新型自动微生物分析系统对临床氧化酶阴性革兰阴性杆菌鉴定和药敏的评估

doi:10.16150/j.1671-2870.2017.01.010

摘要/Abstract

摘要： 目的评价新型自动微生物分析系统与目前临床常用微生物分析系统间对常见氧化酶阴性革兰阴性杆菌（oxidase-negative gram-negative bacilli,ONGNB）的鉴定和药敏结果的一致性。方法分别以临床常用的基质辅助激光解析电离飞行时间质谱技术（matrix-assisted laser desorption/ionization time of flight mass spectrometry,MALDI-TOF MS鉴定和VITEK2 compact AST-GN13药敏卡作为对照方法,采用新型自动微生物分析系统（TDR-300B Plus）及其配套肠杆菌科细菌检测试剂盒对临床标本中常见的ONGNB进行鉴定和药敏试验,计算Kappa值并进行McNemar检验,分析新型自动微生物分析系统与对照系统间的一致性。对2种系统鉴定不一致的菌株,采用16S rRNA测序结果作为最终鉴定结果。对于新型自动微生物分析系统与VITEK2 compact AST-GN13药敏卡2种药敏结果相差2级[敏感（S）/耐药（R）或R/S]的菌株,按照美国临床和实验室标准协会（Clinical and Laboratory Standards Institute,CLSI） M07-A9中推荐的微量肉汤稀释法进行测试作为最终药敏结果。结果通过对17个属32个种209株ONGNB鉴定结果的分析表明,新型自动微生物分析系统对各种常见ONGNB的鉴定结果与对照系统相比,Kappa值均>0.90,McNemar检验的P值均>0.05。在2种系统检测200株临床分离ONGNB对14种抗菌药物的药敏结果比对中发现,除氨曲南（86.02%）、头孢他啶（85.79%）、头孢吡肟（82.63%）、替加环素（82.76%）外,其他10种药物的完全一致率均>90%;所有药物的基本一致率均>90%;除替加环素（Kappa=0.704 8）外,其余12种药物Kappa均>0.80,其中只有氨曲南、头孢他啶和头孢吡肟3种药物McNemar检验的P<0.05。总体重大不一致率为3.16%,出现重大不一致最多的是大肠埃希菌（29/48）,最常出现的类型为“待测方法R/对照方法S/金标准R”（36/48）,以头孢他啶和头孢吡肟最为常见;总体严重不一致率为2.87%,最常出现的类型为“待测方法S/对照方法R/金标准S”（14/21）,以美罗培南和复方新诺明最为常见。结论新型自动微生物分析系统对常见ONGNB的鉴定及药敏检测结果与目前临床常用系统间的一致性较高,结果准确、可靠,可作为补充系统确保常规临床工作顺利进行。

关键词: 自动微生物分析系统, 细菌鉴定, 细菌药敏, 一致性

Abstract: Objective: To evaluate the agreement between TDR-300B Plus automatic microbial analysis system and the existing clinical microbial analysis system for identification and antimicrobial susceptibility test of clinical oxidase-negative gram-negative bacilli (ONGNB). Methods: The TDR-300B Plus analysis system and matched Enterobacteriaceae ID&AST Kit were adopted to proceed identification and antimicrobial susceptibility test of ONGNB, and results of MALDI-TOF and VITEK 2 compact AST-GN13 were used as the controls. The Kappa value was calculated and McNemar test was performed to evaluate the agreement between TDR-300B Plus and controls. 16S rRNA sequencing was used as the final identification when there was an inconsistent result between TDR-300B and MALDI-TOF. The CLSI M07-A9 broth microdilution method was used as the final for antimicrobial susceptibility test when the susceptibility result of TDR -300B Pluswas obviously different from VITEK (S/R or R/S). Results: Identification of 209 strains of ONGNB showed that results of TDR-300B Plus had good consistency with those of the control method (Kappa values >0.90, and McNemar P values >0.05). Antimicrobial susceptibility tests showed that among the 14 antimicrobials, the complete agreement (CA) of 10 were above 90% apart from aztreonam （ATM）(86.02%), ceftazidime （CAZ）(85.79%), cefepime(FEP) (82.63%) and tigecycline(TGC) (82.76%). The almost agreement(AA) of all the antimicrobials were >90%. Except TGC (Kappa=0.704 8), the Kappa of the others were >0.80, with only 3 (ATM, CAZ and FEP ) having a McNemar P values <0.05. The total MD was 3.16%, and Escherichia coli (29/48) appeared to be the most. The most frequent type of MD was R/S/R(36/48) with CAZ and FEP the most common. The total very major disagreement(VMD) was 2.87%. The most frequent type of VMD was S/R/S (14/21), with meropenem(MEM) and sulphamethoxazole/trimethoprim(SXT) the most common. Conclusions: For identification and antimicrobial susceptibility test of ONGNB, results of TDR-300B Plus have high agreements with those of existing microbial analysis system, which can be served as a supplement and ensure routine clinical work smoothly.

Key words: TDR-300B Plus, Bacterial identification, Antimicrobial susceptibility, Agreement

中图分类号:

R372

王粟, 朱德栋, 孙景勇, 韩立中. 新型自动微生物分析系统对临床氧化酶阴性革兰阴性杆菌鉴定和药敏的评估[J]. 诊断学理论与实践, 2017, 16(01): 48-54.

WANG Su, ZHU Dedong, SUN Jingyong, HAN Lizhong. Identification and antimicrobial susceptibility test of clinical oxidase-negative gram-negative bacilli with TDR-300B Plus automatic microbial analysis system[J]. Journal of Diagnostics Concepts & Practice, 2017, 16(01): 48-54.

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