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Optimized Kappa-Index Test Protocol to Detect Intrathecal Immunoglobulin Synthesis in Multiple Sclerosis.

Joel Björklund1, Outi Itkonen1, Pasi Nokelainen1

  • 1Department of Clinical Chemistry, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.

European Journal of Neurology
|November 3, 2025
PubMed
Summary

The Kappa-index (K-index) effectively detects intrathecal immunoglobulin synthesis, potentially replacing oligoclonal banding (OCB). A reflex approach optimizing K-index cutoffs improves diagnostic efficiency for neuroinflammatory diseases like multiple sclerosis (MS).

Keywords:
K‐indexbiomarkerkappa free light chainmultiple sclerosisoligoclonal band

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Area of Science:

  • Neurology
  • Immunology
  • Clinical Chemistry

Background:

  • Kappa free light chain (KFLC)-based Kappa-index (K-index) shows promise in detecting intrathecal immunoglobulin synthesis, potentially serving as an alternative to oligoclonal banding (OCB).
  • Current diagnostic protocols exhibit variability in K-index cutoffs, necessitating further research to optimize its diagnostic utility.

Purpose of the Study:

  • To compare different approaches for optimizing the K-index assay for diagnostic utilization in neuroinflammatory diseases.
  • To evaluate the K-index's effectiveness in detecting intrathecal immunoglobulin synthesis compared to OCB.

Main Methods:

  • Analysis of 432 paired cerebrospinal fluid (CSF)/serum samples from patients with multiple sclerosis (MS), clinically isolated syndrome (CIS), and other neuroinflammatory diseases (non-MS).
  • Measurement of K-index using the Optilite platform and OCB via isoelectric focusing on the Hydrasys platform.
  • Comparison of K-index values between OCB-positive and OCB-negative groups, and across different disease cohorts (MS, CIS, non-MS).

Main Results:

  • OCB-positive cases demonstrated significantly higher K-index values compared to OCB-negative cases.
  • The MS group exhibited a higher K-index than CIS (p=0.0066) and non-MS (p<0.0001) groups.
  • Established K-index cutoffs for differentiating MS from CIS (80.9) and non-MS (61.4). Optimized cutoffs using the limit of detection (LOD) with 95% sensitivity and specificity were <4.45 (negative) and >12.92 (positive).

Conclusions:

  • Published K-index cutoffs vary due to inconsistent handling of CSF KFLC results below the LOD.
  • A reflex approach, considering samples within a K-index gray area for OCB verification and classifying CSF KFLC below LOD as negative, represents the most efficient laboratory algorithm.
  • The K-index may hold prognostic value in MS, warranting further investigation.