What is the Origin of LAL Test?

The test is named for its biological source, the amebocytes found in the unique blue blood of the Atlantic horseshoe crab, Limulus polyphemus. The assay was developed after the discovery that a lysate prepared from these amebocytes clots dramatically upon contact with minute amounts of bacterial endotoxin. The LAL test was a significant advancement, replacing the less precise and more ethically challenging rabbit pyrogen test as the standard.

What is the Mechanism of LAL Test?

The core mechanism relies on a cascade of clotting enzymes contained within the LAL reagent, which is activated with high specificity by the endotoxin molecule. This enzymatic reaction ultimately results in the formation of a detectable product, such as a firm gel-clot in the original method, or a measurable turbidity or color change in modern kinetic assays. The assay's exceptional sensitivity allows for the detection of endotoxin concentrations at levels far below the threshold that would cause a febrile reaction in a human patient.

LAL Test

Meaning

The LAL Test, which stands for Limulus Amebocyte Lysate Test, is a highly sensitive in vitro assay used extensively in pharmaceutical quality control to detect and quantify bacterial endotoxins, the pyrogenic lipopolysaccharides (LPS) from Gram-negative bacteria. This assay is a mandatory test for all compounded sterile preparations (CSPs), injectable drugs, and medical devices that come into contact with the bloodstream or spinal fluid. A negative LAL test is essential for ensuring the non-pyrogenic safety of parenteral products.

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