Biochemical ReagentsTop ProductsImmunoglobulin G4 Assay Kit

Immunoglobulin G4 Assay Kit

Abbreviation: IgG4Method: Latex-Enhanced Immunoturbidimetric Assay

Product Overview
  • Ready-to-use liquid two-reagent formulation, supplied in dedicated packaging and compatible with a wide range of automated clinical chemistry analyzers.
  • Measurement method: Two-point endpoint assay with a primary wavelength of 570 nm.
  • Wide linear range: Excellent linearity from 0.20–3.00 g/L (r ≥ 0.990).
  • Excellent stability: Stable for 12 months when stored at 2–8°C protected from light. Once opened, the reagents remain stable for up to 1 month at 2–8°C.
  • Sample compatibility: Suitable for serum and EDTA plasma.
  • Strong anti-interference performance: Effectively minimizes interference from lipemia, hemolysis, bilirubin, vitamin C (ascorbic acid), and other nonspecific substances.
  • Clinical Background

    This assay is intended for the in vitro quantitative determination of Immunoglobulin G4 (IgG4) in human serum or plasma as an aid in clinical diagnosis.

    Serum IgG4 measurement is widely used for the evaluation of immune function and as an important laboratory marker in the diagnosis of IgG4-related disease (IgG4-RD).
    IgG4-RD is a chronic, progressive fibroinflammatory disease that can involve multiple organs. Historically, organ-specific manifestations were regarded as separate diseases, including Mikulicz disease affecting the salivary glands, autoimmune pancreatitis, IgG4-related sclerosing cholangitis, and retroperitoneal fibrosis/periaortitis. These conditions are now recognized as manifestations of a single systemic disease because they share common immunopathological characteristics, including dense lymphoplasmacytic infiltration and abundant IgG4-positive plasma cells within affected tissues.

    Patients with IgG4-RD typically present with elevated serum IgG4 concentrations, infiltration of IgG4-positive plasma cells in affected organs, tissue sclerosis or fibrosis, and obliterative phlebitis. The disease occurs predominantly in middle-aged and elderly men. Because it frequently presents as tumor-like lesions, IgG4-RD may be misdiagnosed as a malignant neoplasm.

  • Assay Principle

    The assay employs proprietary technology to directionally immobilize IgG4-specific antibodies onto latex microparticles. IgG4 present in the sample specifically binds to the corresponding antibodies in the reagent, forming antigen-antibody immune complexes that produce an increase in turbidity. The latex particles significantly enhance the turbidity change, thereby improving assay sensitivity.
    The increase in turbidity is directly proportional to the IgG4 concentration in the sample. By comparing the measured turbidity with that of calibrated standards, the IgG4 concentration in the serum or plasma specimen can be quantitatively determined.

  • Available Packaging

    R1:1×15ml,R2:1×5ml   R1:2×75ml,R2:1×50ml   R1:1×30ml,R2:1×10ml   R1:2×96ml,R2:1×64ml  Siemens Analyzer Configuration：480 tests/kit(R1:1×45ml,R2:1×15ml)

    R1:1×45ml,R2:1×15ml   R1:3×15ml,R2:1×15ml   R1:1×60ml,R2:1×20ml   R1:4×30ml,R2:4×10ml  Calibrator：6×0.5ml

    R1:1×75ml,R2:1×25ml   R1:4×60ml,R2:4×20ml   R1:2×30ml,R2:2×10ml   R1:6×15ml,R2:6×5ml   Quality Control：2×0.5ml

    R1:2×45ml,R2:2×15ml   R1:6×30ml,R2:6×10ml   R1:2×60ml,R2:2×20ml   R1:6×60ml,R2:6×20ml