ProGnosis Biotech proudly announces that its Symmetric Histamine lateral flow test has been awarded AOAC Performance Tested Methods℠ (PTM) certification for the determination of histamine (HA) in seafood, under PTM number 082502.
By certifying the method, the AOAC Research Institute recognizes its strong analytical performance. The test was evaluated for:
- quantitative application by testing its accuracy, precision, specificity, consistency, stability and robustness
- visual qualitative use detecting HA at a threshold value of 35 mg/k
This confirms its suitability for both compliance testing and daily plant operations.
The PTM evaluation included an independent laboratory study at ILVO (Melle, Belgium), further confirming performance across relevant seafood matrices.
Certification Highlights
- Matrices: Include fresh, frozen and water-packed/canned fish such as tuna, anchovy, sardine, bonito, mackerel, cod, marlin, bluefish and mahi-mahi. Test portion 2 g, deionized water extraction.
- Quantitative range: 9.3–300 mg/kg using the S-Flow software. LOD 3.3 mg/kg and LOQ 9.3 mg/kg.
- Performance: The Symmetric Histamine kit demonstrated strong analytical performance, yielding an overall recovery of 98.3% across all spiked matrices with RSDi values generally within 5% and 13%. Using a comparable evaluation method, the ILVO Laboratory obtained a pooled recovery of 86.2%, further confirming the performance of the assay across different laboratories.
- Scope & threshold (qualitative): Detection threshold at 35 mg/kg with visual read after a 3-minute incubation.
- Selectivity: No interference observed from 14 structurally related amines (e.g., cadaverine, putrescine, tyramine, etc.) at 250 mg/kg when histamine contamination level is at 0 or 35 mg/kg.
From Sample to Result
Symmetric Histamine is a competitive immunochromatographic LFD that only takes 3 minutes. If histamine is absent, a visible Test line appears (≥35 mg/kg indicated by a Test line darker than the Control line). The presence of histamine reduces the Test line intensity, enabling both visual detection at the threshold level of 35 mg/kg and quantification via the S-flow reader.
As part of the PTM certification, ILVO cross-checked results against HPLC (Codex/ISO 19343:2017-based) reference analysis and evaluated two S-Flow readers and multiple production lots, supporting the method’s repeatability and lot-to-lot consistency.
This AOAC PTM certification, reinforces ProGnosis Biotech’s commitment to delivering validated, high-quality diagnostics that support global food safety compliance and public health protection.
Learn more about Symmetric Histamine here.
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 Methods℠ (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.
