | Fujirebio Inc., Tokyo, Japan | | Test Name: | Olympus® PK® TP System | | List Number: | PH3000 |
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Confirmatory Tests:
| Anti-HCV RIBA | | Manufacturer: | Chiron Corporation, Emeryville, CA | | Test Name: | Chiron RIBA HCV 3.0 Strip Immunoblot Assay (SIA) | | License: | U.S. License No. 1106 |
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| Anti-HIV-1 Western Blot | | Manufacturer: | Bio-Rad Laboratories Blood Virus Division, Redmond, WA | | Test Name: | Human Immunodeficiency Virus Type 1 (HIV-1) Genetic SystemsTM Western Blot Kit | | License: | U.S. License No. 1109 |
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| Anti-HIV-2 EIA | | Manufacturer: | Bio-Rad Laboratories Blood Virus Division, Redmond, WA | | Test Name: | Human Immunodeficiency Virus Type 2, Genetic SystemsTM | | License: | U.S. License No. 1109 |
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| Anti-HTLV-I/HTLV-II EIA | | Manufacturer: | Abbott Laboratories, Abbott Park, IL | | Test Name: | Human T-Lymphotropic Virus Types I and Type II. Abbott HTLV-I/HTLV-II EIA | | License: | U.S. License No. 43 | | List Number: | 7A92 |
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| HBsAg Confirmatory ChLIA | | Manufacturer: | Abbott Laboratories, Abbott Park, IL | | Test Name: | Abbott PRISM® Antibody to Hepatitis B Surface Antigen (Human) | | License: | U.S. License No.43 |
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| INNO-LIA HTLV I/II Score | | Manufacturer: | Innogenetics N.V., Gent, Belgium | | Test Name: | HTLV I/II | | License: | Not Applicable |
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Supplemental Tests:
| Alternate Cytomegalovirus (CMV) Screen | | Manufacturer: | Immucor, Inc., Norcross, GA | | Test Name: | Capture-CMV® | | License: | U.S. License No. 0886 |
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| Cytomegalovirus (CMV) Screen | | Manufacturer: | Fujirebio Inc., Tokyo, Japan | | Test Name: | Olympus® PK® CMV-PA System | | List Number: | PA2300 |
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| HDL Cholesterol | | Manufacturer: | Olympus America Inc., Center Valley, PA | | Test Name: | Cholesterol | | List Number: | OSR195 |
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| HLA Antibody Screen (ELISA) | | Manufacturer: | GTI Diagnostics, Inc., Milwaukee, WI | | Test Name: | DonorScreen HLA Class I and Class II | | List Number: | DSI + II |
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| Nucleic Acid Testing (NAT) HBV | | Manufacturer: | Roche Molecular Systems, Inc., Branchburg, NJ | | Test Name: | cobas® AmpliScreen HBV Test | | License: | U.S. License No. 1636 |
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| Nucleic Acid Testing (NAT) HCV | | Manufacturer: | Roche Diagnostics, Branchburg, NJ | | Test Name: | cobas® AmpliScreenTM HCV Test, Version 2.0 | | License: | U.S. License No. 1636 |
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| Nucleic Acid Testing (NAT) HIV-1 | | Manufacturer: | Roche Diagnostics, Branchburg, NJ | | Test Name: | cobas® AmpliScreenTM HIV-1 Test, Version 1.5 | | License: | U.S. License No. 1636 |
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| Sickle Cell Reagent | | Manufacturer: | MichClone Associates, Inc. | | Test Name: | SickleHeme | | List Number: | MCA100AF |
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| Total Cholesterol | | Manufacturer: | Olympus America Inc., Center Valley, PA | | Test Name: | Cholesterol | | List Number: | OSR6116 |
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| Triglycerides | | Manufacturer: | Olympus America Inc., Center Valley, PA | | Test Name: | Cholesterol | | List Number: | OSR60118 |
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