More than 120 HCT/P providers from across the U.S. choose Memorial Blood Centers for quality testing services. In close partnership with reproductive medicine providers, cryobanks, university stem cell programs and biotech firms, we deliver:
Regulated and licensed by the FDA to conduct HCT/P testing, Memorial Blood Centers uses only FDA-approved test kits to test donors of human cells, tissues, and cellular and tissue-based products.
The FDA has issued a guidance for industry that describes the FDA’s approach to reducing the risk of transmission of West Nile Virus (WNV) from living donors of HCT/Ps. The FDA is recommending the use of an FDA-licensed NAT to test living donors on HCT/Ps recovered from June 1st through October 31st every year. For establishments intending to import HCT/Ps into the United States, the FDA recommends that donors be tested year-round for WNV by NAT.
Feel free to download a copy of the guidance. Memorial Blood Centers’ donor testing menu includes an FDA-cleared WNV test.
Confirmatory/supplemental testing is also available on select screening tests listed above, including:
Learn more about HCT/P Donor Testing Services.
Why choose Memorial Blood Centers?Hundreds of reproductive medicine organizations, independent clinics and cryobanks, academic medical facilities, and stem cell programs turn to Memorial Blood Centers for:
Regulated and licensed by the FDA, our donor testing facilities and expert staff provide a comprehensive menu of competitively-priced screening and confirmatory tests, including male and female test panels, immunoassays for infectious disease markers, and NAT (PCR) tests. Please review our detailed information on our HCT/P Donor Testing Services guide.
How do I request HCT/P donor testing services?All new customers must first establish an account with Memorial Blood Centers. To set up an account, download a copy of our Prospective Client Information Form. Complete and fax this form to the Memorial Blood Centers HCT/P Donor Testing Laboratory at 651-332-7007, or contact Tracy Hanks, Customer Service Lead, 651-332-7115.
Where can I find a complete list of testing services and any specific requirements?Memorial Blood Centers’ Testing Catalog contains detailed information on the various tests available through the HCT/P Donor Testing Laboratory, including storage instructions, assigned CPT codes, shipping requirements, etc.
What are the costs of testing?Fees for testing vary. For a specific price quote, contact:Email: [email protected]Call: 651-332-7115How soon will my HCT/P donor testing results be available?Turnaround time is generally 48-72 hours.
Are collection supplies provided by Memorial Blood Centers?Yes. Blood collection tubes and urine/swab collection kits are available, free of charge for testing customers. All materials are shipped UPS Ground and take approximately two weeks for delivery.
How do I request additional supplies?To reorder supplies—specimen shippers, glass blood collection tubes, etc.—download and complete our Supply Reorder Form, and fax your request to 651-332-7010. Standard requests, shipped UPS Ground to arrive in approximately two weeks, are filled free of charge. Requests for immediate replacement of supplies will be charged a $100 STAT fee.
Do I pay additional charges to ship samples back to Memorial Blood Centers?No. The cost of shipping samples to us for testing is included in your pricing.
Is Memorial Blood Centers licensed with the FDA for HCT/P testing?Yes. Memorial Blood Centers is Regulated and Licensed by the FDA, and compliant with European Union (EU) standards for blood manufacturing and testing.
What tests are required by the FDA for an IVF donor?The FDA regularly issues guidance documents describing the agency’s current thinking on a topic and making recommendations for practice. Memorial Blood Centers adheres to these recommendations to comply with Current Good Tissue Practice (CGTP) requirements, including the latest FDA Guidances for HCT/P Donors.
Which test kits are used for HCT/P screening?Memorial Blood Centers uses FDA-approved screening kits for testing. A HCTP Donor Screening Test Kit list with details regarding manufacturer, format, sample, and platform is available.
When is staff available to answer my questions?The Donor Testing Department is staffed seven days a week, from 2:00 PM Sunday through 6:00 AM Sunday.
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