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临床试验/NCT05414890
NCT05414890Unknown不适用

Comparison of the Specificity, Sensitivity, and Clinical Correlation of Cell-based Assay (CBA) and CBA-TSA (Tyramide Signal Amplification) in Detecting AQP4, MOG, and NMDAR-IgG in Central Nervous System Diseases; a National Multicenter Study

Beijing Tiantan Hospital1 个研究点 分布在 1 个国家目标入组 2,500 人开始时间: 2022年6月30日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
2,500
试验地点
1
主要终点
CBA-TSA is consistent with CBA in terms of specificity and clinical correlation in detecting autoantibodies.

研究概览

简要总结

Determination of autoantibodies against fragments derived from neurons, glia, and myelin sheath is instrumental in aiding diagnosis, differential diagnosis, as well as determining disease status of neuromyelitis optica spectrum disorders (NMOSD), myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD), autoimmune encephalitis (AE). Cell based assay (CBA) has been frequently recommended to detect autoantibodies of neuroantigens in the aforementioned neurological disorders. However, antibodies with low abundance or low affinity often fall beyond the threshold of CBA and pose significant challenges in practice. To this end, the investigators adopted a tyramide signal amplification (TSA) technology with the basis of CBA to improve sensitivity. The preliminary results suggest that this TSA-CBA platform is superior to conventional CBA in registered signals of the titer autoantibodies. In elevating the sensitivity, TSA-CBA also preserves antigen confirmation. This prospective study is launched to compare the sensitivity, specificity, clinical correlation between CBA and CBA-TSA, in determining autoantibodies against aquaporin 4 (AQP4-IgG), myelin oligodendrocyte glycoprotein (MOG-IgG), N-methyl-D-aspartate receptor (NMDAR-IgG) in a multicenter, double-blind setting.

详细描述

Participants: The sera of patients with CNS demyelinating autoimmune diseases (NMOSD, MOGAD, AE).

Primary aim: 1) Compare the specificity, sensitivity, and clinical correlation between CBA and CBA-TSA, in detecting AQP4, MOG, and NMDAR IgG. 2) Analyze the advantage of CBA-TSA assay over conventional CBA in detecting antibodies to AQP4, MOG, and NMDAR IgG with low abundance and low affinity.

Secondary aim: Comparison of the turn-around time and the cost of CBA and CBA-TSA in detecting AQP4, MOG, and NMDAR IgG.

Study design: Multicenter, double-blind, CBA and CBA-TSA methodology comparison

Total cases:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The patients with suspected NMOSD, MOGAD and AE will be recruited.
  • Male and female patients, ≥ 18 years old.

排除标准

  • Abnormal sera, such as hemolysis or lipemia, which will affect the final interpretation of CBA and CBA-TSA;
  • The samples with incomplete clinical data that would affect the disease characterization.

结局指标

主要结局

CBA-TSA is consistent with CBA in terms of specificity and clinical correlation in detecting autoantibodies.

时间窗: 2022.6.30-2024.6.30

Comparsion the specificity, sensitivity, positive likelihood ratio (LR), negative LR and clinical correlation of CBA and CBA-TSA assay in autoantibodies detection of AQP4, MOG, NMDAR respectively.

CBA-TSA is superior to CBA for detecting antibodies to AQP4, MOG, and NMDAR IgG with low abundance and low affinity.

时间窗: 2022.6.30-2024.6.30

Comparsion the sensitivity of CBA and CBA-TSA assay in detecting the AQP4, MOG or NMDAR IgG in low abundance and low affinity.

次要结局

  • Compared with CBA, CBA-TSA uses a smaller sample and costs less, but the experiment turn-around time takes longer.(2022.6.30-2024.6.30)

研究者

发起方
Beijing Tiantan Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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