[1]冯飞雪,王大望,史小武,等.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,2021,36(01):108-111.[doi:10.3969/j.issn.1671-7414.2021.01.027]
　FENG Fei-xue,WANG Da-wang,SHI Xiao-wu,et al.Performance Verification of DA3200-ABI7500 Automatic Nucleic Acid Extraction Platform for High Sensitive HCV RNA Quantitative Detection[J].Journal of Modern Laboratory Medicine,2021,36(01):108-111.[doi:10.3969/j.issn.1671-7414.2021.01.027]
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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()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第36卷
期数:
2021年01期
页码:
108-111
栏目:
研究简报 实验技术
出版日期:
2021-02-05

文章信息/Info

Title:
Performance Verification of DA3200-ABI7500 Automatic Nucleic Acid Extraction Platform for High Sensitive HCV RNA Quantitative Detection
文章编号:
1671-7414（2021）01-108-04
作者:
冯飞雪; 王大望; 史小武; 等
（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）
Author(s):
FENG Fei-xue;  WANG Da-wang;  SHI Xiao-wu;  et al
（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）
关键词:
丙型肝炎病毒; HCV RNA; 高敏检测; 性能验证
分类号:
R446
DOI:
10.3969/j.issn.1671-7414.2021.01.027
文献标志码:
A
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　核酸提取后 A260nm/ A280nm比值为 2.02。高、低两个浓度样本的批间精密度和批内精密度 CV值均≤ 5%。正确度与抗干扰能力方面，标本实测值与靶值之间的偏离度≤ ±0.4lg。在 13～ 1.3 E+06 IU/ml范围内，检测结果与靶值有良好的线性关系（Y=0.984X-0.186， r2=0.998）。最低检出限为 20 IU/ml的检出率为 100%，且系统具有较强的特异度和抗污染能力。结论　基于 DA3200-ABI7500全自动核酸提取高敏检测 HCV RNA各项分析性能指标均较好，高敏检测对治疗过程的监测及治疗终点判定具有重要意义。

参考文献/References:

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备注/Memo

备注/Memo:
作者简介：冯飞雪（1986-），女，博士，讲师，主要从事临床分子诊断。
通讯作者：史小武，E-mail:feixue0422@126.com。
更新日期/Last Update: 2021-02-05