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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Mc Nemar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 r RNA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Mc Nemar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。
OBJECTIVE: To evaluate the identity and susceptibility to common oxidase-negative gram-negative bacilli (ONGNB) between the new automated microbial analysis system and the currently available clinical microbiological analysis system. Methods: Matrix-assisted laser desorption / ionization time of flight mass spectrometry (MALDI-TOF MS) and VITEK2 compact AST-GN13 drug sensitive card were used as control methods. The automatic microbiological analysis system (TDR-300B Plus) and its supporting Enterobacteriaceae bacteria detection kit for identification and drug susceptibility testing of common ONGNB in clinical specimens, calculation of Kappa value and McNemar test, analysis of new automatic microbiological analysis system and The consistency between the two control systems was verified by using 16S rRNA sequencing results as the final identification results.The results of two susceptibility results of the new automated microbiological analysis system and VITEK2 compact AST-GN13 drug susceptibility card were two-level difference [Sensitive (S) / drug resistant (R) or R / S] strains were tested according to the micro broth dilution method recommended in the Clinical and Laboratory Standards Institute (CLSI) M07-A9 as The final drug susceptibility results.Results: Through the analysis of the identification results of ONGNB of 209 strains of 32 genera in 17 genera, the results showed that the new automatic microorganism Analysis of the system for a variety of common ONGNB identification results compared with the control system, Kappa values were> 0.90, McNemar test P values were> 0.05 in two systems detected 200 clinical ONGNB isolates of 14 antimicrobial susceptibility results The comparison found that the other 10 kinds of drugs except for aztreonam (86.02%), ceftazidime (85.79%), cefepime (82.63%) and tigecycline (82.76% ; All drugs were basically the same rate of> 90%; except for tigecycline (Kappa = 0.704 8), the remaining 12 Kappa drugs were> 0.80, of which only aztreonam, ceftazidime and cefepime 3 drugs Mc Nemar Test P <0.05. The overall major inconsistency was 3.16%, and the most significant discrepancy was E. coli (29/48), the most commonly occurring type being “Test Method R / Control S / Gold R (36/48), with ceftazidime and cefepime the most common, with a total overall concordance rate of 2.87%. The most commonly occurring type was ceftazidime and cefepime, ”the test method S / control method R / gold standard S" 21) to meropenem and cotrimoxazole is the most common.Conclusion: The new automatic microbiological analysis of common ONGNB identification and drug sensitivity test results and the current clinical The consistency between the systems is high, the results are accurate and reliable, and can be used as supplementary system to ensure the smooth progress of routine clinical work.