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Allergen Test Kit Shortage

Started by , Dec 01 2023 04:44 PM
7 Replies

We have not been able to get a steady supply of certain allergen tests due to supply chain issues at Neogen. We have been relying on an emergency method of visual checks then ATP testing while waiting for the backorders to be fulfilled. Is anybody aware of an alternative lateral flow test detect multiple tree nuts? If not, could anyone share their experience with protein swabs vs ATP? Neither is preferred, but we are in a tight spot. 

 

Thank you.

 

 

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Romer Labs has pretty decent allergen LFDs, for some tests they're not quite as sensitive as the Neogen/3M ones are but they're still good.

 

Conversely, if you're under FSMA the only requirement from that is for a visual inspection to ensure all oily sheens have been removed from the surfaces. Since there have been no established thresholds for which allergic reactions would or wouldn't occur when exposure occurs. FDA's position is simply that the tests on the market are not sensitive enough to verify there is absolutely no allergen residue on the surface swabbed. So, all you actually need is the visual to be compliant; however, we as an industry prefer having some degree of confirmation/confidence the allergen proteins have at least been reduced below detection levels.

Be sure to put 2-3 backup suppliers in place now as Neogen and 3M are on the cusp of having bigger issues with supply chain being the beginning of the issues - it's roller coaster time in the food and food related corporations.  December is going to be a very turbulent time indeed.

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While not as sensitive as specific allergen test swabs, there's enough research out there to justify the use of a standard ATP swab for allergens.

 

Surface testing: What is the difference between Allergen and ATP Testing? (emportllc.com)

 

I would do some internal verifications between your allergen tests and your standard ATP, make sure the numbers line up.  If you find that a pass on your ATP still results in residue detected by your tree nut test kit, find what ATP RLU consistently pairs with a negative on the more sensitive allergen swab.  You may want to further verify this with some samples sent to the lab who does your EMP swabs.  Then I'd be confident you could write into your program what RLU is considered passing when forced to use ATP to verify allergen sanitation.

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Thank you all for the insight. 

 

We have had one instance where the allergen test (peanut) failed and ATP passed which makes it a concern to rely on ATP for verification. I'm interested in if anyone can share their experience with LFDs compared to general protein swabs like AllerSnap.  

We use LFD for gluten, almond, and soy, they work great and are easy to use.  Protein indicators are used in conjunction so we can blanket areas after change overs.  ATP is a dirty meter IMO, only use this to verify that our cleaning system works at removing soils and staged items are in good shape for usage when needed.  

 

Check out Emport/Hygiena they have similar options to Neogen/3M.  

Also interested in answers, as we're about to significantly increase the amount of routine allergen residue testing being performed.

I don't know if it's forum-allowed (apologies if not) but I'm happy to help out here as needed — Emport LLC carries a lot of specific-allergen LFD kits. We are also about to start offering a new-to-the-market LFD for multiple tree nuts (not a Hygiena product, although a lot of what we carry is Hygiena).  


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