By Allergen Bureau

r-Biopharm Discusses The Meaning Of Incurred Samples For Food Analysis

Allergen and gluten analysis is an essential part of food safety management. It involves identifying the presence and level of allergens or gluten in food products to ensure that they are safe for consumption by individuals with food allergies or gluten intolerance. One method for quality control and reliability of allergen analysis is the use of incurred samples, which are samples mimicking real food products that have been deliberately contaminated with allergens ideally before any processing step. In this short article, we will discuss the advantages of incurred samples with allergen analysis and the opinion of the AOAC about it. The advantages apply equally to gluten analysis.

Advantages of incurred samples with allergen analysis

1.  Realistic assessment of risk

Incurred samples provide a realistic assessment of the risk of allergen contamination in food products. They represent the actual level of contamination that can occur during food processing, storage, and handling. This approach is more reliable than using artificially contaminated samples (spiking of the material after food production) since it considers the variability in production processes and raw materials.

2.  Accurate detection of allergens

Using incurred samples increases the accuracy of allergen detection. The complexity of food matrices can interfere with the detection of allergens, and artificially contaminated samples may not reflect this complexity. Incurred samples, on the other hand, are more likely to contain the same interfering substances as real food products, resulting in more accurate detection of allergens.

3. Improved validation of analytical methods

Analytical methods used in allergen analysis must be validated to ensure their accuracy and reliability. Using incurred samples in method validation provides a more realistic assessment of the performance of the method in detecting and quantifying allergens in real food products. This approach is recommended by regulatory agencies such as the US FDA, the European Commission and standardization bodies like the European Committee for Standardization (CEN).

AOAC’s opinion on incurred samples with allergen analysis

The AOAC (Association of Official Analytical Chemists) is a non-profit organisation that sets standards for analytical methods used in food safety management. In 2012, the AOAC released a guidance document on the use of incurred samples in allergen analysis. A revision is in process (Guidance on Food Allergen Immunoassay Validation).

The document recommends the use of incurred samples in the validation of analytical methods used in allergen analysis. It emphasizes the importance of using realistic samples that reflect the complexity of food matrices and the variability in production processes. In compliance with these criteria, the RIDASCREEN® Gliadin ELISA got the AOAC Official Method of Analysis approval for “in food” using samples from around 16 different food categories that were incurred according to state-of-the-art knowledge in 2021. The general “in food” wording was used since the method showed its applicability in an international collaborative study with samples reflecting various food processing techniques.

In conclusion, using incurred samples with allergen analysis provides several advantages, including a more realistic assessment of risk, accurate detection of allergens, and improved validation of analytical methods. Furthermore, incurred samples in proficiency testing programs allow at least partially a comparison of the participating assays’ calibration. The AOAC recommends the use of incurred samples in allergen analysis and emphasizes the importance of using realistic samples in method validation. These approaches are critical for ensuring the safety of food products for individuals with food allergies.

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