Development and Diagnostic Use of Rapid Immunoassays

快速免疫分析的开发和诊断应用

• 批准号: 6227890
• 负责人: Alan Thomas Remaley
• 金额: --
• 依托单位: CLINICAL CENTER
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/6227890
• 关键词: adenoma; adrenocorticotropic hormone; calcitonin; clinical research; computer assisted diagnosis; diagnosis design /evaluation; gastrins; human subject; human tissue; hyperparathyroidism; immunologic assay /test; parathyroid hormones; rapid diagnosis

Several endocrine tumor markers are routinely used in the diagnosis and management of various cancers. The current assays, however, typically take several hours to perform, which precludes their use in the intraoperative management of patients. The majority of the endocrine tumor markers have a half-life in the circulation of less than 5 minutes. Thus, if a rapid assay was available, the concentration of the hormones during surgery or during localization procedures could be monitored. The primary indication for such assays would be in assessing the extent of residual tumor after surgery and in the localization of the tumors by selective venous or arterial sampling. In the past year, we have evaluated a commercial rapid assay for parathyroid hormone (PTH) on over 50 patients and found that it provides valuable information for the surgical management of patients with hyperparathyroidism. We have developed an algorithm for the kinetic analysis of PTH decay following the excision of any adenomas that produces fewer misclassifications compared to the cur-rent procedure for interpreting the data. We have also developed an automated version of the assay using magnetic beads, that is faster and has a superior error-to-noise ratio. We plan in the upcoming year to compare the results of the new assay with the current assay. Similarly, we have developed a rapid ACTH assay, using magnetic beads, that we will also evaluate for its clinical utility. We also have plans to develop rapid assays for calcitonin and gastrin.

通常将几种内分泌肿瘤标记用于各种癌症的诊断和管理。但是，目前的测定通常需要几个小时才能进行，这排除了他们在患者的术中治疗中的使用。大多数内分泌肿瘤标记物在不到5分钟的循环中具有半衰期。因此，如果有快速的测定，可以监测手术期间或在定位过程中激素的浓度。此类测定法的主要指示是通过选择性静脉或动脉采样来评估手术后残留肿瘤的程度以及肿瘤的定位。在过去的一年中，我们评估了50多名患者的甲状旁腺激素（PTH）的商业快速测定，并发现它为患有甲状旁腺功能亢进症患者的手术管理提供了宝贵的信息。与解释数据的租赁程序相比，所有腺瘤切除了较少的错误分类后，我们开发了一种用于PTH衰减的动力学分析算法。我们还使用磁珠开发了一种自动化版本的测定版本，该版本更快且具有较高的误差比。我们计划在接下来的一年中，将新测定的结果与当前测定法进行比较。同样，我们使用磁珠开发了快速的ACTH分析，我们还将评估其临床实用性。我们还计划开发降钙素和胃蛋白的快速测定法。