Selection of Pathogen Strains for Evaluating Rapid Pathogen Test Methods Applied to New Matrices
Before first use of a validated method, laboratories verify their ability to apply the method as designed. In routine laboratory operations, new matrices will appear occasionally, with insufficient data ensuring method performance for the matrix. Approaches have been documented to the “fitness for purpose” testing then required, but the question of how to select the pathogen strain or strains for this activity has received scant attention. This article reviews factors that may influence strain selection for method evaluation, including processing environment, geographical origin or proximity, seasonality, environmental factors, intrinsic characteristics of matrices, public health data, and the logistics, cost, and complexities involved in managing large challenge-strain collections. We conclude that food safety is served best when laboratories conduct method application studies for new matrices with one or more appropriately stressed members of a small, conveniently managed panel of challenge strains. However, if stakeholders have clear knowledge of a strong link between the matrix and a particular strain of concern, that would be a reason to favor acquisition and use of that strain. The worst approach is to not conduct application studies because of perceived limitations in accessing one or more highly specific strains.
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