Grifols, Barcelona, a leading producer of plasma-derived medicines and a global leader in the development of innovative diagnostic solutions, has received FDA premarket approval for its ID Core XT molecular diagnostic test for in vitro diagnostic (IVD) use in the United States. The blood group genotyping kit has been CE marked in Europe since 2014.
Carsten Schroeder, Grifols.
“We are proud to welcome ID Core XT to our family of FDA-approved blood typing products and services,” says Carsten Schroeder, president of the commercial diagnostics division at Grifols. “This test reinforces our commitment to provide high-quality solutions that improve transfusion medicine practices and patient care.”
Molecular red blood cell typing provides significant advantages for patients as well as for donor management. Individuals requiring frequent transfusions are at a higher risk of receiving incompatible blood, which can result in life-threatening and costly adverse reactions.1 The ID Core XT kit benefits patients who require ongoing transfusions, including individuals with hemoglobinopathies such as sickle cell disease (SCD) and thalassemia. SCD affects approximately 100,000 Americans and is a major health concern in the United States.2 Beta-thalassemia affects approximately one in 100,000 individuals worldwide.3
The kit is also useful for cancer patients who require more thorough blood typing. Other patients who may benefit from the kit include those with warm autoimmune hemolytic anemia, those who have recently received a transfusion, and those undergoing daratumumab therapy.1,4
ID Core XT simultaneously types 37 antigens of 10 blood group systems—including Cartwright, Colton, Diego, Dombrock, Duffy, Kell, Kidd, Lutheran, MNS, and Rh—providing detailed information for the most clinically relevant blood groups. The predicted antigen profiles assist in building donor databases for the optimized management of antigen-negative units that are often needed to support the above-mentioned patients.
The kit also helps minimize alloimmunization risk in blood transfusions, and serves as an effective tool to generate rare donors databases and expedite antibody identification in complex workups.
The ID Core XT test will soon be available from Grifols as a kit for use in laboratories and as a send-out testing service from the Grifols immunohematology center in San Marcos, Texas. The test is an integral part of the BloodChip product line manufactured by Progenika, a Grifols company. The diagnostic kit uses polymerase chain reaction technologies to amplify DNA samples and, combined with Luminex technology, permits the precise identification of the genetic markers that code for red blood cell antigens. The technology is easy to use, with a workflow consisting of a few pipetting steps and requiring only 30 minutes of hands-on time and 4 hours from DNA to result.
In addition to ID Core XT, the positive controls (ID Core Control) and proprietary software (BIDS XT) have also been granted FDA approval. BIDS XT is a unique software platform designed to hold a database, help maintain traceability, and transfer data to the organization’s laboratory information system.
To learn more, visit Grifols.
References
- AABB Endorsement of CPT Tier 1 Code for Blood Group Genotyping [letter to CPT Advisory Committee]. Bethesda, Md: AABB, 2014. Available at: www.aabb.org/advocacy/reimbursementinitiatives/documents/aabb-endorsement-of-cpt-tier-1-code-for-blood-group-genotyping.pdf. Accessed October 18, 2018.
- Sickle Cell Disease [online]. Atlanta: Centers for Disease Control and Prevention, 2017. Available at: www.cdc.gov/ncbddd/sicklecell/data.html. Accessed October 18, 2018.
- Beta Thalassemia [online]. Danbury, Conn: National Organization for Rare Disorders, 2018. Available at: https://rarediseases.org/rare-diseases/thalassemia-major. Accessed October 18, 2018.
- Mitigating the Anti-CD38 Interference with Serologic Testing. AABB Bulletin #16-02. Bethesda, Md: AABB, 2016. Available at: www.aabb.org/programs/publications/bulletins/documents/ab16-02.pdf. Accessed October 18, 2018.
