First Affiliated Hospital of Chongqing Medical University
Phase
Observational
Started
2023-11-11
Last updated
2025-01-09
Condition(s) studied
NMOSD
Study 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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Sensitivity (CI%), Specificity (CI%), Accuracy (CI%), PLR (CI%), NLR (CI%) — immediately 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.
Trial sites (1)
Facility
City
Region
Status
First Affiliated Hospital of Chongqing Medical University
Chongqing
Chongqing Municipality
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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