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TLA Panel Allergens: priorities and challenges for food allergen detection

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MPR for gluten: CEN activities (III)

- Structure follows CEN requirements but also contains important AOAC SMPR elements

-

Title

: Minimum Performance Requirements for quantitative gluten measurement by

ELISA

-

Scope

: …specifies minimum requirements on information and performance for

immunological methods that quantify intact or fragmented gluten from wheat, rye, and

barley in raw and processed foodstuffs. Information on applicability, antibody,

construction of the test system, calibration material, curve fitting algorithm, and

reporting of results shall be given by the method provider. Performance characteristics

that shall be validated for each method are specificity, selectivity, limit of detection,

limit of quantification, cross reactivity, interfering substances, recovery, precision,

accuracy, trueness, and robustness.

TLA Panel Allergens: priorities and challenges for food allergen detection

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MPR for gluten: CEN activities (IV)

- Normative References

- Terms and Definitions: gluten, prolamin, exception for oats

- General information on the test system

- Performance criteria (how to determine…..)

- Overview on Minimum Performance Requirements

- Table 1: Intact gluten

- Table 2: fragmented gluten

Parameter

Gluten

Analytical Range

[mg/kg]

10 to 40

LOQ [mg/kg]

10

LOD [mg/kg]

5

Recovery [%]

70 to 130

RSD

r

[%]

15

RSD

R

[%]

30

Specificity

Gluten from wheat, rye, and barley