摘要
目的探讨不同生化检测系统间测定丙氨酸氨基转移酶(ALT)活性结果的差异及其可比性。方法使用ALT试剂中含有磷酸吡哆醛的DADE Dimension RXL检测系统、强生Vitros-350检测系统以及ALT试剂中未含有磷酸吡哆醛HITACHI7170检测系统同时测试164例患者和152例健康人群ALT活性并作比较,另外按照美国临床实验室标准化委员会EP-9A文件的要求,在三检测系统间分两组进行对比试验:第一组以HITACHI7170检测系统为对比方法,以DADE Dimension RXL检测系统为实验方法;第二组以DADEDemension RXL检测系统为对比方法,以强生Vitros-350检测系统为实验方法,操作过程严格按照文件的要求进行。结果 DADE Demension RXL检测系统和强生Vitros-350检测系统的ALT活性较HITACHI7170检测系统增加近20.2%～56.5%,其中有两个标本的差异超过两倍,差异均具有统计学意义(P<0.01);而DADE Dimension RXL检测系统与强生Vitros-350检测系统的ALT活性检测结果差异无统计学意义(P>0.05),对比实验也表明HITACHI7170检测系统与DADE Dimension RXL检测系统的ALT活性检测结果存在着明显的系统误差;而DADE DimensionRXL检测系统和强生Vitros-350检测系统的ALT活性检测结果却相关良好。结论 DADE Dimension RXL检测系统和强生Vitros-350检测系统与HITACHI7170检测系统的ALT活性检测结果因方法学的差异不能达到检测结果的一致性,发出检验报告时应建立起各自的参考值范围,而DADE Dimension RXL检测系统和强生Vitros-350检测系统的ALT活性检测结果差异较小,可以达到检测结果的一致性。
Objective To study the difference and comparability of alanine aminotransferase（ALT） results detected by three biochemistry analyzer systems.Methods The ALT activities of 164 cases of patients and 152 cases of healthy adults were detected by DADE Dimension RXL system,Johnson Vitros-350 system that containing pyridoxal-5-phosphate in their reagents and HITACHI7170 system that not containing pyridoxal-5-phosphate in its reagents,respectively.According to the document EP9-A described by the NCCLS,two group parallel contrast tests had being established：In the first group,ALT detected by HITACHI7170 system was selected as the standard method and DADE Dimension RXL system as the empirical method.In the other group,ALT detected by DADE Dimension RXL system was selected as the standard method and Johnson Vitros-350 system as the empirical method.Results The assay results of ALT activity detected by DADE Dimension RXL and Johnson Vitros-350 systems were higher（20.2%~56.5%） than that detected by HITACHI7170 system and there was no significant difference between DADE Dimension RXL system and Johnson Vitros-350 system.The parallel contrast tests also showed that there was an obvious systematic error between HITACHI7170 system and DADE Dimension RXL system,but there was a good correlation between DADE Dimension RXL system and Vitros-350 system.Conclusion Because of the difference of methodology the results of ALT activity detected by DADE Dimension RXL and Johnson Vitros-350 biochemistry analyzer systems couldn＇t obtain consistency with those by HITACHI7170 system,but there was a higher consistency between DADE Dimension RXL system and Vitros-350 system.
出处
《海南医学》
CAS
2011年第2期108-110,共3页
Hainan Medical Journal
