一种进口呋喃妥因药敏纸片试验性能评价

Evaluation of the performance of one kind of imported nitrofurantoin susceptibility test disk

目的:评估一种进口呋喃妥因药敏纸片产品的检测性能。方法:收集北京地区一家三甲医院2016—2017年从临床标本中分离的118株病原菌,包括肠杆菌目细菌61株、葡萄球菌属48株、肠球菌属9株。依照美国临床和实验室标准协会(Clinical and Laboratory Standards Institute,CLSI)文件M100ED30,对国产和进口呋喃妥因药敏纸片采用纸片扩散法进行体外药物敏感性试验检测,并根据其临床折点进行结果判读,比较2种纸片判读结果的分类一致率(CA)。结果:118株病原菌中,有73株对呋喃妥因敏感,4株中介,41株耐药。进口与国产体外药敏实验纸片的分类一致率为100%。结论:该呋喃妥因进口药敏实验纸片体外抗菌药物敏感性试验结果可靠,与国产体外药敏实验纸片一致性好,可以满足实验室需求,为临床感染性疾病诊疗提供用药参考。

Objective: To evaluate the detection performance of one kind of imported nitrofurantoin susceptibility test disk for antimicrobial susceptibility test by disk diffusion method. Methods: A total of 118 strains of pathogenic bacteria were collected from a Class A tertiary comprehensive hospital in Beijing from 2016 to 2017, including 61 isolates of Enterobacterales, 48 isolates of Staphylococcus spp. and 9 isolates of Enterococcus spp. Antimicrobial susceptibility test was performed following Clinical and Laboratory Standards Institute(CLSI) documents M100 ED30, using disk diffusion method. The differences of susceptibility between domestic disks and imported disks against 118 bacteria strains were detected according to the breakpoints described in CLSI documents M100 ED30. The rate of categorical agreement(CA) of susceptibility conducted by the two kinds of disks was calculated. Results: Among the 118 isolates, 73, 4 and 41 were categorized as susceptible(S), intermediate(I),and resistant(R) to nitrofurantoin, respectively.The rate of categorical agreement of susceptibility to nitrofurantoin using imported disks and domestic disks was 100%. Conclusion: The results of susceptibility test using imported nitrofurantoin disks are reliable, and consistent with the results by domestic nitrofurantoin disks. Imported nitrofurantoin disk can meet the requirements of clinical laboratory. The test results will provide direct reference data for clinical application for nitrofurantoin in infectious diseases.