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Eurofins Donor & Product Testing is a clinical laboratory that performs infectious disease screening, transplant compatibility testing, microbiology testing, and regulatory compliance testing for organ, tissue, and cellular therapy donors and products, helping ensure they are safe and suitable for transplantation and therapeutic use.
1303 W. Optical Drive, Azusa, CA 91702, Los Angeles United States
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4550 Norris Canyon Road, Suite 100, San Ramon CA 94583, United States
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60 1st Avenue, Suite 2, Waltham MA 02451, United States
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Issuing Body ASHI
Issuing Body Country US - United States
Issuing Body Website https://www.ashi-hla.org/
Issuing Body CLIA
Issuing Body Country US - United States
Issuing Body Website https://www.cms.gov/medicare/quality/clinical-laboratory-improvement-amendments
Issuing Body College of American Pathologists
Issuing Body Country US - United States
Issuing Body Website https://www.cap.org/
Issuing Body German Health Authorities
Issuing Body Country US - United States
Issuing Body Website https://www.bundesgesundheitsministerium.de/en/
Issuing Body State of California
Issuing Body Country US - United States
Issuing Body Website https://www.cdph.ca.gov/Programs/OSPHLD/LFS/Pages/Home.aspx
Issuing Body State of Hawaii
Issuing Body Country US - United States
Issuing Body Website https://dlslab.com/careers/hawaii-license/
Issuing Body State of Maryland
Issuing Body Country US - United States
Issuing Body Website https://health.maryland.gov/ohcq/Pages/Clinical-Laboratories.aspx
Issuing Body State of Massachusetts Dept of Health
Issuing Body Country US - United States
Issuing Body Website https://www.mass.gov/how-to/apply-for-a-massachusetts-clinical-laboratory-license
Issuing Body State of New York
Issuing Body Country US - United States
Issuing Body Website https://www.wadsworth.org/regulatory/clep/clinical-labs/obtain-permit
Issuing Body State of Pennsylvania
Issuing Body Country US - United States
Issuing Body Website https://www.pa.gov/agencies/health/healthcare-and-public-health-professionals/laboratories/laboratory-improvement
Issuing Body State of Rhode Island
Issuing Body Country US - United States
Issuing Body Website https://health.ri.gov/licensing/laboratory
Issuing Body State of West Virginia
Issuing Body Country US - United States
Issuing Body Website https://dhhr.wv.gov/ols/regulatory/Pages/HIV-AID-Certification.aspx
Issuing Body Therapeutic Goods Administration
Issuing Body Country US - United States
Issuing Body Website https://www.tga.gov.au/
Eurofins Donor and Product Testing has ten Donor Testing Laboratories, all of which are solely committed to the transplant community. Each laboratory is focused and equipped to perform donor eligibility testing for both STAT and routine testing, utilizing state-of-the-art technology with FDA-licensed test kits and reagents. All of our laboratories are staffed with a dedicated and professional team of laboratory technologists and support staff. Additionally, each laboratory is equipped with multiple and redundant systems, to ensure the timely delivery of test results.
In addition to donor eligibility testing our Denver, Colorado laboratory performs high complexity microbiology and immunogenetics testing, and our Los Angeles, California, Philadelphia, Pennsylvania and Honolulu, Hawaii laboratories additionally also perform histocompatibility testing for organ donation.
Eurofins Donor and Product Testing laboratories are FDA-registered for screening human cells, tissues, and cellular- and tissue-based products (HCT/Ps) and also hold current certifications, licenses or accreditations for CLIA, various state agencies, the Therapeutic Goods Administrations and German Health Authority.
As an organization, we are committed to exceeding the needs and expectations of our customers. We strive to deliver value, accurate and timely results, and excellent customer service. Our organization is committed to creating a culture of continuous improvement to achieve and sustain performance excellence.
With over 35 years of experience in donor testing, Eurofins Donor and Product Testing has a national reputation for its expertise in providing comprehensive laboratory services to meet the unique testing needs of the transplant community.
Eurofins Donor and Product Testing laboratories are FDA-registered for screening human cells, tissues, and cellular- and tissue-based products (HCT/Ps) and also hold current certifications, licenses or accreditation's for CLIA, various state agencies, and the Therapeutic Goods Administrations and German Health Authority.
As an organization, we are committed to exceeding the needs and expectations of our customers. We strive to deliver value, accurate and timely results, and excellent customer service. Our organization is committed to creating a culture of continuous improvement to achieve and sustain performance excellence.
Eurofins Donor and Product Testing sets itself apart by its commitment to its customers and its quality of performance in high complexity testing for the transplant community.
Eurofins DPT supports the safe and compatible transplant of donor organs and tissues. As part of this mission, we have expanded our geographical footprint to bring our exceptional testing services closer to the source, supporting clients’ increasingly stringent quality and safety standards and the expanding demands of regulatory authorities on transplantable organs, tissues and cellular therapies worldwide.
If you would like to learn more about what Eurofins DPT can do for your organization in your specific area, please contact Kimberly Elliott, Director Business Development for more information.
Eurofins DPT supports the safe and compatible transplant of donor organs and tissues. This requires testing donor specimens using FDA-approved screening kits and reporting data that confirms the release to transplant. Eurofins DPT sets itself apart by its commitment to its customers and its quality of performance. By providing an array of service offerings, Eurofins DPT delivers consistent performance that exceeds client expectations.
Eurofins DPT's focus is performing donor eligibility screening and microbiology testing, using the most appropriate regulated testing technologies for the transplant and medical communities. Eurofins DPT brings together a diverse professional team with experience in testing, quality, regulatory, and customer service.
We perform infectious disease testing by serological and nucleic acid methodologies. Analyzed pathogens depend on the tissue or cells tested as prescribed by 21 CFR 1271. In addition to HIV and Hepatitis testing, which are routinely performed in all donors, additional screening may include West Nile Virus, EBV, Chagas, Strongyloides, Toxoplasmosis, Human T-lymphotropic virus and Cytomegalovirus (CMV). Reproductive donors must always be tested for Chlamydia trachomatis and Neisseria gonorrhea.
Assay offerings include:
Donor Eligibility Testing Services Support:
Human Leukocyte Antigen (HLA) testing is used to successfully match organ transplant recipients with compatible donors. Matching of the donor antigens in the recipient improves long-term graft survival and lowers rejection rates as well as incidents of infection due to decreased use of immunosuppression.
Microbiology testing is used to assess the overall microbial cleanliness of the manufacturing environment and process. To satisfy regulatory agency requirements, cultures of the human cellular and tissue product (HCT/Ps) are taken prior to the process, during the process and at final release of the product. All that is intended to reduce and eliminate microorganisms that would compromise the recipient of the transplanted product. We also offer consultative services to processors to ensure that the appropriate testing methodology is used.
Eurofins DPT offers traditional microbiology assays that support the transplant community. Testing methods are based upon <USP> and industry standards.
Eurofins DPT utilizes matrix-assisted laser desorption/ionization – Time of Flight (MALDI-TOF) mass spectrometry instruments as the primary means of microorganism identification. The instruments identify approximately 80% of the bacterial isolates recovered or received by the laboratory. VITEK-2 instruments as well as rapid identification panels are also used for supplemental testing as companion testing to the MALDI-TOFs, as needed. In addition to our two (2) MALDI-TOF and Vitek-2 instruments, Eurofins DPT utilizes traditional biochemical methods to supplement microorganism identifications. Sequencing can also be performed at request by Eurofins Lancaster laboratories. The critical factor in offering these identifications is the competency and experience of the microbiologist. Eurofins DPT microbiologists have years of experience in the culture and identification of organisms recovered from HCT/Ps and from the environment.
This test determines the total number of viable microorganisms in or on a component. It is performed on any product that requires control and/or monitoring of bioburden counts as part of the sterilization program. Eurofins DPT performs bioburden testing according to the United States Pharmacopeia Chapters <61> on Microbial Enumeration Tests, as well as applicable AAMI Radiation Sterilization Standard (AAMI/ANSI/ISO 11137 and EO Sterilization Standard (AAMI/ISO 11135).
Environmental monitoring programs are used to evaluate the effectiveness of cleaning and disinfection procedures and to assess the overall microbial cleanliness of the manufacturing environment.
Eurofins DPT offers consultation to aid in the establishment and maintenance of cost-effective programs to meet FDA requirements for monitoring the microbial cleanliness of the manufacturing environment and the assessment and efficacy of the production area disinfection procedures. Our qualified staff can train personnel in the proper collection of microbial environmental samples. Eurofins DPT supplies all necessary media and swabs to successfully meet the needs of the environmental monitoring program.
As a precursor to product sterility testing, Eurofins DPT offers this test to satisfy regulatory requirements. Testing establishes if the design processes inhibits the growth of fungus or bacteria. If microorganisms cannot be recovered from the sample in growth media due to the presence of residual antimicrobials or processing chemicals, subsequent tests using larger volumes of media or neutralizers may be used to compensate for any inhibiting effects. This test determines how the client product will be tested. Customized detailed reports are provided to the client for their quality and regulatory needs.
This test consists of a quantitative microbial assessment for bacterial, yeast, mold and a screening for the presence of Staphyloccus aureus, Streptococcus pyogenes, Gram-negative bacteria, Enteroccocus species, Enterobacteriaceae, Clostridium species, yeast and fungus or other specific organisms of interest. Enumeration methods can use membrane filtration with plate counts or if the product naturally has a low bioburden, the Most Probable Number Method may be used.
To satisfy AATB, FDA, and other regulatory agency requirements, cultures are taken of the HCT/P prior to any processing steps that are intended to reduce and eliminate microorganisms that would compromise the recipient of transplanted product. For musculoskeletal recovered tissues, Eurofins DPT has validated both the Amies without charcoal culturette and the E-Swab transport system. Extractions with filtration, direct inoculation of tissue pieces or transport solutions can be used to provide that information as well. Eurofins DPT can consult with processors to assist in the decision of the type of sample to be submitted for these cultures.
This test evaluates samples for sterility by placing them in the appropriate growth promotion media, incubating them for a minimum of 14 days, and checking them for evidence of microbial growth. Samples may be tested using either direct transfer or membrane filtration. Product sterility testing is performed according to the recommendations in USP General Chapter <71> and ANSI/AAMI/ISO 11737-2. Product sterility test methods are validated by performing a Method Suitability (Bacteriostasis/Fungistasis) test.
Eurofins Donor and Product Testing provides multiple web resources to assist our customers with their day-to-day operations.
Eurofins DPT recognizes that we are considered a critical vendor for clients like you, and that you need oversight over our testing activities as a regulatory requirement for your products/services. To assist in the need for oversight of our laboratories, Eurofins DPT offers you access to the documents below.
Eurofins DPT Portal is currently a web-based portal for test order entry, tracking of tests in progress, and result delivery that is powered by our LIMS system.
Data management is a very critical part of laboratory medicine and the delivery of that data as rapidly as possible is critical to our client’s needs. Eurofins DPT is dedicated to providing client integration solutions that will drive business processes for our clients now and into the future.
To learn more about Eurofins DPT Portal or to become a portal user, please contact us
Our web-based portal for test order entry, tracking of tests in progress and result delivery that is powered by our LIMS system.
Access the directory of tests offered by Eurofins Donor & Product Testing.
Donor Eligibility Testing You Can Trust
In order to process service or change requests, please send written requests via email to the specific Eurofins DPT location where testing has or will be performed.
For ease of use, a service request form is provided below.
A test may be cancelled by the ordering client with no charge incurred prior to initiation of testing at Eurofins DPT. The client must provide written confirmation of the test cancellation. Eurofins DPT begins processing each sample immediately upon receipt. If cancellation request is sent after sample receipt, there is no guarantee that the cancellation will be processed prior to testing.
Eurofins DPT will make every effort to accommodate a client’s request to add or change a test, as long as there is adequate sample and/or appropriate sample type to perform the requested test. If a verbal or phone request to add or change a test is received from the ordering client, the entire order is read back to verify accuracy. A written authorization from the ordering client is required within 30 days of the request. Secondary clients may order additional tests such as confirmatory tests, if a confirmatory reflex agreement is not in effect, after written authorization from the primary client is received.
Eurofins DPT will honor requests to ship a sample to another laboratory. Please provide the following information in writing: shipping instructions, complete address and contact information of the laboratory to which the sample will be shipped, and a courier account number. Eurofins DPT is not responsible for samples lost or damaged in the shipping process, nor is it responsible for the cost or billing of the shipment.
Eurofins DPT will honor requests to return a sample due to client error or wrong sample type for analysis. A courier account number and complete shipping address must be provided in writing. Eurofins DPT is not responsible for samples lost or damaged in the shipping process.
For non-urgent inquiries, such as supply orders, setting up a new account, add-on testing, etc., please fill in the information below and your inquiry will be routed to a representative that is best suited to help you.
Eurofins Donor & Products Testing offers multiple custom logistic solutions tailored to meet the needs of our clients.
Eurofins Donor and Product Testing (DPT) can provide numerous vendors to choose from to match the best service level for each shipping location. Have your own favorite courier? Eurofins DPT will establish transportation protocols with each client’s courier of choice.
Quick International Courier Tracking
Due to the fact that Eurofins DPT performs testing to screen for infectious agents and not to diagnose disease states, samples can be shipped as an Exempt Human Specimen. This status allows for samples to be transported via a larger number of air carriers. Exempt Human Specimen labeling should appear on the outer carton of all packages inbound to Eurofins DPT. For more questions regarding proper package labeling, please contact Specimen Logistics.
Eurofins DPT offers innovative solutions to collection and packaging systems.
Questions on supplies? Contact our support team