Abstract
Objectives
Define the cutoff thresholds of the Kappa (K) and Lambda (L) free light chains (FLC) indices for the detection of intrathecal immunoglobulin synthesis (IIS) using the new K and L FLC ELISA from SEBIA. The reference technique, which is not readily standardized between laboratories, is based on the demonstration of oligoclonal banding (OCB) in cerebrospinal fluid (CSF) which is absent in serum. For the past 6 years, we have also routinely calculated the K FLC index using The Binding Site (TBS) reagents on an Optilite instrument, an approach increasingly used as an alternative and/or a complement to electrophoretic analysis.
Methods
We analyzed 391 serum/CSF pairs divided into three groups. The first group were cases without OCB and with normal albumin CSF/serum ratio (n=174). The second group were cases with specific OCB (n=73). The last group included patients with increased albumin CSF/sera ratio without OCB (n=142).
Results
Analysis of the first group determined that the cutoffs for detection of IIS are respectively 2.55 and 1.02 for the K FLC and L FLC indices. Of the 73 cases with IIS, only 2 had a K FLC index below this threshold (sensitivity of 97.26%), while 16 out of 73 cases (78.08%) and 13 out of 72 cases (81.94%) had an IgG and L FLC index below the cutoffs, respectively. Additionally, we illustrate equivalent performances for prediction of the presence of OCB between SEBIA and TBS methods.
Conclusions
Sebia K FLC and L FLC assays are adequate alternative methods for the diagnosis of IIS.
Acknowledgments
ELISA Kits for this study were provided by Sebia.
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Research funding: None declared.
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Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
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Competing interests: JB has been invited for congress by The Binding Site and Sebia and received consultation honoraria from Sebia. AB received consultation honoraria from The Binding Site. The other authors declare no competing interests for this study.
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Informed consent: Informed consent was obtained from all individuals included in this study.
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Ethical approval: This observational retrospective study is declared on the AP-HM health data access portal, in accordance with the general data protection regulations (registration number 2021-155). The local Institutional Review Board deemed the study exempt from review.
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