不同检测系统钾钠氯测定结果的偏倚评估

目的通过方法学比较和偏倚评估,探讨不同检测系统钾、钠、氯检测结果是否具有可比性。方法根据EP-9A文件,取朗道水平2和水平3质控物,以及44例不同浓度的患者新鲜血清,在4个不同的生化检测系统(VlTROS 250、罗氏COBAS 400、日立7170A、NOVA及其配套的校准物、试剂等,分别命名为检测系统1~4)上进行钾、钠、氯检测,并对数据进行相关的统计学分析。以美国临床实验室修正法规(CLIA’88)规定的室间质量评价允许误差范围的1/2为临床接受范围,判断不同检测系统的可比性。结果朗道质控物和新鲜血清标本钾、钠、氯测定经随机区组设计资料的方差分析,各检测系统间的总体差异均有显著性(P<0.001)。各检测系统新鲜血清标本钾、钠、氯测定可靠性系数α分别为0.997 90、.998 6和0.997 2,各系统间的相关系数均大于0.975。各检测系统测定钾、钠、氯的批间精密度变异系数均<3%,以可溯源的检测系统1为目标检测系统,钾、钠、氯均有超过CLIA’88允许范围1/2的待评检测系统。结论4个检测系统测定钾、钠、氯的精密度符合临床要求,临床接受性能评价均有不可比性。实验室应经常进行同一项目不同检测系统间的偏倚评估,判断临床接受性能,采取整改措施,保证结果的可比性。

Bias evaluation on the results of serum potassium,sodium and chlorine with different biochemical detecting system

Objective To explore comparability of potassium(K~+),sodium(Na~+) and chlorine(Cl~-)with different biochemical detecting system.Methods Four different kinds of biochemistry detection systems(VITROS 250,ROCHE COBAS 400,HITACHI 7170A and NOVAl6 detecting systems were named detecting system 1-4.) were used to detect serum potassium,sodium and chlorine concentrations at 2 levels of Randox quality controls and 44 clinical specimen according to EP9-A file.The collected data were deal with statistics analysis.Results Analysis of variance showed K~+,Na~+,Cl~-results from different controls and patients sera have significant difference in various detection system(P<0.001).The correlation coefficient of each detection system was above 0.975 and the reliability coefficient of them were 0.9979,0.9986,0.9972,respectively.The CV value of K~+,Na~+,Cl~-at 4 detection systems was not excelled 3.0%.System 1 was regarded as target detection system and evaluated the acceptability of other detection systems.As a result,The items of K~+,Na~+,Cl~-at 3 detection systems were partly excelled permitted error of clinic assessment.Conclusion The precision of K~+,Na~+,Cl~-results in the 4 kinds of detection system accorded to clinic requirement.However.incomparability existed in the evaluation of clinical acceptability.