ABSTRACT
The Limulus test was compared with the official pyrogen test in rabbits for detecting pyrogens in medical devices for single use. 46 samples were examined. Two of them were positive in the rabbit test and also in the Limulus test; 5 samples were only positive in the Limulus test. This is in agreement with published papers. Against endotoxins of gram-negative bacteria the Limulus test is more sensitive than the common test in rabbits, but not sensitive for other pyrogens. Therefore, the Limulus test cannot replace the official rabbit test in the quality control of medical devices. We recommend the Limulus test as a quick, simple and highly sensitive screening method for gram-negative bacterial endotoxins, the most common pyrogen contaminants in drugs.
