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Endotoxin tests detect lipopolysaccharides in a sample, which are produced by Gram negative bacteria and can cause health issues like septic shock. Manufacturers use the test to ensure product safety, while research labs use it to verify sample purity. The classic test uses a compound from horseshoe crab blood to detect endotoxins. Contamination can be dangerous, so regular testing is necessary. Testing facilities must follow precise protocols and provide documentation for safety inspections.
An endotoxin test is a laboratory test to check for the presence of endotoxins such as lipopolysaccharide in a sample. Endotoxins are chemical compounds, mainly produced by Gram negative bacteria. They can be very dangerous to humans, leading to health conditions such as septic shock if they enter the bloodstream. Drug and medical device manufacturers use endotoxin testing in quality control to ensure their products are pure and safe for use. This test can also be useful for laboratories concerned about contamination of samples used in research.
The classic endotoxin test is based on a compound found in the blood of horseshoe crabs. This compound causes clotting when endotoxins are present. Manufacturers collect blood from horseshoe crabs to provide a constant supply for endotoxin testing kits. A lab technician can perform a variety of types of tests using this compound to see if there are endotoxins in a sample and to determine their concentrations.
When drugs or devices are contaminated with endotoxins, it can put patients at risk. People who are already ill may be less able to metabolize the toxin and could become seriously ill if they take contaminated medications or use contaminated devices. Manufacturers and other facilities routinely perform endotoxin testing to look for signs of contamination. If the endotoxin test reveals a problem, the manufacturer may stop distributing a batch or recall it in cases where it is already on the market. Testing takes place on a regular basis along with other quality control measures for safety.
In research laboratories, endotoxin contamination is a constant problem. Many samples require treatment to remove endotoxins and an endotoxin test should verify the success of the treatment. People researching contaminated samples will not get reliable, repeatable, or useful results. In cases where contamination compromises an experiment, it can also be helpful to learn more about the nature of the contamination and the source, as this can help avoid future problems and understand the results of the experiment.
Many laboratories offer endotoxin testing services to people who only need periodic testing. Other companies maintain their own testing facilities. In all cases, very precise protocols determine how the technicians perform the test. People need to register their activities and provide careful documentation. This allows checks of testing practices in case of problems. In manufacturing facilities, safety inspectors may request to review these records as part of a routine inspection to ensure that the facility complies with legal requirements.
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