2015年全国VITEK-2细菌药敏检测系统药敏试验结果准确性调查研究

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目的调查全国细菌耐药监测网中使用VITEK-2药敏检测系统的医院微生物实验室药敏检测结果的准确性。方法向参加调研的425所医院的微生物实验室同时发放两株编号分别为Carss-14-QC001(产ESBLs大肠埃希菌)和Carss-14-QC002(产KPC肺炎克雷伯菌)的质控测试菌株,以微量肉汤稀释法作为参考方法,通过计算各实验室药敏结果基本一致性(EA)、分类一致性(CA)、非常重大误差(VME)、重大误差(ME)和小误差(mE)分析评估参评实验室药敏结果测定的准确性。结果 Carss-14-QC001的药敏测试结果:氨苄西林/舒巴坦和头孢曲松的EA(24.7%、51.6%)和CA(21.9%、79.2%)较低,其他抗菌药物的EA和CA值均>90.0%;氨苄西林、氨苄西林/舒巴坦、头孢曲松、头孢替坦和磺胺甲噁唑/甲氧苄啶各出现一个VME结果;仅一个参评实验室(0.3%)的ESBL检测结果错误;Carss-14-QC002药敏结果:头孢替坦的EA(24.6%)和CA(21.2%)最低,美罗培南和头孢吡肟的EA(81.0%和82.1%)和CA(41.0%和76.9%)较低,其他抗菌药物的EA和CA均>90.0%;美罗培南VME百分率为6.2%,其余抗菌药物VME百分率较低为0~1.2%;抗菌药物对二株测试菌株药敏结果的ME均较低为0~0.7%。结论全国VITEK-2细菌药敏检测系统中氨苄西林/舒巴坦、头孢曲松、头孢替坦、美罗培南和头孢吡肟的药敏检测结果一致性和准确性较低,其他抗菌药物的药敏结果均具有很好的一致性和较高的准确性。 Objective To investigate the accuracy of the drug susceptibility test results of hospital microbiology laboratories using VITEK-2 drug susceptibility testing system in the national bacterial resistance surveillance network. Methods The quality control of two strains of Carss-14-QC001 (ESBLs-producing Escherichia coli) and Carss-14-QC002 (KPC-producing Klebsiella pneumoniae) were simultaneously distributed to the microbes laboratories of 425 hospitals participating in the survey. The test strains were diluted with broth as a reference method. The basic consistency (EA), classification consistency (CA), very significant error (VME), significant error (ME) and small error (mE) analysis to evaluate the accuracy of the determination of drug susceptibility results in participating laboratories. Results Susceptibility test results of Carss-14-QC001: EA (24.7%, 51.6%) and CA (21.9%, 79.2%) of ampicillin / sulbactam and ceftriaxone were lower, EA and CA of other antibacterial drugs (> 90.0%). One VME result was found in ampicillin, ampicillin / sulbactam, ceftriaxone, cefotetan and sulfamethoxazole / trimethoprim. Only one ESBL Results of the Susceptibility Test of Carss-14-QC002: EA (24.6%) and CA (21.2%) were the lowest in cefotetan and EA (81.0% and 82.1%) and CA (41.0%) in meropenem and cefepime And 76.9%, respectively. The other antibacterials had EA and CA> 90.0%. The percentage of VME in meropenem was 6.2% and the percentage of VME in other antibiotics was 0-1.2% The MEs were lower from 0 to 0.7%. Conclusion The sensitivity and accuracy of ampicillin / sulbactam, ceftriaxone, cefotetan, meropenem and cefepime in the nationwide VITEK-2 bacterial susceptibility testing system are lower and the sensitivity of other antibacterial drugs Sensitive results have good consistency and high accuracy.
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