US Food and Drug Administration, 5001 Campus Drive, College Park, MD, USA.
US Food and Drug Administration, 5001 Campus Drive, College Park, MD, USA.
Infect Genet Evol. 2019 Sep;73:214-220. doi: 10.1016/j.meegid.2019.04.026. Epub 2019 Apr 27.
We review how FDA surveillance identifies several ways that whole genome sequencing (WGS) improves actionable outcomes for public health and compliance in a case involving Listeria monocytogenes contamination in an ice cream facility. In late August 2017 FDA conducted environmental sampling inside an ice cream facility. These isolates were sequenced and deposited into the GenomeTrakr databases. In September 2018 the Centers for Disease Control and Prevention contacted the Florida Department of Health after finding that the pathogen analyses of three clinical cases of listeriosis (two in 2013, one in 2018) were highly related to the aforementioned L. monocytogenes isolates collected from the ice cream facility. in 2017. FDA returned to the ice cream facility in late September 2018 and conducted further environmental sampling and again recovered L. monocytogenes from environmental subsamples that were genetically related to the clinical cases. A voluntary recall was issued to include all ice cream manufactured from August 2017 to October 2018. Subsequently, FDA suspended this food facility's registration. WGS results for L. monocytogenes found in the facility and from clinical samples clustered together by 0-31 single nucleotide polymorphisms (SNPs). The FDA worked together with the Centers for Disease Control and Prevention, as well as the Florida Department of Health, and the Florida Department of Agriculture and Consumer Services to recall all ice cream products produced by this facility. Our data suggests that when available isolates from food facility inspections are subject to whole genome sequencing and the subsequent sequence data point to linkages between these strains and recent clinical isolates (i.e., <20 nucleotide differences), compliance officials should take regulatory actions early to prevent further potential illness. The utility of WGS for applications related to enforcement of FDA compliance programs in the context of foodborne pathogens is reviewed.
我们回顾了 FDA 监测如何通过全基因组测序 (WGS) 识别几种方法，这些方法可改善公共卫生和合规性的可操作性结果，案例涉及冰淇淋工厂李斯特菌污染。2017 年 8 月下旬，FDA 在一家冰淇淋工厂内部进行环境采样。这些分离株被测序并存入 GenomeTrakr 数据库。2018 年 9 月，疾病控制与预防中心在发现三例李斯特菌病（2013 年两例，2018 年一例）的病原体分析与上述从冰淇淋工厂收集的李斯特菌高度相关后，联系了佛罗里达州卫生部。2017 年。2018 年 9 月下旬，FDA 回到冰淇淋工厂，进一步进行环境采样，并再次从与临床病例具有遗传相关性的环境副样本中回收李斯特菌。发布了自愿召回令，包括所有 2017 年 8 月至 2018 年 10 月生产的冰淇淋。随后，FDA 暂停了该食品工厂的注册。在工厂和临床样本中发现的李斯特菌的 WGS 结果通过 0-31 个单核苷酸多态性 (SNP) 聚集在一起。FDA 与疾病控制与预防中心、佛罗里达州卫生部以及佛罗里达州农业和消费者服务部合作，召回了这家工厂生产的所有冰淇淋产品。我们的数据表明，当食品工厂检查中可用的分离株进行全基因组测序，随后的序列数据表明这些菌株与近期临床分离株之间存在关联（即<20 个核苷酸差异）时，合规官员应及早采取监管行动，以防止进一步发生潜在疾病。本文综述了 WGS 在与食品病原体相关的 FDA 合规计划执行方面的应用。
