雅培AXSYM化学发光残留试剂检测癌胚抗原的初步评估

Preliminary evaluation of CEA detection using residual reagent of AbbottAXSYM chemiluminescent immunoassay

目的评估雅培AXSYM化学发光残留试剂检测癌胚抗原(CEA)的性能。方法回收残留试剂,评价其检测CEA的精密度和回收率,并依据美国临床实验室标准化委员会(NCCLS)EP9-A2文件方案,每天选取临床样本4～5份,分别用新试剂和残留试剂进行测定,共测定10 d 41个样本,以新试剂为比较方法,残留试剂作为实验方法,比较检测结果的相关性和偏倚。结果残留试剂检测CEA的批内精密度2.81%～3.20%,日间精密度3.35%～4.71%,回收率为96.78%～104.84%,两种试剂检测CEA的相关系数r=1.000,回归方程为Y=1.069X-0.256,在各医学决定水平(X1=5μg·L-1,X2=20μg·L-1,X3=100μg·L-1)的预期偏倚在允许偏倚内。结论雅培AXSYM化学发光仪残留试剂检测CEA的性能符合临床要求,可以回收利用。

Aim To evaluate the efficiency of CEA detection using residual reagent of Abbott AXSYM.Methods Recycling residual reagents to carry out precision experiment and recovery rate performance of CEA detection.Referring to the document of NCCLS EP9-A2,4～5 clinic samples were detected everyday by residual reagent and new reagent respectively.The testing results of total 41 samples were recorded within 10 days.The testing results derived from two kinds of reagents were analyzed comparatively and their bias was evaluated by analysis in new reagent as a control method and analysis in residual reagent as experimental methods.Results The value for CEA detection using residual reagent was 2.81%～3.20% within-run precision experiments,3.35% ～4.71% between-day precision experiments and 96.78%～104.84% percent recovery,respectively.Between the two kinds of reagents,the correlation coefficient was 1.000,and regression equation was Y=1.069X-0.256.Their anticipated biases were within allowed biases on the medical decision level of CEA（X1=5 μg·L-1,X2=20 μg·L-1,X3=100 μg·L-1）.Conclusion Residual reagent of Abbott AXSYM chemiluminescent immunoassay can meet the needs of CEA detection in clinical practice.It is acceptable for clinical practice to recycle residual reagent.