COMPARISON OF LAL TEST WITH THE RABBIT PYROGEN TEST

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Samples of lots subject to the rabbit pyrogen test submitted to the Center for Biologics Evaluation and Research for release are first tested using one of the three (3) LAL test methods. The test with the least inhibition or enhancement is the established test for that product. The manufacture is then notified of our results and it is recommended that the LAL method is the test of choice for detecting endotoxin that product instead of the rabbit pyrogen test. The LAL test is more sensitive, requires less sample, can be completed in less than 1 hour, and is much less expensive than the rabbit test.