摘要
目的了解国产沙眼衣原体核酸检测试剂的检测性能,更好地为临床服务。方法选取7种国产试剂平行检测不同浓度的衣原体纯培养物,并对101例临床拭子样本中的DNA同步进行扩增。根据试剂性能比较结果,选取E试剂和D试剂作为参考试剂,比较各种检测试剂对临床DNA样本的检测性能。结果 2种参考试剂对101份DNA样本检测的结果一致,其他5种试剂与2种参考试剂比较,敏感性为88.89%～100%,特异性为97.59%～100%,各种检测试剂与参考试剂的检测敏感性有一定的差异,但差异无统计学意义(P>0.05)。结论7种沙眼衣原体核酸检测试剂的敏感性有差异,且部分试剂在检测低浓度样本时性能欠佳,需要进一步优化其扩增条件以提高扩增的敏感性和特异性;建议增加对无创性样本的考量,以更好地适应大规模的筛查需求。
Objective To investigate the performance of domestic Chlamydia trachomatis nucleic acid test reagents,and to provide a reference for clinic.Methods For parallel comparison,7 kinds of domestic Chlamydia trachomatis nucleic acid test were selected to analyze the clinical swab samples with different levels of Chlamydia trachomatis.E and D reagents were used as reference.The DNA from101clinical swab samples were amplified,and the performance of various reagents were analyzed.Results The2reference reagants had consistent results for the101clinical swab samples.Compared to the results of the 2 reference reagents,the sensitivities for the other5reagents were88.89%-100.00%,and the specificities were97.59%-100.00%.There was difference for sensitivities between the other5reagents and the 2 reference reagents without statistical significance(P>0.05).Conclusions The7domestic reagents have different sensitivities,some reagents have poor performance for determining low-level samples,and the sensitivity and specificity for some reagents should be improved for the screening of Chlamydia trachomatis infection,further considering non-invasive samples.
作者
陈凯
韩燕
尹跃平
钟铭英
朱邦勇
施美琴
CHEN Kai;HAN Yan;YIN Yueping;ZHONG Mingying;ZHU Bangyong;SHI Meiqin(Reference Laboratory,Dermatology Hospital(Institute of Dermatology),Chinese Academy of Medical Sciences and Peking Union Medical College,National Center for Sexually Transmitted Disease,Chinese Center for Disease Control and Prevention,Nanjing 210042,Jiangsu,China;Institute of Dermatology of Guangxi Zhuang Autonomous Region,Nanning 530003,Guangxi,China)
出处
《检验医学》
CAS
2018年第12期1081-1085,共5页
Laboratory Medicine
基金
中国医学科学院医学与健康科技创新工程(2016-12M-3-021)
关键词
沙眼衣原体
核酸检测
试剂
平行比较
Chlamydia trachomatis
Nucleic acid test
Reagent
Parallel comparison
