In the European medical diagnostic landscape, a significant shift occurred with the introduction of the IVDR regulation on May 26, 2017. The availability of standards or reference materials is central to the generation of reliable and interpretable laboratory results, which, in turn, are vital for accurate patient diagnosis and management. At BÜHLMANN, we seized this opportunity to adapt the BÜHLMANN GanglioCombi® MAG ELISA. Furthermore, we documented our journey towards IVDR compliance for our anti-MAG Antibodies ELISA and shared the data collected recently, establishing it as the Gold Standard.
anti-MAG Antibodies ELISA
The challenge we face is the absence of recognized standards for antibodies or an internal unit system for IVDD products. In fact, such requirements were previously not necessary, resulting that no traceability chains existed. Traceability chains is one of the vital components for medical diagnostic products to receive IVDR certification. To establish a traceability of these reference material, pooling of patient samples exhibiting positivity for anti-MAG IgM antibodies had to be done, eventually allowing the production of standardized calibrators. Overall, the implementation for a transparent traceability chain displays for stable results and confirms its Gold Standard status amongst others.
BÜHLMANN GanglioCombi® MAG ELISA
We established a transparent traceability chain using internal, reference materials monoclonal anti-GM1 (IgG and IgM) to produce standardized calibrators. Given the structural similarities among different gangliosides on the microtiter plate, anti-GM1 was used as a surrogate standardization. Out of all the gangliosides, GM1 not only is the most abundant ganglioside in the human body, but the antibodies (both isotypes: IgG and IgM) directed against GM1 are the most frequently tested in large case series from daily routine.
The two posters displayed at the PNS conference demonstrate the data collection process for the validation procedure required to ensure the technical performance of the test. This extensive and comprehensive validation procedure, necessary for IVDR compliance, confirms the robustness and standardization of the GanglioCombi MAG ELISA.