地区性肌酸激酶及乳酸脱氢酶检测标准化途径设计与实施

The design and implementation of regional creatine kinase/lactate dehydrogenase detectionstandardization

目的基于嘉兴市临床实验室现状设计适合此地区的肌酸激酶（CK）／乳酸脱氢酶（LDH）检测的标准化方案并实施，以减小检测结果的室问变异，保证检测结果的正确性及溯源性。方法基于临床检验结果溯源性要求，于2012年10月至2013年2月期间，在嘉兴市6家医院，以国家一级标准物质GBW09167、GBW09168以及新鲜血清作为样本在嘉兴33家医院的临床实验室进行正确度验证以及室内不精密度调查；筛取其中6家室内不精密度（CV）小于2％的实验室，以血清基质标准物质GBW（E）091361作为校准品，GBW（E）091360作为正确度质量控制品，比较实施标准化前后检测结果的差异。结果33家实验室中，31家实验室室内CV小于2％，肌酸激酶偏移为-7％～12％，乳酸脱氢酶偏移为-22％～15％。6家CV小于2％的实验室，标准化实施过程中，具统计意义的5家实验室血清样本检测结果如下：肌酸激酶室间变异由校准前的4．95％～6．55％降低到校准后的1．81％～2．33％，乳酸脱氢酶则由5．75％～11．68％降低到1．39％～1．80％；肌酸激酶的偏倚由校准前的-0．84％～6．23％降到-0．15％～2．44％；乳酸脱氢酶的偏倚由-10．18％-0．34％降低到校准后的-3．07％～0．58％。结论基于实验室全面质量管理，以统一的校准方案，统一的具有互通性的标准物质作为校准品，可降低不同实验室室问检测结果的差异，提高检测准确性。（中华检验医学杂志，2014．37：947-950）

Objective To design and implement the standardization scheme of creatine kinase （CK）/lactate dehydrogenase （LDH） detection based on the present situation of clinical laboratory in Jiaxing, and attempt to reduce the imprecision and bias of the results in different clinical laboratories, obtain the traceable results. Methods According to the requirements of traceability in clinical laboratory, the CK/ LDH standardization scheme was explored in Jiaxing from 2012, October to 2013, February, CK/LDH national reference material GBW09167, GBW09168 and serum pool were as samples for aeeuraey verification and impression in 33 local hospitals; then the reference materials GBW（E） 03061 was as calibrator, while the GBWE03060 was performed as calibration verification material during the tests, the SOP for calibration made by the clinical quality control center was operated in calibration; as a result a scientific, practical standard scheme was developed. Results The equipment of clinical labrotories in Jiaxing are all imported, the laboratory management is well. However the bias of CK is - 7% -12% and the bias of LDH is above -22%-15%. And then the standardization scheme was implemented in 6 Laboratories in which CV was lessthan 2% , and high-quality data of 5 laboratories are as follows ： imprecision of CK and LDH in different labs were reduced from 4. 95% -6. 55% to 1.81% -2.33% and 5.75% -11.68% to 1.59% -1.80% individually, bias for CK is reduced from -0. 84 %-6. 23% to -0. 15%-2.44% ; while in lactate dehydrogenase test, the bias is decreased from - 10. 18% 4）. 34% to - 3.07% 4）. 58% . Conclusion Using the commutable and traceable reference material as calibrator, strengening the laboratory management such as nmking a calibration SOP will be a effective methods to realize the standardization in measurement. （ Chin J Lab Med, 2014,37 ： 947-950 ）