CAJ | 학술논문

目的：采用方法性能决定图对法国Stago R Evolution全自动血凝分析仪的性能进行评价。方法参照美国临床实验室改进修正案的总误差要求，以室间质评及室内质控结果绘制方法性能决定图，并对凝血酶时间（PT ）、部分活化凝血酶时间（APTT）、纤维蛋白（Fg）3项的6个指标进行分析。结果全自动血凝分析仪的PT正常水平与APTT异常水平2项指标合格， PT异常水平良好，APTT正常水平、Fg正常水平及Fg异常水平3项指标优秀。结论方法性能决定图能够对血凝分析仪的6个指标进行评定分级，与σ值的统计表相比结果更加直观清晰。
목적：채용방법성능결정도대법국Stago R Evolution전자동혈응분석의적성능진행평개。방법삼조미국림상실험실개진수정안적총오차요구，이실간질평급실내질공결과회제방법성능결정도，병대응혈매시간（PT ）、부분활화응혈매시간（APTT）、섬유단백（Fg）3항적6개지표진행분석。결과전자동혈응분석의적PT정상수평여APTT이상수평2항지표합격， PT이상수평량호，APTT정상수평、Fg정상수평급Fg이상수평3항지표우수。결론방법성능결정도능구대혈응분석의적6개지표진행평정분급，여σ치적통계표상비결과경가직관청석。
Objective To adopt the method performance decision chart to evaluate the performance of the Stago R Evolution au-tomatic blood coagulation analyzer .Methods The method performance decision chart was drawn by the results of external quality assessment and internal quality control according to the requirement of the total error in the clinical laboratory improvement amend-ment (CLIA′88) .The 6 indexes of 3 items including prothrombin time(PT) ,activated partial thromboplastin time(APTT) and fi-brin (Fg) were analyzed .Results The 2 indexes of the PT normal level and APTT abnormal level in the automatic blood coagula-tion analyzer were qualified .The PT abnormal level was fine and 3 indexes of the APTT normal level ,Fg normal level and abnormal level were excellent .Conclusion Six indexes of automatic blood coagulation analyzer could be evaluated by the method evaluation decision chart and it was more directly and clearly compared with σvalue statistical table .