FDA Guidance on Transfusion and Transplantation - NAT based HLA Test Kits

Recommendation

7/8 May 2024

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Regulatory Requirements and Practical Implementation

In July, the U.S. Food and Drug Administration published a Guidance for Industry "Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation".

The proteins encoded by HLAs are those on the outer part of body cells that are (in effect) unique to that person. The immune system uses the HLAs to differentiate self cells and non-self cells. Any cell displaying that person's HLA type belongs to that person and, therefore, is not an invader. Clinical complications, such as graft rejection or graft-versus-host disease, may occur if the immune system recognizes transplanted cells, tissues, organs, bone marrow, or a transfused unit of blood or blood components as being foreign on the basis of HLA nonidentity or if transplanted immune system cells react in response to the recipient’s HLA.

Therefore, the performance of HLA test kits is critical for ensuring precise and successful matching between donors and recipients of blood and blood components, cells, tissues, bone marrow, and organs. Failure of the kit will cause massive risks for the recipient.

Related to the increasing complexity of the available testing methodology from serology and cell-based methods with little instrumentation to deoxyribonucleic acid (DNA) based and multiplex assays, the FDA provides recommendations to submitters and FDA reviewers in preparing and reviewing premarket notification submissions for human leukocyte antigen (HLA) in vitro diagnostic (IVD) device test kits. The document contains detailed information on the types of studies FDA recommends for validation of HLA test kits submitted as 510(k)s and used for the matching of donors and recipients in transfusion and transplantation.

Fore more details please read the Guidance for Industry "Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation".