Development of a new reference material for the validation of molecular detection methods for microbiological analysis |
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Authors: | Raquel Múrtula M Adela Yáñez Elena Soria Vicente Catalán |
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Institution: | (1) LABAQUA, S.A., C/Dracma, 16-18. Pol. Ind. Atalayas, 03114 Alicante, Spain; |
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Abstract: | The standard methodology used for the detection of bacteria in environmental samples and food is primarily based on bacterial
growth on specific culture media and confirmation by biochemical and/or immunological tests of all presumptive colonies. However,
this methodology presents a number of drawbacks, such as low sensitivity and specificity, and the long time needed to obtain
results. For this reason, the implementation of molecular methods in diagnostic laboratories has increased over the past several
years. Nevertheless, most of these newer methods have not been included in current legislation, and, in most of cases, they
have not yet been normalized. In this sense, the availability of appropriate reference materials (RMs) can help to overcome
these deficiencies. The aim of this study was to develop and validate, following ISO Guide 34, a new RM, in a tablet format,
for the quantification of Legionella pneumophila and Salmonella spp. by quantitative PCR (qPCR). This new RM can be used as a work reference sample in internal quality control, in the organization
of proficiency testing schemes (PTS), as well as for the validation of molecular methods based on qPCR. |
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