Cord Blood Typing
All cord blood units (CBUs) listed in the Be The Match Registry are HLA-A, -B, and -DRB1 typed. Confirmatory typing of a CBU to verify HLA typing is used to verify the HLA typing and must be performed before a CBU is available for shipment. The information below provides a high-level overview of the cord blood unit typing process. Full details of the process can be found in the Transplant Center Manual of Operations: Chapter 9: Requesting a Cord Blood Unit (PDF).
As of October 20, 2011, each individual CBU is classified by the FDA as licensed or unlicensed. For full details, please consult the 10-CBA protocol page. If a patient is being treated within the U.S., an unlicensed unit cannot be shipped for infusion until the patient has been enrolled in an FDA-accepted IND protocol.
There are differences in the type of information and services available between U.S. cord blood banks and non-U.S. cord blood banks. Contact your NMDP Case Manager for assistance in evaluating the differences and time restraints when selecting units.
CBUs from NMDP Member and Affiliate Listing CBBs
Substantial amounts of information are available about a specific CBU in MatchSource®. The NMDP can provide CBU information to transplant centers not using MatchSource. The requirements to list CBUs on the Be The Match® Registry have changed over time. Newly registered CBUs will display more robust information in MatchSource than those CBUs registered in the past.
CBUs Previously Confirmatory Typed
CBUs that have been previously confirmatory typed using segment material at an NMDP Contract Laboratory are identified with a “Y” (Yes) indicator in the CT field of MatchSource and on the search report.
When a CBU is confirmatory typed by an NMDP Contract Laboratory, no further HLA typing is required. If a previously typed CBU meets the requirements of the transplant center, it can be immediately requested for shipment or ‘held’ for further consideration.
However, when the known typing does not meet the transplant center’s requirements, additional typing (e.g. higher resolution and/or additional loci) may be requested by the transplant center. In these cases, requests for additional typing may be submitted as noted below.
CBUs Not Previously Confirmatory Typed
CBUs that have not yet been confirmatory typed using segment material at an NMDP Contract Laboratory are identified with an “N” (No) indicator in the CT field of MatchSource and on the search report. The transplant center must choose (at minimum) one of the following typing packages as described below.
CBU Confirmatory Typing Requests
The transplant center selects one or more CBUs for HLA confirmatory typing (HLA-CT), which is HLA typing of an attached (contiguous) segment or segment material in order to verify the prior HLA typing results. The cord blood bank sends material from an attached segment to the NMDP contract laboratory, unless a sample is not available. If there is not an available attached segment, the transplant center will be notified of possible testing options by the NMDP Case Manager.
Before a CBU can be released for shipment from an NMDP Member or Affiliate Listing Cord Blood Bank, HLA-CT must be performed at HLA-A, -B, -C and -DRB1 by an NMDP Contract Laboratory at least once. The only exception to this would be in the case that critical illness of the patient does not permit the extra time. HLA-CT will still be required, but the CBU may be released before HLA-CT results are available. This decision is made by the transplant center physician with the physician/hospital assuming responsibility for the decision to receive the unit prior to the HLA-CT results and for agreeing to wait to infuse the CBU until the HLA-CT is complete. This decision must also be agreed upon by an NMDP physician prior to proceeding.
The transplant center selects the CBU for HLA-CT and requests the desired HLA typing, resolution, and turnaround time.
Laboratory Turn-around Time
Requests are completed in 3 business days, beginning when the CBU sample arrives at the laboratory, unless there are technical testing issues.
HLA Typing Options
- High resolution HLA-A, -B, -C, -DRB1, -DQB1, -DPB1
- High resolution HLA-A
- High resolution HLA-B
- High resolution HLA-C
- High resolution HLA-DRB3, 4, 5
- High resolution HLA-DQB1
- High resolution HLA-DPB1
- High resolution HLA-DQA1
- High resolution HLA-DPA1
*If a CBU HLA-CT has not been previously completed, optional requests are only available in conjunction with a typing package. If a CBU HLA-CT has already been completed, optional requests may be placed independently of a typing package.
For information on fees, please see the Transplant Center Fee Schedule.
Several methods are used to communicate CBU HLA-CT requests to the NMDP:
- Select CBU(s) in the MatchSource application (preferred method)
- Submit request directly to your NMDP Case Manager, preferably using the Cord Blood Unit HLA Confirmatory Typing Request form (PDF). The following information must be included:
- Service requested (HLA-CT);
- CBU identification number(s); and
- Priority (if CBU is from a non-U.S. center that offers multiple turn-around time options)
After the request is processed, the cord blood bank ships a CBU sample to the NMDP contract laboratory within two business days and confirmatory testing begins.
Additional Immunogenetic Testing Requests
NMDP facilitates these immunogenetic tests for CBUs*:
- KIR presence/absence testing
- CCR5 ∆32 mutation presence/absence testing
- Maternal HLA typing
*If a CBU HLA-CT has not been previously completed, these requests are only available in conjunction with a typing package. If a CBU HLA-CT has already been completed, these requests may be placed independently of a typing package.
Communicate requests for this testing by contacting your Case Manager or complete the Cord Blood Unit HLA Confirmatory Typing Request form (PDF) IR testing and maternal HLA typing requests. Test results will be reported to the transplant center by the NMDP Case Manager.
Outcomes of a CT Request
There are a variety of possible outcomes after requesting CBUs for CT.
Confirmatory Typing is Completed
Most commonly, the outcome of a cord blood unit HLA-CT is the completion of HLA typing. The transplant center is notified of the HLA-CT results via the MatchSource Workflow Management screen. Additionally, a copy of the CBU HLA-CT laboratory report is provided to the transplant center. The transplant center has 30 days after receiving the HLA-CT results to decide to request the CBU for shipment, place it on hold, or release the CBU. When no determination is made after 30 days, the CBU is released from the patient search and the transplant center is notified on the MatchSource Workflow Management screen.
CBU is not available for testing
Although not very common, occasionally a CBU HLA-CT cannot be performed. Some reasons include: the CBU is reserved for another patient, there are no samples available for CT testing, or the CBU is withdrawn from inventory. When a CBU CT cannot be completed for one of these reasons, the transplant center is notified of the status via a MatchSource Workflow message and/or by your NMDP Case Manager.
Additional HLA typing is requested
A transplant center may decides that additional HLA typing is needed on the CBU, after the HLA-CT results are received. Inform the NMDP of what loci and level of typing are desired.
Request Additional Services
As a result of the confirmatory testing, the transplant center may request additional activities. These activities may include:
Request CBU Hold
To provide additional time for CBU evaluation, a transplant center can reserve a CBU*. At the end of the reservation request (the amount of time of a cord hold varies from cord blood banks, although the standard time is 120 days), the transplant center can:
- request the CBU for shipment;
- release the CBU; or
- provide information to support continuation of the held status (some non-U.S. cord blood banks do not allow extended reservation requests—contact your NMDP Case Manager for details)
*Some non-U.S. cord blood banks may charge a fee to reserve a CBU—see the Transplant Center Fee Schedule for details.
In certain conditions, a TC may put a unit on hold prior to performing the NMDP CT with the understanding that the NMDP CT must be performed prior to unit shipment. This option is only available in special situations monitored on a case-by-case basis and should be discussed with your NMDP Case Manager.
Request CBU for Shipment and Infusion
If the CBU meets NMDP requirements and minimum criteria for release, the transplant center may request the CBU for shipment. See Cord Blood Shipment & Infusion for more information.
Billing for Cord Typing
The transplant center is billed for confirmatory HLA typing of all CBUs requested. If a CBU HLA-CT request is the first request on a patient search, it transitions from a preliminary to a formal search. A one-time formal activation fee is generated upon the formalization of any preliminary search.