AOAC Gluten QL assays validation document available for public comment

AOAC INTERNATIONAL (AOAC) has recently announced the availability for public comment of its validation guidance document for qualitative assays of gluten.    

Gluten, a dietary protein found in wheat, barley and rye, is the responsible of coeliac disease, an autoimmune condition that occurs in genetically predisposed people where the ingestion of gluten leads to damage on the villi, small fingerlike projections that line the small intestine, that promote nutrient absorption. When the villi get damaged, nutrients cannot be absorbed properly into the body. It is estimated to affect 1 in 100 people worldwide, but only about 30% are properly diagnosed. Celiac disease can develop at any, and, if left untreated, it can lead to additional serious health problems. There's no cure for coeliac disease, however, following a gluten-free diet should help control symptoms and prevent the long-term complications of the condition.  

The purpose of the AOAC document is to provide comprehensive technical guidelines for conducting validation studies for qualitative gluten methods, for example methods submitted for AOAC INTERNATIONAL (AOAC) Performance Tested MethodsSM (PTM) status and/or for AOAC Official Methods of AnalysisSM (OMA) status.  

The requirements for method developer (single- laboratory) validation studies, independent validation studies, and collaborative validation studies are described. The document provides also specific examples for lateral-flow devices.  

These guidelines are intended to be applicable to the validation of candidate qualitative gluten methods, whether proprietary or non-proprietary, including those that may be submitted to AOAC for OMA status or PTM certification.  

Developers or users of qualitative methods for gluten detection can submit their opinions till March 1, 2023.