The first validated Reference Materials for Food Allergen Analysis are now available and can be ordered from MoniQA Association. The first set of materials includes testing materials for milk allergen analysis comprising a Positive Control (SMP-MQA 092014, characterized dried skim milk powder, validated protein content), Negative Control (BLANK-MQA 082015, based on a gluten free cookie), and 2 Incurred Materials: LOW-MQA 102016 (SMP incurred in gluten free cookies, milled, concentration approx. 3.5 ppm milk protein, validated) and HIGH-MQA 082016 (SMP incurred in gluten free cookies, milled, concentration approx. 35 ppm milk protein, validated).
The materials were produced by Trilogy Laboratories USA (MoniQA Member since 2013) and have been commercially available starting 01 January 2017 through MoniQA Association. All materials come with a data sheet and a reference certificate to the analytical results, a measurement uncertainty and validation information. Distribution and shipment of the materials is subcontracted to Authorized Distributors among the MoniQA Member Institutions.
How to order – distribution and shipments:
Order the materials by using the online order form and return the completed, signed/stamped form to moniqa [at] moniqa [dot] org. The materials come in 5 g pouches (air tight sealed) and sold for 220.- Euro per pouch or 792.- € for the set of all 4 materials. The Reference Materials for Food Allergen Analysis can be ordered from MoniQA Association. MoniQA Members may also qualify as Authorized Distributor of these reference materials and receive a distributor/re-seller discount (170.- € per pouch or 612.- € for the set of all 4 materials). If your company/organization is interested to become an authorized distributor, please contact roland [dot] poms [at] moniqa [dot] org. Draft sales agreement templates have been drafted and are currently reviewed. Further reference materials are in preparation (gluten, egg, soy) and will become available shortly.
The initiative – who is behind the project:
The design and production of these materials was in response to the urgent need for reference materials expressed by the food industry and food analytical laboratories, as well as providers of food allergen test kits and other methodologies, and national authorities. An international initiative (since 2013) led by MoniQA Association discussed and agreed upon the requirements for food allergen reference materials. For this purpose MoniQA has liaised with the EU funded project iFAAM, the Prolamin Working Group, Health Canada, FARRP, Australia’s Allergen Bureau (Vital), and others. The initial group of 15 experts from the global analytical community grew over time to a group of some 50 institutions contributing to the design of the materials and giving scientific and technological input during the testing and production phase of the materials.
Why food allergen reference materials?
Effective food allergen risk assessment and food allergen management are important to protect allergic consumers and to comply with allergen labelling regulations. Such approaches require reliable analytical tools for the detection of allergens in food. Due to the nature of the analytes and their susceptibility to various processing effects, reliability and comparability of results have posed a great challenge. Both reference methods and reference materials are urgently needed to assure the quality, reliability and comparability of analytical results obtained with different methods. Being an important component of this analytical quality assurance, reference materials contribute to reliable and accurate results. Ensuring the correctness of analytical results is crucial to laboratories, since incorrect results may trigger decisions that can cause economic damage or pose a risk to public health.
The use of reference materials:
Validated reference materials/quality control materials and certified reference materials are indispensable for
The quality of reference materials
is critical for accuracy and comparability of analysis results. Reference materials must be sufficiently homogenous, stable and traceable. Usually extensive material characterisation and testing for homogeneity and stability of the material precede the availability of reference materials. Ideally a certified reference material (CRM) shall be used, which has been validated by accredited institutions and is subject to strict quality testing. Certified reference materials usually come with a certificate with information on the methods used for validation/assigning a value, the measurement uncertainty and traceability of the numerical value of the analyte’s concentration in the material or the analyte’s purity. According to ISO/IEC 17025, accredited laboratories are required to use certified reference material. At this point the currently available knowledge base and methodological abilities do not allow to certify food allergen reference materials according to international standards requirements, however, for the currently available internationally validated materials the international task force led by MoniQA Association is discussing appropriate procedures for the certification of the offered food allergen reference materials according to ISO Standards.