Résumé
Objective To evaluate the relationship and bias of the Stago-CT and CA1500 automatic coagulation analyzer.Meth-ods The relationship and bias of PT,APTT,INR,FIB,TT,DD examined by the Stago-CT and CA1500 automatic coagulation ana-lyzer by using NCCLS EP9-A2.Results For the six items(PT,APTT,INR,FIB,TT,DD)the r2 were 0.996 9,0.969 1,0.967 7, 0.955 8,0.972 6,0.949 6,respectively,and the bias were 2.9,0.88,5.22,1.16,3.48,20.3.Conclusion The five items (PT, APTT,INR,FIB,TT)at a good relationship(r2 >0.95)by the Stago-CT and CA1500 automatic coagulation analyzer except for the DD(r2 =0.949 6);The bias of the five items(PT,APTT,INR,FIB,TT)were within in the United States of demanding that a third of the clinical laboratory of CLIA 88′bias,except for the DD.
Résumé
Objective To discuss the comparability and bias evaluation on the results of serum creatine kinase (CK ) ,aspartate aminotransferase (AST) ,lactate dehydrogenase (LDH) inspection results between the two different kinds of biochemical analysis system .Methods The control quality materials with two concentration were detected respectively for degree of precision ,and the assessment standard was from manufacturer introductions and laboratory setting .Then in accordance with American Clinical and Laboratory Standard Institute(CLSI) document EP9‐A2 ,100 patients serum CK、AST、LDH were detected .Afterwards the relative bias(SE% ) was calculated ,and the comparative analysis bias evaluation was judged according to the half of CLIA′88 allowed total error .Results The variable coefficients mainly conformed to the requirements ,and the experimental results were reliable .The oth‐ers mainly lower than the acceptable limit besides SE% for LDH higher than it .Conclusion It is necessary to execute comparative analysis and bias evaluation to ensure the accuracy and comparability if the same item is detected in two analysis system .