Lu Jin-Chun, Lu Kun-Gang, Zhang Hong-Ye, Feng Rui-Xiang
Department of Laboratory Science, Nanjing Hospital, Jiangsu Corps of the Armed Police Force, PLA, Nanjing, Jiangsu 210028, China.
Nanjing Xindi Biological Pharmaceutical Engineering Co., Ltd, Nanjing, Jiangsu 211112, China.
Zhonghua Nan Ke Xue. 2013 Dec;19(12):1077-81.
To establish an automatic method for seminal plasma gamma-L-glutamyl transpeptidase (GGT) detection and evaluate its accuracy, repeatability and linear range.
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, accuracy, 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 laboratories.
The average absorbance of reagent blank was 0.0476, and the average change rate of blank absorbance (deltaA/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 Kappa value of 0.776 (P < 0.05) and a coincidence rate of 90.43%.
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 commonly used in clinical laboratories. It is simple, rapid and suitable for screening large numbers of samples, avoids the necessity of diluting the seminal plasma sample, and saves a lot of manpower and reagents.
建立一种精浆γ-L-谷氨酰转肽酶(GGT)的自动检测方法,并评估其准确性、重复性和线性范围。
采用速率法检测精浆中GGT活性,并在自动生化分析仪上建立检测参数。然后,评估该自动方法的试剂空白吸光度、准确性、重复性和线性范围,并将该方法与临床实验室常用的精浆GGT检测试剂盒(南京新迪生物制药工程有限公司)检测结果进行比较。
试剂空白平均吸光度为0.0476,空白吸光度平均变化率(deltaA/min)为0.000168。对3份GGT活性高、中、低的精浆样本分别进行10次检测,变异系数(CV)分别为0.26%、4.83%和1.60%。通过对比试验评估自动方法的准确性,40份精浆样本各浓度点的相对偏差范围为13.38%至11.05%,满足<15%的要求。当精浆GGT活性在299至1833 U/L之间时,具有良好的线性关系(r>0.99)。以精浆GGT检测试剂盒(比色法)作为对照,自动方法作为检测试剂,对115份精浆样本检测结果进行比较,两者呈显著正相关(r=0.981,P<0.01),Kappa值为0.776(P<0.05),符合率为90.43%。
所建立的精浆GGT活性自动检测方法试剂空白低,重复性和准确性好,与临床实验室常用比色法一致性良好。该方法简便、快速,适用于大量样本筛查,无需对精浆样本进行稀释,节省大量人力和试剂。