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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04388072
Enrollment
200
Registered
2020-05-14
Start date
2020-05-15
Completion date
2021-02-20
Last updated
2022-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuromyelitis Optica Spectrum Disorders

Brief summary

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.

Interventions

None listed

Sponsors

MyBiotech Co. Ltd, China
CollaboratorUNKNOWN
Third Affiliated Hospital, Sun Yat-Sen University
CollaboratorOTHER
First Affiliated Hospital of Fujian Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
14 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
results of AQP4 -immunoglobulin G detection kitthrough study completion, an average of 6 monthsThe Serum test results of participants using AQP4 -immunoglobulin G detection kit

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026