Bacterial Endotoxin (LAL) Test

Limulus amebocyte lysate (LAL) is an in vitro test method used to detect bacterial endotoxins. This test method uses lysate obtained from blood cells of horseshoe crabs to detect bacterial endotoxins .

Limulus amebocyte lysate (LAL) is considered the most sensitive and specific method available for detecting endotoxins. More than 70 million endotoxin tests are performed annually for injectable pharmaceutical products and implantable medical devices. However, there has never been a single FDA-approved pyrogenic (fever) outbreak because of a false-negative limulus amebocyte lysate (LAL).

In advanced laboratories today, all bacterial endotoxin testing systems and reagents use LAL. A qualitative bacterial endotoxin gel-clot test was converted into a 15-minute quantitative bacterial endotoxin test located directly on the production floor. The development of new technologies and innovative products continues to improve the quality of endotoxin testing and accelerate the development process.

Bacterial endotoxin is a type of fever-causing agent and is found in the cell wall of gram-negative bacteria. If certain amounts of endotoxin are introduced into the bloodstream or spinal fluid with a parenteral drug or a medical device, fever, septic shock, organ failure, or death may occur. Because of the risk of serious illness or death, all injectable pharmaceutical products and implantable medical devices that come into contact with the bloodstream or spinal fluid are tested for endotoxins to ensure patient safety. These products and devices are tested for endotoxins by bacterial endotoxin testing. Among the test methods, the most popular bacterial endotoxin test uses limulus amebocyte lysate to detect bacterial endotoxins.

All injectable pharmaceutical products and implantable medical devices must be tested to ensure they are free of endotoxins that can cause fever and septic shock symptoms.

The lysate used in the tests and obtained from the blood cells of horseshoe crabs reacts with bacterial endotoxins.

Our organization also provides bacterial endotoxin (LAL) testing services with its trained and expert staff and advanced technological equipment, among the numerous test, measurement, analysis and evaluation studies it provides for businesses in various sectors.