针对传统PKU 测量仪器由于不能监测激发光强度的波动, 从而导致所测得的荧光数据具有较大不稳定误差的缺点, 本文构建了一套新型的以N 型光纤为核心的光路检测系统, 研制出一种专用于PKU 检测的光纤型荧光仪。根据美国临床实验室标准化委员会(NCCLS)文件, 美国质量协会(ASQ)的QS-9000 标准以及相关文献, 采用将研制的荧光仪和国家规定的标准仪器(雷勃仪器,THERMO Varioskan Flash 全波长多功能酶标仪)相比较的方法, 提出了一种可定量评价仪器相关各项指标的评价方案。并运用其标准对所研发的荧光仪进行了全面评价, 结果表明荧光仪的各项指标均符合要求, 同时为仪器的进一步改进指明了方向。

The optical system with N-type fiber (patent pended) was constructed, and a new fiber-type fluorescence analyzer of PKU was developed for overcoming the disadvantage of traditional PKU, which could not monitor the exciting light intensity fluctuations and made the measured fluorescence data have greater error of the instability. According to the U.S. Committee for Clinical Laboratory Standards (NCCLS) documents, American Society for Quality (ASQ) of the QS-9000 standards and related literatures, a quantitative evaluation of the related equipment indexes was presented by computing between fluorescence analyzer and the national standard equipment (THERMO Varioskan Flash). Using the standard, the results show that the indicators of fluorescence analyzer are in line with requirements, and then point out the direction of the instrument to be improved.