生化分析系统检验结果的可接受性评估

目的 研究不同生化分析系统检测结果的可接受性,为临床提供准确、可接受的生化检验结果.方法全自动生化分析系统Hitachi 7170检测系统,与可溯源的Hitachi 7600比较,建立回归方程,以医学决定水平或参考值作为自变量计算偏倚,以1/2CLIA′88允许误差为标准判断偏倚是否可接受.仪器维护后将不可接受的项目再作简易比对,直接计算偏倚是否可接受.结果 两分析系统ALT、AST、GGT、ALP、LDH、TP、ALB、TB、DB、BUN、CR、UA、GLU、TC、TG、HDL和CK测定结果比较,差异无统计学意义（P＞0.05）,临床可接受性能评价均在可接受范围内.其中TB、BUN高值和TG低值的偏倚不可接受,其简易比对偏倚均无统计学意义（P＞0.05）,即全部检验结果均具有可比性.结论 相同实验室使用不同生化分析仪检测时,应定期执行比对试验,分析、排查影响检测结果的因素,以便为临床疾病的诊疗提供准确、可比的生化检验数据.

Acceptable Assessment of the Biochemistry Analytic Results

Objective To study the acceptability of the results determined by different biochemistry analytic systems, and apply accu- rate and comparable biochemistry test data for the clinic. Methods The test data determined by detection system Hitachi 7170 were com- pared with the results determined by traceable Hitachi 7600, and regression equations were established. At the same time, medical decision levels （MDL） or reference values were introduced as independent variables in order to calculate biases, 1/2 allowable errors of CLIA＇88 were employed to judge whether the biases were acceptable or not. Results The differences of ALT, AST, GGT, ALP, LDH, TP, ALB, TB, DB, BUN, CR, UA, GLU, TC, TG, HDL and CK projects determined by the two analyzers had no statistical significance （P 〉 0.05 ） and didn＇t have acceptance in clinic, while the biases in TB, high level of BUN, low level of TG analysis were without acceptance. All bia- ses of simple comparison tests were with no statistical significance （ P 〉 0. 05 ） resulting in all data within acceptance in clinic. Conclusion When different biochemistry analyzers in the identical laboratory are applied, in order to obtain reliable and comparable test results, to analyze and investigate factors affecting test data, and to provide biochemistry testing data periodic comparative tests.