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Assay manufacturers point of view
- 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
Advantages
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Difficult to provide a simple solution all in one including all the required controls
Drawbacks
Assay manufacturers point of view
-
- 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
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- 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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