Commercial Diagnostic Kits
There are many commercial diagnostic qPCR kits for diagnostic testing that are available on the market and in use within control programmes internationally. Information on their performance is required; analytical performance information is available, however limited information is recorded in the published literature regarding diagnostic performance in differing production settings.
Alinovi et al. (2009) evaluated the performance of the Tetracore VetAlertTM kit, which incorporates a probe-based qPCR detection assay targeting the MAP hspX gene, compared with HEYM and Trek ESP culture and serum antibody ELISA. The diagnostic sensitivity was estimated using a Baysian approach to be 0.6. Although the diagnostic specificity was difficult to evaluate, given that the two herds tested in this study were both infected and no unexposed animals were assessed, it was estimated to be 0.9 7.A few studies have been published evaluating the performance of commercially available kits for MAP extraction and qPCR, determining analytical and diagnostic characteristics, comparing kits with each other, available culture methods and/or new, ‘in-house' qPCR assays (Laurin et al., 2015; Alajmi et al., 2016; Mita et al., 2016; Heuvelink et al., 2017; Schwalm et al., 2018; Arsenault et al., 2019). Such studies can be time consuming and costly, however they are important to ultimately achieve the goals of control programmes. It would be useful to have more published data on the use of commercially available qPCR tests in the international setting, including interlaboratory comparisons, to enable informed selection of the appropriate qPCR tool to achieve the desired diagnostic outcomes.
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