全自动阴道分泌物分析系统复检规则制订及验证的多中心研究  

Multi-center study on the development and validation of review criteria for automatic vaginal secretion analysis system

作　　者：陆庭嫣[1] 王萍[2] 曹永彤[2] 渠巍[3] 刘怡 杨军兰 王丽滨 陈晓军[5] 吕林佳 唐振华[1] LU Tingyan;WANG Ping;CAO Yongtong;QU Wei;LIU Yi;YANG Junlan;WANG Libin;CHEN Xiaojun;LYU Linjia;TANG Zhenhua(Department of Clinical Laboratory,the International Peace Maternity and Child Health Hospital,School of Medicine,Shanghai Jiao Tong University,Shanghai 200030,China;Department of Clinical Laboratory,China-Japan Friendship Hospital,Beijing 100029,China;Department of Clinical Laboratory,Guiyang Maternity and Child Health Hospital,Guiyang,Guizhou 550003,China;Department of Clinical Laboratory,Northwest Women′s and Children′s Hospital,Xi′an,Shaanxi 710061,China;Department of Clinical Laboratory,Changchun Obstertrics-Gynecology Hospital,Changchun,Jilin 130022,China)

机构地区：[1]上海交通大学医学院附属国际和平妇幼保健院检验科,上海200030 [2]中日友好医院检验科,北京100029 [3]贵阳市妇幼保健院检验科,贵州贵阳550003 [4]西北妇女儿童医院医学检验中心,陕西西安710061 [5]长春市妇产医院检验科,吉林长春130022

出　　处：《国际检验医学杂志》2024年第7期828-836,共9页International Journal of Laboratory Medicine

摘　　要：目的制订并验证GMD-S600全自动阴道分泌物分析系统的复检规则。方法收集来自5家医院检验科2021年7月至2022年7月的4155份女性阴道拭子,其中3407份用于全自动分析系统复检规则的建立,748份用于复检规则的验证。所有标本通过GMD-S600分析系统检测、人工湿片和革兰染色显微镜镜检(简称联合镜检结果),对细菌性阴道病(BV)、外阴阴道假丝酵母菌病(VVC)、滴虫性阴道炎(TV)等疾病项目进行检测分析。以联合镜检结果为标准,筛选出全自动分析系统的复检规则,再通过国际通用复检规则评估指标进行验证。结果(1)联合镜检结果显示,建立复检规则的3407份标本中BV阳性率为10.86%(370份),VVC阳性率为17.38%(592份),TV阳性率为1.29%(44份),总阳性率为26.74%。(2)以联合镜检结果为标准,最终选定37条复检规则及附加其中22条规则强制显微镜检查的条件。应用规则后,BV、VVC、TV的假阴性率和灵敏度分别为3.40%、68.65%,5.22%、69.98%,0.21%、84.44%;显微镜镜检复查率为23.10%。(3)应用748份标本复检规则验证,BV、VVC、TV假阴性率分别为4.81%、3.61%、0.00%,镜检复查率为22.19%。(4)仪器镜检与人工湿片镜检白细胞等级偏差超出一致性界限外的百分率为4.81%。结论多中心研究制订的37条复检规则及附加22条镜检条件适用于临床对BV、VVC、TV疾病的初筛,能有效控制检测项目的假阴性率及假阳性率,且触发规则后的人工干预率及显微镜复检率均可被接受;仪器计数白细胞半定量结果基本可信。该研究结果可应用于同型号检测系统,但还需结合实验室实际使用情况对相关规则进行周期性验证调整。Objective To establish and verify the review criteria for the GMD-S600 automated analysis system of vaginal secretion.Methods A total of 4155 female vaginal swabs were collected from the clinical laboratory departments of 5 hospitals from July 2021 to July 2022,of which 3407 were used for establishing review rules by the automatic analyzer while the remaining 748 samples were used to verify the review criteria.All samples were detected by GMD-S600 automatic system,artificial wet smear and Gram staining combined microscopic examination(hereinafter referred to as combined microscopic examination results),and diseases such as bacterial vaginosis(BV),vulvovaginal candidiasis(VVC)and trichomoniasis vaginitis(TV)were detected and analyzed.Based on the results of combined microscopic examination results,the review rules for automatic analysis systems were refined.Then it was verified by the evaluation indicators of the international review criteria.Results(1)Of the 3407 samples,the combined microscopic examination results showed that BV accounted for 10.86%(370 samples),VVC accounted for 17.38%(592 samples)and TV accounted for 1.29%(44 samples),with an overall positivity rate of 26.74%.(2)Based on the combined microscopic examination results,ultimately,37 review rules were chosen and 22 of them were added to enforce the conditions of microscopy.The false negative rates and sensitivities of BV,VVC and TV were 3.40%and 68.65%,5.22%and 69.98%,0.21%and 84.44%,respectively,while the reexamination rate of microscopy was 23.10%.(3)The final selected review criteria and additional microscopy conditions were validated using 748 clinical samples.The false negatives rates of BV,VVC,and TV were 4.81%,3.61%and 0.00%,respectively,and the review rate was 22.19%.(4)The proportion of white blood cell grades exceeding the limits of agreement between instrument microscopy and artificial wet slides microscopy was 4.81%.Conclusion The 37 review rules and 22 additional microscopic examination conditions established in this multi-center exper

关 键 词：阴道分泌物 全自动分析系统 有形成分分析 干化学酶检测 显微镜检查 复检规则 

分 类 号：R711.31[医药卫生—妇产科学]