Bacterial Endotoxin Test

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Introduction :

   The bacterial endotoxin test is a critical quality control test used in the pharmaceutical industry to ensure the safety of parenteral drugs and medical devices. Endotoxins are bacterial lipopolysaccharides (LPS) found in the cell walls of Gram-negative bacteria. When introduced into the human body, particularly through injection or infusion, endotoxins can trigger strong immune responses and cause severe adverse reactions, including fever, shock, and even death.   

Key aspects of the bacterial endotoxin test :

Purpose: The primary purpose of the bacterial endotoxin test is to confirm that pharmaceutical products, particularly those intended for injection, are free from harmful levels of endotoxins. This test helps ensure the safety and efficacy of drugs and medical devices.

Test Methods: There are various methods for conducting the bacterial endotoxin test, but the most common one is the Limulus Amebocyte Lysate (LAL) test. 

⇒The LAL test uses an enzyme derived from the blood cells of horseshoe crabs, which is sensitive to endotoxins. 

⇒When endotoxins are present in the sample, they activate the LAL enzyme, leading to a gel formation or color change, which can be quantified.

 
   Blood sample    

Since the initial development of the LAL test, other methods for endotoxin detection have been introduced. Protein-based biosensors such as CD14 have been used to develop sensitive endotoxin assays. However, these methods have been criticized for a large margin of error and the potential for false positives, since CD14 does not bind specifically to endotoxins.

Other types of endotoxin biosensors have also been proposed, including peptides, antibodies, adaptamers, cells, and nanoparticles. However, these assays suffer from a similar cohort of problems, including a lack of binding specificity, poor sensitivity, high cost, and a time- and labor-intensive production process. For this reason, the LAL assay still remains the most reliable and cost-effective method for endotoxin detection.

 Result :

After incubation at 37°C, the mixture is checked for evidence of a clotting reaction (gel clot), and the test samples are compared to parallel dilutions of a reference endotoxin. 

The formation of a gel clot indicates the presence of bacterial endotoxins in the sample and the test is considered positive.

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