For Laboratory Or Hospital High Accuracy H.Pylori IgG Elisa Test Kit

                              For Laboratory Or Hospital High Accuracy H.Pylori IgG Elisa Test Kit

INTENDED USE

  The H.Pylori IgG assay is an enzyme-linked immunosorbent assay (ELISA) for the in vitro quantitative determination of H.Pylori antibody of IgG type in human serum or plasma.

Test principle

Indirect method, total duration of assay: 70 minutes.

The H.Pylori IgG ELISA employs solid phase, indirect ELISA method for detection of antibodies to H.Pylori IgG in two-step incubation procedure. Polystyrene microwell strips are pre-coated with highly immunoreactive human H.Pylori antigens. During the first incubation step, anti-H.Pylori IgG specific antibodies, if present, will be bound to the solid phase pre-coated H.Pylori antigens. The wells are washed to remove unbound serum proteins, and rabbit anti-human IgG antibodies (anti-IgG) conjugated to the enzyme horseradish peroxidase (HRP-Conjugate) are added. During the second incubation step, these HRP-conjugated antibodies will be bound to any antigen antibody(IgG) complexes previously formed and the unbound HRP-conjugate is then removed by washing. Chromogen solutions containing Tetramethylbenzidine (TMB) and urea peroxide are added to the wells and in presence of the antigen-antibody-anti-IgG (HRP) immunocomplex, the colorless Chromogens are hydrolyzed by the bound HRP conjugate to a blue-colored product. The blue color turns yellow after stopping the reaction with sulfuric acid. The amount of color intensity can be measured and it is proportional to the amount of antibody captured in the wells, and to the amount of antibody in the sample respectively.

Materials provided

• Coated Microplate - symbol human TG antigen.

• Calibrators - symbol HP PLATE HP CAL A-F , 8 x 12 strips, 96 wells. Pre-coated with , 6 vials, 1 mL each, ready to use; Concentrations: 0(A), 10(B), 25(C), 50(D), 100(E) and 150(F) U/mL* *’s reference value

• Enzyme Conjugate - symbol HP CONJ , 1 vial, 11.0 mL of HRP (horseradish peroxidase) labeled rabbit anti-human IgG antibodies (anti-IgG) in Tris-NaCl buffer containing BSA (bovine serum albumin). Contains 0.1% ProClin300 preservative.

• Sample Diluent - symbol salts and a dye

• Substrate - symbol HP DILUT SUBSTRATE 1 vial, 11mL. Ready to use. Containing buffer 1 vial, 11mL, ready to use, (tetramethylbenzidine) TMB. STOP • Stop Solution - symbol 1 vial, 6.0 mL of 1 mol/L sulfuric acid.

• Wash Solution Concentrate - symbol PBS-Tween wash solution.

• IFU: 1 copy.

• Plate Lid: 1 piece.