[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658922":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":33,"studyPopulation":34,"armGroups":35,"interventions":29,"overallOfficials":48,"centralContacts":52,"locations":61,"responsibleParty":124,"collaborators":127,"id":131,"slug":132,"hasResults":133,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":133,"sex":139,"minAge":140,"maxAge":141,"enrollmentInfo":142,"targetDuration":29,"studyType":145,"phases":29,"briefSummary":146,"conditions":147,"keywords":151,"overallStatus":157,"whyStopped":29,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":167},{"fullName":5,"class":6},"Third Affiliated Hospital, Sun Yat-Sen University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":29},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Sensitivity of novel DAB chromogenic TBA for detection of anti-GABABR antibodies","Sensitivity of the novel DAB chromogenic tissue-based assay (TBA) for detecting anti-GABABR antibodies, calculated as true positive \u002F (true positive + false negative), using CBA results as the reference standard.","up to 3 months",{"measure":14,"description":15,"timeFrame":12},"Specificity of the novel DAB chromogenic TBA for detection of anti-GABABR antibodies","Specificity of the novel DAB chromogenic tissue-based assay (TBA) for detecting anti-GABABR antibodies, calculated as true negative \u002F (true negative + false positive), using CBA results as the reference standard.",{"measure":17,"description":18,"timeFrame":12},"Area under the ROC curve (AUC) of DAB chromogenic TBA for anti-GABABR antibody detection","ROC curve and AUC value of the novel DAB chromogenic TBA for anti-GABABR antibody detection with CBA as reference standard.",[20,23,26],{"measure":21,"description":22,"timeFrame":12},"Cohen's kappa coefficient between DAB-TBA and CBA reference method","Concordance between the novel DAB chromogenic TBA and the CBA reference method for anti-GABABR antibody detection, quantified by Cohen's kappa coefficient.",{"measure":24,"description":25,"timeFrame":12},"Agreement between serum and CSF detection results by DAB-TBA","Concordance of DAB chromogenic TBA results between paired serum and CSF samples, expressed as agreement percentage and Cohen's kappa.",{"measure":27,"description":28,"timeFrame":12},"Subgroup detection performance of DAB-TBA","Sensitivity and specificity of the DAB chromogenic TBA stratified by the four predefined subgroups (anti-GABABR-positive encephalitis, CBA-negative suspected autoimmune encephalitis, non-autoimmune neurological disease, and anti-NMDAR encephalitis).",null,{"allocation":29,"interventionModel":29,"interventionModelDescription":29,"primaryPurpose":29,"observationalModel":31,"timePerspective":32,"maskingInfo":29},"CASE_ONLY","CROSS_SECTIONAL","Anti-GABAB receptor (anti-GABABR) encephalitis is a recognized subtype of autoimmune encephalitis. Antibody detection is essential for diagnosis and differential diagnosis, and cell-based assays (CBA) are the current recommended reference method. The tissue-based assay (TBA) using DAB chromogenic immunohistochemistry offers a widely accessible complement for detecting anti-neuronal antibodies. This study validates the clinical performance of a novel DAB chromogenic TBA developed by Guangzhou KingMed Diagnostics Center. Participants are recruited from neurology departments across multiple centers and enrolled into four groups based on clinical diagnosis and CBA results. Residual serum and CSF samples (no additional sampling) are tested in a blinded manner, and the sensitivity, specificity, and ROC curve of the DAB-TBA for detecting anti-GABABR antibodies are evaluated against the reference standard.","Patients aged 14-85 years recruited from neurology departments across participating centers, grouped as: (a) anti-GABABR antibody-positive encephalitis; (b) suspected autoimmune encephalitis with negative anti-neuronal antibody CBA; (c) non-autoimmune disease (Alzheimer's disease); (d) anti-NMDAR antibody-positive encephalitis.",[36,39,42,45],{"label":37,"type":29,"description":38,"interventionNames":29},"Group A","Anti-GABABR antibody-positive encephalitis group (n=50)",{"label":40,"type":29,"description":41,"interventionNames":29},"Group B","Suspected AE with negative anti-neuronal antibody CBA (n=100)",{"label":43,"type":29,"description":44,"interventionNames":29},"Group C","Non-autoimmune disease group: Alzheimer's disease (n=50)",{"label":46,"type":29,"description":47,"interventionNames":29},"Group D","Anti-NMDAR antibody-positive encephalitis group (n=100)",[49],{"name":50,"affiliation":5,"role":51},"Wei Qiu, MD","PRINCIPAL_INVESTIGATOR",[53,57],{"name":50,"role":54,"phone":55,"phoneExt":29,"email":56},"CONTACT","+86-15899968330","qiuwei120@vip.163.com",{"name":58,"role":54,"phone":59,"phoneExt":29,"email":60},"Yaqing Shu, MD","+86-13724865420","shuyaqing@126.com",[62,80,90,100,109],{"facility":63,"status":29,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"Guangdong Provincial Hospital of Chinese Medicine","Guangzhou","Guangdong","518000","China","CN",{"type":70,"coordinates":71},"Point",[72,73],113.25,23.11667,{"lat":73,"lon":72},[76],{"name":77,"role":54,"phone":78,"phoneExt":29,"email":79},"Yuanqi Zhao, MD","+86-19120265011","tcm2008@126.com",{"facility":81,"status":29,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":82,"geoPoint":84,"contacts":85},"The First Affiliated Hospital of Guangzhou Medical University",{"type":70,"coordinates":83},[72,73],{"lat":73,"lon":72},[86],{"name":87,"role":54,"phone":88,"phoneExt":29,"email":89},"Mingshu Mo, MD","+86-15975632425","momingshu123@163.com",{"facility":91,"status":29,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":92,"geoPoint":94,"contacts":95},"The First Affiliated Hospital of Jinan University",{"type":70,"coordinates":93},[72,73],{"lat":73,"lon":72},[96],{"name":97,"role":54,"phone":98,"phoneExt":29,"email":99},"Xiaoyan Liu, MD","+86-13527719577","591713041@qq.com",{"facility":101,"status":29,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":102,"geoPoint":104,"contacts":105},"The Third Affiliated Hospital of Sun Yat-sen University",{"type":70,"coordinates":103},[72,73],{"lat":73,"lon":72},[106,107],{"name":50,"role":54,"phone":55,"phoneExt":29,"email":56},{"name":108,"role":54,"phone":59,"phoneExt":29,"email":60},"Shu, MD",{"facility":110,"status":29,"city":111,"state":112,"zip":113,"country":67,"countryCode":68,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"The First Affiliated Hospital of Zhengzhou University","Zhengzhou","Henan","450000",{"type":70,"coordinates":115},[116,117],113.64861,34.75778,{"lat":117,"lon":116},[120],{"name":121,"role":54,"phone":122,"phoneExt":29,"email":123},"Yanjie Jia, MD","+86-13513802916","Jiayanjie1971@zzu.edu.cn",{"type":51,"investigatorFullName":125,"investigatorTitle":126,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Wei Qiu","Chief Physician",[128],{"name":129,"class":130},"Guangzhou KingMed Center for Clinical Lab.Co., Ltd","UNKNOWN","100658922","clinical-evaluation-of-a-novel-dab-chromogenic-tissue-based-assay-for-detecting-anti-gababr-antibodies-100658922",false,"NCT07858175","Clinical Evaluation of a Novel DAB Chromogenic Tissue-Based Assay for Detecting Anti-GABABR Antibodies","Anti-GABAB Receptor Encephalitis: Evaluation of Autoantibodies by a Novel DAB Chromogenic Tissue-Based Assay - A Multicenter, Blinded, Cross-Sectional Study","GREAT","Inclusion Criteria:\n\nGroup a: age 14-85 years; anti-GABABR antibody CBA positive; diagnosed with GABABR antibody encephalitis. Group b: age 14-85 years; suspected autoimmune encephalitis with acute\u002Fsubacute onset (\\\u003C3 months) and one or more neurological\u002Fpsychiatric symptoms (e.g. memory impairment, seizures, psychiatric\u002Fbehavioral abnormalities); anti-neuronal antibody CBA negative; other etiologies reasonably excluded; identifiable address and resident in the region during treatment; willing to provide informed consent and comply with follow-up. Group c: age 14-85 years; non-autoimmune disease patients (Alzheimer's disease confirmed by serum\u002FCSF AD biomarker testing). Group d: age 14-85 years; anti-NMDAR antibody CBA positive; diagnosed with NMDAR antibody encephalitis.\n\nExclusion Criteria:\n\n1. Residual serum or CSF volume insufficient for DAB-TBA and confirmatory testing.\n2. Sample quality unacceptable (gross hemolysis, lipemia, contamination, or clot).\n3. Freeze-thaw cycles exceeding the predefined limit (specify N).\n4. Key clinical information (final diagnosis, CBA result, or demographic data) unavailable or incomplete.\n5. Sample previously included in this study (repeat sample from the same patient).","ALL","14 Years","85 Years",{"count":143,"type":144},300,"ESTIMATED","OBSERVATIONAL","This multicenter, blinded, cross-sectional study aims to evaluate the clinical performance of a novel DAB chromogenic tissue-based assay (TBA) for detecting anti-GABAB receptor (anti-GABABR) antibodies. A total of 300 participants will be enrolled across four groups: (a) 50 patients with anti-GABABR antibody-positive encephalitis; (b) 100 patients with suspected autoimmune encephalitis and negative anti-neuronal antibody cell-based assay (CBA); (c) 50 patients with non-autoimmune disease (Alzheimer's disease); and (d) 100 patients with anti-NMDAR antibody-positive encephalitis. Residual serum and cerebrospinal fluid samples will be tested using the optimized DAB-TBA. Discordant results between CBA and DAB-TBA will be adjudicated by an independent panel using confirmatory methods (immunoblot, repeat CBA, and clinical follow-up), and inter-reader agreement will be reported. The sensitivity, specificity, and ROC curve of the assay will be evaluated against the reference standard.",[148,149,150],"Autoimmune Encephalitis","Anti-NMDAR Encephalitis","Anti-GABABR Encephalitis",[152,153,154,155,156],"GABABR","autoimmune encephalitis","DAB","tissue-based assay","autoantibody","NOT_YET_RECRUITING","2026-10-02",{"date":160,"type":161},"2026-10-05","ACTUAL",{"date":163,"type":144},"2026-10",{"date":165,"type":144},"2028-10",{"name":5,"class":6},5]