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Martin D’Agostino and David Rodr´ıguez-La´zaro
D’Agostino et al., 2004; Heuvelink et al., 2004; Josefsen et al., 2004; Malorney et al., 2004). In all, the FOOD-PCR project produced more than 30 publications, many of which are now frequently cited in the scientific literature. The evidence shows that this work is highly valued and, in particular, that the need for robust validated methods is recognized by the scientific community. Indeed, there has been a lot of interest shown in the methods by various organizations who wish to incorporate these methods into their routine sampling strategies. Furthermore, many members of the FOOD-PCR consortium have contributed to the activities of the standardization body (TAG 3 of CEN/ TC 275/WG 6), and the standards now published (ISO/TS 20836, 2005; ISO 20837, 2006; ISO 20838, 2006; ISO 22174, 2005) were based on the findings of the FOOD-PCR project. The publication of these standards highlights the requirement that PCR-based methods should be implementable for food analysis. One of the visions of the CEN/TAG3 group was to have PCR-based methods used routinely alongside conventional standard methods in enduser laboratories by the year 2010. To our knowledge, the FOOD-PCR methods developed thus far are not used routinely alongside conventional methods for food analysis, although there is enormous diagnostic potential. Part of the problem in progressing their use is technical, however a lack of international validation, the need for training of analysts, and difficulties in the transfer of technology also play major roles. Why are these problems seemingly insurmountable? Perhaps one reason is that many analysts still regard the conventional ‘gold standard’ as the only completely trustworthy method, and as mentioned earlier, any new method should be shown to work at least as well as and reliably as conventional methods. This really is what is required to convince the potential end-users of the effectiveness of FOOD-PCR methods and little if any progress has been made to reach this goal, although the technology has been around for many years now. This is why the focus of the FOOD-PCR project was the removal of these barriers through establishment of a research group whose goal was development, harmonization, and validation of methodology.
II.E. Implementation – how will it be achieved? A direct comparison between the traditional standard method and the PCR-based method where the performance criteria for both methods are known is essential. This like other ring trials would ideally involve 10–12 partners. The two specific elements of both methods, which would be determined and compared, are diagnostic specificities (related to number of false positives) and diagnostic sensitivities (related to number of true positives). This direct comparison should be performed according to a standard