Development of control serum for microbial antibody tests.
Control sera are an essential component of in-vitro clinical diagnostic reagents. We have developed a control serum for HBsAg, anti-HCV, anti-HIV and anti- Treponema pallidum testing. Since this control serum is prepared from human plasma, we paid special attention to viral safety. We incorporated three viral inactivation methods into the manufacturing process that maintain the necessary characteristics of a stable control serum.
Uemura
Y
Y
R & D Division, International Reagents Corporation, 1-1-2, Murotani, Nishi-ku, Kobe, 651-2241, Japan. y-uemura@irc-net.co.jp
Baba
T
T
Hasegawa
Y
Y
Yanagihara
O
O
Matsumoto
K
K
Kawai
T
T
D000907:Antibodies, Bacterial / Q000097:blood; D004797:Enzyme-Linked Immunosorbent Assay; D006678:HIV / Q000276:immunology / Q000302:isolation & purification*; D015483:HIV Antibodies / Q000097:blood; D016174:Hepacivirus / Q000276:immunology / Q000302:isolation & purification*; D006510:Hepatitis B Antibodies / Q000097:blood; D006515:Hepatitis B virus / Q000276:immunology / Q000302:isolation & purification*; D006801:Humans; D007106:Immune Sera; D014210:Treponema pallidum / Q000276:immunology / Q000302:isolation & purification*
D000907:Antibodies, Bacterial; D015483:HIV Antibodies; D006510:Hepatitis B Antibodies; D007106:Immune Sera