应用EP10-A文件对乙醇测定方法的初步评价

Preliminary Evaluation of Quantitative Laboratory Method for Alcohol

目的初步评价乙醇(ALC)定量测定方法的临床应用性能。方法依据美国临床实验室标准化委员会(NCCLS)颁布的《定量临床检验方法的初步评价:批准指南(EP10-A)》提供的方法,按特定的顺序连续5天测定高、中、低浓度标准品中的ALC,对美国强生VITROS 250自动生化分析仪测定ALC的方法进行初步评价。结果当标准品的ALC浓度为86mg/dl、131.5mg/dl、177mg/dl时,ACL测定的回归方程为Y=1.01X-0.59,相关系数r2=0.9995;绝对偏差分别是0.81mg/dl、-0.46mg/dl、1.69mg/dl;总不精密度分别是1.724%、0.903%、0.952%。结论VITROS250测定ALC方法的检测性能符合临床应用要求。

Objective To preliminary evaluate the quantitative chinical laboratory method for Alcohol(ALC).Mothods Using the NCCLS Document EP10-A,i.e.Preliminary Evaluation fo Quantitative Clinical Laboratory.Methods Using the NCCLS Document EP10-A,i.e.Preliminag Evaluation of Quantitative Clinical Laboratory Methgs,Approved Guideline to preliminary evalvate the VITROS 250 Chemistry Systemn' mensuration method for ALC.Results When the control serum's concentration of ALC are 86mg/dl,131.5mg/dl,177mg/dl,the teturn equation is Y=1.01X-0.59,r^2=0.9995;bias are 0.81 mg/dl,-0.46mg/dl,1.69mg/dl,imprecision are 1.724%,0.903%,0.952%.Conclusion The performance of VITROS ALC tallies the chinical applicable request.