ProGnosis Biotech has received the esteemed AOAC Performance Tested Methods SM (PTM) certification for its Bio-Shield Histamine ELISA test. Τhis significant milestone underscores the test’s reliability in delivering fast and accurate histamine determination for seafood producers. The certification validates the test’s ability to generate dependable results in just 20 minutes, helping companies meet international regulations while enhancing internal quality assurance procedures.
Why AOAC PTM Matters
The AOAC PTM certification carries global recognition as an endorsement of analytical methods. This independent validation confirms that the Bio-Shield Histamine test offers consistent accuracy, repeatability and robustness. This translates into:
- Confidence in test results during inspections or export audits
- Strengthened trust among regulatory bodies and industry partners
- Compliance with both European and U.S. food safety standards
Key Highlights of Bio-Shield Histamine ELISA
- Extreme Sensitivity and Speed: The kit delivers results within a validated range of 2.74–200 mg/kg in just 20 minutes. With one of the lowest LOQs in the market, it guarantees product safety, while its speed allows manufacturers to act quickly on production decisions.
- Proven Performance: Evaluations conducted by ILVO (Melle, Belgium) showed excellent pooled recovery rates of 98.5% and 103.8% in naturally and artificially contaminated seafood samples, in comparison to the Codex-referenced HPLC method (Duflos protocol).
- Validated Accuracy: 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.
- Variety of Matrices: Validated use across a wide range of fresh, canned (in water or water-packed) and frozen seafood. Validated species include tuna, mackerel, sardine, anchovy, bonito, marlin, bluefish and cod. Additionally, the kit is effective for fish-derived products like anchovy-based fishmeal, fish flour and salmon flour.
- Regulatory Compliance: Sensitive enough to quantify histamine below regulatory action levels (100 mg/kg EU limit; 35 mg/kg U.S. FDA guidance level for histamine).
Supporting Compliance Without Sacrificing Efficiency
The Bio-Shield Histamine ELISA kit avoids some of the complicated steps typical of older approaches. It uses a simple distilled water extraction and skips time-consuming acylation steps, making it safer and easier to implement on a daily basis.
Compared to HPLC-based methods—which are often slower, more expensive and test limited samples per day—the Bio-Shield Histamine allows in-house testing with minimal training, setup and overhead. This means QA teams can get real-time insights and keep production moving without sending samples offsite or delaying release.
Sustainability at the Forefront
In alignment with ProGnosis Biotech’s sustainability goals, the Bio-Shield test kit also minimizes environmental impact through:
- Non-toxic extraction using only distilled water
- Lower carbon footprint thanks to a compact, portable reader and reduced transport emissions by avoiding external lab testing
- Minimal waste through efficient consumables, digital documentation and recyclable packaging
A Smarter Path to Seafood Safety
With AOAC PTM-certified accuracy, the Bio-Shield Histamine is an ideal solution for seafood producers and laboratories who prioritize both precision and practicality. ProGnosis Biotech encourages industry professionals to explore how this test can fit into their food safety programs—offering compliance, speed and a lighter environmental footprint all in one package.
Learn more at: www.prognosis-biotech.com/bio-shield-histamine
