A groundbreaking pilot study within the framework of an external quality assurance program (EQA) has investigated the analytical variability of neurofilament light chain (NfL) measurements. NfL is considered a promising biomarker for neuronal damage in diseases such as multiple sclerosis, Alzheimer’s disease and amyotrophic lateral sclerosis. However, the study shows significant differences between measurement platforms that make standardized clinical application difficult.

25 laboratories took part in the study, mainly from Germany and other European countries. Two NfL concentration levels (approx. 30 and 500 pg/ml) were tested with lyophilized serum samples. The overall top score was 88%, but varied depending on the sample (64% for the high concentration, 88% for the low). The largest deviation was seen in the electrochemiluminescence method from one manufacturer (0% top grade), while other methods achieved 100%. The reasons for the differences lie in calibration problems, antibody detection and sample handling.

The results make it clear that NfL values are not directly comparable between platforms. It is recommended to establish method-specific reference areas and to document the method used in clinical studies. Future approaches include the development of a reference method and commutable materials by the IFCC working group to harmonize the analytics.

The details of this groundbreaking study can be seen as a poster at DKLM 2025 in Leipzig. Interested media can receive the poster in advance in compliance with the strict embargo period of 23.10.2025 / 00:01 and presentation of a valid press card. To do so, send us your enquiry including a copy of your press card to: redaktion@medlabportal.de

The German Congress of Laboratory Medicine (DKLM) 2025 promises exciting insights into the interface between science and clinical practice. Under the motto “Science for Precision Medicine”, the German Society for Clinical Chemistry and Laboratory Medicine (DGKL) and the Umbrella Association for Technologists and Analysts in Medicine Germany (DVTA) invite experts from research, clinics and industry to meet on October 23 and 24 at the Congress Center Leipzig (CCL). The two-day event is aimed at laboratory physicians, biomedical analysts and decision-makers to discuss current advances in diagnostics and strengthen networks. The ceremonial opening of the congress will take place on 22 October with the presentation of the MedLabAwards in the Salles de Pologne.

Editor: X-Press Journalistenbüro GbR

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