AOAC ISPAM Meeting eBook, March 17 2015

Assay manufacturers point of view

Advantages

- If you follow the standard, this is a great opportunity to have a chance to sell more, at higher price, and gain competitive advantage -More labs will be able to start virus testing. More food companies will trust the advantages of testing. – possibility to make comparison of on performance criteria available commercial assays in comparison with the ISO standard method

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Assay manufacturers point of view

Drawbacks

Difficult to provide a simple solution all in one including all the required controls - - Methods very different from bacteria testing (several labs asked for practical training + technical support): you need skilled people in foodborne virus issue for technical support - No available referential to follow for certification (ISO 16140 non applicable) - Absence of valuable reference materials (ex: no cell culture for NoV = human stool samples only) - Numbers of details in informative annexes that labs considered as normative - Several normative points related to IP issue - Several matrices, several viruses : cost of validation - Absence of reference laboratories except for viruses in shellfish (NRL, CRL in Europe), difficulties to ask for validation or interlaboratory studies - A limited number of matrices within the scope, hence difficulties for complex ones (requests from service labs customers) -

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