ArticleNeurology and therapy2026
Threshold-Dependent Discordance Between STRATIFY JCV™ and IMMUNOWELL™ Assays in Relapsing Multiple Sclerosis.
Article in Neurology and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionAnti-JC virus (JCV) antibody testing is central to progressive multifocal leukoencephalopathy (PML) risk stratification in patients treated with natalizumab. While STRATIFY JCV™ is the historical reference assay, IMMUNOWELL™ is increasingly used in the context of biosimilar adoption. We aimed to determine whether inter-assay discordance reflects true biological divergence or threshold-dependent interpretative effects within clinically relevant PML risk categories.
methodsIn this single-center observational study, 250 consecutive patients with relapsing multiple sclerosis (RMS) underwent same-day paired STRATIFY and IMMUNOWELL testing. Agreement was evaluated under two interpretative frameworks: (i) manufacturer-defined analytical cutoffs and (ii) clinically adopted PML risk-based thresholds. Quantitative comparability was assessed using Pearson correlation and Bland-Altman analysis.
resultsUsing analytical cutoffs, concordance was 78.0% (κ = 0.55), with discordance predominantly in borderline index ranges. When applying clinically adopted risk thresholds, concordance increased to 93.2% (κ = 0.73). Index values correlated strongly (r = 0.922; p < 0.0001). Bland-Altman analysis showed minimal mean bias (+0.06), with wider deviations confined largely to low-to-intermediate index values rather than high-risk profiles.
conclusionsInter-assay discordance between STRATIFY and IMMUNOWELL is largely threshold-driven and substantially attenuated when applying clinically meaningful PML risk categories. These findings support practical interchangeability for routine monitoring in the biosimilar era, while underscoring the need for cautious interpretation of borderline results.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.