Development of sera reference panels for quality control of ELISA diagnostic kits in Russia

Kanev, A.N.; Vorob'eva, M.S.; Shalunova, N.V.; Karpovich, L.G.; Netesov, S.V.; Maksiutov, A.Z.; Usova, S.V.

Vestnik Rossiiskoi Akademii Meditsinskikh Nauk 1998(3): 47-51

1998


ISSN/ISBN: 0869-6047
PMID: 9608278
Document Number: 910
In the past 5 years, the investigators of the "VECTOR" SRB VB and the L. A. Tarasevich State Institute of Standardization and Control of Medical Biological Preparations have jointly designed sera reference panels containing anti-HIV-1 IgG, anti-HCV IgG, and anti-HAV IgM which have been approved as national standard panels. The panels.are intended for use in controlling the specificity and stability of the most widely used ELISA diagnostic kits and immunoblot test systems during production, control, and application stages. Some problems of development and production of these panels, including the representation of different sera in the panels and the selection of specific IgG concentrations in the different sera in the panel are described. The authors also attract attention to the stabilization of the specific characteristics of panel sera during storage and transportation.

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Development of sera reference panels for quality control of ELISA diagnostic kits in Russia