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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
| 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 |
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Inclusion Criteria:
the following 'high risk' clinical and laboratory features had to be met
Exclusion Criteria:
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Sex, Gender, diagnose, the number of relapses in NMOSD patients
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| Name | Affiliation | Role |
|---|---|---|
| Jinzhou Feng, Ph.D | First Affiliated Hospital of Chongqing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | 400016 | China |
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Blood samples are collected.