SIMPLIFIED POPULATION SCREENING FOR ADULT HYPOTHYROIDISM

胸腺功能减退症在某些人群中是一种常见疾病，并且由于微妙的非特异性症状和体征而通常无法早期诊断。使用滤纸干血斑（DBS）筛查新生儿的非常经济有效和准确的方法的适应性可以应用于儿科和成人人群，以在残疾和严重症状发展之前检测疾病，并在治疗期间监测患者，提供比传统方法更高的成本效益，可比的准确性和更高的患者依从性。我们开发并验证了敏感和精确的方法来测量甲状腺刺激激素（TSH）和甲状腺抗体，甲状腺过氧化物酶抗体（TPOAb）和甲状腺球蛋白抗体（TGAb）在DBS标本。具体目标：我们将从以下三个人群中收集DBS样本，这些人群具有发生自身免疫性甲状腺炎和甲状腺功能减退症的高风险：（a）目前居住在护理和个人护理院的老年人将每年接受筛查，为期两年。(b)将对诊断为妊娠的母亲、常规六周访视和产后一年访视进行筛查，因为她们在产后第一年甲状腺功能减退的风险增加，并且如果母亲在妊娠早期甲状腺功能减退，可能会对未出生的孩子产生有害影响。(c)胰岛素依赖型糖尿病（IDDM）患者发生自身免疫性甲状腺疾病的风险为30%至40%。我们每年采集血液时测量DBS样本中的甲状腺抗体，以常规筛查甲状腺功能减退症或进行其他测试，作为常规医疗护理的一部分，以确定甲状腺抗体的存在是否可以预选那些需要每年进行促甲状腺激素筛查的患者。将开发DBS样本采集试剂盒，以便向患者或医疗保健专业人员提供，以便于收集DBS样本并将其邮寄至人群筛查实验室，用于测量TSH和甲状腺抗体。可以确定材料、样本收集、运输和群体测试的成本，并与收集、运输和测试血清样本以测量这些相同测试的成本进行比较。有了这些信息和三个研究人群中甲状腺功能减退症和甲状腺炎患病率的数据，我们可以确定使用一种非常低成本、准确的方法测量的容易收集的标本筛查甲状腺功能减退症风险增加的成年人的成本效益。本研究的结果将确定该筛查方法对风险人群的适用性。拟定商业应用：类似于目前规定的，非常具有成本效益的人口筛查新生儿的遗传和代谢疾病，筛查大人口的成年人可以开发和实施的区域商业实验室。由于患者、亲属、朋友或包括医生办公室在内的医疗保健专业人员可以很容易地收集4至8滴血液并将样本邮寄到实验室，因此使用干血斑滤纸样本可以提高商业应用的成本节约，其成本远低于血清样本的收集和运输。筛选大量的人群和使用非常便宜的标本大大提高了测试的成本效益和这项技术的商业应用。

Hypothymidism is a common disease in certain populations, and often is not diagnosed early because of subtle, non-specific symptoms and signs. The adaptation of the very cost effective and accurate method for screening newborn infants using filter paper dried blood spots (DBS) can be applied to pediatric and adult populations to detect diseases before disability and severe symptoms develop, and to monitor patients during therapy, providing greater cost effectiveness, comparable accuracy and greater patient compliance than found with traditional methods. We developed and validated sensitive and precise methods to measure thyroid stimulating hormone (TSH)and the thyroid antibodies, thyroperoxidase antibodies (TPOAb) and thyroglobulin antibodies (TGAb)in DBS specimens. Specific Aims: We shall collect DBS specimens from the following three populations who are at high risk for the development of autoimmune thyroiditis and hypothyroidism: (a) An elderly population currently Living in Nursing and Personal Care Homes will be screened annually for two years. (b) Mothers at diagnosis of pregnancy, at their routine six week visit and at their one year postpartum visit will be screened because they are at increased risk for hypothyroidism during the first postpartum year, and because there may be a deleterious effect on the unborn child if the mother is hypothyroid during early pregnancy. (c) Patients with insulin dependent diabetes mellitus (IDDM) have a 30 to 40% risk of autoimmune thyroid diseases. We are measuring thyroid antibodies in DBS specimens when blood is collected annually to routinely screen for hypothyroidism or for other tests as part of their routine medical care to determine if the presence of thyroid antibodies can preselect those patients who need annual TSH screening. DBS specimen collection kits will be developed so they can be provided to patients or health care professionals to facilitate the collection and mailing of DBS specimens to a population screening Laboratory for the measurement of TSH and thyroid antibodies. The cost for materials, specimen collection, transportation and testing of the populations can be established and compared to the cost to collect, transport and test serum specimens to measure these same tests. With this information and the data on the prevalence of hypothyroidism and thyroiditis in the three populations studied, we can determine the cost effectiveness of screening adults who are at increased risk for hypothyroidism using an easily collected specimen measured by a very Low cost, accurate method. The results of this study will determine the appropriateness of this screening methodology for the populations at risk. PROPOSED COMMERCIAL APPLICATION: Analogous to the currently mandated, very cost-effective population screening of newborns for genetic and metabolic diseases, screening Large populations of adults can be developed and implemented by regional commercial Laboratories. The cost savings for commercial applications is enhanced by the use of the dried blood spotted filter paper specimen since the patient, relative, friend or health care professional including the physician's office can easily collect the four to eight drops of blood and mail the specimen to the Laboratory at a much Lower cost than the collection and shipment of serum specimens. Screening Large populations and using very inexpensive specimens greatly enhance the cost- effectiveness of the test and the commercial application of this technology.