IMMUNE-ENZYME TEST SYSTEM FOR HEPATITIS B VIRUS SURFACE ANTIGEN DETECTION AND METHOD OF HEPATITIS B VIRUS SURFACE ANTIGEN DETECTION

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