Raúl Alonso, Pedro Razquin, Vanesa Carrascón, Luis Mata
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The device is sealed during the analysis, avoiding risks of contamination, and is therefore safe to use in food production environments.</p><p><strong>Objective: </strong>This report details the method validation study for raw ground beef, raw turkey (thermal processed, marinated), fresh cheese, deli ham, and pasteurized liquid egg.</p><p><strong>Methods: </strong>Matrix studies and inclusivity/exclusivity, product consistency/stability, and robustness testing were conducted to assess the method's performance.</p><p><strong>Results: </strong>Inclusivity/exclusivity testing showed that the Microlab Salmonella method was able to detect Salmonella O Group A-E isolates while excluding the non-Salmonella strains. In the matrix studies, the differences between the candidate and reference methods were not statistically significant. Minor variations in test parameters (enrichment time, time to read results, and enrichment temperature) did not affect the performance of the Microlab assay. There were no statistically significant differences between recently manufactured lots and those that were halfway through their expiration period or between those that were close to expiring.</p><p><strong>Conclusions: </strong>The reported data confirm that Microlab Salmonella is reliable for detecting Salmonella in raw ground beef, raw turkey (thermal processed, marinated), fresh cheese, pasteurized liquid egg, and deli ham.</p><p><strong>Highlights: </strong>Microlab Salmonella is validated to detect Salmonella in select food matrixes. 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引用次数: 0
摘要
背景:Microlab Salmonella 是检测 A-E 组 O 型沙门氏菌的一体化解决方案,它在一个一次性设备中集成了进行分析的所有要素:即用型富集肉汤、侧流免疫层析测试和细菌灭活化学制剂。Microlab 沙门氏菌分析仪可方便地在现场使用,不需要特定的实验室设备或技术技能。该设备在分析过程中是密封的,可避免污染风险,因此可在食品生产环境中安全使用:本报告详细介绍了对生碎牛肉、生火鸡肉(热加工、腌制)、新鲜奶酪、熟食火腿和巴氏杀菌液态蛋的方法验证研究:方法:进行基质研究和包容性/排他性、产品一致性/稳定性和稳健性测试,以评估该方法的性能:结果:包容性/排他性测试表明,Microlab 沙门氏菌检测方法能够检测出 A-E 组 O 型沙门氏菌分离物,同时排除了非沙门氏菌菌株。在基质研究中,候选方法和参考方法之间的差异在统计学上并不显著。检测参数(富集时间、读取结果的时间和富集温度)的微小变化不会影响 Microlab 检测方法的性能。最近生产的批次与有效期过半的批次或接近有效期的批次之间没有统计学意义上的差异:报告的数据证实,Microlab 沙门氏菌检测试剂盒可以可靠地检测生碎肉、生火鸡(热加工、腌制)、新鲜奶酪、巴氏杀菌液体鸡蛋和熟食火腿中的沙门氏菌:Microlab Salmonella 已通过验证,可检测特定食品基质中的沙门氏菌。Microlab Salmonella 将富集、检测和灭活等步骤集成在一个设备中。
Validation of the Microlab Salmonella for Detection of Salmonella O Group A-E in Selected Foods: AOAC Performance Tested MethodSM 052401.
Background: Microlab Salmonella is an all-in-one solution for detection of Salmonella O Groups A-E that integrates, in a single disposable device, all elements to perform the analysis: a ready-to-use enrichment broth, a lateral flow immunochromatography test, and a chemical agent for bacterial inactivation. Microlab Salmonella can be easily used on-site and does not require specific laboratory equipment or technical skills. The device is sealed during the analysis, avoiding risks of contamination, and is therefore safe to use in food production environments.
Objective: This report details the method validation study for raw ground beef, raw turkey (thermal processed, marinated), fresh cheese, deli ham, and pasteurized liquid egg.
Methods: Matrix studies and inclusivity/exclusivity, product consistency/stability, and robustness testing were conducted to assess the method's performance.
Results: Inclusivity/exclusivity testing showed that the Microlab Salmonella method was able to detect Salmonella O Group A-E isolates while excluding the non-Salmonella strains. In the matrix studies, the differences between the candidate and reference methods were not statistically significant. Minor variations in test parameters (enrichment time, time to read results, and enrichment temperature) did not affect the performance of the Microlab assay. There were no statistically significant differences between recently manufactured lots and those that were halfway through their expiration period or between those that were close to expiring.
Conclusions: The reported data confirm that Microlab Salmonella is reliable for detecting Salmonella in raw ground beef, raw turkey (thermal processed, marinated), fresh cheese, pasteurized liquid egg, and deli ham.
Highlights: Microlab Salmonella is validated to detect Salmonella in select food matrixes. Microlab Salmonella integrates the steps of enrichment, detection, and inactivation in a single device.