Press Release

STEMart, a U.S.-based provider of comprehensive services for all stages of medical device development, has recently introduced the Limulus Amebocyte Lysate (LAL) Testing Services under the guidance of industrial standards, including the FDA Guidance for Industry Pyrogen and Endotoxins Testing, the USP , and the USP .

LAL is a reagent derived from the blood of the horseshoe crab. In the presence of bacterial endotoxins, blood cell lysate reacts to form a clot or color change. The LAL test is also known as the Bacterial Endotoxin Test (BET) and is sometimes called the pyrogen test because bacterial endotoxins can cause fever in mammals, including humans. This test is an in vitro assay for the detection and quantification of bacterium-negative bacteria within the cell wall.

BET is a batch-release test for the evaluation of medical devices in contact with the cardiovascular system, lymphatic system, or cerebrospinal fluid. This test determines the presence of bacterial endotoxins utilizing blood cell lysates of horseshoe crabs. In addition, BET is required for any products that come into direct or indirect contact with the intravascular, intralymphatic, intrathecal, and intraocular systems to ensure the endotoxin content of products is below the allowable release limit, which is less than 20.0 EU/device, 2.15 EU/device for medical devices come into contact with cerebrospinal fluid, and 0.2 EU/device for ophthalmic implants.

With extensive expertise in microbiology and sterility testing, STEMart can provide comprehensive services to support manufacturers in meeting regulatory goals and minimizing compliance risk. STEMart now offers a variety of standard Limulus Amebocyte Lysate Testing Services for medical industries, covering kinetic turbidimetric, kinetic chromogenic, and gel-clot test solutions.

For the kinetic turbidimetry solution, tube readers or 96-well plate readers can be used to monitor the changes in solution clarity due to the presence of endotoxins. The time interval for solution clarity change is negatively correlated with the concentration of endotoxins within the sample. Therefore, reaction time can be used for the calculation of endotoxin concentrations with the standard reaction time or standard curve.

As for the gel clot method, scientists can mix the gel clot LAL and an equal amount of tested materials for incubation. In the presence of endotoxins, the solution coagulates and forms gel precipitation.

If you have additional questions regarding these Limulus Amebocyte Lysate Testing Services for medical devices or would like to know more about STEMart's medical device development service, please visit https://www.ste-mart.com.

About STEMart

STEMart is an industry-leading eCommerce platform incorporated with an extensive global footprint and a broad portfolio of more than 10,000 products. It aims to provide better lab materials, medical instruments and consumables, excellent technologies, and high-quality services to global customers in the fields of science, technology, and engineering, from the discovery stage upward to the manufacturing process. STEMart is dedicated to enhancing research and biotech production with simpler and safer protocols in order to access better health worldwide.

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