Blood Screening Assays. CTS lab locations where assays are performed are indicated by alpha codes D, P, and T.
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1 Blood Screening Assays CTS lab locations where assays are performed are indicated by alpha codes D, P, and T. D= performed in Dallas lab FEI: P= performed in Phoenix lab FEI: T= performed in Tampa lab FEI: ABO/Rh (P, D, T) Manufacturer: Diagast, Loos Cedex, France for Beckman Coulter Beckman Coulter PK System Blood Grouping and Phenotyping ReagentsPK7200 and PK7300 Automated Immunohematology Analyzers License: U.S. License No Alternate ABO/Rh (P, D, T) Manufacturer: ImmucorGamma, Norcross, GA Reagent Red Blood Cells for ABO Serum Grouping, Blood Grouping Reagents Anti-A (Series 1), -B (Series 1), -B (Series 3), -A,B (Series 1), -D (Series 4), -D (Series 5) Galileo /Neo Automated Blood Bank System License: U.S. License No Antibody Identification Manufacturer: Micro Typing Systems, Inc. an Ortho Clinical-Diagnostics Company, Raritan NJ MTS Anti-IgG Card Reagent Red Blood Cells 0.8% Resolve Panel A and Panel B ProVue Analyzer License: U.S. License No and 1236 Alternate Antibody Identification Manufacturer: ImmucorGamma., Norcross, GA Capture-R Ready ID, Extend I and Extend II License: U.S. License No Antibody Screen (P, D, T) Manufacturer: ImmucorGamma., Norcross, GA Capture-R Ready Screen (Pooled) License: U.S. License No for Capture-R Ready Screen test wells only and BK Alternate Antibody Screen (P, D, T) Manufacturer: Micro Typing Systems, Inc. an Ortho Clinical-Diagnostics Company, Raritan NJ MTS Anti-IgG Card Reagent Red Blood Cells 0.8% Surgiscreen ProVue Analyzer License: U.S. License No and 1236 Page 1 of 12
2 Blood Screening Assays Anti-HBc (ChLIA) (P, D, T) Abbott PRISM HBcore, Hepatitis B Virus Core Antigen (E. coli, Recombinant) Anti-HCV (ChLIA) (P, D, T) Abbott PRISM HCV, Hepatitis C Virus Encoded Antigens (Recombinant c100-3, HCr43, NS5) Generation: 2 Anti-HIV-1/HIV-2 ChLIA (P, D, T) Abbott PRISM HIV O Plus, Human Immunodeficiency Virus Types 1 and 2 (E. coli, B. megaterium, Recombinant) Antigen and Synthetic Peptide Anti-HTLV-I/HTLV-II (ChLIA) (P, D, T) Abbott PRISM HTLV-I/HTLV-II, Human T-Lymphotropic Virus Types I and II Babesia (P, T) Manufacturer: Immunetics, Inc. Babesia microti ELISA Kit License: Information not available NOTE: This assay is for investigational use only and requires IRB approval prior to implementation. Cholesterol (P, D, T) Manufacturer: Beckman Coulter, Inc. Cholesterol License: Information not available Cytomegalovirus (CMV) Screen (P, D, T) Manufacturer: Fujirebio Diagnostics, Inc. Malvern, PA Beckman Coulter Beckman Coulter PK CMV-PA Test System and Controls PK7200 and PK7300 Automated Immunohematology Analyzers License: BK Ferritin (P, D, T) Manufacturer: Beckman Coulter, Inc. Ferritin License: Information not available Blood Screening Assays Page 2 of 12
3 HBsAg (ChLIA) (P, D, T) Abbott PRISM HBsAg, Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal IgM) Hemoglobin A1c (D) Manufacturer: Beckman Coulter, Inc. HbA1c (Hemoglobin A1c) License: U.S. License No Nucleic Acid Testing (NAT) cobas TaqScreen MPX Test, Version 2.0 (licensed for use with cadaveric samples) Manufacturer: Roche Diagnostics, Brachburg, NJ cobas TaqScreen MPX Test, Version 2.0 License: U.S. License No (T) Nucleic Acid Testing (NAT) cobas TaqScreen West Nile Virus Manufacturer: Roche Diagnostics, Brachburg, NJ cobas TaqScreen West Nile Virus Test License: U.S. License No (T) Nucleic Acid Testing (NAT) Procleix Ultrio Plus (P, D, T) (licensed for use with cadaveric samples) Manufacturer: Gen-Probe Incorporated, San Diego, CA Procleix Ultrio Assay License: U.S. License No Nucleic Acid Testing (NAT) Procleix WNV RNA (P, D, T) Manufacturer: Gen-Probe Incorporation, San Diego, CA Procleix WNV Assay License: U.S. License No Rh + K Phenotyping (P, D, T) Manufacturer: Diagast, Cedex Loos, France for Beckman Coulter PK Systems Blood Grouping Reagents (for the Beckman Coulter PK Systems) License: U.S. License No Syphilis Serology (P, D, T) Manufacturer: Fujirebio Diagnostics, Inc. Brea, CA for Beckman Coulter. Beckman Coulter PK TP System PK7200 and PK7300 Automated Immunohematology Analyzers License: BK T. cruzi Antibody ChLIA (P, D, T) Abbott PRISM Chagas, Trypanosoma cruzi (E. coli, Recombinant) Antigen Page 3 of 12
4 Parvovirus B19 / HAV Testing Parvovirus B19 Manufacturer: License: Roche Molecular Systems, Inc. cobas TaqScreen DPX Test Information not available Parvovirus B19 / HAV Manufacturer: License: Roche Molecular Systems, Inc. cobas TaqScreen DPX Test Information not available TRALI Mitigation Testing Donor Screen- HLA Class I and II (P, T) Manufacturer: GTI Diagnostics Crossroads Circle, Suite 200, Waukesha, WI Donor Screen- HLA Class I and II License: BK Page 4 of 12
5 Source Plasma Anti-HCV (ChLIA) (P, D, T) Abbott PRISM HCV, Hepatitis C Virus Encoded Antigens (Recombinant c100-3, HCr43, NS5) Generation: 2 Anti-HIV-1/HIV-2 ChLIA (P, D, T) Abbott PRISM HIV O Plus, Human Immunodeficiency Virus Types 1 and 2 (E. coli, B. megaterium, Recombinant) Antigen and Synthetic Peptide HBsAg (ChLIA) (P, D, T) Abbott PRISM HBsAg, Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal IgM) Nucleic Acid Testing (NAT) Procleix Ultrio Plus (P, D, T) (licensed for use with cadaveric samples) Manufacturer: Gen-Probe Incorporated, San Diego, CA Procleix Ultrio Assay License: U.S. License No Page 5 of 12
6 Source Plasma Ancillary Testing RPR (P, T) Manufacturer: Arlington Scientific, Inc., Springville, UT ASI RPR Card Test for Syphilis License: Not Applicable Serum Protein Electropheresis Manufacturer: Sebia Electrophoresis, Norcoss, GA Capillarys Protein (E) 6 License: Not Applicable Total Protein Manufacturer: License: Beckman Coulter, Inc. Total Protein Not Applicable ABO/Rh (P, D, T) Manufacturer: Diagast, Loos Cedex, France for Beckman Coulter Beckman Coulter PK System Blood Grouping and Phenotyping ReagentsPK7200 and PK7300 Automated Immunohematology Analyzers License: U.S. License No Antibody Screen (P, D, T) Manufacturer: ImmucorGamma., Norcross, GA Capture-R Ready Screen (Pooled) License: U.S. License No for Capture-R Ready Screen test wells only and BK Page 6 of 12
7 Anti-HBc EIA Manufacturer: Supplemental/Confirmatory Assays and Alternate Screening Assays ORTHO-Clinical Diagnostics, Inc., Raritan, NJ ORTHO Hepatitis B Virus Core Antigen (Recombinant) ORTHO HBc ELISA Test System License: U.S. License No Anti-HBs EIA Manufacturer: License: Bio-Rad Laboratories, Redmond, WA Monolisa Anti-HBs EIA Not applicable Anti-HCV EIA (licensed for use with cadaveric samples) Manufacturer: ORTHO-Clinical Diagnostics, Inc., Raritan, NJ Hepatitis C Virus Encoded Antigen (Recombinant c22-3, C200 and NS5) ORTHO HCV Version 3.0 ELISA Test System License: U.S. License No Anti-HIV-1 IFA Manufacturer: Sanochemia Pharmazeutika AG Vienna, Austria Immunodeficiency Virus Type 1 (HIV-1): Fluorognost HIV-1 IFA License: U.S. License No Anti-HIV-2 EIA Manufacturer: Bio-Rad Laboratories Blood Virus Division Redmond, WA Human Immunodeficiency Virus Type 2, GS License: U.S. License No Anti-HIV-1/2 Plus O EIA (licensed for use with cadaveric samples) Manufacturer: Bio-Rad Laboratories Blood Virus Division Redmond, WA Human Immunodeficiency Virus Types 1 and 2 (Recombinant and Synthetic Peptides) GS HIV-1/HIV-2 Plus O EIA License: U.S. License No Anti-HTLV-I/II Confirmatory Assay Manufacturer: MP Biomedicals Asia Pacific Pte. LTD HTLV Blot 2.4 Western Blot Assay License: Not applicable US Patent 5,066,579; 5,614,366; 5,763,572 ; 5,814,441 ; 5,871,933 ; 5,643,714: HBsAg Confirmatory ChLIA Abbott PRISM Antibody to Hepatitis B Surface Antigen (Human) HBsAg EIA (licensed for use with cadaveric samples) Manufacturer: Bio-Rad Laboratories Blood Virus Division, Redmond, WA Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal):GS HBsAg EIA 3.0 License: U.S. License No Generation: 3 Page 7 of 12
8 Supplemental/Confirmatory Assays and Alternate Screening Assays HBsAg EIA Neutralization Manufacturer: Bio-Rad Laboratories Blood Virus Division Redmond, WA Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal) GS HBsAg Confirmatory Assay 3.0 License: U.S. License No HTLV I/II EIA (Avioq) Manufacturer: Avioq, Inc., Research Triangle Park, North Carolina Avioq HTLV-I/II Microelisa System License: U.S. License No Nucleic Acid Testing (NAT) Procleix Ultrio Plus Discriminatory dhbv (P, T) (licensed for use with cadaveric samples) Manufacturer: Gen-Probe Incorporation, San Diego, CA Procleix Ultrio Plus dhbv Assay License: U.S. License No Nucleic Acid Testing (NAT) Procleix Ultrio Plus Discriminatory dhcv (P, T) (licensed for use with cadaveric samples) Manufacturer: Gen-Probe Incorporation, San Diego, CA Procleix Ultrio Plus dhcv Assay License: U.S. License No Nucleic Acid Testing (NAT) Procleix Ultrio Plus Discriminatory dhiv-1 (P, T) (licensed for use with cadaveric samples) Manufacturer: Gen-Probe Incorporation, San Diego, CA Procleix Ultrio Plus dhiv-1assay License: U.S. License No RPR and Quantitative RPR (P, T) Manufacturer: Arlington Scientific, Inc., Springville, UT ASI RPR Card Test for Syphilis License: Not Applicable Syphilis-G EIA Manufacturer: License: Trinity Biotech, Jamestown, NY CAPTIA Syph - G Not Applicable T. cruzi Antigen ESA Abbott ESA Chagas, Trypanosoma cruzi (E. coli, Recombinant) Antigen Page 8 of 12
9 Supplemental/Confirmatory Assays and Alternate Screening Assays Referral Testing Services Assay available through Memorial Blood Centers Anti-T Cruzi EIA Unlicensed assay available through California Department of Health Services Laboratory Anti-HIV-2 Western Blot Unlicensed assays available through Quest Laboratories Anti-HBc IgM EBV IgG Toxoplasma IgG (Toxoplasma Gondii) WNV IgG Antibody WNV IgM Antibody Page 9 of 12
10 Component Quality Control WBC Counts on Leucoreduced Products LeucoCOUNT Kit Manufacturer: Becton Dickinson Immunocytometry Systems, San Jose, CA LeucoCOUNT Kit License: Information is not available Factor VIII and Fibrinogen on Cryoprecipitated and Fresh Frozen Plasma Units Dade-Behring Factor VIII Chromogenic Assay Manufacturer: Dade-Behring, Inc., Newark, DE Factor VIII Chromogenic Assay License: Information is not available Dade-Behring Multi-Fibren U Fibrinogen Assay Manufacturer: Dade-Behring, Inc., Newark, DE Fibrinogen Assay License: Information is not available Dade-Behring Standard Human Plasma Manufacturer: Dade-Behring, Inc., Newark, DE Factor VIII Chromogenic Assay License: Information is not available Bacterial Detection for Leukoreduced Platelet Components BacT/ALERT SA Manufacturer: biomérieux, Inc. BacT/ALERT License: Information is not available Page 10 of 12
11 Revision History The following table represents the revision history of this document. Date Revised Reason for Change Addition cobas Taqscreen MPX /01/2016 Discontinuation of AmpliScreen and FTA Addition of MP HLTV Western Blot /17/16 Removal of HTLV Inno-LIA 11/23/15 Ferritin implementation Tampa Removed Alternate CMV on Galileo platform Added Babesia Added Tampa site to Ferritin Added Source Plasma section: Anti HIV 1/HIV 2 Anti-HCV 09/21/15 HbsAg Procleix Ultrio plus assay ABO/Rh Antibody Screen RPR Serum Protein Electropheresis Total Protein Addition of Roche NAT HCV in Phoenix 08/20/15 Addition of HbA1c in Dallas Addition of Generation HCV ChLIA and HbsAg EIA 07/10/15 Removed Referral testing from Illinois Department of Health 04/01/15 Removed CTS Chicago and added Ferritin 03/23/15 Implementation of Rh, kell in Tampa Addition of T. Cruzi ESA 11/04/14 Addition of Syphilis FTA Addition of Phoenix location to HLA Screen Class I and II 09/23/14 Removed T. cruzi Antibody RIPA 04/14/14 Removed Dallas and Tampa locations from Antibody ID assay Addition of Reference testing of Anti-T Cruzi 02/03/14 Removal of Reference testing of Anti- HCV 09/17/13 NEO implementation for Red Cell Testing 07/15/13 Prism implementation for viral marker testing 07/01/13 Prism implementation for T. Cruzi testing 04/15/13 Implementation of Procleix Ultrio plus assay Updated Supplemental/Confirmatory section to reflect 03/11/13 consolidation of Tampa and Phoenix Special Testing Added assays performed by CTS Chicago 01/01/13 Updated Parvo B19 assay to Roche Removed LabScreen Mixed Class I and II Antibodies 11/06/12 Removed HCV RIBA from Supplemental Assays Added Anti-HCV ChLIA to Referral Testing 05/21/12 Updated the HTLV assays from Prism to Avioq. Removed ALT assay from Supplemental/Confirmatory under 04/26/12 Referral Assays. 04/17/12 Update Vendor Name from Olympus to Beckman Coulter Page 11 of 12
12 03/19/12 Updated the Anti-HBc and HBsAg assays from Prism to Ortho 01/17/12 Added the Donor Screen HLA Class I and Class II Removed Bio-Rad Anti-HIV-1 EIA from Supplemental/ 3/28/11 Confirmatory Assays list. Moved Roche PCR assays from Supplemental/Confirmatory to 10/28/10 Referral Assays. Removed NAT Procleix HIV-1/HCV assay from Blood Screening 10/13/10 Assays. Added NAT HIV-1/HCV/HBV Ultrio to Blood Screening Assays. 8/2/10 Added NAT Discriminatory dhbv to Supplemental/Confirmatory Assays. Removed Abbott Anti-HTLV-I/II EIA from Supplemental/ 4/19/10 Confirmatory Assays. Page 12 of 12
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