FIELD: medicine.
SUBSTANCE: detection or confirmation of hepatitis B virus surface antigen (HBsAg). Immune-enzyme test system for HBsAg identification in blood serum (plasma) and blood preparations (albumin, fibrinolysin, immunoglobulins and leukocytic interferon) containing: solid phase containing immunosorbent that is mice HBsAg monoclonal antibodies fixed on tray strips; conjugate -1 - biotin with HBsAg monoclonal antibodies and conjugate-2 - streptavidine marked with horseradish peroxidase as liquid concentrates; positive control sample; negative control sample; washing solution; solution for conjugates dilution; substrate buffer solution; tetramethyl benzidine as chromogen; sulfuric acid as stop-reagent; neutralizing reagent, liquid or lyophilized that is goat HBsAg antibodies immunoglobulins; control reagent liquid or lyophilized that is goat immunoglobulins without HBsAg antibodies; weakly-positive control sample that is HBsAg lyophilized blood serum in concentrations 0.02-0.06 ME/ml. Method of hepatitis B virus surface antigen (HBsAg) detection is performed through immune-enzyme test of biological sample by means of the given test system.
EFFECT: invention allows to detect required antigen of low sensibility at high specificity level.
4 cl, 1 ex, 8 tbl
| Title | Year | Author | Number |
|---|---|---|---|
| METHOD FOR BRANCH STANDARD SAMPLE PRODUCTION OF HEPATITIS B VIRAL SURFACE ANTIGEN, USED IN QUALITY CONTROL OF TEST SYSTEMS AND ANTIGEN QUANTITATIVE IMMUNE-ENZYME DETERMINATION IN HUMAN BLOOD SERUM (PLASMA) AND PREPARATIONS | 2007 |
|
RU2342158C2 |
| TEST SYSTEM FOR DETECTING ANTIBODIES TO HBS ANTIGEN AND TEST SYSTEM BLOCKER | 2001 |
|
RU2206095C1 |
| METHOD FOR ASSESSING ANTIBODY LEVEL SPECIFIC TO DIFFERENT VARIANTS OF HEPATITIS B VIRUS HBsAg | 2016 |
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|
RU2283497C1 |
| METHOD OF DETECTION OF ANTIBODY TO HEPATITIS VIRUS C NUCLEAR PROTEIN | 1997 |
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| COMPLEX DIAGNOSTIC TECHNIQUE FOR INFECTIOUS DISEASES BY ENZYME-LINKED IMMUNOSORBENT ASSAY | 2012 |
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RU2488832C1 |
| IMMUNOSORBENT FOR DETECTION OF ANTIBODY TO HEPATITIS C VIRUS NUCLEAR PROTEIN IN BLOOD SERUM | 1997 |
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| TEST SYSTEM FOR DETECTING ANTIBODIES TO NUCLEAR PROTEIN OF HEPATITIS C OF IGM CLASS | 1997 |
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| MOSAIC RECOMBINANT POLYPEPTIDE CONTAINING FRAGMENTS OF HEPATITIS E VIRUS PROTEINS OF GENOTYPES 1 AND 3 IN ONE POLYPEPTIDE CHAIN, INTENDED FOR USE IN TEST SYSTEMS USED IN THE SERODIAGNOSIS OF HEPATITIS E | 2020 |
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RU2754791C1 |
