Evaluation of Two Cell-based Assays for Diagnosing MOG-IgG Associated Disorders
Evaluation of The Diagnostic Value of Two Cell-based Assays for MOG-IgG-associated Diseases: A Multicenter, Paired Design Observational Study
Huashan Hospital
240 participants
Nov 18, 2024
OBSERVATIONAL
Conditions
Summary
Anti-myelin oligodendrocyte glycoprotein-IgG-associated disorders (MOGAD) is a rare inflammatory autoimmune disease. In addition, since the international MOGAD group proposed live-cell based assays for MOGAD diagnosis in 2023, there are still no real-world cohort validation studies on this methodology. This study intends to establish a large sample cohort with multi-center and paired design. MOG-IgG detection based on live cells and fixed cells was performed on the study participants with high suspicion of MOGAD and the negative control population, to obtain the diagnostic performance parameters and consistency evaluation of the two methodologies, evaluate their clinical diagnostic value, and explore the best individual assay cutoffs for MOG-IgG detection suitable for the diagnosis of MOGAD in China.
Eligibility
Inclusion Criteria7
- age ≥18 years old, male and female.
- MOGAD is highly suspected.
- Other inflammatory CNS disease control groups include: According to the diagnostic criteria and consensus of various diseases, the diagnosis of multiple sclerosis, Autoimmune encephalitis (except NMDAR encephalitis), Guillain-Barre syndrome (GBS), Chronic Inflammatory Demyelinating polyradiculopathy (CIDP), Retinal Cerebrovascular disease (SUSAC), POEMS syndrome (POEMS), and neuropathy were confirmed. The monoclonal gammopathy of unknown significance (MGUS), Sarcoidosis and so on.
- The control group of non-inflammatory central nervous system diseases included: Migraine, CSVD, benign cranial hypertension, Glioma with definite diagnosis and no other autoimmune diseases.
- Healthy controls include healthy people who have no autoimmune diseases through physical examination and other means.
- Complete clinical data.
- Informed consent of the patient or his guardian has been obtained.
Exclusion Criteria7
- According to the Guidelines for Diagnosis and Treatment of Optic Neuromyelitis Spectrum Diseases (2021), patients with optic Neuromyelitis Spectrum diseases (NMOSD) with positive AQP4 were clearly diagnosed.
- According to the Expert Consensus on the Diagnosis and Treatment of Autoimmune encephalitis in China (2022), the diagnosis was confirmed as NMDAR encephalitis.
- Patients with positive anti-glial fibrillary acidic protein antibody (GFAP-IgG) in serum and/or cerebrospinal fluid.
- Lack of clinical data.
- Unqualified blood samples.
- The patient\'s informed consent was not obtained.
- Misdiagnosis in the research process went wrong in this study.
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Interventions
1. Study participants with high clinical suspicion of MOGAD: 2mL serum samples were collected for detection. CBA method of live cells and fixed cells was used for all samples. Sensitivity, specificity, positive predictive value and negative predictive value of the two detection methods were calculated according to the detection results and combined with the 2023 MOGAD diagnostic criteria. 2. Control group：2mL serum samples were collected for detection. CBA method of live cells and fixed cells was used for all samples.
Locations(1)
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NCT06617962