Calibration of the limulus test for blood products

The Protein Fractionation Centre has been using the Limulus Amoebocyte Lysate test for detecting the presence of pyrogens for some five years. All tests on final plasma products have been carried out in parallel with the EP rabbit pyrogen test. Good correlation between both tests has been obtained with products such as distilled water and crystalloid solutions. However, it is more difficult to correlate results when dealing with plasma proteins. Each product appears to react differently. Some normally pass the limulus test undiluted while others, such as immune globulins and albuminoid products, have to be diluted to various concentrations before they pass. A preliminary statistical analysis has been carried out on the results of pyrogen testing on Stable Plasma Protein Solution, firstly to ascertain that a significant correlation does exist between the LAL test and the rabbit test, and secondly to try to obtain "cut off" values for the limulus test which compare well with the official EP temperature rises in the rabbit test.