Performance verification and evaluation of Stago STA-R automatic blood coagulation analyzer
10.3969/j.issn.1673-4130.2017.05.031
- VernacularTitle:Stago STA-R全自动血凝分析仪性能验证与评价
- Author:
Na LIU
;
Weihua ZHAO
- Keywords:
STA-R automatic blood coagulation analysis system;
performance verification;
system evaluation
- From:
International Journal of Laboratory Medicine
2017;38(5):654-656
- CountryChina
- Language:Chinese
-
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 .
