CLSI肠杆菌目及铜绿假单胞菌折点更新后对自动化药敏系统的影响及分析  

Analysis and the impact of CLSI on the automated antimicrobial susceptibility testing system after the update of Enterobacterales and Pseudomonas aeruginosa breakpoints

作　　者：杨硕[1] 王启[1] 喻华[2] 黄湘宁[2] 廖康[3] 王辉[1] Yang Shuo;Wang Qi;Yu Hua;Huang Xiangning;Liao Kang;Wang Hui(Department of Clinical Laboratory,Peking University People′s Hospital,Beijing 100044,China;Department of Clinical Laboratory,Sichuan Provincial People′s Hospital,Chengdu 610041,China;Department of Clinical Laboratory,the First Affiliated Hospital of Sun Yat-sen University,Guangzhou 510080,China)

机构地区：[1]北京大学人民医院检验科,北京100044 [2]四川省人民医院检验科,成都640041 [3]中山大学附属第一医院检验科,广州510080

出　　处：《中华检验医学杂志》2025年第2期230-240,共11页Chinese Journal of Laboratory Medicine

基　　金：2023年全国细菌耐药监测网委托研究课题(A202301);2022年度北京市重大疫情防治重点专科医学检验科卓越项目。

摘　　要：目的评价环丙沙星、左氧氟沙星、哌拉西林/他唑巴坦、阿米卡星、庆大霉素和妥布霉素在美国临床实验室标准化委员会折点更新前后不同自动化药敏系统的准确性。方法收集了2023年北京大学人民医院、四川省人民医院、中山大学附属第一医院3家医院65株肠杆菌目细菌(大肠埃希菌34株、肺炎克雷伯菌31株)及33株铜绿假单胞菌。以微量肉汤稀释法(BMD)为参考方法,评价我国目前主要在用的7种自动化药敏系统的10种药敏板卡(NMIC-413、GN09、N335、NMIC45、GN4F、NMIC-150、DL-120E、DL-120NE、ONE-96和NF-96)准确性。结果除了GN-09、N-335和NMIC-150卡,其他板卡报告的最低抑菌浓度在验证中存在未覆盖折点的情况。除折点未覆盖的情况,验证结果无极重大误差(VME)。所测的65株肠杆菌目细菌中,环丙沙星及左氧氟沙星基本一致率(EA%)超过92.3%(60/65),使用新折点环丙沙星分类一致率(CA%)由100%(65/65)至98.5%(64/65)降低到86.2%(56/65)至95.4%(62/65),N-335卡重大误差率(ME%)由1.5%(1/65)升高至4.6%(3/65);左氧氟沙星除GN-09和N-335卡以外,其余板卡新折点CA%≥96.9%(63/65),无ME;哌拉西林/他唑巴坦的EA%≥93.8%(61/65),新折点CA%≥92.3%(60/65),N-335卡ME%由1.5%(1/65)升高至4.6%(3/65);阿米卡星、庆大霉素及妥布霉素的EA%和新折点CA%都≥96.9%(63/65),且无ME。所测的33株铜绿假单胞菌中,环丙沙星EA%≥93.8%(30/32),应用新折点后环丙沙星CA%由90.6%(29/32)至100%(33/33)降低到84.4%(27/32)至100%(33/33),NMIC-413卡有2株菌出现ME;左氧氟沙星EA%均≥90.9%(30/33),新折点判读CA%由90.6%(29/32)至100%降低到69.7%(23/33)至93.8%(30/32),无ME;阿米卡星及妥布霉素EA%≥93.8%(30/32),大多数板卡阿米卡星及妥布霉素新折点CA%≥96.9%(31/32)。结论当前,我国较多自动化药敏系统中板卡无法覆盖更新折点;多数药敏系统中环丙沙星和左氧氟沙星对肠杆菌目和铜绿假单胞菌不满足验证要求。�Objective To assess the precision of various automated antimicrobial susceptibility testing systems for ciprofloxacin,levofloxacin,piperacillin/tazobactam,amikacin,gentamicin and tobramycin before and after the update of the breakpoints by Clinical and Laboratory Standards Institute.MethodsA total of 65 strains of Enterobacterales(34 Escherichia coli and 31 Klebsiella pneumoniae)and 33 strains of Pseudomonas aeruginosa were collected from Peking University People′s Hospital,Sichuan Provincial People′s Hospital,and the First Affiliated Hospital of Sun Yat-sen University in 2023.Broth microdilution(BMD)was employed as the reference method to assess the accuracy of ten antimicrobial susceptibility panels(NMIC-413,GN09,N335,NMIC45,GN4F,NMIC-150,DL-120E,DL-120NE,ONE-96 and NF-96)in seven automated antimicrobial susceptibility testing systems currently utilized in China.ResultsExcept for the GN-09,N-335,and NMIC-150,there were breakpoints that were not covered for the minimum inhibitory concentrations reported by the other panels in the validation.There was no very major error(VME)in the verification results except for the cases of not covered.Among the 65 strains of Enterobacterales,the essential agreement rate(EA%)of ciprofloxacin and levofloxacin was higher than 92.3%(60/65),and the categorical agreement rate(CA%)of ciprofloxacin using the new breakpoint decreased from 100%(65/65)-98.5%(64/65)to 95.4%(62/65)-86.2%(56/65).The major error rate(ME%)of N-335 card increased from 1.5%(1/65)to 4.6%(3/65);except for GN-09 and N-335 cards,the CA%of other cards under new breakpoint was≥96.9%(63/65)with no ME;the EA%of piperacillin/tazobactam was≥93.8%(61/65),and the CA%under new breakpoint was≥92.3%(60/65),and the ME%of N-335 card increased from 1.5%(1/65)to 4.6%(3/65).The EA%and CA%under new breakpoint of amikacin,gentamicin and tobramycin were all≥96.9%(63/65)with no ME.Among the 33 tested Pseudomonas aeruginosa isolates,the EA%of ciprofloxacin was≥93.8%(30/32),and after applying the new breakpoints,the CA%of

关 键 词：大肠杆菌 克雷伯菌 肺炎 假单胞菌 铜绿 性能验证测试 

分 类 号：R965[医药卫生—药理学]