Why allergen detection by ELISA is insufficient to protect allergic consumers

Background In 2010, a multi-allergen detection method based on mass spectrometric (LC-MS/MS) analysis was developed as described in JCA1218. This method was able to demonstrate that seven allergens could be detected in a single analysis. Later, it could be shown that the same method is capable to detect allergens in processed materials while conventional methods like ELSIA and PCR failed in the same matrix, even when amounts as high as 1000mg/kg were present. This was reported in JAOAC 94/4. In mid-2012 a case of a finished product was reported, which caused allergic reactions in children. The product was analysed by ELISA and LC-MS/MS. The ELISA failed to detect the allergens while mass spectrometric analysis clearly demonstrated the presence. This is the first case where evidence suggests that conventional methods like ELISA and PCR are not sensitive enough in some processed materials to protect allergic individuals, while LCMS/MS is still able to detect these allergens.