半自动生化分析仪检测试剂温育时间对献血者ALT测定结果的影响

The Influence of Reagent Incubation Time on ALT Level of Blood Donors Using Semi-automatic Biochemical Analyzer

目的通过延长ALT检测试剂的温育时间,分析温育时间对街头采血车ALT检测结果的影响。方法向不同温育时间的ALT检测试剂中加入定量已知靶值的标准质控品,半自动生化分析仪温育3 min后,采用半速率法立即检测结果,以首次测量3 min温育样本结果为真值,分别计算不同温育时间段测定结果的偏离度,得出结果可靠的试剂温育时间上限。结果温育时间在2.5 h(包括2.5 h)以内时,ALT检测结果偏离度小于10%,且呈随机性;当温育时间等于3.0 h,ALT检测结果偏离度为10.33%,且随着温育时间的延长,偏离度也随之增加,存在一定的线性关系。根据美国CLIA'88文件,A L T试验允许误差为正负20%,偏离度要小于允许误差的二分之一,即10%。当检测结果偏离度大于10%,结果不可信,失去检测意义,所以得出2.5 h为试剂温育时间上限。结论 ALT检测试剂温育时间对检测结果有较明显的影响,2.5 h为街头采血车ALT检测试剂温育时间上限,此研究可为街头献血者ALT初筛试剂温育时间上限提供可参考的理论依据。

Objective To analyze the influence of incubation time on the testing of alanine aminotransferase（ALT） by extending its incubation time of the detection reagents in mobile blood collecting. Methods The standard materials for quality control were added to the reagents for ALT measurements at various intervals of incubation time. The results were read immediately with half rate method by semi-automatic biochemical analyzer. The first reading of sample tests at 3 min of incubation was taken as the true value. The deviations of the results were calculated at different intervals of incubation time,and the reliable upper limit of reagents incubation time was obtained. Results The deviation of ALT test results was below 10% on or in 2.5 h. However,the deviation was up to 10.33% or even higher when incubation time was extended. A certain linear relationship between the two factors was found. The permissible error of ALT test results is limited to ± 20% according to American CLIA88 regulations and the deviation should be less than half of the permissible error which is determined as 10% at present observation. The results showed that the reagent incubation time of 2.5 h is taken as the upper limit. Conclusion Reagent incubation time for ALT detection has remarkable influence on the test results,and 2.5 h would be believed as the incubation time upper limit of the reagents for ALT detection.