Performance Evaluation of an Automated Neurofilament Light Chain Immunoassay

Area of Science:

• Clinical Chemistry
• Neuroscience
• Biomarker Assay Development

Background:

• Elevated neurofilament light chain (NfL) in bodily fluids signifies neuroinflammatory damage and predicts disease progression.
• The clinical utility of NfL as a biomarker necessitates robust analytical assays for accurate quantification.

Purpose of the Study:

• To evaluate the analytical performance of the Siemens Healthineers Atellica IM NfL assay for serum and plasma.
• To verify the assay's suitability for in vitro diagnostic use in monitoring neurological conditions.

Main Methods:

• Assay performance was assessed according to Clinical Laboratory Standards Institute (CLSI) guidelines.
• Key analytical parameters evaluated included detection limits, linearity, precision, interference, and specimen equivalence.
• Method comparison studies were conducted across different platforms and with reference materials.

Main Results:

• The assay demonstrated excellent precision (CVs 0.9%-8.6%) and a wide analytical measuring interval (3.0–300.0 pg/mL, extendable to 3000 pg/mL).
• No significant interference was observed from common substances, and serum and plasma yielded equivalent NfL results.
• Age-specific reference ranges were established, with a 95th percentile range of 3.7–18.9 pg/mL for healthy adults.

Conclusions:

• The Siemens Healthineers Atellica IM NfL assay exhibits strong analytical performance, meeting all verification requirements.
• The assay is suitable for quantitative measurement of NfL in human serum and plasma (EDTA) on the Atellica IM analyzer.
• Results obtained from healthy individuals and patients with neurological conditions fall within the assay's reportable range.