[1]张 睿,叶阿里,孔令君,等.全自动核酸提取仪对三种性传播病原体检测的性能评价[J].现代检验医学杂志,2017,32(06):142-144.[doi:10.3969/j.issn.1671-7414.2017.06.001]
　ZHANG Rui,YE A-li,KONG Ling-jun,et al.Feasibility of Detection Three Kinds of Sexually Transmitted Pathogenby MGX Automatic Nucleic Acid Extraction Workstation[J].Journal of Modern Laboratory Medicine,2017,32(06):142-144.[doi:10.3969/j.issn.1671-7414.2017.06.001]
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全自动核酸提取仪对三种性传播病原体检测的性能评价()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第32卷
期数:
2017年06期
页码:
142-144
栏目:
研究简报·实验技术
出版日期:
2017-12-25

文章信息/Info

Title:
Feasibility of Detection Three Kinds of Sexually Transmitted Pathogenby MGX Automatic Nucleic Acid Extraction Workstation
文章编号:
1671-7414(2017)06-142-03
作者:
张 睿; 叶阿里; 孔令君; 窦亚玲; 伊 洁
中国医学科学院 北京协和医学院 北京协和医院检验科,北京 100730
Author(s):
ZHANG Rui; YE A-li; KONG Ling-jun; DOU Ya-ling; YI Jie
Department of Clinical Laboratory,PUMC Hospital,CAMS and PUMC,Beijing 100730,China
关键词:
沙眼衣原体;  淋病奈瑟菌;  解脲脲原体;  全自动核酸(RNA)提取仪
分类号:
R446
DOI:
10.3969/j.issn.1671-7414.2017.06.001
文献标志码:
A
摘要:
目的 评价全自动核酸(RNA)提取仪(型号MagX)对沙眼衣原体(Chlamydia trachomatis,CT)、淋病奈瑟菌(Neisseria gonorrhoeae,NG)和解脲脲原体(Ureaplasmaurealyticum,UU)检测结果应用于临床的可行性。方法 收集检测CT样本159例、NG样本128例、UU样本144例,应用荧光核酸恒温扩增检测技术(Simultaneous Amplification and Testing,SAT),同一样本分别采用手工提取分装加样和MagX提取分装加样两种检测方法,然后进行实时荧光PCR。以手工检测结果为金标准,对MagX检测结果进行阳性符合率(灵敏度)、阴性符合率(特异度)、总符合率(准确度)的评价。同时,对该仪器进行防污染验证。全自动核酸(RNA)提取仪与手工检测结果进行Kappa一致性分析。结果 159例CT,128例NG和144例UU样本的阳性符合率、阴性符合率、总符合率依次为CT:0.910 6,92.59%,98.48%和97.48%; NG:0.938 3,100.00%,98.18%和98.44%; UU:0.885 6,93.33%,95.24%和94.44%; 其Kappa系数均>0.8(CT:Kappa=0.910 6,NG:Kappa=0.938 3,UU:Kappa=0.885 6),CV值均<5%; 没有携带污染现象存在。结论 上海仁度生物科技生产的CT,NG和UU核酸检测试剂盒(RNA恒温扩增)在全自动核酸(RNA)提取仪(型号MagX)的检测符合临床检测标准,可在临床使用。
Abstract:
Abstract:Objective To verify the feasibility of Chlamydia trachomatis(CT),Neisseria gonorrhoeae (NG),Ureaplasma urealyticum(UU)detection by automatic nucleic acid extraction workstation(MagX).Methods The test samples of CT(159),NG(128)and UU(144)were collected.The samples were extracted of nucleic acid two methods:manual extraction,which entailed manually preparing PCR reaction system and MagX automatic nucleic acid extraction workstation,which automatically prepared the reactionsystem.The two parts of nucleic acids proceeded to the Simultaneous Amplification and Testing(SAT).The result of manual extraction was set as the golden standard and the Kappa consistency analysis was conducted.Meanwhile,the sensitivity,specificity,accuracy and carry pollution experiments of MagX were verified.Results The sensitivity of MagX automatic nucleic acidsextraction workstation were 92.59%(CT),100.00%(NG)and 93.33%(UU).The specificity were 98.48%(CT),98.18%(NG)and 95.24%(UU).The accuracy were 97.48%(CT),98.44%(NG)and 94.44%(UU).The results of kappa consistency analysis were greater than 0.8(CT:Kappa=0.910 6,NG:Kappa=0.938 3,UU:Kappa=0.885 6).MagX detected the precision of CT,NG and UU:Coefficient of Variation(CV)<5%.There was no pollution phenomenon.Conclusion MagX automatic nucleic acids extraction workstation could be used to test three kinds of sexually transmitted pathogen in clinical settings.

参考文献/References:

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[5] 张 睿,叶阿里,孔令君,等.临床患者三种性传播疾病分子生物学检测分析[J].现代检验医学杂志,2015,30(3):107-110. Zhang R,Ye AL,Kong LJ,et al.Clinical molecular biology analysisof three kinds of sexually transmitted diseases in Patients[J].Journal of Modern Laboratory Medicine,2015,30(3):107-110. 收稿日期:2017-07-19 修回日期:2017-09-27

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　ZHANG Rui,YE A-li,KONG Ling-jun,et al.Clinical Molecular Biology Analysis of Three Kinds of Sexually Transmitted Diseases in Patients[J].Journal of Modern Laboratory Medicine,2015,30(06):107.[doi:10.3969/j.issn.1671-7414.2015.03.031]
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备注/Memo

备注/Memo:
作者简介:张 睿(1983-),女,硕士研究生,助理研究员,研究方向:感染与肿瘤相关分子生物学诊断及其机制的研究; E-mail: zhangrui_pumc@163.com。 通讯作者:窦亚玲,E-mail:douyling@163.com。
更新日期/Last Update: 2017-12-26