Standards Development

Scope

This document describes general workflows and protocols for the validation and the verification of (semi-)quantitative screening tests for the detection of Aflatoxin M1 in liquid milk (raw, pasteurized, UHT and reconstituted milk powders and whey protein extracts). This guideline applies to methods of which the result of the measurement is a numerical value, for example a (relative) response from a dipstick reader, and that normal statistics apply. This guideline does not apply to methods that do not give numerical values (e.g. only a line that is present or absent), which require different validation approaches.

This guideline does not cover the validation of aflatoxin M1 analysis by HPLC, UHPLC or LC-MS/MS. This document is intended to be useful for manufacturers of screening test kits, laboratories validating screening methods or tests, competent authorities and dairies or end users of reagents or tests for the detection of Aflatoxin M1 in milk products. This document facilitates and improves the validation and verification of (semi-)quantitative screening methods. The goals of this document are a harmonization in validation of methods or tests kits in order that all stakeholders have full trust on the result of a mycotoxin screening and to limit overlap and multiplication of validation work in different laboratories by sharing the validation results generated by an independent laboratory. Furthermore, a harmonized validation and verification procedure allows for comparison of the performance of different screening methods.

This document does not imply that all end users are forced to perform all verification work proposed. 

The verification of the correct use of reagents/kits for the detection of antimicrobials is not part of the scope of this document.

Purpose

The purpose of this project is to provide IDF/ISO guidelines regarding validation and verification of rapid quantitative test procedures for aflatoxin M1. Improved versions of traditional ELISA tests, and newer generations of quantitative methods such as LFD (Lateral Flow Devices), sometimes combined with IAC (immunoaffinity columns) are available. This document will detail how to validate any rapid, quantitative aflatoxin M1 method in comparison to a reference method such as HPLC. Aflatoxin M1, a mycotoxin metabolite found in milk, is a known carcinogen and must be controlled. Furthermore, as dairy alternatives gain popularity, proactive food safety measures like surveillance of aflatoxin M1 in raw milk aim to protect consumer confidence in the global dairy sector. This new work item aims to provide consistency in how rapid method for its detection are evaluated for use.