[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-D-glucan are used, a definite correlation was found between the results with the two LAL test methods. Endotoxin added to HSA products was recovered in a quantitative manner showing neither inhibition nor enhancement by HSA to the both LAL test methods. Results of the LAL tests showed a significant correlation with that of the rabbit pyrogen test. The correlation was much improved with endotoxin-added HSA. The present results indicate the practical applicability of the LAL test as an alternative method for the rabbit pyrogen test.
National Institute of Health, Tokyo, Japan.
S
S
Asakawa
H
H
Fujiwara
S
S
Naito
R
R
Homma
S
S
Ishida
F
F
Chino
M
M
Tsuchiya
S
S
Matsuura
S
S
Tanaka
M
M
Ohki
D000818:Animals; D001688:Biological Products / Q000737:chemistry*; D004340:Drug Contamination; D004731:Endotoxins / Q000032:analysis*; D005334:Fever / Q000139:chemically induced; D006801:Humans; D008033:Limulus Test; D011786:Quality Control; D011817:Rabbits; D012709:Serum Albumin / Q000737:chemistry*
D001688:Biological Products; D004731:Endotoxins; D012709:Serum Albumin