Quantitative Endotoxin test (European Pharmacopoeia 2.6.14: Method E –Chromogenic end-point method): LAL (Limulus Amebocyte Lysate). Biological Evaluation of Medical Devices.
Test Accredited by ENAC (National Accreditation Entity).
Test with the Certificate of Good Laboratory Practices (GLPs).
The chromogenic LAL (Limulus Amebocyte Lysate) test is used to detect and quantify endotoxins associated with gram-negative bacteria, but does not detect pyrogens related to chemicals. In the test, a synthetic substrate equivalent to the lysate of the amebocytes of the crab Limulus polyphemus is used, and it is considered the most convenient because: a) its high sensitivity; b) the results of the test are linear with the concentration of endotoxin; c) this test is recognized by the FDA, and it is recommended to guarantee that the products analyzed do not contain endotoxins (pyrogenic substances); d) in this test, a synthetic substrate linked to a chromogen is used that facilitates the reading and quantification of the reaction; e) the use of five standards in duplicate allows to elaborate a standard line for each test, to quantify the amount of endotoxin present in the sample analyzed.
This test is different from the pyrogenicity test:
Pyrogenicity induced by materials (ISO 10993-11: 2006 –Biological Evaluation of Medical Devices-Part 11. Tests for Systemic Toxicity; European Pharmacopoeia, 2.6.8. Pyrogens).