Abstract
Gluten has a central role in the pathogenesis of several gluten-related disorders, with coeliac disease being one of the most well-known. A rigorous gluten-free diet is recognized as the only safe and efficient coeliac disease therapy. This study intended to use the enzyme-linked immunosorbent assay (ELISA) R5 Méndez method to determine gluten contamination in labelled gluten-free food products marketed in China and to evaluate the performance of two ELISA platforms (the Neogen Veratox(®) R5 and the Romer Labs AgraQuant(®) G12) for analyzing gluten, using R5 Méndez as the reference. In 2024, 119 prepackaged products labelled as gluten-free were purchased from internet suppliers. The results showed that among the 119 products, 13.4% contained gluten exceeding 20 mg/kg, and 5.0% contained over 100 mg/kg, ranging from 333.1 to 2737.4 mg/kg. When the threshold for gluten-free products was 20 mg/kg, the two ELISA platforms yielded results comparable to R5 Méndez. However, when the threshold was 10 mg/kg and 5 mg/kg, the McNemar x(2) test showed significant differences between the proportions of positive results of the two ELISA platforms and R5 Méndez (p-value < 0.05); using R5 Méndez as the reference, the two ELISA platforms showed 53.1% to 70.3% positive predictive values, suffering the drawback of high false-positive results. When using stricter gluten limits of ≤10 mg/kg and ≤5 mg/kg, different ELISA platforms may produce different results for the same food product. These findings highlight the need for China to accelerate the development of national standards for gluten-free foods, and for food regulatory agencies to impose requirements of production that lead to the prevention of gluten contamination, confirmed by the possible monitoring of such compliance through routine sampling and testing. Such measures will no doubt contribute to protecting and improving the health of patients with gluten-related disorders.