全自动核酸提取仪对三种性传播病原体检测的性能评价

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:0.9106,92.59%,98.48%和97.48%;NG:0.9383,100.00%,98.18%和98.44%;UU:0.8856,93.33%,95.24%和94.44%;其 Kappa系数均>0.8(CT:Kappa=0.9106,NG:Kappa=0.9383,UU:Kappa=0.8856),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.%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 au-tomatically prepared the reaction system.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 con-ducted.Meanwhile,the sensitivity,specificity,accuracy and carry pollution experiments of MagX were verified.Results The sensitivity of MagX automatic nucleic acids extraction 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:Kap-pa=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.