LAL TEST

Limulus amebocyte lycate test, or widely known as LAL test, is a test practiced in pharmaceutical and food & drug industrial vertical since several decades. This test is used for the detection and quantification of bacterial endotoxins. Endotoxins are toxic substance bound to the bacterial cell wall and released when the bacterium erupts or disintegrates.

LAL test was introduced in food and drug industry when it was approved for testing drugs, products, samples and devices that come in direct contact with the blood cells in 1970. Prior to this, these drugs and products were first tested on rabbits which were highly expensive and delivered results inconsistently and slowly, delaying the quality process of the sample. In 1956, scientist Fred Bang observed the clotting of Horseshoe crab blood into semi solid mass due to endotoxins. This observation was later used in the development of LAL test. To test a sample for endotoxins, it is mixed with lysate and water. If coagulation occurs, it is concluded that endotoxins are present in the sample.

There are three distinctive methodologies followed for the LAL test - gel-clot, turbidimetric, and chromogenic. Several precautionary measures must be followed to conduct LAL test. Proper endotoxin recovery must be proven before LAL can be used to release product. In United States of America, the Food and Drug Association has published a guideline for validation of the LAL test as an endotoxin test, which is mandatorily followed.

Thermolab Analytic excels in conducting LAL test to bring flawlessness in its results.