What is an endotoxin assay?
What is an endotoxin assay?
What is Endotoxin Testing? LAL (Limulus amebocyte lysate) endotoxin testing is an in-vitro assay used for the detection and quantitation of bacterial endotoxins in injectable products or implantable medical devices that will make direct or indirect contact with the bloodstream or spinal fluid.
What causes endotoxin contamination?
Endotoxin contamination sources include water used as a solvent, water used in instrument cleaning and terminal reprocessing, packaging components and raw materials or equipment used in production (FDA, 1985).
What causes Lal?
Lipopolysaccharides, which are chemical species that are considered toxic upon producing the cell lysis of Gram-negative bacteria, activate a series of chain reactions that occur in the hemolymph of horseshoe crab, finally causing turbidity in the sample. This is the analytic signal used to develop the LAL test.
Why are all assays standardized using endotoxin in water?
All assays, independent of methodology, are standardized using endotoxin in water. Therefore, unless your sample is water, some components of the solution may interfere with the LAL test such that the recovery of endotoxin is affected. If the product being tested causes the endotoxin recovery to be less than expected, the product is
How is the LAL assay dependent on endotoxin recovery?
Proper endotoxin recovery must be proven before LAL can be used to release product. The LAL assay is dependent on the proper activation of the cascade of serine proteases that comprises the lysate. Initiation of the cascade involves recognition of endotoxin in the sample by the first enzyme in the system.
How does the BET Test for bacterial endotoxins work?
The bacterial endotoxins test (BET) is a test to detect or quantify endotoxins from Gram- negative bacteria using amoebocyte lysate from the horseshoe crab (Limulus polyphemusor . Tachypleus tridentatus). There are three methods for this test: • Method A.
What are the driving forces of endotoxin detection?
In order to analyze the driving forces of LER, endotoxin detection in samples containing nonionic surfactants in various buffer systems was investigated. The results show that the process of LER is kinetically controlled and temperature-dependent.