【Product Name】Detection Kit for Hepatitis E virus IgM antibody (enhanced chemiluminescence immunoassay)

【registration certificate number】 国械注准20163401102

This product is used in qualitative detection of hepatitis E virus IgM antibodies in human serum in vitro.

Hepatitis E virus (HEV) is a single-stranded positive-sense RNA virus, it is spherical in shape and has a non-encapsulated membrane with a diameter of 27 to 34nm. The nucleocapsid is symmetrical twenty-four tetrahedron.  The genome of the HEV is 7.6kb in length, it has a poly A tail at the 3 'end and have three open reading frames (ORFs). ORF1 located at the 5' end (about 2kb) is a nonstructural protein gene containing an RNA-dependent polymerase. The ORF2 located at the 3 ' end (about 2kb) is the main part of the structural protein, it can encode the nucleocapsid protein. The overlap of ORF3, ORF1 and ORF2 (full length 369bp) is also a viral structural protein gene, it can encode a virus-specific immune response antigen. HEV excreted with the patient's excrement, it can be spread through the contact in daily life. Outbreak would caused by contaminated food or water, so the peak period of disease is usually after the rainy season or flood. At present, the common method for the clinical diagnosis of HEV is the examination of anti-HEVIgM or IgG in serum.  Acute hepatitis patients can be diagnosed as acute HEV infection after excluding A, B and C, such as anti-HEV IgM or IgG positive. 

This kit uses capture method. The microplate was pre-coated with anti-human IgMμchain antibody, firstly the test samples were added and then the horseradish enzyme-labeled hepatitis E virus antigen was added, if there are antibodies to be tested, a complex ( antibodies (μchain)-anti HEV IgM antibody-enzyme labeled  hepatitis E antigen) will be formed. The luminescent substrate added and HRP can generate luminescent signal.

The main route of transmission of hepatitis E is the route of faeces and mouth, it has  the characteristics of rapid transmission, severe morbidity and high mortality. In addition to fatigue, loss of appetite, nausea, vomiting, there may be fever, jaundice, cholestasis, liver pain, hoar excrement, bloating, diarrhea and so on.

The symptoms of hepatitis E can be divided into initial symptoms and advanced symptoms.

Initial symptoms are: gastrointestinal symptoms such as loss of appetite, nausea, vomiting, bloating, diarrhea; fatigue symptoms such as the weakness of whole body, weakness in the hands and legs, shake hands not tight, there is always the feeling of acid, while there will be itchy skin , Joint pain; jaundice symptoms such as urine yellow, yellow eyes, yellow skin and so on. Advanced symptoms are mainly hepatomegaly, splenomegaly, liver pain and so on. At present, compared with other hepatitis, hepatitis E is still relatively good and can be mostly cured within three months.

Remind patients with liver disease, the treatment of liver disease should go to a large professional hospital and accept professional treatment timely, which is in order to delay disease. Treatment of liver disease is different from other diseases, improper treatment may lead to deterioration.

Application department

Clinical laboratory, physical examination center.