Undeclared allergens and unintended allergen cross-contact can pose serious concerns regarding consumer safety, labeling, and product recalls. The Food and Drug Administration (FDA) recognizes nine major food allergens in the United States: milk, egg, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame.
Biotrax offers comprehensive food allergen testing for raw materials, ingredients, in-process or finished products, and environmental surface testing. This testing assists manufacturers in evaluating cleaning effectiveness, investigating potential cross-contact issues, addressing product or supplier concerns, and generating vital data for allergen-control programs and product specifications.
The appropriate analysis depends on the target allergen, product matrix, sample type, and reason for testing. If you're uncertain about which test or sample type is applicable for your cross-contact control measures, please contact us before submitting your request.
Accreditation is specific to the analyte-and-method combinations listed in Biotrax’s current scope of accreditation. Any other analyses that may be coordinated could fall outside this scope. For confirmation, please review the current scope or reach out to Biotrax directly.
Food manufacturers and quality teams may request allergen testing to:
Testing should be selected around the specific question your team needs to answer.
Allergen tests are essential for food allergen testing as they look for proteins associated with specific allergenic foods. Unlike ATP or general-protein testing, allergen-specific methods focus on detecting selected targets, such as milk, peanut, soy, egg, sesame, or gluten-associated proteins, which is crucial for effective cross-contact control in food production environments.
It’s important to note that 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, which is a key aspect of environmental surface testing.
- Whether additional investigation or corrective action may be appropriate.
Allergen testing is target-specific, meaning a result for one allergen does not demonstrate whether another allergen is absent or present.
The sample type should correspond with the question your team aims to answer regarding cross-contact control, environmental surface testing, or food allergen testing.
Finished-product testing may help evaluate:
- Possible undeclared allergen presence through food allergen testing.
- Potential cross-contact during production, highlighting the importance of cross-contact control.
- 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, supplemented by environmental surface testing.
A result applies to the tested portion of the submitted sample.
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. This environmental surface testing plays a crucial role in effective cross-contact control and 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, particularly in the context of food allergen testing.
At Biotrax, we utilize various testing methods based on the specific target allergen, product matrix, and purpose of the analysis, including food allergen testing and environmental surface testing.
Please Note: Some allergen analyses may require cross-contact control as well as positive and negative controls. Contact Biotrax before submitting your sample to confirm the requirements for the selected analysis.
ELISA, or Enzyme-Linked Immunosorbent Assay, utilizes allergen-specific antibodies to detect targeted proteins in food products and environmental samples. For effective cross-contact control, Biotrax employs R-Biopharm allergen test kits and microplate instrumentation, including the ChemWell analyzer. Additionally, the laboratory’s Stat Fax system offers extra plate-reading capability when suitable for the chosen method and essential for environmental surface testing. Depending on the specific test, ELISA can yield either a qualitative result, indicating whether a target was detected, or a quantitative result that estimates the concentration of the targeted protein. Biotrax conducts comprehensive food allergen testing for: Milk or dairy, Egg, Peanut, Soy, Sesame, and Gliadin or gluten.
Lateral-flow methods utilize antibody-based test strips for food allergen testing to detect specific allergen proteins. These methods prove beneficial for cross-contact control, targeted environmental surface testing, and cleaning verification in situations where a rapid qualitative screen is necessary. Biotrax provides lateral-flow testing for targeted tree-nut residue and coconut residue. It is essential to confirm the specific tree-nut target covered by the selected test before submitting samples.
When an allergen analysis is not performed in-house, Biotrax may coordinate the food allergen testing through a qualified partner laboratory or help direct the client toward an appropriate testing resource for cross-contact control. Testing may be coordinated for environmental surface testing involving: Mustard, Fish, and Crustacean shellfish.
Detects targeted proteins associated with milk or dairy ingredients. This food allergen testing may support cross-contact control, assist in cleaning verification, investigate dairy cross-contact, and evaluate products manufactured on shared equipment through environmental surface testing.
Detects targeted egg-protein residue through environmental surface testing. This food allergen testing may support sanitation verification, product investigations, and evaluation following an egg-containing production run, aiding in cross-contact control.
Detects targeted peanut proteins. Environmental surface testing may support finished-product evaluation, cleaning verification, supplier concerns, and investigation of possible peanut cross-contact to enhance cross-contact control in food allergen testing.
Detects targeted soy proteins through environmental surface testing. This testing may help evaluate cleaning effectiveness, assess cross-contact control, address formulation concerns, or provide data relevant to a soy specification in the context of food allergen testing.
Measures gliadin or other gluten-associated proteins, depending on the selected method.
Testing may support gluten-control programs, cross-contact control investigations, environmental surface testing, cleaning verification, and evaluation of products associated with a gluten-related specification or claim.
Important: Gluten testing is not automatically equivalent to food allergen testing for every possible wheat-allergy concern. Confirm the testing objective before submitting.
Detects targeted sesame proteins through environmental surface testing. This testing may support cleaning verification, finished-product evaluation, and cross-contact control in sesame allergen-control programs.
Screens for residue from a selected tree-nut protein are essential for effective cross-contact control. Environmental surface testing can facilitate rapid surface checks, ensure cleaning verification, and assist in investigating potential tree-nut cross-contact. It is crucial to note that tree nut is not a universal analyte; therefore, the specific nut associated with the selected food allergen testing must be confirmed.
Screens for targeted coconut-protein residue enhance cross-contact control. Environmental surface testing may support cleaning verification, product investigations, and specific food allergen testing programs for customers.
Testing may be coordinated for products or programs where mustard is a declared or customer-specified allergen, with a focus on food allergen testing, cross-contact control, and environmental surface testing.
Testing may be coordinated to evaluate targeted fish-protein residue for product investigations, cleaning verification, or cross-contact control concerns. Additionally, environmental surface testing can be conducted to ensure safety against potential food allergen testing issues. The applicable species or target should be confirmed before submission.
Testing may be coordinated to evaluate targeted shellfish-protein residue for cleaning verification, product investigations, or possible cross-contact control. Environmental surface testing should be conducted to ensure thorough verification, and confirmed food allergen testing is essential to identify applicable species or targets before submission.
Although these activities, such as cross-contact control and environmental surface testing, are related, they answer different questions, particularly in the context of food allergen testing.
Validation helps establish whether a defined cleaning procedure is capable of removing the targeted allergen under the evaluated conditions, which is crucial for effective cross-contact control. A validation plan may consider: the target allergen, product and processing conditions, difficult-to-clean or worst-case locations, cleaning chemicals, concentrations, contact time, and temperature. It should also include environmental surface testing, with testing before and after cleaning, as well as, where appropriate, food allergen testing on product samples. Lastly, predetermined acceptance criteria must be established.
Verification checks whether the established cleaning procedure continues to be effectively implemented over time for cross-contact control.
Periodic food allergen testing may be used alongside:
- Visual inspection
- Sanitation records
- Documented cleaning procedures
- Production-changeover checks
- Environmental surface testing and other facility monitoring activities
Important: While food allergen testing plays a crucial role, it does not replace a written allergen-control program. It provides objective data that may support validation, verification, investigations, and corrective actions.
Allergen testing is target-specific, meaning that one test does not screen for every allergen. For instance, a result for milk does not indicate whether peanut, egg, sesame, or other allergens are present. Each concern necessitates a specific analysis tailored to that target, such as food allergen testing.
The interpretation of a result may also hinge on several factors:
- 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 environmental surface testing swab.
- The specification or product claim.
- How representative the submitted sample is.
It's crucial to note that processes such as heating, fermentation, and hydrolysis can alter proteins, potentially influencing the method's performance.
A 'not detected' result means the targeted protein was not found in the tested portion at or above the method's applicable limit. However, it does not guarantee that an entire production lot, line, or facility is free from that allergen, underscoring the importance of cross-contact control in managing allergen risks.
When contacting Biotrax, please let us know:
- Which allergen you need to evaluate regarding food allergen testing.
- What the product, ingredient, or surface is, particularly if it involves environmental surface testing.
- What prompted your testing request.
- Whether the sample supports cleaning validation, routine verification, investigation, or a product claim related to cross-contact control.
- If 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.
- If a particular method is required for the testing.
You do not need to have every detail figured out before reaching out to us. Our team can assist you in clarifying an appropriate place to begin with analyte selection, method, sample type, submission requirements, and more before the samples are submitted and testing begins.
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