By Jay Alappat, Ph.D, Chief Science Officer – Chemistry, Certified Group
Food allergies affect millions of consumers worldwide1, with the FDA identifying nine major allergens, including peanuts, tree nuts, dairy, soy, and wheat as critical for food safety regulation.
Undeclared allergens are one of the leading causes of food recalls (34.1%) in the U.S.2, making precise and reliable allergen testing essential for food manufacturers, suppliers, and regulatory agencies.
Industry Trends in Allergen Testing
As consumer awareness and regulatory scrutiny increase, the allergen testing market is expected to grow. The global Food Allergen Testing industry was estimated to be worth USD 900.1 million in 2024. It is projected to reach USD 1,909.3 million by 2034, reflecting a CAGR of 7.8% over the assessment period 2024 to 20343.
With stricter global food safety laws, including FSMA (Food Safety Modernization Act) in the U.S. and FSA (Food Standards Agency) regulations in the U.K., manufacturers must ensure their products are free from allergen cross-contamination.
One of the most widely used methods for allergen detection is ELISA (Enzyme-Linked Immunosorbent Assay), known for its high sensitivity and specificity. While advanced technologies such as PCR (Polymerase Chain Reaction) and HPLC-MS (High-Performance Liquid Chromatography-Mass Spectrometry) are emerging, ELISA remains the gold standard for routine allergen screening due to its cost-effectiveness and accuracy4.
Certified Group’s Expertise in ELISA Allergen Testing
At Food Safety Net Services (FSNS) and Certified Laboratories, both part of Certified Group, we specialize in ELISA-based allergen testing at three of our ISO 17025-accredited laboratories in our national lab network: Aurora, Ill.; Melville, N.Y.; and San Antonio, Texas.
Our ELISA allergen testing capabilities allow us to detect allergens at low parts per million (ppm) levels, ensuring compliance with regulatory standards. We provide testing for priority allergens, including gluten, milk, egg, peanut, soy, and others in processed food and raw ingredients.
Additionally, we conduct cross-contamination risk assessments and offer routine batch monitoring and validation to ensure food safety and compliance.
Why ELISA is the Preferred Choice for Allergen Testing
- High Sensitivity & Specificity: ELISA can detect allergens at trace levels, ensuring food safety.
- Regulatory Compliance: Approved by the FDA, USDA, and other global agencies for food safety testing.
- Cost-Effective: Compared to PCR and HPLC-MS, ELISA offers a faster and more economical approach for routine allergen screening3.
- Reliable for Various Food Matrices: ELISA is highly effective for detecting allergens in processed foods, beverages, and raw ingredients.
The Future of Allergen Testing & Our Commitment
While ELISA remains the gold standard for routine allergen screening, Certified Group also has PCR (Polymerase Chain Reaction) technology to expand its testing versatility and precision. PCR allows for the detection of allergen-specific DNA, making it especially valuable in complex or highly processed food matrices where proteins may be denatured or degraded—conditions that can limit ELISA’s effectiveness. This capability reinforces our commitment to offering clients a scientifically rigorous, multifaceted approach to allergen control.
When and Why Customers Should Consider PCR
PCR serves as a powerful complement to ELISA in several scenarios. It is particularly useful in confirming allergen presence in thermally processed products, such as baked goods or extruded snacks, where protein targets may be altered beyond ELISA’s detection range. It also provides an additional layer of assurance for cross-reactivity investigations. With its high specificity and sensitivity, PCR enhances risk management strategies and gives manufacturers more confidence in their allergen labeling and mitigation efforts.
Partner with Certified Group for Allergen Testing Excellence
With our expertise, ELISA and PCR methodologies, and commitment to food safety, Certified Group companies, including FSNS and Certified Laboratories, are the trusted choice for allergen testing.
Contact us today to discuss your allergen testing needs and ensure your products meet the highest standards of safety and compliance.
References:
- Feast for Thought: A Comprehensive review of food allergy 2021-2023, Irene, B. et al J Allergy Clin Immunol 2024, 5 (153), 576-594
- Food for Thought 2025, U. S. PIRG Education Fund; February 2025
- https://www.futuremarketinsights.com/reports/food-allergen-testing-market
- https://academic.oup.com/jaoac/article/103/4/997/5861018
