Scientific Publications by FDA Staff

J AOAC Int 2016 Sep-Oct;99(5):1338-55

Validation of the Biofish-300 HIS enzymatic biosensor for the detection of histamine in fishery products.

Salleres S, Gonzalez I, Arantzamendi A, Gonzalez R, Maza S, Jaureguibeitia A, Hungerford JM, DeWitt CA, Benner RA

The Biofish-300 HIS method is a simple, reliable, and specific enzymatic biosensor for the detection of histamine. This technology is highly specific and selective and allows quantification of histamine in fishery products (fresh/frozen and processed) in a short time frame (2-3 min). Histamine in raw tuna, raw mackerel, raw sardine, raw anchovy, boiled tuna, canned tuna in water, canned tuna in oil, canned mackerel in tomato sauce, canned pickled sardine, and canned salted anchovy was analyzed using a water-based extract. Matrix-specific assay procedures and calibration curves were used to enable analyses to be carried out across multiple sample types. The performance of this assay was examined using samples that were naturally contaminated (reference materials and interlaboratory studies) and spiked with histamine. All data were judged against previously established acceptance criteria. Performance measures were evaluated for linearity, selectivity, matrix, lot consistency, and robustness. Results produced in all performance measures, except robustness, were within acceptable ranges. Out-of-range robustness results reflected deviation in sample volume compared to the standard assay procedures. Positive interferences from the presence of agmatine were shown.