New QC-Scheme for GanglioCombi – Summary from PNS 2025 Poster Presentation
We are pleased to inform you about recent developments presented at the Peripheral Nerve Society (PNS) Annual Meeting 2025 in Edinburgh, where we showcased our latest work on improving the quality control of the multiparametric GanglioCombi IVD test kits (BÜHLMANN GanglioCombi® MAG ELISA, in conformity with IVDR and BÜHLMANN GanglioCombi®, RUO version).
Click here to download the poster.
Summary of Key Findings
Anti-ganglioside antibody testing plays a central role in the diagnosis of various inflammatory peripheral neuropathies such as Guillain-Barré Syndrome (GBS), Multifocal Motor Neuropathy (MMN), and CANOMAD/CANDA. The specificity of such tests is critical, as peripheral autoimmune neuropathies are relatively rare, and most patient samples tested are negative or originate from differential diagnostic workups.
Due to the complexity of anti-ganglioside antibody detection — involving diverse isotypes, affinities, and specificities — even minor variations in raw materials or production can lead to unwanted background signals, affecting the clinical accuracy of the test.
To address this, we performed an extensive evaluation across 10 production kit lots of GanglioCombi tests, using 59 sera from both healthy donors and diseased patients. A total of 2,856 data points were collected and analyzed. Our investigation demonstrated:
- Unspecific background is largely consistent across different donor groups.
- The vast majority of healthy donor samples (approx. 91%) fall within the negative reference range.
- A statistically supported QC scheme was established, utilizing a set of 36 randomly selected control sera.
- This scheme enables early identification of production lots that may display unwanted background reactivity, thus ensuring high specificity and reducing the risk of false positives.
Implementation of the New QC Scheme
Based on these findings, we are implementing this enhanced QC scheme into our production and validation processes for the GanglioCombi tests. This will further strengthen the robustness and clinical relevance of our assay.
Impact on Validation and Clinical Use
It is important to emphasize that this approach reflects the real-life clinical setting, where the majority of tested sera are negative and only a small fraction represent true positive cases. The new QC framework allows us to safeguard the high specificity required for such rare autoimmune neuropathy diagnostics and ensures continued confidence in GanglioCombi test results.
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