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作 者:刘玉文[1] 杨岩[1] 康敬[1] 赵宇[1] 张春年[1]
机构地区:[1]黑龙江省疾病预防控制中心,哈尔滨150030
出 处:《首都公共卫生》2011年第3期106-109,共4页Capital Journal of Public Health
摘 要:目的建立尿碘全自动生化分析仪检测方法,对方法的技术指标进行试验,与尿碘测定卫生行业标准方法进行对比评价。方法按照尿碘定量检测试剂盒的技术要求,结合全自动生化分析仪的仪器特性建立与之相适应的尿碘检测方法。根据《研制生物样品监测检验方法指南》(WS/T68-1996)的规定对所建立的方法的灵敏度、精密度、准确度进行测试,并与国家卫生行业标准方法《尿中碘的砷铈催化分光光度测定方法》(WS/T107-2006)进行对比实验。结果标准曲线线性范围为0~400μg/L碘;方法的检测限(灵敏度)为2.4μg/L碘(取样量25μl);对不同浓度的尿样测定结果的批间变异系数为1.5%~5.3%(n=6);对不同浓度的尿样加标后测得回收率为94.5%~105%(平均99.3%);对两个尿碘国家一级标准物质测定的相对偏差均<6%(n=6);40份现场尿样的测定结果与卫生行业标准方法测定结果相比,其差异无统计学意义(配对资料t检验,P>0.5)。测定40份样品需时约1.5h(卫生行业标准方法约3.5h);对剧毒品砷的用量为行业标准方法的5%。结论该方法是准确的尿碘定量检测方法,其灵敏度、精密度、准确度与卫生行业标准方法一致。该方法较卫生行业标准方法操作步骤少,标准曲线线性范围宽,自动化程度高,误差来源少,省时省力,环保。但全自动生化分析仪品种多,不同仪器需研究设置不同的测定参数,专业技术要求高。开展多项目检测的生化分析仪容易交叉污染,是使用此方法测定尿碘的主要误差来源。Objective To establish a method for determination of urine iodine by automatic biochemical analyzer with a urine iodine test kit and evaluate its technical specifications, as compared to the results using the national standard method set by the Ministry of Health. Methods A method for measuring urine iodine was established using automatic biochemistry analyzer in accordance with both requirements of urine iodine test kit and characteristics of automatic biochemistry analyzer. In addition, sensitivity, precision and accuracy of the established method were evaluated according to the provisions in "Guides for Development of Monitoring and Testing Methods for Biological Samples" set by the Ministry of Health (WS/T 68-1996), and compared with those using the national standard method of "Determination of Urine Iodine by Arsenic and Cerium Catalytic Spectrophotometry" (WS/T 107-2006) set by the Ministry of Health.Results With this method, iodine levels at range of 0 μg per liter urine to 400 μg per liter urine presented a linear trend in the standard curve, with a detection limit (sensitivity) of 2.4 μg iodine per liter urine using specimen volume of 25 μL. Coefficient of variation between different batches of six specimens containing different iodine concentrations varied from 1.5 percent to 5.3 percent. Recovery of the marked urine specimens with different iodine concentrations was measured as 94.5 percent to 105 percent, with an average of 99.3 percent. Relative deviations was less than six percent when determining two portions of national class A standard reference materials of urine iodine for 6 times repeatedly. There was no significant difference in iodine determinations for 40 portions of urine specimens collected on-site between using this method and using the national standard method (P0.5 with paired t-test). Determination of 40 specimens cost about 1.5 hours, as compared to about 3.5 hours by the national standard method, while the amount of arsenic used in this method was about f
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