己糖激酶法与葡萄糖氧化酶法测定血糖的实验研究

Experimental research of HK and GOD-PAP assays for glucose detection

目的评价己糖激酶法(HK法)与葡萄糖氧化酶法(GOD-PAP法)测定血糖的稳定性、可靠性及临床应用,为临床实验室方法的选择和检验结果的评价提供理论依据。方法依据美国国家临床实验室标准委员会(NCCLS)和中华人民共和国卫生行业标准的有关文件对HK法与GOD-PAP法测定血糖精密度、正确度及线性进行评价,对两种测定方法的相关性进行比较。结果两种方法的总不精密度(CV)均小于2.5%;GOD-PAP法和HK法正确度偏倚符合要求,GOD-PAP法的均值与定值比较,t=1.5,P=0.155;HK法的均值与定值比较,t=1.7,P=0.115。两种方法的均值与定值比较,差异无统计学意义(P>0.05);HK法与GOD-PAP法方法学比较:以HK法为比较方法,GOD-PAP法为实验方法,血糖的回归方程,Y=0.988 X+0.053,相关系数(r)=0.999,相对偏倚(0.31%)小于实验室的质量要求(2%),t=1.754,P=0.087。因此认为总体上2种方法的结果比较,差异无统计学意义(P>0.05),具有可比性;GOD-PAP法与HK法线性范围较宽,线性回归方程分别GOD-PAP法:Y=1.011 X-0.066,相关系数(r)=0.999,P=0.000。HK法:Y=1.002 X-0.007,相关系数(r)=1.000,P=0.000,说明2种方法的实测值与预期值呈显著相关,实验范围内2种方法线性关系良好。结论 HK法与GOD-PAP法测定血糖的精密度、正确度、相关性、线性均较好,均适用于临床实验室检测,各实验室可根据自己的条件选择不同的检测方法。

Objective To evaluate the stability,reliability and clinical application of the hexokinase （HK） method and the glu- cose oxidase method （GOD-PAP） for detecting blood glucose to provide the theoretical basis for the selection of clinical laboratory methods and the evaluation of the detection results. Methods To evaluate the precision,accuracy and linearity of HK and GOD- PAP according to NCCLS and the related documents about the standards of health profession of PRC. And the correlation between the two detection methods was compared. Results The total imprecision （CV） of the two methods were less than 2.5 % ; the accu-racy bias of HK and GOD-PAP met the requirement,comparing the mean value with the definite value in GOD-PAP, t= 1.5, P= 0. 155; comparing the mean value with the definite value in HK,t= 1.7, P=0. 115. The mean value and the definite value had no statistically significant difference between the two methods （P〉0.05）. In the methodological comparison of HK and GOD-PAP, HK was the comparative method, while GOD-PAP was the experimental method. The regression equation of blood glucose was Y= 0. 098X＋0. 053,r=0. 999,the relative bias （0.31%） was less than the requirement of the laboratory（2%）,t= 1. 754,P=0. 087. The detection results had no statistical difference between the two methods （P〉0. 05）. The linear range of GOD-PAP and HK methods was wider, their linear regression equation were Y=1. 011X-0. 066,r=0. 999,P=0. 000 and Y= 1. 002X-0. 007,r= 1. 000,P= 0. 000,which indicated that the practical test value of the two methods were significantly associated with the predicted value,the linear relation of the two methods was good in the range of the experiment. Conclusion HK and GOD-PAP have good precision, accuracy, comparability and linearity in the determination of blood glucose,which are suitable for the laboratory detection. Clinical laboratory can choose an appropriate method according to its own conditions.