Food Allergen Testing
& Gluten-Free Verification

Protect your consumers and verify your "Free From" labels with ISO/IEC 17025:2017 accredited Gluten-Free verification, plus quantitative screening for the FDA "Big 9" allergens and environmental cleaning validation.

Accreditation
ISO/IEC 17025:2017 · PJLA #117946 · Houston, TX
Accredited Method
Gluten/Gliadin by R5 ELISA (SOP 041) · ISO 17025 & FDA LAAF
Also Offered (in-house screen)
FDA Big 9 allergen panel + Sulfites
Turnaround
5–7 Business Days · Rush available

Prevent Recalls with Reliable Food Allergen Testing

Undeclared allergens are consistently the leading cause of Class I food recalls in the United States, according to FDA recall and Reportable Food Registry data. Under the FASTER Act of 2021, manufacturers must label nine major allergens, including sesame, which took effect on 1 January 2023. Accurate compliance combines allergen verification with strong nutritional analysis and food labeling data on the final pack.

AGT Food Labs supports your "Free From" claims through validated commercial ELISA methods. Whether you need to confirm a gluten-free production run or validate your facility's food hygiene and cleaning procedures to prevent cross-contact, our food allergen testing program delivers actionable data for your Allergen Control Plan.

Scope note: Allergen analysis is performed at our Houston, TX facility. Our PJLA ISO/IEC 17025:2017 accreditation (Accreditation No. 117946, Cert L26-535) includes Gluten/Gliadin by R5 ELISA (Veratox for Gliadin R5, SOP 041) — the method used for FDA Gluten-Free verification — on food products, environmental sponges and swabs, and water. This method is additionally recognized under the FDA LAAF program. The broader FDA Big 9 allergen panel, sulfites, and competitive ELISA for hydrolyzed products are offered as validated in-house screening outside the accredited scope; ISO/IEC 17025:2017 accredited reporting for those analytes is available through our partner laboratory network when required.

The Food Allergen Testing Workflow

Enzyme-Linked Immunosorbent Assay (ELISA) for precise allergenic protein detection.

01. Submission
Send 100 g of finished product or environmental swabs. Double-bag samples to prevent cross-contamination during transit.
02. Extraction
We extract the specific allergenic proteins (not DNA) from the food matrix using validated buffers.
03. ELISA Analysis
Target proteins bind to specific antibodies, producing a color change proportional to the allergen concentration.
04. Quantitative Report
Receive a quantitative report in ppm, stating clearly whether each result is accredited (gluten) or in-house screening.

Our Food Allergen Testing Services

Comprehensive screening for ingredients, finished products, and manufacturing surfaces.

Analyst running gluten verification by R5 ELISA for an FDA Gluten-Free claim
ISO 17025 & FDA LAAF Accredited · FDA <20 ppm

Gluten-Free Verification

To label a product "Gluten-Free," the FDA requires it to contain less than 20 parts per million (ppm) of gluten. Our Gluten/Gliadin analysis uses the R5 antibody method (Veratox for Gliadin R5) under SOP 041 to detect gluten from wheat, rye, and barley, with a limit of quantitation of 5 ppm — well below the regulatory threshold.

Within our PJLA ISO/IEC 17025:2017 accredited scope (Cert L26-535, Houston, TX) and recognized under the FDA LAAF program, for food products, environmental sponges and swabs, and water.

Hydrolyzed & fermented products: Standard sandwich ELISA can under-report on fermented and hydrolyzed products such as beer, soy sauce, and sourdough, because the gluten has been broken into fragments the sandwich format cannot bridge. For these matrices we run a competitive ELISA, which detects those peptide fragments.

Competitive ELISA for hydrolyzed and fermented products is validated in-house screening and sits outside the current accredited scope. Where an accredited result is required for a hydrolyzed product, we coordinate testing through our partner laboratory network.

ELISA microplate prepared for FDA Big 9 food allergen screening including sesame
FASTER Act Compliance

The "Big 9" Allergen Screen

We screen for all major allergens mandated by US law using validated commercial ELISA kits. Quantitative data supports VITAL 3.0 risk assessment, moving you beyond a simple pass/fail answer. We also apply the FDA's definition of tree nuts, which includes coconut — a common compliance trap for manufacturers.

We Screen For:
  • Peanuts & Tree Nuts (Almond, Walnut, Cashew, Pecan)
  • Milk (Casein & Beta-Lactoglobulin)
  • Egg (Ovalbumin)
  • Soy, Wheat, Fish, Crustacean
  • Sesame (Newest FDA Requirement)

The Big 9 allergen panel, other than Gluten/Gliadin, is offered as validated in-house screening outside the current PJLA accredited scope. Accredited reporting is available through our partner network.

Environmental allergen swab being taken from a stainless steel processing surface for cleaning validation
Cleaning Validation

Environmental Allergen Swabs

Preventing cross-contact is the heart of any Food Safety Plan. If you run allergenic and non-allergenic lines in the same facility, you need evidence that your sanitation actually works.

We provide environmental allergen swab kits for sampling equipment surfaces such as mixers, conveyor belts, and fillers. Swabs are analyzed to confirm that Clean-in-Place procedures remove allergenic proteins, supporting FSMA Preventive Controls expectations.

Gluten/Gliadin environmental swabs are within our accredited scope (SOP 041, ISO/IEC 17025:2017 and FDA LAAF). Swabs for other allergens are offered as in-house screening.

Detection Limits (LOQ)

Validated commercial ELISA kits with low-ppm sensitivity for trace allergenic proteins.

AGT Food Labs — Food Allergen Testing Detection Limits & Accreditation Scope (Cert L26-535, Houston, TX)
Allergen Method Limit of Quantitation (LOQ) Accreditation Status
Gluten (Gliadin)R5 ELISA, SOP 0415.0 ppmPJLA accredited · FDA LAAF
PeanutQuantitative ELISA2.5 ppmIn-house screening — not accredited
Milk (Total)Quantitative ELISA2.5 ppmIn-house screening — not accredited
EggQuantitative ELISA2.5 ppmIn-house screening — not accredited
SoyQuantitative ELISA2.5 ppmIn-house screening — not accredited
Almond / WalnutQuantitative ELISA2.5 ppmIn-house screening — not accredited
SesameQuantitative ELISA5.0 ppmIn-house screening — not accredited
SulfitesOptimized Monier-Williams10.0 ppmIn-house screening — not accredited

Gluten/Gliadin by R5 ELISA (SOP 041) is run at our Houston, TX facility under PJLA ISO/IEC 17025:2017 accreditation and is recognized under the FDA LAAF program. The remaining allergen and sulfite methods are commercial validated kits run as in-house non-accredited screening. Where an accredited Certificate of Analysis is required for those analytes — for retailer audits, customs documentation, or regulatory submissions — results are issued through our accredited partner laboratory network.

Industries We Serve

Food allergen testing across every food and beverage category that carries an FDA "Free From" claim.

Breads and cereals submitted for gluten-free verification by R5 ELISA

Bakery & Cereals

Gluten and wheat verification for breads, fortified cereals, snack bars, and gluten-free bakery lines.

Packaged snacks and confectionery submitted for peanut, tree nut and milk allergen screening

Snacks & Confectionery

Peanut, tree nut, milk, and soy screening for chocolate, candy, granola bars, and savory snacks where shared lines drive cross-contact risk.

Craft beer and plant-based beverages submitted for gluten and milk protein verification

Beverages

Gluten and milk-protein checks for craft beer, plant-based milks, RTD beverages, and protein shakes selling into "Free From" categories.

Protein powders and capsules submitted for soy, milk, peanut and gluten verification

Dietary Supplements & Sports Nutrition

Soy, milk, peanut, and gluten verification for protein powders, capsules, and bars where allergen-free labeling is a core marketing claim.

Common Triggers for Food Allergen Testing

Most manufacturers commission food allergen testing when one of these situations comes up.

Pre-Launch Verification

A new SKU, recipe, or co-pack run is heading to market and you need a documented Big 9 baseline before printing labels and shipping. Our packaged food launch testing checklist sets out what else belongs in that first round.

Retailer or Buyer Audit

A major retailer, food-service buyer, or private-label brand has requested third-party allergen verification as part of supplier qualification or annual surveillance.

FSMA Allergen Control Plan

Your written Food Safety Plan requires periodic verification of allergen-control preventive measures. Environmental swabs and finished-product checks both feed this evidence file.

Recall or Complaint Investigation

A consumer reaction, retailer complaint, or undeclared-allergen alert needs a fast quantitative answer to size the issue and scope a corrective action.

"Free From" Certification

Programs such as the Gluten-Free Certification Organization (GFCO) require ongoing allergen evidence for renewal cycles.

Cleaning Validation

A new piece of shared equipment or a change to a CIP procedure needs validation that protein removal works before production resumes.

Regulatory Compliance

Meeting US allergen labeling requirements.

FALCPA & FASTER Act

Our food allergen testing program covers all nine major allergens defined by the Food Allergen Labeling and Consumer Protection Act and the FASTER Act, which added sesame with effect from 1 January 2023.

FDA Gluten-Free Rule

We verify compliance with 21 CFR 101.91 under our accredited SOP 041 method (ISO/IEC 17025:2017 and FDA LAAF), confirming your product tests below the 20 ppm threshold required for "Gluten-Free" claims.

FSMA Preventive Controls

Our environmental swabbing program supports your written Allergen Control Plan, a key requirement for FSMA Preventive Controls audits.

Frequently Asked Questions

Common questions about allergen thresholds, testing methods, and accreditation scope.

Is AGT's food allergen testing PJLA-accredited?
Partly. Gluten/Gliadin by R5 ELISA (SOP 041) — the method used for FDA Gluten-Free verification — is within our PJLA ISO/IEC 17025:2017 accreditation scope (Cert L26-535, Houston, TX) and is additionally recognized under the FDA LAAF program, for food products, environmental sponges and swabs, and water. The broader FDA Big 9 allergen panel, sulfites, and competitive ELISA for hydrolyzed products are performed as in-house non-accredited screening. When you require an accredited Certificate of Analysis for those analytes — for retailer audits, customs documentation, or regulatory submissions — we coordinate testing with our accredited partner laboratory network.
What are the "Big 9" allergens?
The FDA mandates labeling for nine major allergens: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soy, and sesame — the last added under the FASTER Act with effect from 1 January 2023.
Is coconut considered a tree nut by the FDA?
Yes. Although coconut is botanically a fruit, FDA classifies it as a tree nut for labeling purposes. It must be declared on food labels, and we include it in our tree nut screen on request.
Does a "May Contain" label remove the need to test?
No. "May Contain" precautionary allergen labeling is voluntary and does not exempt you from Good Manufacturing Practices. You retain a legal duty to prevent cross-contact. Testing validates that your controls are working, regardless of what the label says.
Why use ELISA instead of PCR?
Allergic reactions are caused by proteins, not DNA. ELISA detects the protein that causes the reaction. PCR detects DNA, which can persist after the protein has been denatured, or be destroyed by heat while protein remains. ELISA is the standard approach for finished-product allergen testing.
Can you test hydrolyzed or fermented products like beer and soy sauce?
Yes, using a competitive ELISA format. Sandwich ELISA can under-report gluten in hydrolyzed and fermented matrices because the protein has been broken into fragments the sandwich format cannot bridge. Competitive ELISA detects those fragments. This method is validated in-house screening and sits outside our accredited scope, so tell us the matrix up front and we will confirm whether an accredited result is needed and route it accordingly.

Verify Your "Free From" Claims

Tell us your product and target claim. We'll confirm the method, the accreditation status of each analyte, and turnaround before you ship.

Request an Allergen Quote
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