Abstract presentation by Omixon’s Senior Technical Lead Assay R&D, Dr. Gergely Tölgyesi, from the latest 14th East-West Immunogenetics Conference (Budapest, Hungary).
European transplantation laboratories require the use of CE-marked HLA typing products for diagnostic purposes. The CE mark (“Conformité Européenne”, French for European conformity) is a symbol that a manufacturer affixes to a product label which ensures that the product (namely, the in-vitro diagnostic medical device – IVD) was designed and manufactured according to requirements of the concerning European directive and/or regulation.
In order to qualify for CE-marking products, a manufacturer needs to operate according to the ISO 13485 standards and to implement a valid Quality Management System. This is only the first step in the longer process that is fairly complicated and can take up to 12 months to complete. The next step is to define the category that the IVD product falls under. There are several categories and HLA typing kits fall under the category of “Annex II List B”, meaning that they have increased potential risk on patients’ health and outcome. Because of this classification, the robustness, stability, analytical and clinical performance characteristics of the product need to be established through exhaustive tests and studies. After all the required studies are completed, a Technical File with all the details is compiled and submitted for review to an independent organization, called the Notified Body (NB), who is qualified to deem whether the product fulfills all the quality criteria to be CE-marked and used for clinical purposes by transplantation laboratories.
The work presented here details the steps and experiments that are required for CE-marking of HLA typing products.