Development and Diagnostic Use of Rapid Immunoassays

几种内分泌肿瘤标志物被常规用于各种癌症的诊断和治疗。然而，目前的分析通常需要几个小时的时间才能完成，这排除了它们在患者术中管理中的使用。大多数内分泌肿瘤标志物在循环中的半衰期小于5分钟。因此，如果可以进行快速检测，就可以监测手术或定位过程中激素的浓度。这类检测的主要适应症是评估术后残留肿瘤的程度，以及通过选择性静脉或动脉采样对肿瘤进行定位。在过去的一年里，我们对一种商业化的甲状旁腺激素(PTH)快速检测方法进行了评估，发现它为甲状旁腺功能亢进症患者的外科治疗提供了有价值的信息。我们开发了一种算法，用于任何腺瘤切除后甲状旁腺激素衰退的动力学分析，与当前解释数据的程序相比，该算法产生的错误分类较少。我们还开发了一种使用磁珠的自动化检测版本，它速度更快，具有更高的误噪比。我们计划在未来一年将新化验结果与当前化验结果进行比较。同样，我们开发了一种使用磁珠的ACTH快速检测方法，我们也将对其临床应用进行评估。我们还计划开发降钙素和胃泌素的快速检测方法。

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.