Abstract

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. This report details the method validation study for raw ground beef, raw turkey (thermal processed, marinated), fresh cheese, deli ham and pasteurized liquid egg. Matrix studies and inclusivity/exclusivity, product consistency/stability, and robustness testing were conducted to assess the method's performance. 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. The reported data confirms 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. 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.

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