比较Thermo STP6F药敏测定卡与微量肉汤稀释法测定链球菌对抗菌药物的敏感性
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摘要
目的为临床提供快速、准确、方便的链球菌药敏试验测定方法,比较Thermo STP6F药敏测定卡与金标准微量肉汤稀释法测定链球菌对抗菌药物的敏感性。方法按CLSI要求,用Thermo STP6F药敏测定卡检测199株链球菌(肺炎链球菌、化脓链球菌和无乳链球菌),与微量肉汤稀释法结果进行比较。结果两种药敏测试方法涵盖10种抗菌药物对肺炎链球菌的药敏试验结果,分类一致率(CA)为94.6%,基本一致率(EA)为95.5%,重大偏差(VMD)为0.5%,较大偏差(MD)为1.2%,次要偏差(mD)为4.6%;对化脓链球菌两种方法测试结果的CA为99.2%,EA为95.0%,VMD为0.8%,MD为0.8%,mD为0;对无乳链球菌两种方法测试结果的CA为97.8%,EA为93.6%,VMD为1.1%,MD为0.9%,mD为1.2%。Thermo STP6F药敏测定卡所得数值常比标准方法略高。结论 Thermo STP6F药敏测定卡对链球菌的检测结果与微量肉汤稀释法一致性较好,在用于检测肺炎链球菌对美罗培南敏感性时建议结合E试验法复核确认。
Objective To compare the ability of a rapid test kit, Thermo STP6 F plate, and broth microdilution method in testing the antimicrobial susceptibility of Streptococcus isolates for the purpose to provide a rapid, accurate, and convenient method for testing the susceptibility of Streptococcus. Methods A rapid test kit, Thermo STP6 F MIC plate, and reference method, broth microdilution, were used to test the susceptibility of 199 strains of Streptococcus(S. pneumoniae, S. pyogenes, and S. agalactiae)according to CLSI recommendations. The results were compared critically. Results For S. pneumoniae, Thermo STP6 F plate and manual broth microdilution showed categorical agreement(CA) of 94.6%, essential agreement(EA) of 95.5% in the MIC results of 10 antibiotics. The calculated very major discrepancy(VMD, false susceptible interpretation), major discrepancy(MD,false resistant interpretation), and minor discrepancy(mD, false categorization involving intermediate result) of Thermo STP6 F plate per CLSI requirements was 0.5%, 1.2%, and 4.6%, respectively, compared to manual broth microdilution. The CA and EA for testing S. pyogenes were 99.2% and 95.0% respectively. Both VMD and MD were 0.8%, mD was 0. In testing S. agalactiae, CA was97.8%, EA was 93.6%, VMD 1.1%, MD 0.9%, and mD 1.2%.Thermo STP6 F plate often reported slightly higher MIC values than the reference method. Conclusions Thermo STP6 F plate offers high inter-assay concordance with the reference broth microdilution method. False results should be verified by E-test in clinical practice when testing the susceptibility of S.pneumoniae to meropenem.
Objective To compare the ability of a rapid test kit, Thermo STP6 F plate, and broth microdilution method in testing the antimicrobial susceptibility of Streptococcus isolates for the purpose to provide a rapid, accurate, and convenient method for testing the susceptibility of Streptococcus. Methods A rapid test kit, Thermo STP6 F MIC plate, and reference method, broth microdilution, were used to test the susceptibility of 199 strains of Streptococcus(S. pneumoniae, S. pyogenes, and S. agalactiae)according to CLSI recommendations. The results were compared critically. Results For S. pneumoniae, Thermo STP6 F plate and manual broth microdilution showed categorical agreement(CA) of 94.6%, essential agreement(EA) of 95.5% in the MIC results of 10 antibiotics. The calculated very major discrepancy(VMD, false susceptible interpretation), major discrepancy(MD,false resistant interpretation), and minor discrepancy(mD, false categorization involving intermediate result) of Thermo STP6 F plate per CLSI requirements was 0.5%, 1.2%, and 4.6%, respectively, compared to manual broth microdilution. The CA and EA for testing S. pyogenes were 99.2% and 95.0% respectively. Both VMD and MD were 0.8%, mD was 0. In testing S. agalactiae, CA was97.8%, EA was 93.6%, VMD 1.1%, MD 0.9%, and mD 1.2%.Thermo STP6 F plate often reported slightly higher MIC values than the reference method. Conclusions Thermo STP6 F plate offers high inter-assay concordance with the reference broth microdilution method. False results should be verified by E-test in clinical practice when testing the susceptibility of S.pneumoniae to meropenem.
引文
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[9]熊安英，黄鹂，马莉，等.对VITEK 2-Compact肺炎链球菌GP68药敏卡的性能评估[J].中国感染与化疗杂志，2017, 17(5):558-561.
[10]黄梅，潘庭荣，熊安英，等. VITEK-2 COMPACT系统检测肺炎链球菌对美罗培南药敏结果准确性的探究[J].检验医学与临床，2016, 13(z2):182-184.
[11]李裕军，潘楚芝，赵子文，等.鲍曼不动杆菌常用药物敏感性试验方法之间的差异比较[J].实用医学杂志，2013, 29(1):119-121.
[12]闫少珍，宋玥，陈中举，等. 4种方法检测替加环素对鲍曼不动杆菌和肠杆菌科细菌体外药敏结果分析[J].中华微生物学和免疫学杂志，2014, 34(11):859-862.
[2] Clinical and Laboratory Standards Institute. Methods for dilution antimicrobial susceptibility test for bacteria that grow aerobically[S]. 2012, M07-A9.
[3] Clinical and Laboratory Standards Institute. Performance standards for antimicrobial susceptibility testing[S]. 2016,M100-S26.
[4] ISO. Clinical laboratory testing and in vitro diagnostic test systems—Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices—Part 2:Evaluation of performance of antimicrobial susceptibility test devices(ISO 20776-2:2007)[S]. Geneva,Switzerland:International Organization for Standardization,2007.
[5]中国合格评定国家认可委员会. CNAS-CL01-A001:2018检测和校准实验室能力认可准则在微生物检测领域的应用说明[S/OL].[2019-03-26]. https：//www. cnas. org. cn/images/rkgf/sysrk/rkyyzz/2018/03/05/2CDC9E020FABF4F3B6C3FD6157D4A801. pdf.
[6] U. S. Food and Drug Administration. Class II special controls guidance document:antimicrobial susceptibility test(AST)systems[S/OL].[2019-03-26]. https：//www. fda. gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm388961.
[7] RENNIE R P, TURNBULL L, BRONSNIKOFF C, et al.First comprehensive evaluation of the M.I.C. evaluator device compared to Etest and CLSI broth microdilution for MIC testing of aerobic gram-positive and gram-negative bacterial species[J].J Clin Microbiol, 2012, 50(4):1147-1152.
[8] CHARLES M K, BERENGER B M, TURNBULL L A, et al.Variability ofβ-lactam susceptibility testing for Streptococcus pneumoniae, using 4 commercial test methods and broth microdilution[J]. Diagn Microbiol Infect Dis, 2016, 84(3):240-245.
[9]熊安英，黄鹂，马莉，等.对VITEK 2-Compact肺炎链球菌GP68药敏卡的性能评估[J].中国感染与化疗杂志，2017, 17(5):558-561.
[10]黄梅，潘庭荣，熊安英，等. VITEK-2 COMPACT系统检测肺炎链球菌对美罗培南药敏结果准确性的探究[J].检验医学与临床，2016, 13(z2):182-184.
[11]李裕军，潘楚芝，赵子文，等.鲍曼不动杆菌常用药物敏感性试验方法之间的差异比较[J].实用医学杂志，2013, 29(1):119-121.
[12]闫少珍，宋玥，陈中举，等. 4种方法检测替加环素对鲍曼不动杆菌和肠杆菌科细菌体外药敏结果分析[J].中华微生物学和免疫学杂志，2014, 34(11):859-862.