Banerjee Kakolie, Peirson Brittney, Hu Chuxuan, Carrier Elijah, Malsick Lauren, Tarasova Yekaterina, Daudenarde Sophie, Brownell Daniel, Koeris Michael, Klass Nicole, Bird Patrick, Benzinger M Joseph, Agin James, Goins David
Sample6, 12 Gill St, Suite 4200, Woburn, MA 01801.
Q Laboratories, Inc., 1400 Harrison Ave, Cincinnati, OH 45214.
J AOAC Int. 2018 Sep 1;101(5):1584-1592. doi: 10.5740/jaoacint.17-0484. Epub 2018 Apr 4.
Listeria spp. are an important foodborne human pathogen because of their ability to cause disease and high mortality in individuals, particularly pregnant women, neonates, the elderly, immunocompromised individuals, and children. The Sample6 DETECTTM HT/L Kit is a semi-automated qualitative pathogen detection system designed to detect Listeria spp. (L. monocytogenes, L. innocua, L. ivanovii, L. seeligeri, L. welshimeri, and L. marthii) in environmental samples using the Sample6 BioIlluminationTM technology.
The study was done to evaluate the Sample6 DETECT HT/L Kit. The assay was evaluated for inclusivity, exclusivity, robustness, product consistency, and stability, and a matrix study of one environmental surface.
The performance of the Sample6 DETECT HT/L was compared with U.S. Food and Drug Administration reference culture method for Listeria using an unpaired study design.
The Sample6 DETECT HT/L assay correctly identified all 50 inclusivity isolates and correctly excluded all 30 nontarget strains evaluated. The assay was not affected by minor variations in incubation temperature and time, or sample volume. Results across three production lots spanning the shelf life of the assay were consistent. In the matrix study, the Sample6 DETECT HT/L for Listeria correctly identified each test portion for the presence or absence of Listeria, and there were no statistically significant differences between candidate and reference method results.
The data collected in this study demonstrate that the Sample6 DETECT HT/L assay is a reliable method for the detection of Listeria spp. on stainless-steel environmental surfaces after 22 h of enrichment.
李斯特菌属是一种重要的食源性人类病原体，因为它们能够在个体中引发疾病并导致高死亡率，尤其是孕妇、新生儿、老年人、免疫功能低下者和儿童。Sample6 DETECTTM HT/L试剂盒是一种半自动定性病原体检测系统，旨在使用Sample6生物发光技术检测环境样本中的李斯特菌属（单核细胞增生李斯特菌、无害李斯特菌、伊氏李斯特菌、斯氏李斯特菌、威氏李斯特菌和马氏李斯特菌）。
本研究旨在评估Sample6 DETECT HT/L试剂盒。对该检测方法进行了包容性、排他性、稳健性、产品一致性和稳定性评估，并对一个环境表面进行了基质研究。
采用非配对研究设计，将Sample6 DETECT HT/L的性能与美国食品药品监督管理局的李斯特菌参考培养方法进行比较。
Sample6 DETECT HT/L检测方法正确鉴定了所有50株包容性菌株，并正确排除了所有30株评估的非目标菌株。该检测方法不受培养温度和时间或样本体积的微小变化影响。在该检测方法保质期内的三个生产批次中，结果是一致的。在基质研究中，用于检测李斯特菌的Sample6 DETECT HT/L正确鉴定了每个测试部分中李斯特菌的存在与否，候选方法和参考方法的结果之间没有统计学显著差异。
本研究收集的数据表明，Sample6 DETECT HT/L检测方法是一种在富集22小时后检测不锈钢环境表面李斯特菌属的可靠方法。
