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Active Not RecruitingNCT06767020

Comparative Study on AQP4 Antibody Detection Methods

A Multi-center Comparative Real-World Study on AQP4 Antibody Detection Methods Using Live Cell and Fixed Cell-Based Assay Technologies

Status
Active Not Recruiting
Phase
Study type
Observational
Enrollment
120 (estimated)
Sponsor
First Affiliated Hospital of Chongqing Medical University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

This study aims to determine which method is more suitable for clinical application by comparing the sensitivity, specificity, and accuracy of serum AQP4-IgG detection using live cell CBA and fixed cell CBA methods, thereby improving the diagnostic accuracy of neuromyelitis optica spectrum disorders (NMOSD).

Detailed description

This is a multi-center comparative real-world study on AQP4 Antibody Detection Methods Using Live Cell and Fixed Cell-Based Assay Technologies. This study aims to determine which method is more suitable for clinical application by comparing the sensitivity, specificity, and accuracy of serum AQP4-IgG detection using live cell CBA and fixed cell CBA methods, thereby improving the diagnostic accuracy of neuromyelitis optica spectrum disorders (NMOSD). One hundred and twenty patients from 3 centres in China will be enrolled.

Conditions

Timeline

Start date
2023-11-11
Primary completion
2025-01-27
Completion
2025-01-27
First posted
2025-01-09
Last updated
2025-01-09

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT06767020. Inclusion in this directory is not an endorsement.