QC Toxicity Testing
Limulus Ameobocyte Lysate Gel Clot Assay (LAL)

Bacterial endotoxin may hinder the outcome of assisted reproductive technologies and therefore the potential presence of endotoxin must be addressed.

The Limulus Ameobocyte Lysate Gel-Clot Assay (LAL) is the most sensitive and specific means available to screen medical devices and raw materials for the presence of harmful levels of endotoxin.

The LAL assay is based on a biological enzyme reaction where in the presence of specific endotoxin levels, produces an opaque gel. A firm gel is formed if the concentration of endotoxin exceeds the reagent labeled sensitivity.

Certificates of Analysis are prepared and results reported immediately after interpretation of results. Testing is performed at ELI Monday through Friday and test items are received 7 days per week. Because of this flexible schedule, we offer an immediate turnaround time of 2-3 business days from test article receipt to reporting results.