Inter-assay variability in anti-JC virus testing for natalizumab: A Spanish cohort.

OBJECTIVE

Accurate anti-JC virus (JCV) antibody testing is essential for progressive multifocal leukoencephalopathy (PML) risk stratification in natalizumab-treated patients. This study assessed evaluated inter-assay concordance between ImmunoWELL™ JCV IgG and STRATIFYJCV™ DxSelect™.

METHODS

We conducted a retrospective cross-sectional inter-assay concordance study including 48 patients with multiple sclerosis treated with natalizumab. Paired serum samples were analyzed using both assays. Binary serostatus and ordinal risk categories (negative, low, intermediate, high) according to antibody index value were compared.

RESULTS

STRATIFYJCV™ identified 4.2% of patients as JCV positive versus 33.3% with ImmunoWELL™, an eightfold difference. Overall binary agreement was 66.7%, with PABAK 0.33 (95% CI 0.12-0.54) and significant directional discordance (p = 0.0005). Most discordant results reflected upward reclassification from negative to low or intermediate categories. Only one patient changed high-risk status. A single discordant negative result was identified.

CONCLUSIONS

ImmunoWELL™ and STRATIFYJCV™ show relevant inter-assay variability, predominantly affecting low antibody index values, while preserving substantial agreement at clinically decisive high-risk thresholds. These findings support cautious interpretation of ImmunoWELL™ results and highlight the need for further virological validation.