发明名称 |
METHOD FOR MAKING PANEL OF HBsAg SUBTYPES AD AND AY SERUMS FOR QUALITY CONTROL OF DIAGNOSING HEPATITIS B |
摘要 |
FIELD: medicine. ^ SUBSTANCE: what is presented is a method for making a panel of serums for the purpose of quality control of diagnosing hepatitis B with the certified low concentration of HBsAg subtypes AD and AY which involves the analysis of donor serums for the presence of anti-HIV, anti-HCV and anti-HBs antibodies and the nonspecific HBsAg binding; the selection of donor serums with said parameters not found; the use of the selected serums to prepare diluting solutions with a stabilising additive introduced; the certification of the monopreparations of HBsAg subtypes AD and AY by titration dilutions of international standards and the preparation of a reference panel from the certified monopreparations of HBsAg subtypes AD and AY within the range of 0.01 to 0.5 IU/ml; the lyophilisation of the serums followed by thermal degradation panel testing to determine a shelf life. The use of a new formulation of the stabilising additive containing proline 200-250 mM and benzoic acid 0.05-0.08 wt %, and the selection of an optimum temperature storage conditions promote the prolonged activity preservation at annual loss (at +4C) making less than 0.5%. ^ EFFECT: higher shelf life. ^ 3 cl, 5 tbl, 1 dwg, 1 ex |
申请公布号 |
RU2463610(C1) |
申请公布日期 |
2012.10.10 |
申请号 |
RU20110110828 |
申请日期 |
2011.03.22 |
申请人 |
FEDERAL'NOE BJUDZHETNOE UCHREZHDENIE NAUKI "GOSUDARSTVENNYJ NAUCHNYJ TSENTR VIRUSOLOGII I BIOTEKHNOLOGII "VEKTOR" (FBUN GNTS VB "VEKTOR") |
发明人 |
KANEV ALEKSANDR NIKOLAEVICH;BAKIROV TALGAT SAL'MANOVICH;CHEREPANOVA NATAL'JA SANGIREEVNA;JUDINA IRINA VIKTOROVNA;LOSEV MIKHAIL VIKTOROVICH;NADTOCHIJ OL'GA NIKOLAEVNA |
分类号 |
C07K14/705;G01N33/531;G01N33/576;G01N33/96 |
主分类号 |
C07K14/705 |
代理机构 |
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代理人 |
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主权项 |
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地址 |
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