Limulus amebocyte lysate testing of nomral serum albumin (human) in the United States since 1975.
In order to determine the reactivity of Limulus Amebocyte Lysate to albumin products, over 1500 lots of 25% Normal Serum (Human) produced by 12 U.S. licensed manufacturers were tested over the past 4 years. Representative samples of 5% Normal Serum Albumin (Human) and Purified Protein Fraction (human) were also tested with Limulus Amebocyte Lysate. Problems associated with apparent false negative reactions are discussed. Model test protocols are presented that might be useful in determining the degree of false positivity of albumin products. These models could be adopted by blood fractionators to gather validation data to support substitution of the Limulus Amebocyte Lysate test for the rabbit pyrogen test.
D000818:Animals; D001681:Biological Assay; D006801:Humans; D008033:Limulus Test; D011749:Pyrogens; D011786:Quality Control; D011817:Rabbits; D012016:Reference Values; D012709:Serum Albumin / Q000032:analysis*; D014481:United States
D011749:Pyrogens; D012709:Serum Albumin