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, cholesterol and the detetion of antibodies to RBC antigens.

Each test is performed in strict compliance with current instructions provided by the manufacturer of the test materials and equipment in use. All reagents meet or exceed the requirements of the Food and Drug Administration.

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
Implemented February 2007

Anti- HTLV - I/HTLV- II - Human T-Lymphotropic Virus Type I and Type II
Abbott HTLV-I/HTLV-II ChLIA
Abbott Laboratories
U.S. License No. 0043
Implemented November 2008

HBsAg - Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal)
GS HBsAG EIA 3.0
Bio-Rad Laboratories
U.S. License No. 1109
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
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
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

Nucleic Acid Testing (NAT)

HIV-1 - Cobas AmpliScreen HIV-1 Test
Roche Diagnostics
U.S. License No. 1636
Implemented December 1999

HCV - Cobas AmpliScreen HCV Test
Version 2.0
Roche Diagnostics
U.S. License No. 1636
Implemented April 1999

HBV – Cobas AmpliScreen HBV Test
Version 2.0
Roche Diagnostics
U.S. License No. 1636
Implemented January 2009

MPX – Cobas TaqScreen Multiplex Assay Test
Roche Diagnostics
U.S. License No. 1636
Implemented September 2009

West Nile Virus - TaqScreen WNV Test
Roche Diagnostics
U.S. License No. 1636
Implemented June 2003

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 Gamma
U.S. License No. 0886
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 – Macro-Vue RPR Card Test
Brewer Diagnostic Kit for the Serologic
Detection of Syphilis
Becton Dickinson, Inc.
U. S. License No. Not Applicable
Implemented February 1999

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

Anti-HCV RIBA - Chiron RIBA HCV 3.0 Strip Immunoblot Assay (SIA)
Chiron Corporation
U.S. License No. 1106
Implemented May 1996

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

Syphilis TP-PA - Serodia TP-PA
Fujirebio Diagnostics, Inc.
U.S. License No. – Not Applicable
Implemented September 1992

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
Abbott PRISM HTLV-I/II
GTi QuikScreen HLA Class I & II Antigens
Immucor/Gamma Galileo Antibody Screens
Olympus AU640 Lipid Profiles
(cholesterol, LDL, HDL, triglycerides)
Olympus PK 7300 ABO, Rh, Syphilis, CMV, antigen typing
Olympus Tango Antibody Screens
Ortho Ortho Summit Processor Chagas, HIV-1/2+O, HCV, HBsAg, HBc
Roche cobas
Amplicor
NAT HIV-1 HCV/HBV
Roche cobas
TaqScreen
NAT WNV
Roche cobas s 201 TaqScreen MPX Triplex Assay
(HIV-1 Group M, HIV-1 Group O, HIV-2, HCV, HBV)
BD BioScience FACScan RBC, Platelet Leukoreduction QC
eBDS 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.