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Bacterial Endotoxin Testing
The ability to detect all environmental Gram-negative bacterial endotoxins is a critical element of safe parenteral production and implantable medical device manufacturing. With over 80 million endotoxin tests performed annually, these medical techniques, treatments, and therapies sustain the lives of thousands of patients, requiring a highly sensitive and exquisitely specific in vitro assays to ensure their quality and safety for release.
Rapid and Robust Endotoxin Detection with Endosafe Systems
Endosafe® nexgen-PTS™ is a rapid, handheld spectrophotometer designed to deliver real-time quantitative endotoxin analysis at point of sample collection in as little as 15 minutes.
Endosafe® nexgen-MCS™ is a multi-cartridge benchtop system that addresses the need for higher sample throughput, compatible with our Endoscan-V™ endotoxin measurement and analysis software.
Endosafe® Nexus 200™ is our walk-away automated robotic instrument, capable of testing up to 120 samples and performing serial dilutions in a fully enclosed system.
Endosafe® Kinetic Chromogenic Cartridge Technology
Endosafe FDA-Licensed LAL Cartridges
Our LAL test cartridges use Endosafe® chromogenic LAL reagent to measure color intensity, which directly correlates with the endotoxin concentration in a sample.
Endosafe® Trillium™ Recombinant Cascade Reagent (rCR) Cartridges
Our rCR test cartridges use an optimized Endosafe kinetic chromogenic reagent curated to simulate the natural LAL reaction. The formulation and composition of Trillium includes the 3 biological proteins (recombinant Factor C, recombinant Factor B, and recombinant proclotting enzyme) and a specific concentration of key components.
Beta-Glucan Cartridges
The Beta-glucan assay is a rapid, in-process test used for investigational purposes to ensure that products do not contain (1,3)-β-D glucans. These glucans are known to cause false-positive results in the LAL test, potentially triggering an investigation.
FDA-licensed Limulus Amebocyte Lysate (LAL) Reagents and Recombinant Cascade Reagents (rCR)
Kinetic Chromogenic LAL (KCA)
A fully quantitative and uniquely stable reagent, Endochrome-K™ is an enhanced KCA formulation that delivers an unrivaled combination of sensitivity, linearity, and interference resistance. Our Endochrome-K LAL test reagent provides quantitative endotoxin values in roughly an hour, depending on the desired sensitivity. The stability of the reconstituted LAL allows for extended bench time and reuse, making it a highly economical solution.
Kinetic Turbidimetric LAL (KTA & KTA2)
Our second-generation kinetic turbidimetric LAL reagent, KTA2, has a wide standard curve (to 0.005 EU/mL) and releases one of the fastest turbidimetric LAL reaction times in the industry. Both Kinetic Turbidimetric LAL reagents are buffered to provide significant interference-resistance properties, and our KTA reagent enables you to use a single FDA-licensed product that performs both kinetic and gel-clot analysis.
Gel-clot
Our qualitative lysate features a firm gel over a wide range of sensitivities, with buffered properties to improve interference resistance for routine LAL tests.
Endosafe® Trillium™ rCR (KCA)
Specific to natural environmental endotoxins, our proprietary matrix ensures accurate recovery of relevant and natural environmental endotoxins and demonstrates assay superiority in comparability and robustness compared to single protein recombinant technologies. As a kinetic chromogenic method, Endosafe Trillium is compatible with incubating absorbance plate readers, EndoScan-V™ software, and accessories, which reduces methodology training and qualifications, eliminates the need for additional capital investments, and supports recycling initiatives of electronic lab instrumentation waste.
Frequently asked questions
