Analysis & Testing

Qualitative – a qualitative result indicates that the allergen is present/absent or detected/not detected.

Quantitative – a quantitative result indicates the concentration or how much allergen has been detected. Routinely for allergen analysis a quantitative result will be in mg/kg or ppm.

Limit Of Detection (LOD) – For allergen test kits this is the lowest quantity of an allergen that can be distinguished from background noise of the blank samples. LOD is a theoretical level that a test kit claims it can detect. A result that is below the LOD does not necessarily mean that the sample is free of the allergen.

Limit Of Quantification (LOQ) – For allergen test kits this represents the lowest quantity of an allergen that can be measured with acceptable accuracy and precision. A result reporting at LOQ provides more useful and more robust information and is the internationally accepted best practice.

Test results can provide assurance and verification of critical controls within a comprehensive allergen management plan and assist the implementation of quantitative risk assessment. Analysis has a critical place in allergen management but is not a substitute for a robust allergen management plan and requires a clear understanding of the limitations of analysis.

There are a range of methods available which have their place in allergen analysis. Information about choosing a method of analysis and the appropriate sampling methodology is provided on the Allergen Bureau website.

Where the concentration of allergens identified by analytical testing is greater than found during the VITAL risk assessment, consider reviewing the risk assessment for other factors. Consideration should be given to the type of analysis, nature and form of the allergen. It is important to consider the nature of food processing as some processes may reduce the amount of detectable allergen. Further to this, where quantitative measure is done by both analytical and physical measures, in order to consider the situation of greater risk, the greater of the two should be taken. Where analytical results are significantly higher than would be expected based on calculation, consideration should be given to other possible contributing factors.

Analytical testing may be useful for validation and verification activities, to confirm that the allergen status of raw materials are as specified.
For example:-

• as part of a Certificate of Analysis
• prior to release on site
• a requirement of vendor agreement (supplier program)
• validation of allergen information from suppliers
• verification of ingredient’s allergen status prior to use

Analytical testing is useful for validation and verification activities to check the allergen status of the processing environment. It can be used for confirming assumptions made during a VITAL risk assessment concerning Hang Up, processing impact or environmental cross contact.

Analytical testing can be useful:

• to validate cleaning protocols (use most robust methods available for validation)
• to verify the effectiveness of cleaning procedures
  • surfaces (equipment, utensils, environment)
  • cleaning water (CIP rinse water)
  • flush materials
• for ongoing monitoring of cleaning effectiveness
• to understand more about problem pieces of equipment (such as checking complex equipment which has the potential for Hang Up)
• to monitor the effect of changes to equipment or changes to process flow
• look at impact of processing on environment

When relevant, an effective AMP will include procedures in place for raw material and/or finished product allergen analysis that include a review of the results and actions any to be taken.