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

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 appr...

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Bibliographic Details
Published inVestnik Rossiĭskoĭ akademii medits︠i︡nskih nauk no. 3; p. 47
Main Authors Kanev, A N, Vorob'eva, M S, Shalunova, N V, Karpovich, L G, Netesov, S V, Maksiutov, A Z, Usova, S V
Format Journal Article
LanguageRussian
Published Russia (Federation) 1998
Subjects
Enzyme-Linked Immunosorbent Assay - standards
Hepacivirus - immunology
Hepatitis B Antibodies - analysis
Hepatitis C Antibodies - analysis
Hepatovirus - immunology
HIV Antibodies - analysis
HIV-1 - immunology
Humans
Immunoglobulin G - analysis
Immunoglobulin M - analysis
Quality Control
Reagent Kits, Diagnostic - standards
Reference Standards
Russia
Russia
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Summary: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.
ISSN:0869-6047