ArticleTherapeutic advances in neurological disorders2025
Comparative evaluation of STRATIFY JCV™ and IMMUNOWELL™ assays for anti-JCV antibody detection in natalizumab-treated RRMS patients.
Article in Therapeutic advances in neurological disorders, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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Who cites it
2 citing papers in PubMed.
- Threshold-Dependent Discordance Between STRATIFY JCV™ and IMMUNOWELL™ Assays in Relapsing Multiple Sclerosis.Neurology and therapy · 2026Article
- Inter-assay variability in anti-JC virus serology in the era of natalizumab biosimilars: implications for PML risk stratification.Frontiers in immunology · 2026Review
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Authors and funding
8 authors.
Funding
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Abstract
Background: Two principal methods for detecting anti-John Cunningham virus (JCV) antibodies are currently utilized in clinical practice: STRATIFY JCV™, an ELISA developed by Biogen, and IMMUNOWELL™, a solid-phase ELISA assay by Polpharma Biologics/GenBio. Objective: We aimed to evaluate the concordance between STRATIFY and IMMUNOWELL in detecting anti-JCV antibodies in a real-world population of patients with relapsing-remitting multiple sclerosis (RRMS) undergoing natalizumab therapy. Design: This monocentric observational study screened all patients treated with natalizumab for at least 6 months, referring to the MS Center of the University Hospital of Catania. Methods: Each patient's serum was tested simultaneously using STRATIFY-2 (STRATIFY JCV DxSelect) and IMMUNOWELL assays. The qualitative results (positive/negative) were compared, and the index values were analyzed using Pearson's correlation and Bland-Altman plots. Inter-method agreement was calculated using Cohen's kappa coefficient. Results: Among the 120 patients tested, 82 were positive and 31 negative with both STRATIFY and IMMUNOWELL. Four cases were STRATIFY-negative but IMMUNOWELL-positive, and three were the opposite. Overall concordance was 94.2%, with a Cohen's Kappa of 0.86, indicating strong agreement. The index values showed strong correlation (Pearson Conclusion: STRATIFY and IMMUNOWELL demonstrate a high level of agreement in the detection of anti-JCV antibodies in patients with RRMS receiving natalizumab. IMMUNOWELL may serve as a reliable complementary method, especially in cases where borderline serostatus could influence therapeutic strategy. Regular and accurate monitoring of JCV status remains essential for guiding long-term treatment safety and optimizing individual patient outcomes.
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