Updates for Transplant Centers and Cooperative Registries

Up-to-date information on NMDP/Be The Match response to COVID-19

Updated Jan. 11, 2022

On a daily basis, our Business Continuity, Donor Operations and Patient Operations teams review the information coming from the CDC and agencies like the World Marrow Donor Association (WMDA).

Our commitment is to respond quickly to each advisement so you can have confidence that the products you request can be delivered without issue. Please check back frequently.

Click on the topics below to jump to that section: 

Product Considerations

Interim Guidelines and Programs

Travel and Logistics

Frequently Asked Questions

Product Considerations

Temporary cryopreservation requirement in effect Jan. 17 due to COVID-19 case surge (1/13/2022)

Due to the recent domestic and global surge in COVID-19 cases driven by the omicron variant, we are temporarily requiring that transplant centers plan for cryopreservation upon receipt of all unrelated and related products facilitated by the NMDP/Be The Match prior to initiation of recipient conditioning. We made this difficult decision to ensure both donor and patient safety.

This change is in effect for all products where patient prep is planned to start on or after Jan. 17, 2022. Your Case Manager will reach out for every scheduled patient case that may be impacted.

Certain clinical circumstances make infusion of a fresh product necessary, and we are committed to working with you on a case-by-case basis. In cases where a fresh product infusion is necessary, we will require the identification of a backup graft source. Cord blood units could be considered as an alternative graft source, as they are already cryopreserved and available.

Please work with your Case Manager to discuss these clinical circumstances.

We continue to actively monitor this situation and will adjust this requirement as soon as circumstances allow.

The rationale for the temporary product cryopreservation requirement

While the current rate of facilitated NMDP/Be The Match products planned for fresh infusion is only around 25-30%, we are no longer confident that procurement and delivery of fresh products is a safe alternative under current global circumstances. Since December, we have observed a substantial rise in the number of donors who have tested positive for COVID-19 following clearance with several after the start of filgrastim.

In December 2021 alone, we witnessed a four-fold increase in the number of donors testing positive relative to the prior four months. We saw an even greater increase the first week of January 2022.

The COVID-19 surge has also created numerous logistical challenges, such as canceled flights and supply chain disruptions. For example, FedEx and UPS reported up to 50% of pilots unavailable to fly due to COVID-19 during the week of Jan. 3.

This negatively impacted the ability to procure and deliver filgrastim to donors and filgrastim administration providers in time for injections, putting mobilization and on-time donation at risk. In addition, we are also seeing similar delivery challenges with IDM samples.

Your Case Manager and our Donor teams are proactively managing these situations. If your patient case is impacted, your Case Manager will reach out.

Data shows cryopreservation did not have a negative impact on outcomes

It is important to note that a recent NMDP/Be The Match and CIBMTR analysis did not show a deleterious impact of cryopreservation on early post-HCT outcomes for those patients transplanted during the first six months of the pandemic.

This analysis of more than 1,500 recipients of cryopreserved products is available as an ASH abstract. Additional clinical data on the impact of cryopreservation is available upon request.

If you have any questions about the temporary mandatory requirement or about cryopreservation support, please reach out to your Case Manager.

New guidance on PBSC and bone marrow products due to rise in COVID-19 cases (updated 8/5/21)

Access the Network Announcement for details on this guidance.

On-demand webinar with NMDP/Be The Match leaders addresses your FAQs (1/13/2022)

Many of our Network partners have questions due to the ongoing COVID-19 pandemic as well as the recent updates to our cryopreservation requirements. We brought together leaders from across the NMDP/Be The Match for an FAQ webinar to answer your questions.

The 45-minute webinar is available on demand and addresses topics such as:

  •  Product cryopreservation requirements
  •  Donor availability
  •  Testing donors for COVID-19 infection

During the webinar, you’ll hear from:

  • Meghann Cody, DNP, APRN, NP-C, Nurse Practitioner & Senior Manager, Medical & Quality Services
  •  Steven Devine, MD, Chief Medical Officer
  •  Jamie Margolis, Senior Vice President, Donor Services
  •  Jeni Newman, Director, Case Management
  •  Julie Smolich, Senior VP, Provider Services

Watch the on-demand FAQ webinar.

Update to NMDP/Be The Match process for confirmatory typing (updated 6/1/21)

Given the rapid decline in cases of COVID-19 in the US, as well as rising rates of vaccination, the National Marrow Donor Program® (NMDP)/Be The Match® has made the decision in partnership with our domestic donor centers to return to collecting blood samples, rather than buccal swabs, for fulfillment of confirmatory typing (CT) requests that have an appointment on or after August 30, 2021.

This change will be in effect for donors who are located within the US and Puerto Rico. Please note: at this time we are only able to accommodate one type of sample request. This means that all CT requests will be fulfilled as a blood sample, and the buccal swab option will be unavailable starting August 30.  It is important to note that we are investigating the potential of offering either option, blood sample or buccal swab, in the future but at this time we are only able to accommodate one option with buccal swab now and blood beginning at the end of August. For donor centers using KitMaker, kits created for CT blood samples and IDM draw will resume being charged to your center’s account.

Please reach out to your Case Manager or Partner Liaison (PartnerLiaisons@nmdp.org) for more specifics.

Data Comparing IDM Positivity Rates at Workup vs CT (1/14/2021)

In November, we asked our transplant center partners for feedback on many of our responses to the COVID-19 pandemic. Some of you shared that you would like to see the return of collecting blood samples at the time of confirmatory typing (CT). While we understand the request, we are unlikely to be able to move back to blood draws at CT in the near future.

With widespread community transmission in many parts of the country, we must limit the chance that a donor will become exposed to COVID-19 and be deferred for collection. Additionally, there continues to be a lack of availability of blood draw sites as many of these are now being used for COVID-19 testing instead and we need to leverage existing slots for workup related activities.

We have been keeping a close eye on data associated with impacts that blood draws at workup versus CT may have on your patient, particularly positive IDM rates. We recognize that a positive IDM at workup would delay your patient’s transplant.

Impact on IDM positivity rates

Fortunately, we have not seen a significant impact on IDM positivity rates since moving away from blood draws at CT. We compared pre-COVID data (Jan. 1, 2019-March 31, 2020) to COVID data (April 1, 2020-early January 2021). Pre-COVID, we saw an IDM positivity rate at CT and workup of 1.61% (excluding positive CMV results). During COVID-19, we have seen an IDM positivity rate at workup of 2.81%, a slight increase from pre-COVID. Both are a very small fraction of the full population of donors during those timeframes.

Impact on ABO and CMV testing

In addition, we reviewed ABO and CMV data comparing blood testing at workup to the buccal swabs currently being used for presumptive testing at CT. Both are showing very similar results. The ABO testing data shows 99% concordance while CMV testing shows 85% concordance.

We will continue to keep an eye on this data and will provide additional updates when needed. We appreciate your continued support and understanding as we work together to provide high-quality products while keeping donor and patient safety top of mind.

Registries Impacted by COVID-19 Response Reflected in MatchSource (updated 1/14/2021)

While all registries have been impacted by the COVID-19 crisis, a small number of registries are experiencing significant challenges exporting products. In an effort to still give our transplant center partners visibility to these graft sources, we will be flagging these sources in MatchSource® effective Wednesday, April 22. 

MatchSource will display graft sources from these countries as “Potential Donor” or “Potential Cord” and will prompt you to contact your Case Manager for additional instructions.

Countries with impacted registries include:

We understand it may be valuable to see sources that could be available sometime in the future. Therefore, instead of removing all donor and cord sources from these registries from MatchSource, you will see “Potential Donor” or “Potential Cord” with direction to contact your Case Manager. Provide your Case Manager with the reference number to determine if the donor or cord blood unit can be requested.

As a reminder, “Potential Donor” or “Potential Cord” will either indicate a COVID-19 impact or an OFAC restriction. We continue to monitor the ability to request donors from our partner registries throughout the world and will update the list of countries as COVID-19 restrictions are added or relaxed.

We have updated the MatchSource Interactive Training Guide to reflect these changes. Access the donor details or cord details.

Reduced Fee for Related Donor Workup and Collection (updated 4/7/2020)

During the COVID-19 outbreak, it may be difficult or impossible for a related donor to travel far from home for collection. We have taken the following actions to assist all of our transplant center partners with related donor workups and collections through Related Donor Services:

  1. We reduced the workup and collection fee to $15,000 for all fully matched and haploidentical related donors in the U.S. and Mexico during the COVID-19 outbreak.
  2. We are waiving the requirement to have a signed Related Donor Services agreement in place for a transplant center to receive the reduced fee.
  3. We will start working with your center no matter where you are in the process (e.g., workup has taken place but you need assistance with collection).

We can assist you with a fully matched or haploidentical related donor transplant. When we partner together, we can eliminate travel barriers for your related donors and help you to get your patients to transplant in the timeframe you need.

 Access additional information on your options for related donor workup and collection.

Cord Blood Unit Consideration (updated 4/7/2020)

There may be situations when a donor center may decide the donor is unable to proceed with collection immediately based on the donor’s exposure. A cord blood unit could be a consideration if this occurs.

Cord blood units are readily available for use, lack the inherent donor issues related to infection or exposure to coronavirus, and are not limited by travel restrictions. Our Cord Blood Consultation Service is also available for CBU selection and clinical support. 

We also offer Cord Blood Practice Units that you can request from our Network cord blood banks. They are available for practicing thaw procedures (these units are not viable for transplant). Your center can request up to three units at a time. There is no cost to your center.

The cord blood bank will ship the units to your center in a dry shipper, along with the thaw protocol and Practice Unit Data Form (F00204). Please complete and return the form to cordliaisons@nmdp.org after finishing the thaw process. 

Request practice units by completing the Request for Cord Blood Practice Units form (F00206) and emailing it to cordliaisons@nmdp.org.

For additional information about CBU thawing best practices, access our Cord Blood Thawing presentation . You’ll hear from John D. McMannis, PhD, Executive Vice President, Mesoblast; Donna Regan, Director, Customer Ready Products, NMDP/Be The Match; and Joanne Kurtzberg, MD, Duke University.

Contact your Case Manager if you have any questions. 

Donor Product Delivery After 72 Hours Post Collection (updated 4/6/2020)

Current travel restrictions may occasionally result in products being delivered to your center more than 72 hours after the end of product collection. If a hematopoietic cell product arrives at your center more than 72 hours after collection, NMDP/Be The Match strongly recommends you process and cryopreserve these products according to your standard protocols. This includes obtaining pre- and post-cryopreservation cell counts and viability that may be analyzed for product quality prior to subsequent infusion.

While there is limited data on cell viability for product stored after 72 hours, the rate of decrease up to that time suggests a small amount of additional time should not cause a sharp drop off in viability, cell recovery or colony-forming units (CFU). In a study by Kao and colleagues 1, the majority of PBSC and marrow products stored for 72 hours at 4C were able to maintain a:

  • Total cell viability over 75%
  • Total viable CD34 cell recovery over 80%
  • CFU recovery over 60%

It is important to remember NMDP/Be The Match products do not have expiration times. Rather, NMDP/Be The Match standards indicate that marrow, PBSC and MNC products shall be infused as soon as feasible. 

Ideally, marrow and PBSC should be infused within 48 hours of collection, but that is not required. In practice, infusion may occur up to 72 hours from collection. Since there is no product expiration date, infusion and cryopreservation at greater than 72 hours is not a deviation from NMDP/Be The Match standards and does not require regulatory reporting to the FDA. 

Products collected at international centers are labeled per their country of origin requirements. Some of the labeling elements may vary from products collected at domestic NMDP/Be The Match centers.

  1. Kao GS, Kim HT, Daley H, Ritz J, Burger SR, Kelley L, Vierra-Green C, Flesch S, Spellman S, Miller J, Confer D. Validation of short-term handling and storage conditions for marrow and peripheral blood stem cell products. Transfusion. 2011 Jan;51:137-147.

FastTrackSM Testing available for HLA lab support (updated 3/24/2020) 

If your hospital lab resources are stretched thin due to COVID-19 testing, FastTrack Testing can help your center process new samples and alleviate stress on your lab staff. The turnaround time for FastTrack Testing is three days or fewer.

If you need assistance with HLA typing, please reach out to your Case Manager.

Interim Guidelines and Programs 

Revised Novel Coronavirus (COVID-19) Infection Assessment Questionnaire (updated 4/5/2021)

We have updated the Novel Coronavirus (COVID-19) Infection Assessment Questionnaire (F01190 rev. 7) and Novel Coronavirus (COVID-19) Assessment Tool (A00916 rev. 4) to better reflect the current state of COVID-19 and vaccination efforts. These updates include guidance on how to handle fully vaccinated donors, effective April 12, 2021. Donor centers should begin using these assessments on Monday, April 12.

Donor centers use Form F01190 at the time of the Heath History Screening Questionnaire. Donor centers use the Assessment Tool A00916 when a donor reports risk during the completion of F01190 or at any time during the assessment process. Access the summary of changes to our assessment process at the time of donor CT, HW and workup.

Options for Viewing Donor Search Results in MatchSource (updated 12/23/2020)

We are working to reduce logistical challenges that put a patient’s transplant at risk during the COVID-19 pandemic. As part of this effort, we are encouraging U.S.-based transplant centers to consider U.S.-based donors first in their source selection. Some of our international partners have taken a similar approach in their countries.

As a default, MatchSource® displays domestic donor search results using a pre-applied filter that shows only U.S.-based donors (including Puerto Rico). You can turn off the U.S.-Donors Only filter and save that preference as your default.

This enhancement allows you to set your preference to what works best for your center’s donor searches—using the U.S.-Donors Only filter or expanding the view to include all donor search results as your default. You can toggle back and forth between the two views regardless of the default that is set.

Please continue to give additional consideration to the current challenges of international travel. If you have the option to give preference to U.S.-based donors, we encourage you to do so to reduce the risk of delay in getting a donor product to your patient.

At-home COVID-19 Testing Available for Donor Screening (updated 10/8/2020)

We now have an at-home COVID-19 testing option available for donors if your transplant center’s protocols require confirmation of a donor’s SARS-CoV-2 status.

We continue to recommend that asymptomatic donors are not tested  for COVID-19 because there is no evidence the virus is transmissible via blood or stem cells. We are making at-home testing available to support transplant centers in meeting protocol requirements as well as the desired time to transplant.

If your center requires donor testing prior to collection, let your Case Manager know. Your Case Manager will work with the donor center to arrange for testing. Coordinators at contracted donor centers have been trained on this testing option. Partner Liaisons are available to provide assistance if needed.

When requesting at-home COVID-19 testing for a donor please keep in mind:

  • Samples are only shipped Monday-Friday
  • Test results are expected (but not guaranteed) within 24-48 hours of lab receipt
  • Donor will be tested approximately four days before the start of filgrastim, patient prep or donor collection (whichever comes first)
  • We are limiting the number of times testing can be repeated for a donor

At-home testing is available for donors in the United States. If you would like an international donor to have COVID-19 test, talk to your Case Manager. Your Case Manager will contact the international donor registry to determine if COVID-19 testing can be completed.

If you have any questions, contact your Case Manager.

Complete and Verify Patient’s HLA Typing Before Final Donor Selection (updated 7/16/2020)

On July 13, the WMDA issued a rapid alert after receiving three reports of serious incidents that occurred because final donor selection occurred before the patient’s extended or verification typing had been performed. With the start of patient conditioning being delayed with the use of cryopreserved product, there is an increased risk that final checks of the patient’s eligibility are also delayed.

The NMDP/Be The Match endorses the WMDA’s recommendation that the patient’s HLA-typing is completed and verified before final donor selection. In addition, the donor should not start the donation procedure until the transplant center has confirmed final donor section and confirmed the patient’s eligibility for the scheduled transplant.

Access the WMDA’s full alert and recommendations.

Travel and Logistics

Changes regarding products delivered via hub-and-spoke (updated 11/11/2021)

Effective Nov. 29, 2021, all products that were previously delivered via the hub-and-spoke method from the European Union will be able to be hand-carried by a courier and have a direct delivery to the transplant center. We no longer need to use the hub-and-spoke method because fully vaccinated foreign nationals can now enter the United States and the availability of international flights is more reliable. This process should decrease the amount of time that products are in transit (although individual transit times will vary based on flight availability).

While we are pleased to move away from this method, we are very grateful to those who created this process to ensure we were still able to deliver products into the U.S. from our international partners, particularly our Government Affairs and Logistics teams for securing the only blanket travel waivers during the pandemic.

Please note that we are only able to make this change for the registries that we have been transporting product for through the hub-and-spoke method (mostly our European partners). There are still countries where alternative transport methods are needed. Your Case Manager will guide you through any of those restrictions as you begin the workup process (or earlier depending on the type of restriction).

Thank you to everyone who has made the hub-and-spoke method a success over the last year and a half.

Vaccination Requirement for NMDP/ Be The Match Couriers (updated 9/13/2021) 

Starting Sept. 30, 2021, we are requiring that National Marrow Donor Program® (NMDP)/Be The Match® couriers be fully vaccinated for COVID-19. This includes volunteers, staff and third-party couriers.

We are instituting this requirement to comply with the proof of vaccination upon entry required at clinical facilities at which products may be picked up or delivered. In addition, as a healthcare organization we have an obligation to the safety of our Network partners, patients, donors, NMDP/Be The Match staff and volunteers.

What the vaccination requirement means for couriers
Fully vaccinated is defined as:

  • two weeks or more after receiving a second dose in a 2-dose COVID-19 series, or
  • two weeks or more after receiving a single-dose COVID-19 vaccine (Johnson and Johnson/Janssen)

Couriers must be prepared to show proof of vaccination at any time during the courier trip. Examples of vaccination proof include:

  • Complete COVID-19 vaccination card
  • A clear image of the vaccination card on a phone
  • COVID-19 vaccination record on a mobile app
  • Digital COVID-19 vaccination QR code

Note: Some states may require vaccination cards, so couriers should plan to check local requirements in advance.

Network partners who provide couriers for NMDP/Be The Match transports are expected to be compliant with this courier vaccination requirementThere will be no exceptions. We understand some couriers may not yet be fully vaccinated and ask they refrain from accepting trips until they have done so. This is consistent with our commitment to our patients, donors and each other, and will ensure avoidance of being turned away. Please disseminate this information to the appropriate leaders and staff in your organization as necessary.

If you have any questions, please contact your Case Manager.

Frequently Asked Questions

Frequently Asked Questions for Transplant Centers (updated 11/10/2020)

This information will be updated as changes occur. Click on the question to expand the answer.

Will the NMDP/Be The Match allow higher CD34 collections on prescriptions given the expected cell loss associated with cryopreservation at our transplant center?

Given that the median CD34+ cell dose collected from a G-CSF mobilized donor after one day is close to 7x10^6/kg and the optimal dose for the recipient is > 4.5x10^6/kg (Pulsipher et al, Blood 2009), we do not believe there is a clinical need to request higher CD34+ cell doses.

If there are special circumstances that may warrant this clinically, please work with your Case Manager . An increase in the requested collection volume may need physician approval.

Additionally, given issues related to donor safety and bone marrow harvesting with higher cell dose collections, we will continue with our current policy as to the maximum volume allowed based on donor weight.

Will you follow up with donors after donation to ensure they have no respiratory symptoms? If there is a concern about possible COVID-19 risk, will our transplant center be informed?

Starting with collections that occurred on or after March 11, 2020, we are screening all domestic donors for symptoms of the virus at 2 days, 1 week and 1 month after collection. If there is a possible COVID-19 risk that occurred within 21 days of collection, our medical team will inform your transplant center of the risk.

Are you testing donors prior to collection to ensure they do not have the COVID-19 virus?

Asymptomatic donors are not automatically being tested. However, we now have an at-home COVID-19 testing option available for donors if your transplant center's protocols require confirmation of a donor's SARS-CoV-2 status.

If a donor is asymptomatic but has answered the risk questions with a “yes” response (traveled to a risk area or exposure to someone who has traveled to a risk area), your transplant center will be notified. These donors are being deferred for 28 days at present.

The recommendation to not test asymptomatic donors is mainly based on the challenges in predicting whether an asymptomatic donor with no history of travel or exposure will become infected with SARS-CoV-2, which causes COVID-19, in the interval between workup and the day of the planned bone marrow harvest or PBSC collection.

At this time, we believe the risk of viral transmission to the recipient via bone marrow or PBSC donation is extremely low. The U.S. Food and Drug Administration (FDA) continues to report that there have been no reported or suspected cases of transfusion-transmitted COVID-19 to date.

In addition, no cases of transfusion-transmission were ever reported for the other two coronaviruses that emerged during the past two decades (SARS, the Severe Acute Respiratory Syndrome coronavirus, and MERS-CoV, which causes Middle East Respiratory Syndrome). Based on this, we do not believe there is a need to test asymptomatic donors without any travel or exposure history.

We have put augmented donor screening measures—which may include travel deferrals—in place. These measures aim to prevent individuals with clinical respiratory infections or exposure history from donating bone marrow or PBSC products, ensuring the safety of the grafts we are supplying.

Does filgrastim put donors at higher risk of infection?

The NMDP/Be The Match follows all donors of PBSC for adverse events, including signs and symptoms of infection. In over 35,000 donors, we have not seen an increase in infections in our donors. In transplant patients, filgrastim is actually used to increase the white blood cell count to speed engraftment and reduce the risk of infection.

When our center requests donor product cryopreservation, where would the product be cryopreserved?

The NMDP/Be The Match is requesting that a fresh product is delivered to the transplant center and is cryopreserved on site, versus at an external site. If your transplant center is unable to perform this, please work with your Case Manager to identify additional options to perform the cryopreservation and provide storage until you need the product.

Will you be screening or testing donors after donation? Should we test and/or quarantine the stem cell products?

At this time, there is no evidence that COVID-19 is transmitted via blood, bone marrow or stem cell products. For this reason, NMDP/Be The Match, in conjunction with other regulatory agencies such as the FDA and AABB, does not currently recommend or require product testing or quarantine.

In effort to identify donors who may have or be at risk for contracting the novel coronavirus, the NMDP/Be The Match is screening donors prior to donation at the confirmatory typing, held for workup and workup stages.

Following donation, donors will be contacted at regular intervals: 2 days post, 1 week post, 1 month post and in-between as needed. Additionally, all donors are being counseled to contact their individual workup specialists if:

  • They are diagnosed with COVID-19
  • Learn of exposure to a person diagnosed with COVID-19
  • Develop any acute infectious symptoms prior to and following donation
Pre-donation screening and pertinent post-donation findings will be reported to the transplant center and apheresis/collection center. The NMDP/Be The Match does not recommend delaying transplant to await post-donation findings, product quarantine or product testing. That said, these decisions are at the discretion of the individual transplant center/team.

Does the NMDP/Be The Match provide the ability for transplant centers to request COVID-19 testing for their patients or for related donors when a transplant is not facilitated by NMDP/Be The Match?

No, however, we can provide resources that detail the relationships we have established in order to be able to provide this testing for our donors. 

The testing that we currently have set up through LabCorp uses a kit that is ordered through LabCorp Link. Kits ordered through LabCorp Link and Kashi require a contract with their labs. However, Pixel testing kits through LabCorp are available for individuals to order without having an affiliation with an organization or a contract.

If your center has an account with LabCorp, you can ask your LabCorp representative to have the testing option set up so you can order through LabCorp Link. 

More information about the Pixel kit can be found here: pixel.labcorp.com

What screening is the NMDP/Be The Match providing for couriers?

In order to mitigate risk at local apheresis/collection and transplant centers, we are implementing proper screening of product couriers. Couriers will be asked about exposure to a known COVID-19 patient and about sickness in the past 7 days with diarrhea, vomiting or cold symptoms (including cough, sore throat or runny nose). If either of these are reported, the courier will become unavailable. Couriers are also asked to notify the NMDP/Be The Match if these symptoms occur en route.

How is the NMDP/Be The Match ensuring this screening is occurring for couriers?

If the collection for a U.S. patient occurs on or after March 18, 2020, the NMDP/Be The Match will require our internal Logistics department to manage or provide the transport of the product. The only exception is for DKMS imports transported by the OnTime or TimeMatters courier companies. All U.S. domestic transports will be provided by the NMDP/Be The Match. There may be a few exceptions in this, and they would be communicated on a case-by-case basis.

Why isn’t our transplant center receiving backup itineraries?

Because itineraries are changing frequently and airlines have limited passenger flights, we are not providing a backup itinerary to transplant centers at this time.

We are closely monitoring each delivery. We will communicate any changes to an itinerary to your transplant center. Please be assured that we are continuing to work to ensure products are delivered to your transplant center in a timely matter.

We received a donor product more than 72 hours post collection. Can we still use the product? If so, is it a deviation that must be reported to the FDA?

Current travel restrictions may occasionally result in products being delivered to your center more than 72 hours after the end of product collection. NMDP/Be The Match strongly recommends you process and cryopreserve these products according to your standard protocols.

Ideally, marrow and PBSC should be infused within 48 hours of collection, but that is not required. In practice, infusion may occur up to 72 hours from collection. Since there is no product expiration date, infusion and cryopreservation at greater than 72 hours is not a deviation from NMDP/Be The Match standards and does not require regulatory reporting to the FDA.

What type of material is used to make the buccal swabs?

The buccal swabs are nylon flocked swabs produced by COPAN. If your lab would like to test the DNA extraction prior to testing actual donor samples, we can send your lab a sample kit. Contact your Case Manager if you would like a sample kit sent to your lab.

The applicator is a DNA-free, reinforced regular swab. Additional buccal swab dimension specifications are below.

Applicator

  • Stick length: 150.0 mm ± 1.0 mm
  • Diameter handle part: 2.5 mm ± 0.10 mm
  • Plastic tip diameter: 3.00 mm ± 0.05 mm
  • Fibre tip length: 17.00 mm ± 2.00 mm
  • Fibre tip diameter: 5.50 mm ± 0.50 mm
  • Total length: 151.0 mm ± 2.0 mm
Sterilization method: ETO treatment

Storage temperature: 2/30˚C – DO NOT FREEZE

Shelf life: 36 months

Questions? 

If you have questions about our response to COVID-19 and the impacts to your transplant center, your patients or their donors, contact your Case Manager.