Performance verification and evaluation of Stago STA-R automatic blood coagulation analyzer / 国际检验医学杂志

ABSTRACT

Objective To conduct the performance verification of the Stago STA-R automatic blood coagulation analysis system once every year to evaluate the analysis system for ensuring its accuracy and reliability .Methods According to the related docu-ments of the Clinical and Laboratory Standards Institute (CLSI) ,5 items of prothrombin time (PT ) ,activated partial clotting en-zyme live time (APTT) ,thrombin time (TT) ,fibrinogen (Fib) and antithrombin Ⅲ (ATⅢ) were selected to conduct the verifica-tion and preliminary evaluation on the accuracy ,imprecision ,carry-over rate ,linearity range and reference interval of the instrument analysis system .Results The relative bias(SE% ) of accuracy in each item was less than 5% .The intra-batch and inter-batch im-precisions (CV) were less than 3% and 5% respectively .The carry-over rates were within 4% .The linearity of Fib and AT Ⅲ was very well ,r2 were 0 .9980 and 0 .9979 respectively .Validated reference interval was consistent with quotative reference range . Conclusion The Stago STA-R automatic blood coagulation analysis system has good analytical performance ,can provide accurate and reliable test results for clinical doctors .