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ALLERGEN TESTING
Support for Cross-Contact Control, Cleaning Verification, and Product Testing
Undeclared allergens and unintended allergen cross-contact can create serious consumer-safety, labeling, and recall concerns. The Food and Drug Administration (FDA) currently recognizes nine major food allergens in the United States: milk, egg, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame.
Biotrax provides third-party food allergen testing for raw material or ingredients, in-process or finished products and environmental surfaces. Testing may help manufacturers evaluate cleaning effectiveness, investigate possible cross-contact, examine a product or supplier concern, and generate data for allergen-control programs, specifications, or product investigations.
The appropriate analysis depends on the target allergen, product matrix, sample type, and reason for testing. Contact us before submitting when you are unsure which test or sample type applies.
WHEN ALLERGEN TESTING MAY HELP
Food manufacturers and quality teams may request allergen testing to:
- Evaluate a finished product for a specific undeclared allergen.
- Verify cleaning after an allergen-containing production run.
- Support validation or periodic verification of an established cleaning procedure.
- Investigate possible allergen cross-contact.
- Assess a supplier, ingredient, or raw-material concern.
- Generate data relevant to an allergen-related specification or product claim.
- Follow up on a complaint, suspected labeling concern, or unexpected result.
- Compare results before and after a sanitation change.
- Support an allergen-control or preventive-controls program.
- Investigate a possible formulation, packaging, or production error.
Testing should be selected around the specific question your team needs to answer.
WHAT DOES FOOD ALLERGEN TESTING MEASURE?
Allergen tests look for proteins associated with a specific allergenic food.
Unlike ATP or general-protein testing, allergen-specific methods are designed to detect a selected target, such as milk, peanut, soy, egg, sesame, or gluten-associated proteins.
One test does not screen for every allergen.
Depending on the selected method, results may indicate:
- Whether the target protein was detected.
- Whether residue is present above the test’s reporting limit.
- The estimated concentration of the target protein.
- Whether targeted residue remains on a tested surface after cleaning.
- Whether additional investigation or corrective action may be appropriate.
Allergen testing is target-specific. A result for one allergen does not demonstrate whether another allergen is absent or present.
FINISHED PRODUCT OR ENVIRONMENTAL SURFACE?
The sample type should match the question your team is trying to answer.
FINISHED-PRODUCT ALLERGEN TESTING
Finished-product testing may help evaluate:
- Possible undeclared-allergen presence.
- Potential cross-contact during production.
- A supplier, ingredient, or formulation concern.
- A complaint or unexpected finding.
- A retained or affected production lot.
- Data relevant to a product specification or allergen-related claim.
A result applies to the tested portion of the submitted sample.
ENVIRONMENTAL ALLERGEN SWAB TESTING
Environmental allergen swab testing may help determine whether residue from a targeted allergen remains on equipment, utensils, production lines, or other defined surfaces after cleaning.
Surface testing may support:
- Cleaning validation.
- Routine cleaning verification.
- Production-changeover assessments.
- Corrective-action follow-up.
- Investigation of difficult-to-clean areas.
- Comparison before and after sanitation changes.
HOW ALLERGEN TESTING WORKS AT BIOTRAX
At Biotrax we use different testing methods depending on the target allergen, product matrix, and purpose of the analysis.
Please Note:
Some of the allergen testing may require a positive and negative control. Contact us to discuss specifics on your sample analysis.
ELISA TESTING
ELISA, or Enzyme-Linked Immunosorbent Assay, uses allergen-specific antibodies to detect targeted proteins in food products and environmental samples.
Biotrax performs applicable analyses using R-Biopharm allergen test kits and microplate instrumentation, including the ChemWell analyzer. Additional plate-reading capability is available through the laboratory’s Stat Fax system when appropriate to the selected method.
Depending on the test, ELISA may provide a qualitative result, indicating whether a target was detected, or a quantitative result that estimates the concentration of the targeted protein.
Biotrax performs ELISA testing for:
- Milk or dairy
- Egg
- Peanut
- Soy
- Sesame
- Gliadin or gluten
LATERAL-FLOW TESTING
Lateral-flow methods use antibody-based test strips to screen for a specific allergen protein.
These methods may be useful for targeted surface checks, cleaning verification, or cross-contact investigations where a rapid qualitative screen is appropriate.
Biotrax offers lateral-flow testing for:
- Targeted tree-nut residue
- Coconut residue
The specific tree-nut target covered by the selected test must be confirmed before samples are submitted.
ADDITIONAL ALLERGEN TESTING
When an allergen analysis is not performed in-house, Biotrax may coordinate the work through a qualified partner laboratory or help direct the client toward an appropriate testing resource.
Testing may be coordinated for:
- Mustard
- Fish
- Crustacean shellfish
ALLERGENS WE CAN HELP EVALUATE
DAIRY (ELISA)
PEANUT (ELISA)
DAIRY (ELISA)
Detects targeted proteins associated with milk or dairy ingredients.
Testing may support cleaning verification, investigation of dairy cross-contact, and evaluation of products manufactured on shared equipment.
EGG (ELISA)
PEANUT (ELISA)
DAIRY (ELISA)
Detects targeted egg-protein residue.
Testing may support sanitation verification, product investigations, and evaluation following an egg-containing production run.
PEANUT (ELISA)
PEANUT (ELISA)
PEANUT (ELISA)
Detects targeted peanut proteins.
Testing may support finished-product evaluation, cleaning verification, supplier concerns, and investigation of possible peanut cross-contact.
SOY (ELISA)
GLIADIN/GLUTEN (ELISA)
PEANUT (ELISA)
Detects targeted soy proteins.
Testing may help evaluate cleaning effectiveness, possible cross-contact, formulation concerns, or data relevant to a soy specification.
GLIADIN/GLUTEN (ELISA)
GLIADIN/GLUTEN (ELISA)
GLIADIN/GLUTEN (ELISA)
Measures gliadin or other gluten-associated proteins, depending on the selected method.
Testing may support gluten-control programs, cross-contact investigations, cleaning verification, and evaluation of products associated with a gluten-related specification or claim.
Important: Gluten testing is not automatically equivalent to testing for every possible wheat-allergy concern. Confirm the testing objective before submitting.
SESAME (ELISA)
GLIADIN/GLUTEN (ELISA)
GLIADIN/GLUTEN (ELISA)
Detects targeted sesame proteins.
Testing may support cleaning verification, finished-product evaluation, and sesame allergen-control programs.
TREE NUT (LATERAL FLOW)
MUSTARD (COORDINATED TESTING)
TREE NUT (LATERAL FLOW)
Screens for residue from a selected tree-nut protein.
Testing may support rapid surface checks, cleaning verification, and investigation of possible tree-nut cross-contact.
Important: Tree nut is not one universal analyte. The specific nut covered by the selected test must be confirmed.
COCONUT (LATERAL FLOW)
MUSTARD (COORDINATED TESTING)
TREE NUT (LATERAL FLOW)
Screens for targeted coconut-protein residue.
Testing may support cleaning verification, product investigations, and customer-specific allergen programs.
MUSTARD (COORDINATED TESTING)
MUSTARD (COORDINATED TESTING)
MUSTARD (COORDINATED TESTING)
Testing may be coordinated for products or programs where mustard is a declared or customer-specified allergen.
FISH (COORDINATED TESTING)
CRUSTACEAN SHELLFISH (COORDINATED TESTING)
MUSTARD (COORDINATED TESTING)
Testing may be coordinated to evaluate targeted fish-protein residue for product investigations, cleaning verification, or cross-contact concerns.
The applicable species or target should be confirmed before submission.
CRUSTACEAN SHELLFISH (COORDINATED TESTING)
CRUSTACEAN SHELLFISH (COORDINATED TESTING)
CRUSTACEAN SHELLFISH (COORDINATED TESTING)
Testing may be coordinated to evaluate targeted shellfish-protein residue for cleaning verification, product investigations, or possible cross-contact.
The applicable species or target should be confirmed before submission.
CRUSTACEAN SHELLFISH (COORDINATED TESTING)
CRUSTACEAN SHELLFISH (COORDINATED TESTING)
CLEANING VALIDATION OR ROUTINE VERIFICATION?
Although these activities are related, they answer different questions.
CLEANING VALIDATION
Validation helps establish whether a defined cleaning procedure is capable of removing the targeted allergen under the conditions evaluated.
A validation plan may consider:
- The target allergen.
- The product and processing conditions.
- Difficult-to-clean or worst-case locations.
- Cleaning chemicals, concentrations, contact time, and temperature.
- Testing before and after cleaning.
- Environmental surfaces and, where appropriate, product samples.
- Predetermined acceptance criteria.
ROUTINE VERIFICATION
Verification checks whether the established cleaning procedure continues to be implemented effectively over time.
Periodic allergen-specific testing may be used alongside:
- Visual inspection
- Sanitation records
- Documented cleaning procedures
- Production-changeover checks
- Other facility monitoring activities
Important: Allergen testing does not replace a written allergen-control program. It provides objective data that may support validation, verification, investigations, and corrective actions.
WHAT AN ALLERGEN RESULT CAN—AND CANNOT—TELL YOU
Allergen testing is target-specific. One test does not screen for every allergen.
A result for milk does not determine whether peanut, egg, sesame, or another allergen is present. Each concern requires an appropriate target-specific analysis.
The meaning of a result may also depend on:
- The product ingredients and formulation.
- The degree of processing.
- The sample matrix.
- The sampling location.
- The selected kit and reporting limit.
- Whether the sample is a product or surface swab.
- The specification or product claim.
- How representative the submitted sample is.
Important: Heating, fermentation, hydrolysis, and other processing conditions can alter proteins and may affect how a method performs.
A not detected result means the targeted protein was not detected in the tested portion at or above the method’s applicable limit. It does not prove that an entire production lot, line, or facility is free from that allergen.
BEFORE SUBMITTING A SAMPLE
When contacting Biotrax, tell us:
- Which allergen you need to evaluate.
- What the product, ingredient, or surface is.
- What prompted the testing request.
- Whether the sample supports cleaning validation, routine verification, investigation, or a product claim.
- Whether the product has been heated, fermented, hydrolyzed, or highly processed.
- Whether you have an internal or customer specification.
- How and when the sample was collected.
- Whether a particular method is required.
You do not need to have every detail figured out before contacting us. Our team can help clarify an appropriate place to begin with analyte selection, method, sample type, submission requirements, and more before samples are submitted and testing begins.
NOT SURE WHICH ALLERGEN TEST FITS YOUR NEEDS?
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