EAN 2026 | Preliminary results of PRO-KFLC: kappa-free light chains and oligoclonal bands in MS diagnosis

To give a little background, most people know that the 2024 revised McDonald criteria had several novelties, several changes included. For example, the novel MRI markers, OCT, recognition of optic nerve involvement by OCT and VEP, for example, and several other things. But among them, kappa-free light chains were included alongside oligoclonal bands to demonstrate intrathecal synthesis in patients with multiple sclerosis. And there’s conflicting data in the literature on which biomarker is more suitable, more sensitive, more specific, and there are very, very few multicentric studies. So our aim with the ProKFLC study, which stands for Prospective Multicentric Real-World Evidence for Kappa-Free Light Chains in Multiple Sclerosis, was to assess exactly this question. So in this trial, we are investigating Kappa-Free Light Chains and measure them on three different platforms with three different assays. And we are also assessing the detection of oligoclonal bands with two different assays, the CIE assay, which is the most commonly used in the world, and an in-house assay with a really, really high diagnostic sensitivity. And we also, the third thing that we are looking at is the reported OCB outcome that the senders are reporting to us. So we have three KFLC methods, three OCB methods, which we are going to compare. And for the kappa-free light chains, the last thing that we are looking at is also the interpretation or so to say the cutoff used. It’s on the one hand the KFLC index of 6.1 and on the other hand the Riba graph for KFLC which was published in 2019. And looking at the preliminary results we have included almost 70 centers from all over the world and gathered a thousand RRMS patients right now. The sex and age distribution is really representative of the cohort of the RRMS patients. And when we are looking at the diagnostic sensitivities, we found that the OCB detection reported from the different centers was the least sensitive method with a sensitivity of 88%. The next better sensitivity was reached with the KFLC index of 6.1, here we found a positivity rate of 93%. And on the top of all of that, there was the Riba graph for kappa-free light chains. Here we found a sensitivity of 97%. So to conclude this preliminary data, the least sensitive method were the OCB, although I have to comment on that, that the data on the CIE and the in-house assay are still missing. And for KFLC, it seems to be that we should favor the Riba graph over the Kappa-free light chain index.

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