ProGnosis Biotech is pleased to announce that its Bio-Shield Histamine ELISA Test has been awarded AOAC Performance Tested MethodsSM (PTM) certification for the determination of histamine (HA) in seafood, under PTM number 052501.
This certification, granted by the AOAC Research Institute, verifies that the test meets high standards for accuracy, precision, specificity, consistency, stability, robustness and overall reliability, confirming its suitability for both regulatory compliance and routine use in industrial testing environments. The method is validated for use in fresh, canned (in water or water-packed) and frozen fish, covering commonly consumed species, including tuna, mackerel, sardine, anchovy, bonito, marlin, bluefish, cod. It is also applicable to fish-derived products such as anchovy-based fishmeal, fish flour and salmon flour.
The Bio-Shield Histamine ELISA delivers quantitative results in 20 minutes, with a validated range of 2.74 to 200 mg/kg. Performance evaluations conducted by the Independent Laboratory, Laboratory for Agricultural, Fisheries and Food Research (ILVO, Melle, Belgium) demonstrated excellent pooled recoveries of 98.5% and 103.8% for naturally and artificially contaminated samples, in comparison to the Codex HPLC method based on the Duflos protocol.
Additionally, in the Method Developer’s Laboratory, impressive recoveries of 103.6% and 97.0% were obtained for naturally and artificially contaminated samples, respectively, when compared with the AOAC OMA 977.13 fluorometric method.
Designed for routine screening in seafood production, processing and regulatory control, the kit provides a high-sensitivity, high-throughput solution to monitor HA levels at or below EU (100 mg/kg) and FDA (35 mg/kg) action limits.
With this AOAC PTM certification, ProGnosis Biotech reinforces its commitment to delivering validated, high-quality diagnostics that support global food safety compliance and public health protection.
About AOAC Research Institute
The AOAC Research Institute (AOAC RI) is a division of AOAC INTERNATIONAL that promotes and conducts activities to help develop, improve and validate proprietary testing methods. The AOAC RI Performance Tested MethodsSM (PTM) program helps companies and their customers safeguard their businesses, mitigate risk and protect consumers through trusted, reliable testing methods and products.
About ILVO
The Flanders Research Institute for Agriculture, Fisheries and Food (ILVO), based in Melle, Belgium, is an independent scientific institute under the Government of Flanders. ILVO conducts multidisciplinary research to promote sustainability in agriculture, fisheries and the agri-food sector. With a strong focus on food safety, ILVO develops and validates analytical methods for detecting microbiological and chemical contaminants in food products. Recognized as an expert laboratory by AOAC, ILVO provides accredited validation services for commercial screening tests, ensuring compliance with international food safety standards.
About ProGnosis Biotech
ProGnosis Biotech is a global leader in the development of diagnostic solutions for food, feed and clinical testing. Operating in over 90 countries with subsidiaries in 11, the company delivers high-performance Lateral Flow tests and ELISA kits. It also develops proprietary antibodies, cutting-edge software and digital tools for data sharing. ProGnosis Biotech is committed to ensuring transparency and sustainability in food safety, supported by globally recognized certifications including ISO 9001, ISO 13485 and ISO 37001. With a focus on customer-centric solutions, the company empowers industries to meet regulatory standards and protect public health.
