An Diagnostic Cohort on AQP4-Immunoglobulin G Detection Kit

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-15

Study Completion Date

2021-02-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Neuromyelitis Optica Spectrum Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

14 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes