游离DNA保存管中甘氨酸含量的测定方法与应用  

Quantitative detection method of glycine in cell⁃free DNA collection Tube

作　　者：魏慧慧 刘艳[1] 殷剑峰 苏丽红[1] 王玉梅[1] WEI Huihui;LIU Yan;YIN Jianfeng;SU Lihong;WANG Yumei(National Institutes for Food and Drug Control,Beijing,China,102629;Jiangsu Cowin Biotech Co.,Ltd,Taizhou,Jiangsu,China,225300)

机构地区：[1]中国食品药品检定研究院,北京102629 [2]江苏康为世纪生物科技股份有限公司,江苏泰州225300

出　　处：《分子诊断与治疗杂志》2022年第5期723-726,共4页Journal of Molecular Diagnostics and Therapy

基　　金：国家药品监督管理局医疗器械行业标准制修订计划(N2019055⁃JN)。

摘　　要：目的建立游离DNA保存管中甘氨酸的定量检测方法。方法利用氨基酸在酸性溶液中能与茚三酮作用生成蓝紫色化合物,以其570 nm处吸光度与甘氨酸浓度成正相关的特性来测定甘氨酸的含量。优化使用本方法在检测该类产品的线性范围,考察其定量限、精密度及准确度、特异性指标,并以所建立的方法初步用于游离DNA保存管检测。结果本方法检测的线性范围确定为0.63~10.00 mmoL/L,定量限为2.00 mmoL/L。以高、中、低浓度样品评估分析内精密度,其标准偏差均不大于10%。检测以甘氨酸国家标准品配制的模拟样品,其回收率在85%~115%范围内,且其结果不受常见添加剂的干扰作用。用所建立的方法应用于医疗机构所使用的游离DNA保存管的检测,结果均符合产品的技术要求规定。结论所建立的方法可以用于游离DNA保存管中甘氨酸的定量检测。Objective To develop a quantitative method for the assay of glycine in cell⁃free DNA collection tubes.Methods The amino acids can interact with ninhydrin in acidic solutions to form blue⁃violet compounds.The absorbance was directly correlated with the concentration of glycine,which could be adopted for assay of glycine.The linear range of the method was optimized in this type of product and its sensitivity,intra⁃assay precision,accuracy and specificity performance were studied.The developed method was preliminarily applied to the detection of cell⁃free DNA collection tube.Results The linear range of this method was determined to be 0.625~10.00 mmoL/L,and the limit of quantification was 2.00 mmoL/L.The internal precision was evaluated with high,medium,and low concentration samples,and the standard deviation was not more than 10%.The recoveries of simulated samples prepared with glycine national reference material were in the range of 85%~115%and not disturbed by common additives.The developed method was applied to the detection of cell⁃free DNA collection tubes used in medical institutions and the results were all in line with the technical requirements of the products.Conclusion The developed method can be used for quantitative detection of glycine in cell⁃free DNA collection tubes.

关 键 词：游离DNA保存管 甘氨酸 线性 定量限 精密度 准确度 特异性 

分 类 号：R927[医药卫生—药学]