Establishment and evaluation of ACL TOP automatic blood coagulation analytical system

Objective To evaluate the performance of ACL TOP automatic coagulation analyzer and establish an optimized coagulation analytical system.Methods:According to the documents of Clinical and Laboratory Standards Institute(CLSI),we select the tests which represent three analytical methods to perform repeatability,stability,linearity and anti-interference tests and methodologic comparison of ACL TOP to ACL Futura automatic blood coagulation analyzer.Then 250 specimens from healthy population were collected and assayed to determine the reference range for routine tests on ACL TOP.Results:Results The within-run and between-day coefficient of variability(CV) of prothrombin time(PT),activated partial thromboplastin time(APTT),thrombin time(TT),fibrinogen(Fbg,Clauss method),d-dimer(D-D) and anti-thrombin(AT) were both less than 6%,respectively.P values for Fbg,D-D,AT are less than P0.05,according to the linearity test and G values less than F0.05.The extent of influence of low to middle grade of jaundice,fat and hemolysis on each test are all less than 6%.In the comparison to ACL FUTURA,the coefficient of relativity(r value) for PT,APTT,TT and Fbg was 0.9751,0.9248,0.9766,0.9901,respectively.Only the relative error of Fbg on each medical determination level was less than allowed error.The reference range for PT,APTT,TT and Fbg was 8.8～11.8 s,28～41 s,12～17 s,2.0～4.4g/L,respectively.Conclusion:The ACL TOP coagulation analyzer has good repeatability,stability,linearity and capability of anti-interference.But the results of comparison to ACL FUTURA are not identical.So it is necessary to determine new reference range for tests on ACL TOP coagulation analytical system.