【摘要】 目的 分析可能对妊娠结局产生不良影响的生殖道病原体,研发基于微流控技术的多靶标核酸检测试剂,建立快速多重分子检测新技术,并对该方法的有效性进行验证。方法 对在北京大学第三医院就诊的妊娠期女性生殖道标本中可能对妊娠结局产生不良影响的病原微生物进行回顾性研究。采用微流控芯片核酸检测技术对上述样本进行检测,将检测结果与传统培养法或实时荧光定量聚合酶链反应(q PCR)法结果进行比较,对方法的符合率、检出限、交叉反应和抗干扰能力等方面进行验证。结果 生殖道样本中B族链球菌、大肠埃希菌和白念珠菌阳性的妊娠期女性出现胎膜早破、子痫前期和妊娠期糖尿病等不良妊娠结局率显著高于阴性组(P<0.05)。微流控多重核酸检测技术与培养法相比,阳性符合率为92.59%,阴性符合率为84.72%,与q PCR法相比,阳性符合率为98.75%,阴性符合率为100.00%。结论 微流控多重核酸检测技术具备高效、准确的特点,有望在临床实践中提供更快速、精准的病原体检测,及时诊断妊娠期女性生殖道感染并预防不良妊娠结局的发生。更多还原

【Abstract】 Objective To analyze reproductive tract pathogens that may adversely affect pregnancy outcomes,to develop multi-target nucleic acid detection reagents based on microfluidic chip technology,to establish a new molecular technique for rapid multiplexed detection,and to validate the effectiveness of this mcthod.Methods A retrospective study on pathogenic microorganisms that may adversely affect pregnancy outcomes in genital tract samples of pregnant women visiting Peking University Third Hospital was conducted.Microfluidic chip nucleic acid detection technology was used to test the above samples,and the test results were compared with those by the traditional culture method or real-time fluorescent quantitative PCR(qPCR)method,and the conformity rate,the detection limit,the cross-reaction,and the anti-interference ability of the method were verified.Results Through retrospective analysis,it was determined that pregnant women with positive genital tract samples for group B Streptococcus,Escherichia coli and Candida albicans had significantly higher rates of adverse pregnancy outcomes such as premature rupture of membranes,pre-eclampsia and gestational diabetes mellitus than pregnant women in the negative group(P <0.05).When microfluidic chipbased multiplex nucleic acid detection was compared with the culture method the positive compliance rate was92.59% and the negative compliance rate was 84.72%.The positive compliance rate was 98.75% and the negative compliance rate was 100.00% compared to qPCR method.Conclusion The microfluidic microarray nucleic acid testing technology is characterized by high efficiency and accuracy,and is expected to provide faster and more accurate pathogen detection in clinical practice for timely diagnosis of infections during pregnancy and prevention of adverse pregnancy outcomes.更多还原