摘要
目的：评价日立7600—020与贝克曼CX9检测系统常规生化结果的可比性。方法：根据美国临床实验室标准化委员会（NCCLS）EP9-A2文件标准，以贝克曼CX9检测系统为标准系统，日立7600—020为待评系统，每天随机选取8份临床病人新鲜样本，分别在两个系统上测定20项常规生化指标，连续测定5天，日立检测系统（Y）和贝克曼检测系统（X）之间的相对偏差，以美国临床医学检验部门修正法规（CLIA’88）允许总误差（Teti）的1／4为标准，判断检验结果的可比性。结果：两个系统检测常规20个生化项目，其检测结果具有相关性，r^2〉0．950，相对偏差SE％〈1／4 Tca，两检测系统结果无显著差异，具有可比性。结论：定期对同一实验室检测同一检验项目的不同检测系统进行方法比对和临床可接受性评价，能够及时发现因系统不同造成的系统误差，通过调整与校准可以确保检验结果的可比性，为不同检测系统检验结果的互认和实验室认可提供依据。
Objective To evaluate the Hitachi 7600--020 Detection System with the Beckman CX9 comparability of results between the conventional biochemistry. Methods According to the U.S. Committee for Clinical Laboratory Standards （NCCLS） EP9-A2D3 document standards, in order to Beckman CX9 detection system as a standard system, Hitachi 7600-020 the system to be evaluated for each day of clinical patients were randomly selected eight fresh samples, the two systems were measured 20 conventional biochemical indicators, continuous determination of 5 days, Hitachi detection system （Y） and the Beckman detection system （X） the relative bias, clinical inspection department of the United States, amendments to laws and regulations （CLIA＇88） allows the total error of 1/4 as the standard to judge the comparability of test results. Results The two systems and biochemical detection of conventional 20 projects, their test results are relevant, r^2〉 0. 950, the relative deviation of SE%〈1/4 Tea, the results of the two detection systems were no significant differences between comparable. Conclusions on a regular basis in the same laboratory tests the same test items of different detection systems for line inspection method of comparison and evaluation of clinical acceptability, the ability to detect due to system error caused by different systems, through the adjustment and calibration to ensure the comparability of test results, for different detection system and the mutual recognition of test results provide a basis for laboratory accreditation.
