摘要
目的通过对同一实验室不同生化分析系统进行方法对比及偏差评估试验,探讨不同生化分析系统间检测结果的可比性。方法先按照NCCLS(EP5-T2)文件要求,对美国贝克曼库尔特CX4 PRO及CX9 ALX生化分析仪进行精密度试验;然后按照NCCLS(EP9-A2)文件要求,以CX4 PRO为对比方法,以CX9 ALX为试验方法,用患者血清对丙氨酸氨基转移酶(ALT)、清蛋白(ALB)、总胆固醇(TC)等20个生化项目进行检测,统计计算两方法间的相关系数和直线回归方程,并评估两分析系统间的预期偏差。结果两分析系统的批内及总精密度(CV)与厂商提供的参数相符;所有20个检测项目的测定结果的预期偏差均可接受。结论若同一实验室拥有2套或2套以上生化分析系统时,应当进行方法对比及偏差评估试验,以保证其检测结果准确一致。
Objective To explore the comparability of the test outcome by the trial of method comparison and bias estimation between two different biochemical analysis systems in the same clinical laboratory. Methods First, according to the profile NCCLS （EP5-T2）, to evaluate the precision of BECKMAN COULTER CX4 PRO and CX9 ALX biochemical analysis systems. Then, according to the profile NCCLS（EP9-A2）, CX4 PRO（comparison method） and CX9 ALX（laboratory method）, were used respectively to test 20 serological items such as ALT, ALB and CHO to calculate correlation coefficient and linear regression equation. The coefficient and the equation were used to estimate the outcome bias between the two systems. Results The within-run and total precision fit in with the data of BECKMAN COULTER Instrument. All outcome biases of 20 serological items were acceptable. Conclusion In order to insure the accuracy and comparability of the test results, method comparison and bias estimation should be performed if two or more biochemical analysis systems are used in the same clinical laboratory.
出处
《重庆医学》
CAS
CSCD
2006年第2期142-144,146,共4页
Chongqing medicine
关键词
生化分析系统
精密度
方法对比
偏差评估
biochemical analysis system
precision
method comparison
bias estimation
