APPLICATION OF THE LIMULUS TEST FOR PRACTICAL QUALITY-CONTROL ON ENDOTOXIN CONTENT IN COMMERCIAL HUMAN SERUM-ALBUMIN (HSA) PRODUCTS - IN COMPARISON WITH THE RABBIT PYROGEN TEST

The bacterial endotoxin content in human serum albumin (HSA) products measured by two different Limulus amebocyte lysate (LAL) test methods, colorimetric and kinetic turbidimetric methods, were compared. So far as endotoxin-specific LAL reagents which do not show a false-positive reaction with (1-->3)-beta B-D-glucan are used, a definite correlatio n was found between the results with the two LAL test methods. Endotox in added to HSA products was recovered in a quantitative manner showin g neither inhibition nor enhancement by HSA to the both LAL test metho ds. Results of the LAL tests showed a significant correlation with tha t of the rabbit pyrogen test. The correlation was much improved with e ndotoxin-added HSA. The present results indicate the practical applica bility of the LAL test as an alternative method for the rabbit pyrogen test.