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CSF Free Kappa Light Chain for The Diagnosis of Demyelinating Disorders

NCT05347277 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2022-04-26

No results posted yet for this study

Summary

Multiple sclerosis (MS) is a demyelinating disease of the central nervous system (CNS) which commonly leads to disability. The current preferred clinical laboratory test for the diagnosis is the detection of oligoclonal bands (OCBs) in the cerebrospinal fluid (CSF) by isoelectric focusing electrophoresis (IEF) followed by immunoblotting.Measuring the levels of Kappa Free Light Chain (K-FLC) in CSF has been proposed as a potential alternative to the qualitative assessment of OCBs. The aim of this study is to validate and determine the diagnostic yield of K-FLC in CSF against OCBs via IEF as gold standard.

Conditions

Interventions

DIAGNOSTIC_TEST

Kappa Free Light Chain (K-FLC)

A biochemical test measured on CSF sample via nephelometry on Beckman Immage-800 analyzer using kits from Freelite, The Binding Site, according to the manufacturer's instructions.

Sponsors & Collaborators

  • Aga Khan University

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2021-08-31
Completion
2021-08-31

Countries

  • Pakistan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05347277 on ClinicalTrials.gov