甲苯、二甲苯生物偵測分析與驗證

Method Development and Validation of Biological Monitoring for Workers Exposed to Toluene and Xylene

工業先進國家多利用生物偵測技術，以彌補作業環境測定在勞工有害物暴露評估之不足。國內過去雖然有多項生物偵測相關的研究，但由於缺乏參考分析方法，而阻礙生物偵測技術進一步的提升及研究資料的整合。基於生物偵測技術提升之需求，本研究依據勞工安全衛生研究所「生物偵測分析方法的驗證準則草案」，針對國內使用量大且勞工暴露普遍之兩種有害物－甲苯、二甲苯；引進美國NIOSH 8301「尿中馬尿酸與甲基馬尿酸的分析方法」，並藉由國內三家實驗室進行分析方法之驗證。本研究除了對分析方法的驗證外，同時藉由實驗室間的比較，以了解實驗室間分析能力之差異、分析方法技術推廣時可能遭遇之問題與解決之道、及生物偵測分析方法的驗證準則草案之可行性。研究中，尿中馬尿酸與甲基馬尿酸乃利用高效能液相層析法進行分析。三家實驗室所進行的分析方法驗證工作包括：分析檢量線之建立、分析精密度、儀器偵測極限及添加樣品之分析回收率。驗證之結果皆通過驗證規範之要求，說明本驗證規範有高度之可行性。

Many industrialized countries have recommended or mandated the application biological monitoring (BM) addition to environmental monitoring (EM) in the occupational exposure assessment of workers. In Taiwan, despite that several search activities on BM have been conducted in the past, the lack of BM reference analytical methods obstructs the development of BM technique and the systematic coordination of these research results becomes difficult. Upon to the urgency of improvement in BM analytical techniques, this study validated an analytical method, based on NIOSH analytical method 8301, by three independent laboratories via ‘Guideline on Validation of Analytical Method for Biological Monitoring’ proposed at Institute of Occupational Safety and Health. Beside validation of analytical method, this study evaluated the performance among these laboratories and the feasibility of the guideline, and recognized problems and resolutions during application of the analytical method, by inter-laboratory testing. In this study, urine samples containing hippuric acid and methyl hippuric acids were analyzed by high performance liquid chromatography. The tasks of method validation included establishment of calibration curves, precision, detection limits and recoveries. These results concluded that the guideline is adequate for validation of analytical methods used in biological monitoring.