B族链球菌四种筛查方法的比较  

Comparison of four screening methods for group B streptococcus

作　　者：高坎坎[1] 关小珊 邓秋连 邓蕾 朱素菲 华夏 高飞[1] 刘海英[1] Gao Kankan;Guan Xiaoshan;Deng Qiulian;Deng Lei;Zhu Sufei;Hua Xia;Gao Fei;Liu Haiying(Department of Clinical Laboratory,Guangzhou Women and Children′s Medical Center,Guangzhou Medical University,Guangzhou 510180,China)

机构地区：[1]广州医科大学附属广州市妇女儿童医疗中心检验科,广州510180

出　　处：《中华检验医学杂志》2020年第2期182-185,共4页Chinese Journal of Laboratory Medicine

基　　金：广州市科技创新委员会项目(201804010447)。

摘　　要：目的评估B族链球菌肉汤增菌培养法(Todd-Hewitt型,T-H)、直接培养法、液体显色培养法及核酸环介导恒温扩增法(LAMP)在孕晚期妇女筛查中的临床应用。方法回顾性研究。采集2016年10月至2018年4月在广州医科大学附属广州市妇女儿童医疗中心产科门诊产检妊娠35~37周孕妇直肠阴道分泌物标本969份,采用双盲法,以T-H肉汤增菌培养法为参考方法,分3个研究阶段先后比较直接培养法、液体显色培养法及LAMP法的检验性能。以敏感度、特异度、符合率、阳性预测值、阴性预测值及尤登指数为评价指标,一致性用Kappa检验。结果增菌培养法共检测标本969份,阳性90份(9.3%)。以增菌培养法为参考,敏感度从高到低依次为LAMP法[100%(25/25)]、直接培养法[81.5%(22/27),95%CI:65.8%~97.1%]、液体显色培养法[71.1%(27/38),95%CI:55.9%~86.2%];特异度则依次为直接培养法[100%(282/282)]、液体显色培养法[98.1%(455/464),95%CI:96.8%~99.3%]、LAMP法[94.0%(125/133),95%CI:89.9%~98.1%];符合率依次为直接培养法[98.4%(22+282)/309]、液体显色培养法[96.0%(27+455)/502]、LAMP法[94.9%(25+125)/158]。而直接培养法(0.889)、LAMP法(0.832)与增菌培养法的一致性Kappa值均≥0.75,液体显色培养法则为0.708。直接培养法有18.5%(5/27)的漏检率,LAMP法漏检率为零、假阳性率为6.0%(8/133),液体显色培养法的漏检率、假阳性率分别为28.9%(11/38)、1.9%(9/464)。结论本研究所比较的几种GBS筛查方法中,仅LAMP法与增菌培养法在敏感度、特异度及符合率上均具较好的一致性,而其他两种方法存在一定的漏检。临床实验室可根据实际条件、技术力量选择使用,或参照欧美指南推荐的孕晚期增菌培养筛查与产时核酸检测相结合,以最大程度满足临床需求。Objective To evaluate diagnostic performance of Todd-Hewitt(T-H)broth culture method,direct culture method,liquid chromogenic culture method,and loop-mediated isothermal amplification(LAMP)method for screening group B streptococcus(GBS)during late pregnancy.Methods In the retrospective study,the rectal vaginal secretions samples were collected from pregnant women at 35 to 37 weeks at the obstetrics clinic of Guangzhou Women and Children′s Medical Center affiliated to Guangzhou Medical University during October 2016 to April 2018.For the purposes of clinical evaluation,T-H broth culture was used as the standard reference method,and double-blind trials were used to evaluate diagnostic performance of direct culture method,liquid chromogenic culture method,and LAMP method for screening group B streptococcus during late pregnancy in three research stages.Sensitivity,specificity,positive predictive value(PPV),negative predictive value(NPV),coincidence rate and Yoden index for each method were calculated.Also,the level of agreement between each method and T-H broth was assessed using the kappa(k)coefficient.Results A total of 969 specimens were detected by the T-H enrichment culture method,and 90 were positive(9.3%).The sensitivities from high to low were LAMP method[100%(25/25)],direct culture method[81.5%(22/27),95%CI:65.8%-97.1%],and liquid color culture method[71.1%(27/38),95%CI:55.9%-86.2%].Specificities were direct culture method[100%(282/282)],liquid color culture method[98.1%(455/464),95%CI:96.8%-99.3%],and LAMP method[94.0%(125/133),95%CI:89.9%-98.1%].The coincidence rates were direct culture method[98.4%(22+282)/309],liquid color culture method[96.0%(27+455)/502],and LAMP method[94.9%(25+125)/158].The Kappa values of the direct culture method(0.889),LAMP method(0.832)and the enrichment culture method were all≥0.75,and that of the liquid color culture method was 0.708.The false negative rate of direct culture method was 18.5%(5/27),and no false negative case by LAMP method,but its false positive rate was 6.

关 键 词：妊娠末期 无乳链球菌 细菌学技术 培养基 核酸扩增技术 敏感性与特异性 

分 类 号：R446[医药卫生—诊断学] R714[医药卫生—临床医学]