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ELISA limit for quantifying the surface "free" from allergens?


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#1 Arpagano2

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Posted 16 September 2019 - 07:28 PM

I have a great deal on this website regarding allergen testing on finished goods and swabbing. I wanted to make  statement to get the ball rolling on some opinions in the industry.  For allergen swabbing, based on ELISA, the allowable detection result would be under 5 ppm or 2 ppm?  I have read and discussed under 5 ppm as the allowable limit for quantifying the surface "free" from allergens. Does anybody else have additional clarification or thoughts? Thank you. 



#2 kfromNE

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Posted 16 September 2019 - 07:37 PM

See this article from The Food Allergy Research & Resource Program from the University of Nebraska - one of the experts on food allergens in the food industry.

 

https://farrp.unl.ed...llergenic-foods



#3 Charles.C

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Posted 17 September 2019 - 01:14 AM

I have a great deal on this website regarding allergen testing on finished goods and swabbing. I wanted to make  statement to get the ball rolling on some opinions in the industry.  For allergen swabbing, based on ELISA, the allowable detection result would be under 5 ppm or 2 ppm?  I have read and discussed under 5 ppm as the allowable limit for quantifying the surface "free" from allergens. Does anybody else have additional clarification or thoughts? Thank you. 

 

Hi Arpagano,

 

As I understand, regarding EMP swabbing, you are asking as to -

 

(1) the meaning of a statement such as "free of allergen" (FOA)  for a food contact surface when applying an ELISA methodology.

 

(2) whether a negative result from ELISA  test kits claimed to have detection limits of, respectively 5 and 2 ppm can be associated with a "free from allergen" statement ?

 

 

 

Comments

 

(1) afaik, in a general allergenic context, there is no globally accepted, "standard" interpretation of the phrase, "free of allergens" (FOA). The latter is typically, operationally, associated  with a definition related to the  currently relevant test procedure.

(2) From a scientific POV, "FOA" is IMO not meaningful, preferably replaced by a more "numeric" equivalent.

 

Regarding claimed LODs, these should be validated, eg by AOAC, for example consider this (condensed) 2006 extract - 

 

all  five  commercial  kit manufacturers use a similar ELISA technology for the detection of allergenic residues; hence, they all share the same pitfalls. Using peanut as an example, one manufacturer claims a detection limit of 0.5 ppm peanut proteins while the other four claim detection limits ranging from 1–5 ppm peanuts. Please note, the reporting units are not equivalent. Since the LOD can vary greatly depending on food matrix interferences, extraction efficiency, specificity of antibodies and variation of peanut protein standards, proper validation  is essential.

 

As a (more realistic?) approach (2015) -
 

 

After cleaning, allergens are expected to be present at <1 ppm i.e. the limit of detection of most commercial test kits. The contribution of allergen cross contamination from a cleaned surface into subsequent finished product itself is therefore likely to add a very small non-detectable risk in the finished product. Gross  failure  of  cleaning  or  lack  of  cleaning  would  be  required  to  make  a  gluten-free  product  non-compliant (see example Appendix 3).
 
Specific detection methods alone give partial information about overall safety and risk, and should be used as  a  balanced  analytical  approach.  There  are  several  methods  for  specific  allergens  of  which immunological methods e.g. quantitative plate ELISA tests and qualitative lateral flow tests (LFT) in dipstick formats are the most commonly used. However, the relatively high cost is often an  impediment to their widespread adoption. Plate ELISA tests are more sensitive (typically <0.1 ppm) but require a skilled analyst. LFTs  are  more  convenient  and  have  a  limit  of  detection  of  1  –  10  ppm  but  their  performance  can  be variable.

 

Attached File  Hygiena Allergen White Paper.pdf   687.8KB   29 downloads

 

PS- maybe some of the validated  ELISA limits are lower now ?

 

PPS - VITAL's approach attempts to explicitly implement threshold values but so far has had very limited official acceptance, eg -

Attached File  VITAL-a-threshold-approach-to-allergen-labelling.pdf   515.5KB   24 downloads

 

P3S - JFI here is a comparison (2012) of some reported LOAEL vs LOD values -

 

Attached File  LOAEL vs LOD.PNG   27.29KB   5 downloads

Attached File  Processing Considerations of Allergenic Food Ingredients.pdf   744.01KB   23 downloads


Edited by Charles.C, 17 September 2019 - 02:16 AM.
edited

Kind Regards,

 

Charles.C


#4 GMO

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Posted 17 September 2019 - 10:08 AM

I have a great deal on this website regarding allergen testing on finished goods and swabbing. I wanted to make  statement to get the ball rolling on some opinions in the industry.  For allergen swabbing, based on ELISA, the allowable detection result would be under 5 ppm or 2 ppm?  I have read and discussed under 5 ppm as the allowable limit for quantifying the surface "free" from allergens. Does anybody else have additional clarification or thoughts? Thank you. 

 

If you are doing a validation, it's difficult to justify any limit which is not either not detected or below the limit of detection of the method.  Any detection indicates the cleaning has been incomplete and I believe it's only Australia who have started to adopt limits of contamination (apart from sulphites and the definition of "gluten free" in some legislative regions including the UK.)



#5 Arpagano2

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Posted 17 September 2019 - 12:41 PM

Hi Arpagano,

 

As I understand, regarding EMP swabbing, you are asking as to -

 

(1) the meaning of a statement such as "free of allergen" (FOA)  for a food contact surface when applying an ELISA methodology.

 

(2) whether a negative result from ELISA  test kits claimed to have detection limits of, respectively 5 and 2 ppm can be associated with a "free from allergen" statement ?

 

 

 

Comments

 

(1) afaik, in a general allergenic context, there is no globally accepted, "standard" interpretation of the phrase, "free of allergens" (FOA). The latter is typically, operationally, associated  with a definition related to the  currently relevant test procedure.

(2) From a scientific POV, "FOA" is IMO not meaningful, preferably replaced by a more "numeric" equivalent.

 

Regarding claimed LODs, these should be validated, eg by AOAC, for example consider this (condensed) 2006 extract - 

 

 

As a (more realistic?) approach (2015) -
 

attachicon.gif Hygiena Allergen White Paper.pdf

 

PS- maybe some of the validated  ELISA limits are lower now ?

 

PPS - VITAL's approach attempts to explicitly implement threshold values but so far has had very limited official acceptance, eg -

attachicon.gif VITAL-a-threshold-approach-to-allergen-labelling.pdf

 

P3S - JFI here is a comparison (2012) of some reported LOAEL vs LOD values -

 

attachicon.gif LOAEL vs LOD.PNG

attachicon.gif Processing Considerations of Allergenic Food Ingredients.pdf

 

This is hugely helpful.  Thank you.  






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