3 replies to this topic

[krissy.cwell]

Looking for some discourse / discussion on recommendations for validating Allergen cleaning procedures. For background, we are working to commercialize a product with an ingredient that contains a pecan allergen.  

 

I’ve done some testing and analysis to prepare and I’m running into a roadblock that I’m not sure how to handle so looking for some conversation. 

 

1. I bought two different Allergen testing kits – Reveal 3D from Neogen and 3M Pecan Protein Rapid Detection Kit.  Neither of these kits have been able to detect the allergen on surfaces or in the product.
2. I sent a sample of the finished product to our lab for Elisa testing and it < limit of quantification.

 

How can I validate Allergen removal when I can’t seem to yield a positive result for the allergen that we know is in the product? I assume we would still need to treat this as a product that contains allergens since we know for a fact that it does but how can I confidently say the protein is removed when I can't validate it with a positive control? 

 

Any feedback/advice is much appreciated!

Edited by krissy.cwell, 08 April 2026 - 12:01 AM.

[GMO]

I'd talk to your suppliers and the lab. It's unusual to not detect with ELISA, the rapid testing swabs are less reliable and should really be validated for your matrix if you're going to use them.

 

Questions for the supplier:

• How much pecan is present in the ingredient?
• Is the protein denatured in any way or likely to be? E.g. enzymatically? Extended heat processes?
• Have they validated cleaning of the pecan in any way? If so, how?

 

Questions for your lab doing ELISA testing

• Are there any likely matrix effects with my product or ingredient.
• Is it possible that any mistakes were made with testing? Can they double check and repeat?
• Suggest sending in the ingredient before you process it and how it's made to see if they can detect it in that.
• Or, last resort, try PCR. But it's not quantitative and doesn't directly look for protein. However, it might detect presence / absence.

It's brilliant you started with a positive control. You'd be surprised how many people forget this important step.

[G M]

Looking for some discourse / discussion on recommendations for validating Allergen cleaning procedures. For background, we are working to commercialize a product with an ingredient that contains a pecan allergen.  

 

I’ve done some testing and analysis to prepare and I’m running into a roadblock that I’m not sure how to handle so looking for some conversation. 

 

1. I bought two different Allergen testing kits – Reveal 3D from Neogen and 3M Pecan Protein Rapid Detection Kit.  Neither of these kits have been able to detect the allergen on surfaces or in the product.
2. I sent a sample of the finished product to our lab for Elisa testing and it < limit of quantification.

 

How can I validate Allergen removal when I can’t seem to yield a positive result for the allergen that we know is in the product? I assume we would still need to treat this as a product that contains allergens since we know for a fact that it does but how can I confidently say the protein is removed when I can't validate it with a positive control? 

 

Any feedback/advice is much appreciated!

 

 

By straight mass what is the pecan content of the ingredient and the finished product? 

[krissy.cwell]

Thank you GMO for your responses. After further analysis, the results of the ELISA test were actually less than the limit of quantitation not detection. So we did detect it in the finished product. I would think an in house ELISA kit should detect it on the surfaces so I'm going to try that. If I can't get a positive from an ELISA kit I'll reach out to the supplier for further information. 

 

Thank you again!