Evidence map›Paper›PMID 40197186›Full record

ArticleCurrent neuropharmacology2025

Comparing STRATIFY JCV™ DxSelect™ and IMMUNOWELL™ JCV Tests in RRMS to Assess PML Risk.

Aurora Zanghì, Fabiana Marinelli, Paola Sofia Di Filippo, Carlo Avolio, Emanuele D'Amico

Abstract readComparative Study
In one paragraph

Article in Current neuropharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Aurora ZanghìDepartment of Medical and Surgical Sciences, University of Foggia, Foggia, Italy.
Fabiana MarinelliNeurology Unit, MS Center, F. Spaziani Hospital, ASL Frosinone, Italy.
Paola Sofia Di FilippoDepartment of Medical and Surgical Sciences, University of Foggia, Foggia, Italy.
Carlo AvolioDepartment of Medical and Surgical Sciences, University of Foggia, Foggia, Italy.
Emanuele D'AmicoDepartment of Medical and Surgical Sciences, University of Foggia, Foggia, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe risk of developing progressive multifocal leukoencephalopathy (PML), a rare but potentially fatal opportunistic infection of the central nervous system caused by the J.C. virus (JCV), remains a primary concern associated with natalizumab therapy in the clinical management of patients diagnosed with multiple sclerosis (MS). MATERIALS AND

methodsThis study compared two tests, STRATIFY JCV™ DxSelect™, and IMMUNOWELL ™ JCV antibody tests, for assessing the risk of PML in patients diagnosed with relapsing- remitting multiple sclerosis (RRMS) who had received disease-modifying therapy (DMT) with branded natalizumab (Tysabri®). The main objective was to determine the comparability of these tests in classifying PML risk. Eligible patients were selected from a database, and all specimens for the STRATIFY JCV™ DxSelect™ and IMMUNOWELL™ JCV antibody tests were collected on the same day. Patients were classified into three risk categories (low, intermediate, or high) based on threshold values for each test.

resultsThe analysis showed 85.5% agreement between the two tests for risk classification. Ten discordant cases were identified, mainly between intermediate- and high-risk categories. Compared to STRATIFY JCV™ DxSelect™, IMMUNOWELL™ JCV antibody test tended to categorize more patients as higher risk. No significant association was found between discordance and prior use of immunosuppressant drugs and >24 doses of natalizumab. The agreement between tests, assessed with the weighted Cohen's Kappa coefficient, was substantial (κ=0.6222).

conclusionsCompared to the STRATIFY JCV™ DxSelect™, the IMMUNOWELL™ JCV test tends to place more patients in higher risk categories. Further, longitudinal studies are needed to evaluate the clinical impact of these differences in PML risk assessment.

Indexed as

Antibodies, ViralJC VirusLeukoencephalopathy, Progressive MultifocalMultiple Sclerosis, Relapsing-RemittingAdultFemaleHumansImmunologic FactorsMaleMiddle AgedNatalizumabRisk AssessmentYoung AdultAntibodies, ViralImmunologic FactorsNatalizumabantibody testimmunosuppressant drugs.IMMUNOWELL™ JCVJC virusnatalizumabPML riskSTRATIFY JCV™ DxSelect™

Identifiers

PMID40197186
PMCPMC12307996

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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.