TEST KIT TO QUANTIFY FAT ABSORPTION IN CYSTIC FIBROSIS

这个项目的目标是开发一种检测试剂盒来取代72-h 大便脂肪试验在囊性疾病临床处理中的应用 纤维化(CF)。我们建议这可以通过提供一个测试来实现 同时含有1，3-二硬脂基，2[13C]辛酰甘油(S-*O-S)和 不可吸收标记物氯化镝(DyCl3)的分析 只有一张凳子。这一新方法将：1)高度相关 72小时大便脂肪，2)显著减少单调乏味的操作，3)高度 可重现的。第一阶段研究表明，Dy是定量的 由CF患者排泄，并遵循与13C相同的排泄动力学- 标记甘油三酯(TG)，从而论证了该方法的可行性。 在第二阶段，我们将研究该方法的细节，以便制定 广泛使用的实用检测试剂盒包括： 1-证明S--O-S的吸收是可重复性的。 2-证明对S的吸收--*O-S准确地反映了吸收的程度 在个别CF患者中观察到的吸收不良。 3-验证单个凳子用于量化标记脂肪的使用 排泄物。 4-改进分析程序，以降低成本 结果化验试剂盒。 一旦开发出检测试剂盒和程序，它将通过 生物化学分析公司与所需的分析 向广大生物医学界提供服务(第三阶段)。 建议的商业应用：这项研究将导致 用于准确测量的检测试剂盒和程序的可用性 非侵入性的脂肪吸收，只需要收集 一张凳子。因为这一过程具有很高的重复性 它既准确又相对简单易用，适用于 常规临床应用于个别CF患者的治疗 在研究方案中使用。

The goal of this project is to develop a test kit to replace the 72-h stool fat test in the clinical management of patients with cystic fibrosis (CF). We propose that this can be accomplished by feeding a test meal containing both 1,3-distearyl, 2[13C]octanoyl glycerol (S-*O-S) and the nonabsorbable marker dysprosium chloride (DyCl3) followed by analysis of a single stool. This new approach will be: 1) highly correlated with 72-h stool fat, 2) significantly less tedious to perform, and 3) highly reproducible. Phase I studies have shown that Dy is quantitatively excreted by CF patients and follows the same excretion kinetics as 13C- labeled triglyceride (TG), thus, the feasibility has been demonstrated. During Phase II we will study details of the approach in order to develop a practical test kit for wide-spread use to include: 1- Demonstrating that absorption of S-*O-S is reproducible. 2- Demonstrating that absorption of S-*O-S accurately reflects the degree of malabsorption observed in individual CF patients. 3- Validating use of a single stool for quantifying labeled fat excretion. 4- Refining analytical procedures that would lower the cost of the resultant test kit. Once the test kit and procedure are developed it will be marketed through BioChemAnalysis Corporation together with the required analytical services (Phase III) to the biomedical community at large. PROPOSED COMMERCIAL APPLICATION: This research will lead to the availability of a test kit and procedure for the accurate measurement of fat absorption that is non-invasive and requires the collection of only a single stool. Because the procedure will be highly reproducible and accurate as well as relatively simple to use it will be applicable to routine clinical use in the management of individual CF patients as well as to use in research protocols.