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AbChek HEV IgM Kit

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Introduction

Hepatitis E Virus (HEV) is a non-enveloped, single-stranded RNA virus identified in 1990. Infection with HEV induces acute or sub-clinical liver diseases similar to hepatitis A. HEV infections, endemic and frequently epidemic in developing countries, is seen also in developed countries in a sporadic form with or without a history of traveling to an endemic area. The phenomenon of long-lasting and protective antibodies to HEV was observed which greatly enhance the understanding of the diagnosis, epidemiology, zoonosis-related studies, and vaccine development.

 

About the product

The test utilizes antibodies including a recombinant protein HEV-Ag and goat anti-mouse IgG antibody on the nitrocellulose membrane with colloidal gold marked mouse anti-human IgM as a mark tracer. The reagent is used to detect the HEV IgM antibody in serum/ plasma / whole blood according to the principle of double antibody sandwich method and gold immunochromatography assay.

The sample mixing up mouse anti-human IgM antibody –marker move along the membrane to the T line, and form the T line when the sample contains HEV-IgM antibody, which is a positive result. Conversely, it is a negative result.

Specifications

  1. Specimen: Whole blood / Serum / Plasma
  2. Shelf life and storage temperature: 24 months at 4-30oC
  3. Performance Characteristics: Sensitivity:>93.3%, Specificity: 98.6%Accuracy: 98.9%
  1. Result interpretation time: 15- 20 mins.
  2. No cross-reactivity with HBsAg, anti-HIV, anti-HCV, anti-RF, anti-Syphilis, anti-H. Pylori, anti-Toxo IgG, anti-Rubella IgG, anti-CMV IgG positive specimens.
  3. Any reactive specimen with HEV(IgM) must be confirmed with alternative testing methods such as EIA (Enzyme Immunoassay)
  4. Cost-effective method for diagnosis of HEV IgM antibody.

Each kit contains:

  • Sample pad
  • Colloidal gold marked pad
  • Nitrocellulose membrane
  • Absorbent paper and PVC board
  • Colloidal gold marked pad coated with anti-human hemoglobin monoclonal antibody a
  • Nitrocellulose membrane coated with anti-human hemoglobin monoclonal antibody b
  • Control line coated with goat anti-mouse igg antibody