NATIONAL DONOR TESTING SERVICES
Overview
Tests Performed
Testing Equipment
Service Fees
Lab Management
Overview
Infectious disease testing of donor blood is a critical step in ensuring the safety of the blood supply. By maintaining multiple testing shifts, Your Lab offers customers accurate and rapid detection and confirmation of a variety of infectious and viral diseases, as well as ABO/Rh, and the detection of antibodies to RBC antigens.
Each test is performed in strict compliance with current, manufacturer's instructions and equipment in use. All reagents meet or exceed the requirements of the FDA and many are also EU Compliant or Equivalent.
Tests Performed
Enzyme Immunoassays
Anti-HIV-1/HIV-2 +O - Human Immunodeficiency Virus Types 1 and 2 (Recombinant and Synthetic Peptides)
Genetic Systems HIV-1/HIV-2 Plus O EIA
Bio-Rad Laboratories
U.S. License No. 1109, CE Marked
Implemented February 2007
Anti- HTLV - I/HTLV- II - Human T-Lymphotropic Virus Type I and Type II
Avioq Microelisa System
Avioq Inc.
U.S. License No. 1856, CE Marked
Implemented January 2013
HBsAg - Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal)
GS HBsAG EIA 3.0
Bio-Rad Laboratories
U.S. License No. 1109, CE Marked
Implemented January 2007
Anti-HBc - Hepatitis B Virus Core Antigen (Recombinant)
Ortho-HBc ELISA Test System
ORTHO-Clinical Diagnostics, Inc.
U.S. License No. 1236, Marked Equivalent to CE
Implemented December 1992
Anti-HCV - Hepatitis C Virus Encoded Antigen (Recombinant c22-3, c200 and NS5)
Ortho HCV Version 3.0 ELISA Test System
ORTHO-Clinical Diagnostics, Inc.
U.S. License No. 1236, Marked Equivalent to CE
Implemented May 1996
Anti-T. Cruzi (Chagas) – Trypanosoma cruzi Whole Cell Lysate Antigen
Ortho T. cruzi ELISA Test System
ORTHO-Clinical Diagnostics, Inc.
U.S. License No. 1236, CE Marked
Nucleic Acid Testing (NAT)
MPX – Cobas TaqScreen Multiplex Assay Test (HIV-1, HCV, HBV)
Roche Diagnostics
U.S. License No. 1636, Marked Equivalent to CE
Implemented September 2009
West Nile Virus - TaqScreen WNV Test
Roche Diagnostics
U.S. License No. 1636
Implemented June 2003, CE Marked
Zika Virus – Cobas TaqScreen Zika v. 2.0
Roche Diagnostics
U.S. License No. 1636
Implemented November 6, 2017
Microhemagglutination Assays
ABO/Rh - Olympus Automated Analyzer
Reagent Red Blood Cells
Diagast
U.S. License No. 1744
Implemented February 2009
Antibody Screen – Search-Cyte
Medion Diagnostics for Olympus
U.S. License No. 1702/1740
Implemented September 2006
Antibody Screen – Capture-R Ready
Indicator Red Cells for the Galileo
Immucor
U.S. License No. 0886, CE Marked
Implemented March 2009
CMV-PA System for Olympus PK Automated Analyzers
Fujirebio Diagnostics Inc for Olympus
Tokyo, Japan
Implemented February 2004
Syphilis – Olympus PK-TP System
Fujirebio Diagnostics Inc for Olympus
Clearance No. BK940053
Implemented September 1992
CMV – Antibody to Cytomegalovirus
Capture-CMV Solid Phase
Immucor-Gamma
Implemented Dec 2008
Syphilis – ASI RPR Card Test
Arlington Scientific, Inc.
STN No. K851504
CE Marked
Supplemental Testing
Anti-HIV-1 IFA - Human Immunodeficiency Virus Type 1
Sanochemia Pharmazeutika AG
U.S. License No. 1631
Implemented March 2007
Anti-HIV-2 EIA - Human Immunodeficiency Virus Type 2
GS HIV-2 EIA
Bio-Rad Laboratories
U.S. License No. 1109
Implemented January 2008
HBsAg Neutralization - Antibody to Hepatitis B Surface Antigen (Human)
GS HBsAg Confirmatory Assay 3.0
Bio-Rad Laboratories
U.S. License No. 1109
Implemented January 2007
Miscellaneous Testing
HLA class I and II – QuikScreen
GTi Diagnostics
U.S. License No. – Not Applicable
Implemented September 2008
ID|Core + Blood Chip Technology
Progenika, Inc
U. S. License No. – Not Applicable
Implemented June 2010
Equipment List
| Manufacturer | Equipment | Tests Performed |
| Immucor | GEMINI | HLA Class I & II Antigens |
| Immucor | Galileo Neo | Antibody Screens |
| Bio-Rad | PK 7300 | ABO, Rh, Syphilis, CMV, antigen typing |
| Bio-Rad | Tango | Antibody Screens |
| Ortho | Ortho Summit Processor | Chagas, HIV-1/2+O, HCV, HBsAg, HBc |
| Roche | cobas 8800 System TaqScreen |
NAT WNV and Zika |
| Roche | cobas 8800 System | MPX Triplex Assay (HIV-1 Group M, HIV-1 Group O, HIV-2, HCV, HBV) |
| BD BioScience | NanoEnTek Adam-rWBC | RBC, Platelet Leukoreduction QC |
| Biomerieux BACT/ALERT 3D | Bacteria Detection System | Bacterial contamination detection |
| Sysmex | XE2100-D | Platelet/RBC counts |
Service Fees
For service fee information, please contact Steve Ruth at (713) 791-6202.
Lab Management - Cheri Jennings MTC(ASCP)SBB, CQA(ASQ)
A native of Austin, Texas, Cheri earned her BS degree from The University of Texas – then moved to Houston to complete her certification as a Specialist in Blood Bank technology from The University of Texas Health Science Center.
Cheri is currently Director of Technical Services at Gulf Coast Regional Blood Center in Houston where she has held numerous positions including: Supervisor, Consultation and Reference Laboratory and as Manager of the National Donor Testing Laboratory, Quality Assurance and Operations.
Cheri has presented before the FDA’s Blood Product Advisory Committee, national and regional conferences/conventions and locally. She serves on the Houston Community College Technical Advisory Board and is active in the South Central Association of Blood Banks, American Association for Clinical Laboratory Science, and is an assessor for the American Association of Blood Banks Accreditation Program.