VITROS 5.1 FS干式生化分析仪新批号质控设置

Testing of a new batch of quality control product for Vitros 51 FS dry biochemistry analyzer

目的设置VITROS 5.1 FS干式生化分析仪新批号质控品的暂定靶值(X)、暂定标准差(SD)及质控方法。方法按照《临床实验室定量测定室内质量控制工作指南》进行。结果将新批号质控品与当前使用的质控品一起进行测定,根据20次测定数据,以旧批号质控品室内质控稳定变异系数CV%为基准,参考美国临床实验室改进修改法案(CLIA'88)能力比对验证的分析质量要求及2010年卫生部临检中心室间质评的评价限,并结合强生配套质控品定值范围和临床工作要求,设置了新批号质控的暂定靶值(X)、暂定标准差(SD)与质控方法。结论根据20次独立批测定获得的质控数据计算均值即可作为新批号质控的暂定靶值(X)。但由于20次数据量非常有限,其标准差难以反映实际的测定波动,因此采用旧批号质控品5个月累积所得的稳定变异系数(CV%)乘以暂定靶值,再结合美国临床实验室改进修改法案(CLIA'88)能力比对验证的分析质量要求和强生配套质控品定值范围才能得到满足临床需要的暂定标准差(SD)设置。同时对于质控方法的选择,应按照《临床实验室定量测定室内质量控制工作指南》的要求,明确质量目标(Tea)、不精密度(CV%)、不准确度(bias%),计算临界系统误差(△Sec),再依据Westgard多规则方法质控设计表格得到适用于本仪器的质控规则及质控个数。

Objective To set tentative target value and provisionally standard deviation of the new batch quality control for Vitros 5.1 FS dry biochemistry analyzer.Methods The work was performed according to the guideline of ＂Guideline for Internal Quality Control in Clinical Laboratory Quantitative Measurement＂.Results The new batch quality control product and currently used quality control product were simultaneously analyzed.Tentative target value,provisionally standard deviation and quality control methods were determined based on the results of 20 detections and CV % of the old batch quality control product.The regulations of the Clinical Laboratory Improvement Amendments of 1988（CLIA＇88）,External Quality Assessment（2010） of National Center for Clinical Laboratory,and the value limit of the quality control product provided by Johnson Johnson were also considered.Conclusion The tentative target value was determined according to the mean of 20 measurements.Considering the standard deviation obtained from 20 detections cannot reflect the actual fluctuations because of limited measurements,the CV % of quality control product of the old batch obtained from the past 5 months was adopted and multiplied by tentative target value to obtain provisionally standard deviation of the new batch quality control;and the setting of the provisionally standard deviation also need to meet the requirements of CLIA ＇88 and the value range of quality control product provided by Johnson Johnson.The methods for quality control should be determined according to the guideline of ＂Guideline for Internal Quality Control in Clinical Laboratory Quantitative Measurement＂ to decide TEa,CV %,bias %,△SEc,and the results of Westgard analysis.