青霉素E-test法药敏条临床研究

Clinical study of Penicillin drug sensitivity strips by E-test method

目的通过国内外青霉素E-test法药敏条对临床分离菌株的药物敏感性研究,评价国产E-test法药敏条的临床性能。方法收集2014—2016年临床分离纯化菌株226株,与梅里埃药敏条平行对比,超过±1个稀释倍数的采用微量稀释法进一步确认,对所测MIC值及敏感性进行统计学方法分析。结果国产药敏条与法国梅里埃药敏条比对中,有9株菌的MIC值超出了±1个稀释倍数范围,经微量肉汤稀释法验证后,有6株菌的MIC值回到了±1个稀释倍数的范围内,即纠正后的EA(Essential agreement)%为98.67%(223/226)。另外,有4株菌的体外敏感性判读存在差异,经微量肉汤稀释法验证后,有3株菌的敏感判定结果与国产条完全一致,即最终的CA(Categorical agreement)%为99.56%(225/226),VMD(Very major discrepancy)为0%,MD(Major discrepancy)为0.44%(1/226)。结论国产E-test法药敏条临床性能与国外产品无显著差异,可用于临床微生物药敏的体外检测。

Objective To compare with drug sensitivity against clinical isolates for five kinds of E-test drug sensitivity strip at home and abroad and evaluate the clinical performance of E-test drug sensitivity strip made in China. Methods Collect 226 clinical isolated strains from 2014 to 2016. Compare with Bio Mérieux drug sensitivity strip and for the results of more than ± 1 dilution ration,carry on micro-dilution method for further validation. Compare and analyze the minimum inhibitory concentration and the sensitivity by statistical methods. Results It was compared between drug sensitivity strips made in China and France Bio Mérieux. There are 9 strains of MIC values outside this range. After verification by broth micro-dilution method,there are 6 strains of the MIC values returned to within a range of ± 1 dilution multiples,which is correct EA（Essential agreement） % of 98. 67%（223/226）. There are differences in the interpretation in vitro susceptibility of 4 strains. After validation by broth micro-dilution method,there are 3 strains of susceptibility determination consistent with the results of the domestic E-test sensitivity strips,namely the final CA（Categorical agreement） % for 99. 56%（225/226）,VMD（Very major discrepancy） for 0% and MD（Major discrepancy） for0. 44%（1/226）. Conclusion There is no significant difference on clinical performance between domestic drug sensitivity strip and the corresponding foreign strip,indicating domestic drug sensitivity strip can be used for in-vitro detection for drug susceptibility of clinical microbiology.