全自动精浆锌检测方法的建立及评价

Establishment and evaluation of automatic assay on level of seminal plasma zinc

目的建立全自动精浆锌检测方法并对其准确性、重复性和线性范围等进行评价。方法利用终点法检测精浆锌浓度，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化学比色法精浆锌检测试剂盒进行比较。结果试剂空白吸光度平均为0．028。3份高、中、低锌浓度的精浆样本重复测定10次，其CV值分别为0．67％、2．04％和4．18％。采用回收率分析来评价准确性，回收率范围为95．68％～103．81％。精浆锌浓度在0．2～7mmol／L范围时，具有良好的线性关系（r^2=O．9944）。以精浆锌检测试剂盒（化学比色法）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没有显著性差异[（2．51±1．26）mmol／Lvs（2．54±1．17）mmol／L，t=-1．589，P=-O．115]，且呈显著正相关（，=0．9686，P〈O．01）。结论本研究建立的全自动精浆锌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 assay for the level of seminal plasma zinc, and evaluate its accuracy, repeatability and linear range. Methods The concentration of zinc in seminal plasma was analyzed by an automatic biochemical analyzer, and the detection parameters of endpoint method were established. Subsequently, the reagent blank absorbance, accuracy, repeatability and linear range of the automatic method were evaluated, and the results obtained from the method and the seminal plasma zinc detection kit （a colorimetric method） commonly used in clinical laboratories were compared. Results The average absorbance of reagent blank was 0.028. The coefficients of variation （CV） for 3 seminal plasma samples with high, middle and low zinc concentration detected for 10 times, respectively, were 0.67%, 2.04% and 4.18%. The accuracy of the automatic method was evaluated by a recovery assay, and the recovery rates ranged from 95.68% to 103.81%. There was a good linear relationship （r^2=0.9944） when the seminal plasma zinc concentration ranged from 0.2 to 7 mmol/L. When the the seminal plasma zinc detection kit （a colorimetric method） was as the control, and theautomatic method as the test reagent, there was no any statistical difference （[2.51±1.26] mmol/L es [2.54±1.17] mmol/L, t=-1.589, P=0.115） but a significant positive correlation （r^2=0.9686, P〈0.01） between them for the results of 115 seminal plasma samples. Conclusion The established automatic method for analysis of seminal plasma zinc concentration has low reagent blank, good repeatability and accuracy, and fine concordance with the colorimetric method commonly used in clinical laboratories. The method is simple, rapid, and suitable for screening large numbers of samples, and greatly saves the cost of manpower and reagents, and the seminal plasma samples don＇t need to be diluted.