两种质量规范在临床化学分析性能评价中的应用

摘要

Objective To investigate the application of 2 quality standards in clinical chemical analysis performance evaluation. Methods The internal quality control imprecision and external quality control average deviation of our laboratory (HITACHI analysis system) were selected. The imprecision and inaccuracy of complete test system (Modular PPT analysis system) approved by the Food and Drug Administration ( FDA) were selected. The allowable total error (Tea) according to the Clinical Laboratory Improvement Amendment (CLJA'88) were made by the biological variation (BV). Making use of Westgard performance evaluation decision graph, each detection system analysis performance meeting the prescribed quality requirements or not was analyzed. The analysis performance detection rate and applicability of Modular PPI analysis system with 2 quality standards were analyzed and evaluated. Results In 23 items, with CLIA'88 allow quality standards and requirements, the HITACHI system's urea (Ur) and chlorine (Cl-) determination methods can not satisfy the quality requirements, total protein (TP), creatine kinase (CK) and uric acid (UA) belonged to the critical levels, total bilirubin (Tbil), alkaline phosphatase (ALP), total cholesterol (TC), natrium (Na* ) and magnesium ( Mg) analysis performances were good, and the other 11 item analysis system performances were excellent. In the Modular PPI system, project analysis performance can be accepted. Meanwhile, the excellent rate, good rate, edge rate and discrepancy rate were 75% , 15% , 10% and 0% , and for the BV "low limit", " appropriate" and " ideal" quality standards, its discrepancy rates were 21% , 48% and 65%. Conclusions Westgard performance evaluation decision graph for evaluating the performance of biochemical detection system is accurate, simple and suitable for clinical laboratory application, and CLIA'88 quality requirement is more suitable than the current laboratory quality requirement. BV quality requirements are suitable for a part of excellent performance items.%目的 探讨2种质量规范在临床化学分析性能评价中的应用.方法 选取宁波大学医学院附属医院实验室的日立检测系统(HITACHI)实验项目室内质量控制的不精密度和室间质评的平均偏倚(Bias),同时选取另一美国食品和药物管理局(FDA)认可的完整检测系统(Modular PPI)实验项目的不精密度和不准确性；允许总误差(TEa)选用美国临床实验室修正法案(CLIA' 88)和根据生物学变异(BV)制定的允许质量规范.应用Westgard方法性能决定图评价各自检测系统的分析性能可否达到规定的质量要求；并进一步分析2种质量规范下Modular PPI的分析性能检出率,评价其适用性.结果 在23个测定项目中,用CLIA'88允许质量规范要求,本实验室HITACHI的尿素(Ur)、氯(Cl-)测定方法不能满足质量要求,总蛋白(TP)、肌酸激酶(CK)、尿酸(CA)属于临界水平,总胆红索(TBil)、碱性磷酸酶(ALP)、总胆固醇(TC)、钠(Na+)、镁(Mg)分析性能良好,其余11个项目分析系统性能优秀；在Modular PPI上常规生化项目的分析性能可以接受,同时其分析性能优秀率、良好率、边缘率、不符率分别为75％、15％、10％、0％,而在BV“低限”、“合适”和“理想”的质量规范下其不符率分别为21％、48％和65％.结论 应用Westgard方法性能决定图判定生化检测系统的分析性能准确、简便,适合临床实验室应用；CLIA'88的质量规范要求更适用于当前实验室的质量要求；BV的质量规范适用于部分分析性能优秀的项目.