自动化镜检结合人工智能分析系统对阴道分泌物革兰氏染色涂片形态学的准确性评价

Accuracy Assessment of the Morphological Analysis System with Automated Microscopy and Artificial Intelligence for Gram⁃stained Vaginal Discharge Smears

目的探究自动化镜检结合人工智能分析系统对阴道分泌物革兰氏染色涂片阴道微生态形态学评价的准确性。方法收集2020年1-5月北京协和医院妇产科门诊患者的阴道分泌物标本。标本经涂片、革兰氏染色,分别进行人工镜检和自动化镜检。自动化镜检采用仕达思Comet⁃60au高倍镜检分析系统,并通过人工智能分析自动判定结果。对形态学镜检结果进行半定量评分,并以人工镜检结果为对照,评估自动化镜检对阴道分泌物革兰氏染色涂片阴道微生态形态学评价的准确性。结果共收集400例患者的400份标本。人工镜检Nugent评分判定为细菌性阴道病(bacterial vaginosis,BV)124例(31.0%)、中间型BV 142例(35.5%)、正常134例(33.5%);酵母样孢子或假菌丝阳性137例(34.3%),其中BV合并真菌阳性29例(21.2%)、中间型BV合并真菌阳性68例(49.6%),Nugent分类正常但真菌阳性40例(29.2%)。根据半定量评分结果,自动化镜检与人工镜检对阴道菌群多样性检测结果的完全一致率和基本一致率分别为52.3%和85.3%,对阴道菌群密集度、乳杆菌样革兰氏阳性杆菌、阴道加德纳菌及拟杆菌样革兰氏阴性杆菌、革兰氏染色不定的弯曲杆菌的完全一致率和基本一致率分别为81.8%~99.5%和93.3%~100%,对酵母样孢子和假菌丝定性检测的一致率均高于96%,对白细胞>10个/高倍镜视野检测结果的完全一致率为70.5%。自动化镜检与人工镜检对Nugent评分BV分类和真菌定性检测的准确度分别为90.8%和94.5%,一致性检验Kappa值分别为0.861和0.875(P<0.001)。结论在阴道分泌物革兰氏染色涂片阴道微生态形态学评价中,自动化镜检与人工镜检具有较好的一致性,可较为准确、快速地完成临床检验,显著提高实验室检测效率,并降低人工镜检工作负荷。

Objective To assess the accuracy of an automated microscopy system for the morphological examination of Gram⁃stained vaginal discharge smears.Methods The specimens of vaginal discharge were col⁃lected from outpatients of the clinic of Obstetrics and Gynecology in Peking Union Medical College Hospital from January to May 2020.All of the smears were Gram⁃stained,observed by both manual and automated mi⁃croscopy.The automated microscopy was made by a Comet⁃60au high power microscope and the morphological analyzing system with artificial intelligence.The accuracy assessment of automated microscopy for analyzing the morphology of vaginal micro⁃ecology was evaluated by the semi⁃quantitative score,in which manually micro⁃scopic results were used as control.Results In total,400 patients were enrolled.By manual microscopy,124(31.0%),142(35.5%)and 134(33.5%)patients were diagnosed as bacterial vaginosis(BV),intermedi⁃ate BV,and normal by Nugent scores,respectively.Yeast⁃like spores or pseudohyphae were found in smears of 137(34.3%)patients by manual microcopy,in which the percentage of BV,intermediated BV,and normal Nugent⁃scored patients were 29(21.2%),68(49.6%),and 40(29.2%),respectively.Based on the semi⁃quantitative score of microscopic examination results,the basic and the complete concordance rate of vaginal flora diversity between automated microscopy and manual microscopy were 52.3%and 85.3%,respectively,and those of vaginal flora intensity,lactobacillus morphotypes,Gardnerella and Bacteroides spp.morphotypes and curved gram⁃variable rods were 81.8%-99.5%and 93.3%-100%.Their qualitative consistency rates of yeast⁃like spores and pseudohyphae were both higher than 96%.The complete concordance rate of more than ten white cells per high power⁃field was 70.5%.Compared to manual microscopy,the consistency rates of automa⁃ted microscopy for BV and fungal qualitative examination were 90.8%and 94.5%,0.861 and 0.875 with Kap⁃pa values(P<0.001),respectively.Conclusions In the morphological evaluation of Gram⁃stained vaginal discharge smears,automated microscopy showed good concordance with manual microscopy,which can supply a rapid and accurate clinical test,highly improve the testing efficiency,and reduce the load of manual work.