Food Allergen Detection for Safer, Compliant Production
Undeclared allergens are one of the top causes of food recalls. Food and beverage brands must prove that products are free from allergens like milk, egg, peanut, sesame, soy, and gluten and be able to document it. Hygiena’s rapid PCR, ELISA, and lateral flow solutions help you detect, quantify, and control allergens in ingredients, surfaces, and finished product - before it reaches consumers.
Why Food Manufacturers Rely on Allergen Detection and Control
Undeclared allergens can trigger severe reactions in consumers and drive costly recalls. Regulations now require clear labeling of major allergens - in the U.S., the FDA defines nine major food allergens, including sesame, and in the EU, food businesses must declare 14 allergens, including celery, mustard, lupin and others (FDA).
Reliable in-house allergen testing enables you to release products faster, verify sanitation steps, and defend ‘free-from’ and ‘may contain’ claims with data.
- Protect consumers: Reduce risk of severe allergic reactions.
- Avoid recalls: Catch residue before it leaves the plant.
- Prove label claims: Document ‘dairy-free,’ ‘gluten-free,’ ‘sesame-free,’ etc.
- Satisfy auditors: Demonstrate validated cleaning and changeover controls.
- Speed up release: Get actionable results in minutes (lateral flow), under 2 hours (PCR/ELISA). Hygiena’s lateral flow AlerTox® Sticks are designed for line-side checks with no lab equipment, and PCR/ELISA kits deliver highly sensitive quantitative results.
How Hygiena Supports Allergen Risk Management From Raw Materials to Final Pack
Hygiena® Comprehensive Allergen Diagnostics and Data Management
Allergen risk isn’t just in the finished product. It can come from incoming ingredients, shared lines, tools, air/dust, employees, or rework. Hygiena’s workflow gives you checkpoints from pre-op through final label sign-off.
Testing can be surface-based (to verify sanitation), in-process (during changeovers), or product-based (to quantify allergen content before release or to defend ‘free-from’ claims). Hygiena offers tools for each step: rapid swab & lateral flow tests, quantitative ELISA, and high-sensitivity real-time PCR.
- Incoming ingredients: Verify supplier claims (e.g., peanut-free, gluten-free) using real-time PCR or ELISA kits that can detect down to low ppm levels, often within ~100 minutes.
- Equipment & surfaces: After cleaning, swab and run a lateral flow device (like AllerFlow Gluten) to confirm the line is allergen-free in ~10 minutes, no lab required.
- In-process changeovers: Use AlerTox® Sticks right on the floor during product switches (e.g., peanut → non-peanut SKU). Kits are designed to be run by production staff, not just lab techs.
- Final product & label claim: Quantify allergen content with ELISA or PCR and keep digital records for auditors and regulators. Hygiena’s foodproof® qPCR kits can detect allergens like gluten, peanut, hazelnut, soy, celery, etc., often at levels at low as 0.1–1 ppm in complex matrices such as spices, ice cream, chocolate, and meat products.
End-to-End Allergen Testing Solutions
Rapid Line-Side Screening (Lateral Flow & Swab Tests)
Get a quick yes/no before you start the next run.
- Minutes to result; minimal training
- Works on surfaces, rinse water, and raw/finished goods
- Clear visual readout for pass/fail decisions
- Great for verifying cleaning between allergen/non-allergen SKUs
Quantification for Documentation (ELISA)
When you need numbers, not just a yes/no.
- Numeric, traceable results (ppm) for reports
- Validates sanitation and supplier claims
- Handles a wide range of food matrices
- Runs on standard plate readers with controls and curves
High-Sensitivity Confirmation & Complex Matrices (Real-Time PCR)
For tough products and trace levels.
- Detects very low allergen traces in complex foods
- Built-in controls increase confidence in results
- Complements screening/ELISA for borderline cases
- Compatible with common real-time PCR cyclers
Overview Allergen Testing Solutions by Target Allergen
Browse detection solutions for specific allergens. Each page shows available rapid tests (lateral flow), quantification kits (ELISA), and high-sensitivity PCR assays, along with matrices, detection limits, and validation resources.
| Allergen | Typical Sources / Risk Areas | Detection Methods Available | Example Product | Region(s) Where It’s Legally Declared |
| Peanut | Nut butters, sauces, confections | Lateral Flow, ELISA, PCR | AlerTox® Sticks: Peanut; foodproof® Peanut Detection Kit | US “Big 9”, EU 14 (Peanuts) |
| Gluten | Wheat, barley, rye, oats, shared lines | Lateral Flow (AllerFlow Gluten), ELISA, PCR | AllerFlow Gluten; GlutenTox® ELISA Rapid G12 | EU 14 (Gluten cereals), US (wheat) |
| Milk / Dairy | Dairy, chocolate, bakery fillings | Lateral Flow, ELISA | AlerTox® Total Milk Sticks | US “Big 9” (Milk), EU 14 (Milk incl. lactose) |
| Soy / Soya | Lecithin, sauces, protein isolates | Lateral Flow, ELISA, PCR | AlerTox® ELISA Soy; foodproof® Soya Detection Kit | US “Big 9” (Soybeans), EU 14 (Soybeans) |
| Sesame | Baked goods, tahini, spice blends | Lateral Flow (AlerTox® Sticks: Sesame) | AlerTox® Sticks: Sesame | Sesame is now legally the 9th major U.S. allergen and must be declared on labels. |
| Hazelnut / Tree Nuts | Chocolate, spreads, fillings, inclusions | Lateral Flow, ELISA, PCR | AlerTox® ELISA Hazelnut; foodproof® Hazelnut Detection Kit | US “tree nuts,” EU 14 (“Nuts”) |
| Celery / Mustard / Lupin, etc. | Spice blends, sauces, RTE savory foods | PCR (foodproof®), ELISA | foodproof® Celery Detection Kit | EU 14 requires declaration of celery, mustard, lupin, etc. |
Why Hygiena for Allergen Control?
- ✓ Faster changeovers: Surface validation in minutes so production doesn’t stall between allergen / non-allergen runs.
- ✓ Documented proof for audits: Quantitative ELISA and PCR reports support regulatory inspections and customer requirements.
- ✓ Ultra-low detection limits: PCR down to 0.1–1 ppm in tough matrices like spices, chocolate, ice cream, cooked meats.
- ✓ Validated methods: AOAC PTM approvals and internal controls increase confidence in results.
- ✓ No specialized lab needed: Lateral flow sticks can be run by production staff — no pipettes or thermal cyclers required.
- ✓ Global compliance support: Supports U.S. “Big 9” allergens (including sesame, now mandatory to declare) and EU’s list of 14 required allergens.
Allergen Testing Solutions
Browse detection options for specific allergens across ingredients, surfaces, and finished products. Each page lists rapid lateral flow, ELISA, and PCR kits, along with their detection limits and compatible matrices, to help you choose the right method quickly.
Not found what you are looking for?
FAQs
Quick answers on testing methods, changeovers, and audit-ready documentation, covering the U.S. Big 9 plus additional allergens for global compliance.
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