Applicability of bacterial endotoxins test to various blood products by the use of endotoxin-specific lysates.
Endotoxin contamination is a serious threat to the safety of parenteral drugs, and the rabbit pyrogen test has played a crucial role in controlling this contamination. Although the highly sensitive endotoxin test has replaced the pyrogen test for various pharmaceuticals, the pyrogen test is still implemented as the control test for most blood products in Japan. We examined the applicability of the endotoxin test to blood products for reliable detection and quantification of endotoxin. Nineteen types of blood products were tested for interfering factors based on spike/recovery of endotoxin by using 2 types of endotoxin-specific lysate reagents for photometric techniques. Interfering effects on the endotoxin test by the products could be eliminated by diluting from 1/2 to 1/16, with the exception of antithrombin III. However, conventional lysate reagents that also react with non-pyrogenic substances, such as (1-3)-β-D-glucan, produced results that were not relevant to endotoxin content or pyrogenicity. Our results showed that the endotoxin test would be applicable to most blood products if used with appropriate endotoxin-specific lysate reagents.
Ochiai
Masaki
M
Division of Quality Assurance, National Institute of Infectious Diseases, 4-7-1 Gakuen, Musashimurayama-shi, Tokyo 208-0011, Japan. masakio@nih.go.jp
Yamamoto
Akihiko
A
Naito
Seishiro
S
Maeyama
Jun-Ichi
J
Masumi
Atsuko
A
Hamaguchi
Isao
I
Horiuchi
Yoshinobu
Y
Yamaguchi
Kazunari
K
D000818:Animals; D001688:Biological Products / Q000737:chemistry*; D001769:Blood; D001779:Blood Coagulation Factors / Q000737:chemistry; D005260:Female; D007136:Immunoglobulins / Q000737:chemistry; D007202:Indicators and Reagents; D008070:Lipopolysaccharides / Q000097:blood*; D011817:Rabbits; D012015:Reference Standards; D015203:Reproducibility of Results
D001688:Biological Products; D001779:Blood Coagulation Factors; D007136:Immunoglobulins; D007202:Indicators and Reagents; D008070:Lipopolysaccharides