应用CLSI EP10-A2文件初步评价乙醇检测光度计性能.docVIP

精品论文 参考文献 应用CLSI EP10-A2文件初步评价乙醇检测光度计性能 1.宁波美康生物科技股份有限公司 浙江宁波 315100；2.公安海警学院 浙江宁波 315801 【摘 要】 目的利用CLSI EP 10-A2文件初步评价乙醇检测光度计的性能。方法按照美国临床实验室标准化协会（CLSI）颁布的EP10-A2文件，连续5天用乙醇检测光度计按特定顺序测定高、中、低浓度乙醇样本，计算测定结果的偏差、总不精密度，对截距、斜率、非线性、携带污染和漂移进行多元回归分析。结果低、中、高浓度乙醇样本偏差分别为0.1，0.4 和 -0.1 mg/dL；总不精密度分别为3.1%，1.0%和1.0%；截距、斜率、非线性、携带污染、漂移分别为0.300、0.998、0.059、0.000、-0.042，其t值分别为0.532、-0.108、-0.003、-0.098、0.214，差异均无统计学意义（Pgt;0.01）。结论乙醇检测光度计准确度、精密度良好，线性良好，携带污染率较低，稳定性好，能满足乙醇检测的应用要求。 【关键词】乙醇检测光度计；EP 10-A2；初步评价 Preliminary evaluation of Alcohol detection spectrophotometer by CLSI EP10-A2 Document WO Yanbo1，YAO Xufei2，WANG Ke2 （1.Ningbo Medicalsystem Biotechnology Co.，Ltd，Zhejiang Ningbo，315100； 2. China Maritime Police Academy，Zhejiang Ningbo，315801） [Abstract] Objective Preliminary evaluation of Alcohol detection spectrophotometer for clinical application performance using Clinical and Laboratory Standards Institute（CLSI）EP 10-A2. Methods According to the CLSI Document EP10-A2，specimens of alcohol at high，medium and low concentrations were measured continuously at a specific order for 5 days by Alcohol detection spectrophotometer. The bias and the total imprecision were calculated，the intercept，slope rate，non linearity，carryover contamination and drift were analyzed by multiple regression analysis. Results The bias of the low，medium and high specimens were 0.1，0.4 and -0.1 mg/dL respectively，the total imprecision of the three concentrations were 3.1％，1.0％ and 1.0％ respectively，the intercept，slope rate，non linearity，carryover contamination and drift was 0.300，0.998，0.059，0.000，-0.042 respectively，the t value was 0.532，-0.108，-0.003，-0.098，0.214 respectively，which did not show significant difference（Pgt;0.01）. Conclusion Alcohol detection spectrophotometer had fine bias，fine precision，fine linearity，low carryover contamination and good stability，can meet clinical application requirement. Key words：Alcohol detection spectrophotometer；EP 10-A2；Preliminary evaluation 【中图分类号】TP216【文献标志码】A【文章