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目的评估丙氨酸氨基转移酶(ALT)偏倚是否能被献血者筛查及血液检测标准接受。方法校准品和质控物组成的检测系统为目标检测系统比较方法(X),实验室内半自动生化分析仪待评检测系统(Y1),实验室内酶标板速率法待评检测系统(Y2),献血屋半自动生化分析仪待评检测系统(Y3),献血车干式生化分析仪待评检测系统(Y4);每天在测定标本前测定2种靶值(41.1U/L,120 U/L)室内质控物各1次,连续<20 d,标本采用献血者新鲜血液经干化学试纸条Y4系统测试后血清在其它系统中检测。计算试验方法(Y)与比较方法(X)之间的相对偏差(SE%),以美国临床实验室修正法规(CLIA’88)规定的1/2允许误差(10%),作为检测系统测定结果的可比性和临床可接受标准;同时以批间CV值6.7%,系统误差部分不能被临床接受。Y1和Y3与X不精密度比较差异无统计学意义(P>0.05),质控物批间CV值<6.7%。结论应对不同ALT检测系统进行方法学比对,判断其可接受性能,以保证检测结果的可比性和实验结果的准确性,减少血液报废和献血者流失。
Objective To assess whether alanine aminotransferase (ALT) biases can be accepted by blood donor screening and blood testing standards. Method The calibration system consists of calibration system and quality control system (X), semi-automatic biochemical analyzer in laboratory (Y1), Y2 ), Blood donation room semi-automatic biochemical analyzer to be assessed evaluation system (Y3), blood donation car dry biochemical analyzer to be assessed evaluation system (Y4); daily determination of two samples before the determination of two targets (41.1U / L, 120 U / L) 1 time for each quality control, continuously for <20 d, the samples were tested in other systems after the blood of donors was tested by the Y4 system. The relative deviation (SE%) between test method (Y) and comparative test method (X) was calculated as the allowable error (10%) prescribed by the American Clinical Laboratory Amendment (CLIA’88) Comparability of results, and clinically acceptable standards. The inter-assay CV value 0.05). The CV between control and control was <6.7%. Conclusion The methodological comparison of different ALT detection systems should be carried out to judge their acceptability so as to ensure the comparability of test results and the accuracy of experimental results, and to reduce blood waste and blood loss.