The design and implementation of regional creatine kinase/lactate dehydrogenase detection standardization

Abstract

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 accuracy 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 less than 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 1.39%-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%-0.34% to -3.07%-0.58% . Conclusion Using the commutable and traceable reference material as calibrator, strengening the laboratory management such as making a calibration SOP will be a effective methods to realize the standardization in measurement.（Chin J Lab Med，2014,37：947-950） Key words: Creatine kinase; Lactate dehydrogenases; Reference standards; Laboratories, hospital; Research design