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There were no statistically significant differences found between the candidate and reference methods in the matrix studies. Inclusivity/exclusivity testing showed that the assay was able to detect both Listeria species and monocytogenes strains while excluding the non-Listeria isolates. Small variations in critical test parameters (enrichment time, extraction reagent volume and extracted sample volume) did not adversely affect the assay's performance, and stability testing indicated consistent results for at least one year. The data p