"Export Use Only"
HEV IgM ELISA kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative determination of IgM-class antibodies to hepatitis E virus in human serum or plasma. It is intended for use in clinical laboratories for diagnosis and management of patients related to infection with hepatitis E virus.




Materials Provided with HEV IgM ELISA kit:
1. Microwell strips: anti-IgM antibodies coated wells
2. Negative Control: non-reactive for HEV IgM
3. Positive Control: Purified HEV IgM class antibodies diluted
4. HRP-Conjugated : recombinant HEV antigen
5. Specimen Diluent: Protein buffer solution
6. Stock Wash Buffer: 20 x
7. Chromogen Solution A: Urea peroxide solution
8. Chromogen Solution B: TBM
9. Stop Solution
10. Plastic sealable Bag
11. Cardboard Plate Cover
12. Package Insert

Materials & Instrumentations Required, not provided:
1. Freshly distilled or deionized water
2. Dispensing system and/or pipette & tips
3. Microshaker for dissolving and mixing conjugate with samples
4. EIA kit Microplate Washer
5. EIA kit Microplate Reader at 450nm wavelength




HEV IgM ELISA Test Background Information:
Hepatitis E is a recurring infection in developing countries. In less frequent, isolated cases, it has also been reported in developed countries. Identified in 1990, Hepatitis E (HEV) is a non-enveloped, single stranded RNA virus where infection can lead to acute (or subclinical) liver disease, like that associated to hepatitis A infection. Fatality rates are generally low - averaging 0.5-3 percent for most patients, while pregnant women hold elevated averages around 15-25 percent. In 1995 a theory was introduced that HEV was transmitted to humans from animals (zoonosis). Not long after that, in 1997 and 2001, respectively, HEV was identified as transmitted from swine and from birds. After that time, HEV infection transmission has been associated with several animals, for example, wild monkeys, deer, cow, goats, rodents, dogs, and chickens. Found in both developing and developed countries, these HEV infections (including anti-HEV) consisted of viremia and feces excretion of HEV-affected animals, such as those listed above. A direct link to acute hepatitis E in humans from eating uncooked deer meat, was also reported. Also found in supermarkets in Japan, HEV genome sequences have been identified in pork livers.


HEV IgM ELISA Test Principle:
The HEV IgM ELISA employs a solid phase, two-step incubation, antibody capture assay. Antibodies directed to human immunoglobulin M proteins (anti-u chain) are pre-coated on polystyrene microwell strips. During the first incubation stage, the patient's serum or plasma sample is added. At this point, any IgM-class antibodies will be captured in the wells. Next, all other components of the sample are washed out, especially any IgG-class antibodies. What becomes visible after adding recombinant HEV ORF2 antigens conjugated to horseradish peroxidase (HRP-Conjugate) is the specific HEV IgM captured on the solid phase. In the course of the second incubation stage, the HRP-conjugated antigens will individually react with HEV IgM antibodies. Chromogen solutions are added after the wells are washed to remove the unbound HRP-Conjugate.


Notable features of Infectious Disease ELISA Kits:
User-friendly directions and explanation of test procedures
Simple and safe reagent preparation
Clear instructions on specimen collection
Comprehensive package of required materials
Explicit quality control and storage guidelines
Reliable and easy-to-read test results

Most Infectious Disease ELISA kits follow a similar method. See the HEV IgM ELISA Kit product insert for details on preparation, procedures, quality control, and test result interpretation.



Diagnostic Automation Inc provides other Infectious Disease ELISA Kits. For more information about ELISA Kits, Rapid Tests, IFA Kits, CLIA Test Kits, or Serology tests, please see our website home page, or contact our Customer Service Representative at 818-591-3030.

* Not to be sold, shipped or distributed in The United States.