全自动精浆果糖检测方法的建立及主要性能评价

Performance evaluation and establishment of an automatic assay on seminal fructose level

目的建立全自动精浆果糖检测方法并对其准确度、精密度及线性范围等进行评价。方法在全自动特定蛋白分析仪上利用己糖激酶法检测精浆果糖,评估该方法的准确度、精密度及线性范围,并与临床上常用的吲哚显色法进行比较。结果果糖质控品检测结果在其定值范围内。回收试验结果获得回收率分别为96.15%和103.37%。全自动己糖激酶法测定精浆果糖精密度高,批内精密度与批间精密度的CV值分别为0.63%和1.27%。精浆果糖浓度在0.065~4.16mmol/L范围内,具有良好的线性关系(r^2=1.00)。分别采用吲哚显色法与全自动己糖激酶法检测105个精浆标本的果糖浓度,两种方法的检测结果因其方法学不同而存在差异(P<0.01),但两种方法的检测结果呈显著正相关(r^2=0.96,P<0.01),线性回归方程为:y=1.19x+1.67(R^2=0.93,P<0.01)。结论本研究建立的全自动精浆果糖检测法具有良好的准确度与精密度,与临床常用方法有较好的相关性。该法操作简单,安全快速,更适用于临床大批量样本的检测,建议在男性学实验室推广。

Objective To establish an automatic assay for seminal fructose level and evaluate its accuracy, precision and linear range. Methods The concentration of seminal fructose was measured by hexokinase method on an automatic specific protein analyzer, and the accuracy, precision and linear range of this method were evaluated, and the results of this method were compared with those of indole chromogenic method commonly used in clinical. Results The result of the fructose quality control determined by the automatic method falls within the scope of value. The recovery rates of the recovery experiment were 96.15% and 103.37%. The automatic method had excellent within-run and between-run precision, and the coefficients of variation （CV） were 0.63% and 1.27%, respectively. A good linear relationship （P= 1.00） was shown when the concentration of seminal fructose was between 0.065 and 4.16 mmol/L. Compared with the results of indole chromogenic method, the results of automatic method showed statistical difference （P〈0.01） because of different methodologies. But it had a significant positive correlation between the results of seminal fructose concentration from 105 seminal samples analyzed by indole chromogenic and automatic method （P=0.96, P〈0.01）. The linear regression equation： y= 1.19x＋1.67 （R2=0.93 , P〈0.01）. Conclusion The established automatic method for analysis of seminal fructose level has good accuracy and precision, and it also has good correlation with the commonly used method in clinical. The operation of this method established in our study is simple, safe and fast. It would be more suitable for analyzing large numbers of samples and it could be applied to andrology laboratory.