3Q verification of automatic blood coagulation analyzer under good laboratory practice system / 国际检验医学杂志

ABSTRACT

Objective To explore the procedures of 3Q validation for blood coagulation analyzer under the good laboratory prac‐tice(GLP) system based on the Sysmex CA7000 automatic blood coagulation analyzer .Methods Four test indicators of PT ,APTT , TT and FIB were chosen to conduct the performance verification in the within‐run precision ,between‐day precision ,accuracy ,linear‐ity ,carry‐over contamination rate of the automatic blood coagulation analyzer .They were prothrombin time(PT) ,activated partial thromboplastin time(APTT) ,thrombin time(TT) ,and fibrinogen(FIB) .Results The within‐run precision CV values of PT , APTT ,TT and FIB were 1 .33% ,1 .57% ,1 .47% and 1 .90% ,respectively ;the inter‐day precision CV values of PT ,APTT ,TT and FIB were 1 .73% ,1 .52% ,1 .55% and 2 .14% respectively ;in terms of accuracy ,the normal quality control CV values were 7 .45% ,3 .88% ,-4 .98% and 4 .36% respectively ;the abnormal quality control CV values of PT and APTT were 8 .11% and 8 .77% respectively ;the r value of FIB linear correlation coefficient was 0 .999 3 ,the a value was 1 .02 ;the highest CV value of car‐ry‐over contamination rate was 2 .15% ;the detected results all conformed to the general industry standards and requirements of in‐strument manufacturer .Conclusion The 3Q validation under the GLP system proves that the Sysmex CA7000 automatic blood co‐agulation analyzer is good in performance and is appropriate for the laboratory work of clinical laboratory department .