SIMPLIFIED POPULATION SCREENING FOR HYPOTHYROIDISM

描述：（改编自申请人的摘要）虽然成本 用滤纸干血斑（DBS）筛查的有效性 在世界各地的新生儿筛查项目中， 该方法尚未用于筛查其他年龄组。 甚至 对于测试，如TSH，可用于检测甲状腺功能减退症， 成人以及新生儿，新生儿筛查计划不 包括成人样本，因为年龄较大 激素水平的差异。 其他对筛查成人有用的测试 不用于新生儿筛查项目。 研究人员建议， 开发一个使用DBS的成人筛查项目， 确定可治疗的疾病，如原发性甲状腺功能减退症， 由于非特异性，经常被误诊或未被识别。 症状 TSH测定将适用于检测甲状腺功能减退症， 成人，并将通过平行收集 200名患者的血清和DBS。 DBS样本的正常值为 针对不同年龄段的人群。 甲状腺过氧化物酶测定 抗体将适合于与DBS一起使用，并且其作为一种免疫调节剂的应用将是可行的。 前四个月妇女甲状腺功能减退症筛查试验 产后数月调查。 其他DBS试验将 在第二阶段开发。

DESCRIPTION: (adapted from the applicant's abstract) Although the cost effectiveness of screening with filter paper dried blood spots (DBS) has been recognized all over the world in new born screening programs, the methodology has not been applied to screening other age groups. Even for tests such as TSH which can be used to detect hypothyroidism in adults as well as newborns, the newborn screening programs do not include adult samples in their protocols because of large age related differences in hormone levels. Other tests useful for screening adults are not used in newborn screening programs. The investigators propose to develop an adult screening program using DBS to allow early identification of treatable diseases such as primary hypothyroidism that are often misdiagnosed or not recognized because of nonspecific symptoms. A TSH assay will be adapted to detect hypothyroidism in adults, and the assay will be validated with parallel collection of serum and DBS from 200 patients. Normal values for DBS samples will be determined for different age groups. An assay for thyroid peroxidase antibody will be adapted for use with DBS, and its application as a screening assay for hypothyroidism in women during the first four months postpartum investigated. Additional DBS assays will be developed in Phase II.