ATTRIBUTES OF BACTERIAL ENDOTOXIN TEST (BET) AND ITS COMPARISON WITH RABBIT PYROGEN TEST

Presence of pyrogen (mostly endotoxins) in therapeutics can cause harmful symptoms in patients, so it is mandatory to test the presence of pyrogens in different therapeutics including biologicals. Now-a-days the use of animals is not the preferred method for performance of quality control testing to detect the presence of pyrogens. As Committee for the Purpose of Control and Supervision of Experiments on Animals(CPCSEA) has introduced the 4R?s i.e. Replacement, Reduction, Refinement and Rehabilitation. This has shifted the approach from in-vivo to in-vitro methods. Considering the 4R?s, the Bacterial Endotoxin test (also known as Limulus Amebocyte Lysate Test) has been introduced as alternative method for Rabbit pyrogen test. The current article primarily focuses on comparison of Limulus Amebocyte Lysate Test (LAL test) and Rabbit pyrogen test and came to conclusion that, time taken for performing the Rabbit pyrogen test is approximately 6 hours apart from conditioning the rabbits for 1-3 days. Whereas, Limulus Amebocyte Lysate Test can be performed within 1-2 hours. Secondly, the sensitivity of LAL Test is more than Rabbit pyrogen test for endotoxin, Lipid A and plasma proteins, the range may vary. Lastly, various Pharmacopoeias like European Pharmacopoeia, British Pharmacopoeia, United States Pharmacopoeia and Indian Pharmacopoeia has already included the LAL Test as a replacement method in parenteral preparation and alternative method for Blood products.