妊娠晚期B族链球菌筛查方法性能评价

Evaluation of screening methods for group B streptococcus in late pregnancy

目的评价微生物培养法、胶体金免疫层析法、实时荧光PCR以及质谱快速鉴定法筛查B族链球菌(GBS)的诊断性能。方法对2020年1月至2022年12月就诊于内蒙古自治区人民医院的1506例围产期孕妇同时进行微生物培养法、胶体金免疫层析法、实时定量荧光PCR法以及质谱快速鉴定法GBS筛查,以增菌培养法作为参考标准,对上述几种方法进行方法学比较。结果增菌培养法检出率为8.17%,直接培养法检出率为3.12%,胶体金免疫层析法检出率为5.17%,实时荧光定量PCR法检出率为11.49%,质谱快速鉴定法检出率为7.17%,不同方法检出率比较差异有统计学意义(P<0.05)。实时荧光PCR法灵敏度最高(95.93%),特异度最低(99.42%);质谱快速鉴定法准确度(98.61%)及特异度(99.78%)最高,一致性Kappa值最强(0.902);胶体金免疫层析法灵敏度63.41%,特异度99.42%,准确度96.48%;直接培养法灵敏度(32.52%)及准确度(94.02%)最低。实时荧光PCR以及质谱快速鉴定法最低检测下限为1.5×10^(3)CFU/mL。结论实时荧光定量PCR法和质谱快速鉴定法灵敏度及准确率较高、检测速度快,可用于GBS的快速筛查;胶体金免疫层析法可适用于门诊大规模初步筛查以及基层医院常规筛查;增菌培养法虽耗时,但准确率高,漏诊及误诊率低,建议有条件的医院作为常规筛查项目。

Objective To evaluate the diagnostic performance of microbial culture,colloidal gold immunochromatography,real-time PCR and mass spectrometry in screening group B streptococcus(GBS).Methods A total of 1,506 perinatal pregnant women were admitted to the People's Hospital of Inner Mongolia Autonomous Region from January 2020 to December 2022.They were simultaneously screened using microbial culture,colloidal gold immunochromatography,fluorescent PCR and mass spectrometry rapid identification GBS.The enhanced culture method was used as the reference standard to compare the above methods.Results The detection rates were as follows:increased culture method,8.17%,direct culture method,3.12%,colloidal gold immunochromatography,5.17%,real-time fluorescence quantitative PCR method,11.49%,and mass spectrometry rapid identification method,7.17%.There were statistically significant differences between the detection rates of the different methods(P<0.05).The real-time fluorescence PCR method had the highest sensitivity(95.93%)and the lowest specificity(99.42%).The accuracy(98.61%)and specificity(99.78%)of the mass spectrometry rapid identification method were the highest,with a strong consistency Kappa value of 0.902.The sensitivity of colloidal gold immunochromatography was 63.41%,the specificity was 99.42%,and the accuracy was 96.48%.The sensitivity(32.52%)and accuracy(94.02%)of the direct culture method were the lowest.The minimum detection limit of real-time PCR and mass spectrometry was 1.5×10^(3)CFU/mL.Conclusion Real-time fluorescent PCR and mass spectrometry are rapid identification methods with high sensitivity,accuracy and fast detection speed.They can be used for the rapid screening of GBS.Colloidal gold immunochromatography is suitable for large-scale preliminary screening in outpatient clinics and routine screening in primary hospitals.Although time-consuming,the bacterial culture method has high accuracy and a low rate of missed diagnosis and misdiagnosis.It is recommended that hospitals with the necessary conditions use it as a routine screening project.