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DA3200-ABI7500全自动核酸提取平台高敏HCV RNA定量检测性能验证
引用本文:冯飞雪,王大望,肇玉博,王凯,周嘉迪,王战争,王丽,马艳侠,史小武. DA3200-ABI7500全自动核酸提取平台高敏HCV RNA定量检测性能验证[J]. 现代检验医学杂志, 2021, 0(1): 108-111. DOI: 10.3969/j.issn.1671-7414.2021.01.027
作者姓名:冯飞雪  王大望  肇玉博  王凯  周嘉迪  王战争  王丽  马艳侠  史小武
作者单位:(1.陕西中医药大学附属第一医院检验科,陕西咸阳 712000;2.陕西中医药大学医学技术学院,陕西咸阳 712000;3.咸阳市中心血站检验科,陕西咸阳 712000)
摘    要:目的 验证DA3200-ABI7500全自动核酸提取高敏检测HCV RNA方法 性能.方法 参考美国临床实验室标准化协会批准指南(CSLI-EP),采用DA3200全自动核酸提取平台及荧光定量PCR检测HCV RNA,评价检测方法 的核酸提取纯度、精密度、正确度、线性范围、分析灵敏度、特异度和抗污染能力等性能指标.结果...

关 键 词:丙型肝炎病毒  HCVRNA  高敏检测  性能验证

Performance Verification of DA3200-ABI7500 Automatic Nucleic Acid Extraction Platform for High Sensitive HCV RNA Quantitative Detection
FENG Fei-xue,WANG Da-wang,ZHAO Yu-bo,WANG Kai,ZHOU Jia-di,WANG Zhan-zheng,WANG Li,MA Yan-xia,SHI Xiao-wu. Performance Verification of DA3200-ABI7500 Automatic Nucleic Acid Extraction Platform for High Sensitive HCV RNA Quantitative Detection[J]. Journal of Modern Laboratory Medicine, 2021, 0(1): 108-111. DOI: 10.3969/j.issn.1671-7414.2021.01.027
Authors:FENG Fei-xue  WANG Da-wang  ZHAO Yu-bo  WANG Kai  ZHOU Jia-di  WANG Zhan-zheng  WANG Li  MA Yan-xia  SHI Xiao-wu
Affiliation:(1.Department Clinical Laboratory, the First Hospital of Shaanxi University of Chinese Medicine, Shaanxi Xianyang 712000,China; 2. Academy of Medical Technology of Shaanxi University of Chinese Medicine, Shaanxi Xianyang 712000,China; 3. Department Clinicol Laboratory,Xianyang Central Blood Station, Shaanxi Xianyang 712000,China)
Abstract:Objective To evaluate the DA3200-ABI7500 automatic nucleic acid testing platform for highly sensitive HCV RNA quantitative detection.Methods Based on American standard CLSI-EP,the DA3200 automatic nucleic acid extraction platform and PCR analysis system was applied to high sensitivity detect HCV RNA,the precision,accuracy,linear range,detection ability and anti-pollution ability of this method was analyzed.Results In terms of nucleic acid extraction,the ratio of A260nm/A280nm was 2.02,and the intra-assay and inter-assay precision CV values of high and low concentration samples were both≤5%.In accuracy and anti-interference ability,the deviation between the measured value of the specimen and the target value was≤±0.4lg,and there was a good linear relationship between the test results and the target value in the range of 13~1.3 E+06 IU/ml(Y=0.984X-0.186,r^2=0.998).The detection rate of 20 IU/ml was 100%.Conclusion Based on the DA3200-ABI7500 automatic nucleic acid extraction platform,the high sensitivity HCV-RNA quantitative detection performance indicators were all good,and its high-sensitivity detection is of great significance for the monitoring of the treatment process and the determination of treatment endpoints.
Keywords:hepatitis C virus  HCV RNA  high sensitive detection  performance verificatio
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