An Diagnostic Cohort on AQP4-Immunoglobulin G Detection Kit

An Diagnostic Cohort on Applicability and Accuracy of AQP4-Immunoglobulin G Detection Kit in the Diagnosis of Neuromyelitis Optica Spectrum Disorders

The diagnostic cohort study could will be use to verify the clinical performance of the AQP4 -immunoglobulin G detection kit and whether it has a good correlation with the clinical diagnosis results. The applicability and accuracy of the kit in clinical diagnosis will be verified according to the measured data.

Study Overview

• Status: Completed
• Conditions: Neuromyelitis Optica Spectrum Disorders

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• China
  • Guangzhou, China
    • Third Affiliated Hospital of Sun Yat-sen University
  • Fujian
    • Fuzhou, Fujian, China, 350005
      • Department of Neurology,First Affiliated Hospital of Fujian Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with NMOSD who are diagnosied in the First Affiliated Hospital of Fujian Medical Universtiy by two neurolgists

Description

Inclusion Criteria:

1. The patients who were diagnosed with NMOSD , and the cell-based assay was used to determine the AQP4-IgG-seropositive patients;
2. AQP4-IgG is negative in health people with age and sex matching and determined by cell-based assay;
3. Female or male, age 14-80;
4. Patients or authorized family members volunteered to participate in this study and signed informed consent.

Exclusion Criteria:

1. Patients with coagulation disorders;
2. Infection-related encephalitis;
3. Immune-related encephalitis;
4. A patient with severe mental illness who cannot cooperate clinically;
5. A patient with severe jaundice.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
results of AQP4 -immunoglobulin G detection kit	The Serum test results of participants using AQP4 -immunoglobulin G detection kit	through study completion, an average of 6 months

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Fujian Medical University
• Collaborators: Third Affiliated Hospital, Sun Yat-Sen University; MyBiotech Co. Ltd, China

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2020
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): February 20, 2021

Study Registration Dates

• First Submitted: May 10, 2020
• First Submitted That Met QC Criteria: May 13, 2020
• First Posted (Actual): May 14, 2020

Study Record Updates

• Last Update Posted (Actual): February 3, 2022
• Last Update Submitted That Met QC Criteria: January 19, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Eye Diseases; Optic Nerve Diseases; Cranial Nerve Diseases; Myelitis, Transverse; Optic Neuritis; Neuromyelitis Optica
• Other Study ID Numbers: LS2019-004-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No