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嗜碱性粒细胞激活试验:在临床试验和临床实践中的作用机制及注意事项。

Basophil activation test: Mechanisms and considerations for use in clinical trials and clinical practice.

机构信息

Department of Women and Children's Health (Pediatric Allergy), School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.

Peter Gorer Department of Immunobiology, School of Immunology and Microbial Sciences, King's College London, London, UK.

出版信息

Allergy. 2021 Aug;76(8):2420-2432. doi: 10.1111/all.14747. Epub 2021 Feb 27.

DOI:10.1111/all.14747
PMID:33475181
Abstract

The basophil activation test (BAT) is a functional assay that measures the degree of degranulation following stimulation with allergen or controls by flow cytometry. It correlates directly with histamine release. From the dose-response curve resulting from BAT in allergic patients, basophil reactivity (%CD63 basophils) and basophil sensitivity (EC or similar) are the main outcomes of the test. BAT takes into account all characteristics of IgE and allergen and thus can be more specific than sensitization tests in the diagnosis of allergic disease. BAT reduces the need for in vivo procedures, such as intradermal tests and allergen challenges, which can cause allergic reactions of unpredictable severity. As it closely reflects the patients' phenotype in most cases, it may be used to support the diagnosis of food, venom and drug allergies and chronic urticaria, to monitor the natural resolution of food allergies and to predict and monitor clinical the response to immunomodulatory treatments, such as allergen-specific immunotherapy and biologicals. Clinical application of BAT requires analytical validation, clinical validation, standardization of procedures and quality assurance to ensure reproducibility and reliability of results. Currently, efforts are ongoing to establish a platform that could be used by laboratories in Europe and in the USA for quality assurance and certification.

摘要

嗜碱性粒细胞活化试验 (BAT) 是一种功能检测,通过流式细胞术测量在过敏原或对照物刺激后脱颗粒的程度。它与组胺释放直接相关。从过敏患者的 BAT 产生的剂量反应曲线中,可以得出嗜碱性粒细胞反应性(%CD63 嗜碱性粒细胞)和嗜碱性粒细胞敏感性(EC 或类似物)是该检测的主要结果。BAT 考虑了 IgE 和过敏原的所有特征,因此在诊断过敏性疾病方面比过敏原检测更具特异性。BAT 减少了对体内程序(如皮内试验和过敏原挑战)的需求,这些程序可能导致不可预测严重程度的过敏反应。由于它在大多数情况下密切反映了患者的表型,因此可用于支持食物、毒液和药物过敏以及慢性荨麻疹的诊断,监测食物过敏的自然缓解,并预测和监测免疫调节治疗(如过敏原特异性免疫治疗和生物制剂)的临床反应。BAT 的临床应用需要进行分析验证、临床验证、程序标准化和质量保证,以确保结果的可重复性和可靠性。目前,正在努力建立一个平台,供欧洲和美国的实验室用于质量保证和认证。

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