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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: 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.

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400016
      • First Affiliated Hospital of Chongqing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Sex, Gender, diagnose, the number of relapses in NMOSD patients

Description

Inclusion Criteria:

• NMOSD: Confirm a diagnosis of NMOSD according to 2015 NMOSD diagnostic criteria by IPND (International Panel for NMO Diagnosis) suspected NMOSD: cases having features suggestive of NMOSD but can not confirm a diagnosis of NMOSD according to 2015 NMOSD diagnostic criteria by IPND (International Panel for NMO Diagnosis).

the following 'high risk' clinical and laboratory features had to be met

1. optic neuritis that was either severe with poor recovery (residual visual acuity in better eye worse or equal to 6/36), bilateral (simultaneous orsequential within 3 months) or recurrent (more than 2 attacks) as the sole clinical manifestation of demyelinating disease,
2. severe transverse myelitis with a central cord syndrome (symmetrical, motor, sensory and bladder involvement) and poor recovery (residual EDSS greater than 5.0) or a longitudinally extensive lesion of the spinal cord spanning 3 or more vertebral segments on magnetic resonance imaging (MRI) or
3. demyelinating disease clinically confined to the optic nerve and spinal cord with at least one of the following: normal or atypical MRI of the brain (fewer than 2 periventricular lesions), negative oligoclonal bands in cerebrospinal fluid, raised CSF protein or a CSF pleocytosis (more than 10 cells per μl) 2.All subjects provided written informed consent.

Exclusion Criteria:

• 1.Patients with incomplete clinical information. 2.Patients without serum samples.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
NMOSD; cases confirm a diagnosis of NMOSD according to 2015 NMOSD diagnostic criteria by IPND (International Panel for NMO Diagnosis).
suspected NMOSD; cases having features suggestive of NMOSD but can not confirm a diagnosis of NMOSD according to 2015 NMOSD diagnostic criteria by IPND (International Panel for NMO Diagnosis).
MS; cases confirm a diagnosis of MS according to 2017 McDonald criteria with no features suggestive of NMOSD.
Other disease; cases confirm a diagnosis of neurological disease other than NMOSD and MS, including autoimmune encephalitis, viral encephalitis, myasthenia gravis et al.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity (CI%), Specificity (CI%), Accuracy (CI%), PLR (CI%), NLR (CI%)	The sensitivity, 95% confidence interval (CI) for sensitivity, specificity, and 95% CI for specificity of AQP4 antibody detection methods using live cell and fixed cell-based assay technologies in NMOSD and suspected NMOSD, along with the corresponding results from various control groups and overall controls, are given.	immediately

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agreement ,Cohen's kappa, Spearman correlation coefficient	The agreement ,Cohen's kappa, Spearman correlation coefficient of serum AQP4 antibody detection results using live CBA and fixed CBA.	immediately

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Chongqing Medical University
• Investigators: Principal Investigator: Jinzhou Feng, Ph.D, First Affiliated Hospital of Chongqing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2023
• Primary Completion (Estimated): January 27, 2025
• Study Completion (Estimated): January 27, 2025

Study Registration Dates

• First Submitted: January 4, 2025
• First Submitted That Met QC Criteria: January 4, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 4, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: AQP4; Fixed CBA; Live CBA
• Other Study ID Numbers: AQP4NMO-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No