School of Natural Science, University of Galway, Galway H91 TK33, Ireland.
Dis Aquat Organ. 2023 Aug 31;155:109-123. doi: 10.3354/dao03745.
This work aims to generate the data needed to set epidemiological cut-off values for minimum inhibitory concentration (MIC) and disc-diffusion zone measurements of Vibrio anguillarum. A total of 261 unique isolates were tested, applying standard methods specifying incubation at 28°C for 24-28 h. Aggregated MIC distributions for a total of 247 isolates were determined in 9 laboratories for 11 agents. Data aggregations of the disc zone for the 10 agents analysed contained between 157 and 218 observations made by 4 to 7 laboratories. Acceptable ranges for quality control (QC) reference strains were available for 7 agents and the related multi-laboratory aggregated data were censored, excluding the data of a laboratory that failed to meet QC requirements. Statistical methods were applied to calculate epidemiological cut-off values. Cut-off values for MIC data were calculated for florfenicol (≤1 µg ml-1), gentamicin (≤4 µg ml-1), oxytetracycline (≤0.25 µg ml-1) and trimethoprim/sulfamethoxazole (≤0.125/2.38 µg ml-1). The cut-off values for disc zone data were calculated for enrofloxacin (≥29 mm), florfenicol (≥27 mm), gentamicin (≥19 mm), oxolinic acid (≥24 mm), oxytetracycline (≥24 mm) and trimethoprim/sulfamethoxazole (≥26 mm). MIC and disc-diffusion zone data for the other agents where not supported by QC, thus yielding only provisional cut-off values (meropenem, ceftazidime). Regardless of whether QC is available, some of the aggregated MIC distributions (enrofloxacin, oxolinic acid), disc zone (sulfamethoxazole), and MIC and disc-diffusion distributions (ampicillin, chloramphenicol) did not meet the statistical requirements. The data produced will be submitted to the Clinical Laboratory Standards Institute for their consideration in setting international consensus epidemiological cut-off values.
本研究旨在生成用于设定鳗弧菌最低抑菌浓度(MIC)和药敏纸片扩散法抑菌圈测量的流行病学截断值所需的数据。共检测了 261 株分离株,采用 28°C 孵育 24-28 小时的标准方法。在 9 个实验室中,对 247 株分离株的总 MIC 分布进行了测定,共涉及 11 种药物。对分析的 10 种药物的药敏纸片扩散法抑菌圈数据进行汇总,4 至 7 个实验室共观察到 157 至 218 个数据点。7 种药物有可用的质控(QC)参考菌株的可接受范围,对相关多实验室汇总数据进行了删失,剔除了一个未达到 QC 要求的实验室的数据。应用统计方法计算流行病学截断值。计算了氟苯尼考(≤1μg/ml)、庆大霉素(≤4μg/ml)、氧四环素(≤0.25μg/ml)和甲氧苄啶/磺胺甲噁唑(≤0.125/2.38μg/ml)的 MIC 数据的流行病学截断值。计算了恩诺沙星(≥29mm)、氟苯尼考(≥27mm)、庆大霉素(≥19mm)、噁喹酸(≥24mm)、氧四环素(≥24mm)和甲氧苄啶/磺胺甲噁唑(≥26mm)的药敏纸片扩散法抑菌圈数据的流行病学截断值。由于 QC 不可用,其他药物的 MIC 和药敏纸片扩散法抑菌圈数据(美罗培南、头孢他啶)仅得出暂定的截断值。无论 QC 是否可用,一些汇总的 MIC 分布(恩诺沙星、噁喹酸)、药敏纸片扩散法抑菌圈(磺胺甲噁唑)以及 MIC 和药敏纸片扩散法抑菌圈分布(氨苄西林、氯霉素)都不符合统计学要求。所产生的数据将提交给临床实验室标准化协会,供其考虑用于设定国际共识的流行病学截断值。