Bunko H, Hisada K
Radioisotopes. 1976 Oct;25(10):608-13. doi: 10.3769/radioisotopes.25.10_608.
Although recent progress in radioimmunoassay (RIA) permitted direct RIA for thyroxine (T4), there appeared few reports evaluating clinical applicability of T4 RIA as routine method. The authors evaluated advantage, disadvantage of methods for T4 measurement in comparison between CPBA (competitive protein binding analysis) and RIA, and tried to discuss about selection of methods for T4 measurement. Res-O-Mat T4 was chosen as CPBA, and RIAMAT-T4(St) and T4-RIAKIT(Sp) were chosen as RIAs. Detailed descriptions about both RIA methods appeared elsewhere [2, 3]. From the basic experiments, reproducibility of CPBA, St and Sp within assay were 5.8% (C.V.), 4.0% (C.V.), and 8.5%(C.V.) respectively, and mean recovery rates were 92.2%, 100.7% and 96.1% respectively. T4 value measured by both RIAs correlated well with CPBA, and St showed slightly lower value and Sp showed slightly higher value than CPBA. The normal ranges for RIAs were 3.7-11.7 microng% (St) and 4.6-15.2 microng% (Sp). Diagnostic accuracy for hyperthyroid state were 83.3% (CPBA), 85.7%(St) and 69.2% (Sp), and for euthyroid state were 92.0% (CPBA), 98.8% (St) and 95.7% (Sp). The diagnostic accuracy for hypothyroid state in three methods were lowest. From the economical point of view, cost performance, time performance and total time for single assay were analysed and mathematical equations were obtained from actual assay by each methods. When the number of samples per single assay was less than 10, CPBA was most economic in terms of cost and time performance and total time required. In the assay of more than 20 samples, RIAs were efficient in each point of views. In the point of view of sample volumes required, RIAs were most promising. The authors concluded that guides for selection of methods in T4 assay were as follows: A) CPBA was most efficient in local use especially when less than 10 samples were frequently to be assayed. B) RIAs were efficient in batch processing more than 20 samples, especially in automated laboratories.
尽管放射免疫分析(RIA)技术最近取得了进展,使得可以直接对甲状腺素(T4)进行放射免疫分析,但评估T4放射免疫分析作为常规方法的临床适用性的报告却很少。作者比较了竞争性蛋白结合分析(CPBA)和放射免疫分析(RIA)中T4测量方法的优缺点,并试图讨论T4测量方法的选择。选择Res-O-Mat T4作为CPBA方法,选择RIAMAT-T4(St)和T4-RIAKIT(Sp)作为RIA方法。两种RIA方法的详细描述见其他文献[2, 3]。从基础实验来看,CPBA、St和Sp方法批内重复性分别为5.8%(变异系数)、4.0%(变异系数)和8.5%(变异系数),平均回收率分别为92.2%、100.7%和96.1%。两种RIA方法测得的T4值与CPBA方法相关性良好,其中St方法的值略低于CPBA,Sp方法的值略高于CPBA。RIA方法的正常范围分别为3.7 - 11.7微克%(St)和4.6 - 15.2微克%(Sp)。甲亢状态的诊断准确率分别为83.3%(CPBA)、85.7%(St)和69.2%(Sp),甲功正常状态的诊断准确率分别为92.0%(CPBA)、98.8%(St)和95.7%(Sp)。三种方法对甲减状态的诊断准确率最低。从经济角度分析了成本效益、时间效益以及单次检测的总时间,并通过各方法的实际检测得出了数学方程。当单次检测的样本数量少于10个时,就成本、时间效益和所需总时间而言,CPBA方法最经济。在检测20个以上样本时,RIA方法在各方面都更高效。从所需样本量的角度来看,RIA方法最具前景。作者得出结论,T4检测方法的选择指南如下:A)CPBA方法在本地使用时效率最高,尤其是当经常检测少于10个样本时。B)RIA方法在批量处理20个以上样本时效率更高,尤其是在自动化实验室中。