Development of ELISA and chemiluminescence enzyme immunoassay for quantification of histamine in drug products and food samples.

Histamine (HA) is a biogenic amine associated with allergies and food poisoning. It is an important indicator of food freshness and quality. In recent years, a series of medical negligence cases have been reported to be related to the intravenous injection of antibiotics produced via fermentation with fish peptone due to HA contamination. To detect HA efficiently, mouse monoclonal antibody was developed. An enzyme-linked immunosorbent assay (ELISA) and a chemiluminescence enzyme immunoassay (CLEIA) were developed and compared with conventional HPLC analysis. Both immunoassays showed low cross-reactivity, low 50% inhibitive concentration (IC; 1.2 μg/mL and 1.1 μg/mL), low limits of detection (LODs, IC; 89.0 ng/mL and 73.4 ng/mL), and appreciable recoveries in spiked foods and drugs (from 73.4 to 131.0% and from 77.0 to 119.0%, espectively), demonstrating that the developed methods are sensitive, specific, fast, and reliable for HA detection in complicated real samples. Graphical abstract.