LAL Reagents
For Bacterial Endotoxin Testing
High-Quality Products From the Company That Invented LAL Testing
Limulus amebocyte lysate (LAL) reagents, the gold standard for bacterial endotoxin testing, are known for their accuracy, helping to protect patient safety. ACC pioneered the LAL test and has been a leader in the industry for decades. In pharmaceutical manufacturing and renal dialysis centers, water testing, and other applications, customers rely on ACC’s LAL reagents and unparalleled customer support to provide a high level of confidence in accurate endotoxin detection.
The LAL endotoxin test is critical to ensuring product safety and compliance with regulatory standards. Our reagents for the LAL test procedure are backed by expert support and have a long-standing reputation for reliability. These endotoxin test methods are instrumental in maintaining patient safety and compliance with stringent regulatory standards, including those set by the United States Pharmacopeia (USP) and the European Pharmacopeia (EP).
Pyrotell®
Gel-Clot LAL Reagent
Pyrotell® was the first LAL reagent licensed by the US FDA in 1974. It is easy to use and available as economical multi-test vials (MTV) and convenient single-test vials (STVs). Pyrotell® is a robust reagent that yields firm gel clots in...
Pyrotell®-T
Kinetic Turbidimetric LAL Reagent
Pyrotell®-T is used to quantify endotoxin using the kinetic turbidimetric method. This LAL reagent can be used for a range of samples, from water testing, injectables, biologicals, complex matrixes, medical device extracts to samples with a low...
Pyrochrome®
Kinetic Chromogenic LAL Reagent
This reagent is ideal for kinetic assays but can be also used for endpoint assays, offering high sensitivity and flexibility for a broad range of applications. The chromogenic LAL assay method used by executed by Pyrochrome® provides yields...
Chromo-LAL
Kinetic Chromogenic LAL Reagent
Chromo-LAL is a high-performance kinetic chromogenic LAL reagent designed for precise endotoxin detection using microplate readers. This lysate is colyophilized with substrate reagents and buffered at pH 7, providing a stable and robust reagent...
Pyrosate® Kit
Rapid Endotoxin Test Kit
The Pyrosate® Kit is an easy-to-use solution for rapid gel clot endotoxin testing. It includes everything needed to test samples quickly and confidently, with clear, step-by-step illustrated instructions. The workflow can be completed in minutes,...
FAQs
What is bacterial endotoxin testing, and why is it important?
Bacterial Endotoxin Testing (BET) is a critical quality control test used to detect and quantify endotoxins from gram-negative bacteria. Bacterial endotoxins can trigger severe immune reactions and high fevers in humans. To keep patients safe, every injectable pharmaceutical, biological product, and medical device with a non-pyrogenic (fever-free) claim must pass a strict endotoxin specification before a manufacturer can release it for public use.
What is Limulus Amebocyte Lysate (LAL) reagent?
Limulus amebocyte lysate (LAL) is an aqueous extract of blood cells (amoebocytes) from the horseshoe crab.
What is a recombinant cascade reagent (rCR)?
A recombinant cascade reagent (rCR) is an innovative, animal-free technology applied within BET. It serves as a sustainable alternative to traditional LAL reagents, which are derived from horseshoe crab blood. Recombinant cascade reagents are designed to detect endotoxins with high accuracy while eliminating the need for horseshoe crab blood cells, making them a more ethical and environmentally friendly option.
How does the BET test it work?
All the reagents for BET (whether LAL or rCR) rely on Factor C, a serine protease that recognizes with a high degree of specificity endotoxins from different bacterial species. This initiates a cascade response to the endotoxin and ultimately leads to a formation of gel clot (on a gel clot test) or a change in optical density (on photometric assays). The rate of the change can be quantified and is endotoxin dose dependent. The BET test is highly sensitive and can detect even minute amounts of endotoxins, making it a robust QC method for ensuring product safety. There are three types of BET assays: gel-clot, turbidimetric, and chromogenic methods.
What are the advantages of using LAL BET assays for endotoxin tests instead of the Rabbit Pyrogen Test or Monocyte Activation Test?
BET assays are the most widely accepted method for endotoxin testing due to their ease of use, rapid turnaround, high sensitivity and documented reliability of minute amounts of endotoxins. As a ubiquitous pyrogen of the highest potency, endotoxins are considered to be the most important pyrogen to test for. The BET assays are versatile, with different methods of detection and different configurations that are found to suit various testing environments.
Can LAL testing methods BET be used for applications beyond pharmaceuticals and medical devices?
Yes, BET assays are used in various sectors in addition to the required ones: dialysis centers, and water testing, product development, quality of buffers and media etc. The ability to detect bacterial endotoxins in various samples makes the BET assay essential for ensuring quality across different applications.