全自动精浆γ-L-谷氨酰转肽酶检测方法的建立及评价

Establishment and evaluation of an automatic method for seminal plasma γ-L-glutamyl transpeptidase detection

目的：建立精浆γ-L-谷氨酰转肽酶（GGT）全自动检测方法并对其准确性、重复性和线性范围等进行评价。方法：利用速率法检测精浆GGT活性，并在全自动生化分析仪上建立检测参数，并评估该方法的试剂空白吸光度、准确性、重复性和线性范围，同时与目前临床上常用的精浆GGT检测化学比色法试剂盒（南京欣迪）进行比较。结果：试剂空白吸光度平均为0．0476，空白吸光度变化率（AA／min）平均为0．000168。3份高、中、低GGT活性的精浆样本重复测定10次的变异系数值分别为0．26％、4．83％和1．60％。采用比对试验的方法来评价准确性，40份精浆标本每个浓度点的相对偏差范围为-13．38％-11．05％，均低于15％的要求。精浆GGT活性在299～1833U／L范围时，具有良好的线性关系（r〉0．99）。以精浆GGT检测化学比色法试剂盒作为对照试剂，全自动检测法作为试验试剂，两者对115例精浆样本的检测结果呈显著正相关（r=0．981，P〈0．01），Kappa值为0．776（P〈0．05），符合率为90．43％。结论：本研究建立的精浆GGT全自动检测法有较低的试剂空白，重复性和准确性较好，且与目前临床上使用的化学比色法有很好的一致性。该法操作简单、快速，精浆样本无需稀释，适合临床上大批量样本的检测筛查，大大节省了人力和试剂成本。

Objective： To establish an automatic method for seminal plasma γ-L-glutamyl transpeptidase （GOT） detection and evaluate its accuracy, repeatability and linear range. Methods： We detected the GGT activity in the seminal plasma by rate assay, and established the detection parameters on an automatic biochemical analyzer. Then, we evaluated the reagent blank absorbance, ac- curacy, repeatability and linear range of the automatic method, and compared the results obtained from the method and the seminal plasma GGT detection kit （Xindi Biological Pharmaceutical Engineering Co. , Ltd, Nanjing, China） commonly used in clinical labora- tories. Results ： The average absorbance of reagent blank was 0.0476, and the average change rate of blank absorbance （AA/min） was 0.000168. The coefficients of variation （CV） for 3 seminal plasma samples with high, middle and low GGT activity detected for 10 times, respectively, were 0.26%, 4.83 % and 1.60%. The accuracy of the automatic method was evaluated by a comparison test, and the relative deviation for each concentration point of 40 seminal plasma samples ranged from 13.38% to 11.05% , which met the requirement of 〈 15%. There was a good linear relationship （r 〉 0.99） when the seminal plasma GGT activity was between 299 and 1 833 U/L. A significant positive correlation was found between the seminal plasma GGT detection kit （ a colorimetric method） as the control and the automatic method as the test reagent in the results of 115 seminal plasma samples （ r = 0. 981, P 〈 0.01 ） , with a Kap- pa value of 0.776 （ P 〈 0.05 ） and a coincidence rate of 90.43%. Conclusion ： The established automatic method to detect seminal plasma GGT activity has a low reagent blank, good repeatability and accuracy, and fine concordance with the colorimetric method com- monly used in clinical laboratories. It is simple, rapid and suitable for screening large numbers of samples, avoids the necessity of dilu- ting the seminal plasma sample, and saves a lot of manpower and reagents.