Beijing Taigekexin Biological Technology Co., Ltd.

Detection Kit for hepatitis a virus IgM antibody

(Enhanced chemiluminescence immunoassay)

An instruction manual

Product introduction
【Product Name】Detection Kit for hepatitis a virus IgM antibody (Enhanced chemiluminescence immunoassay)

【registration certificate number】国械注准20163401100

【Packing】48 tests/box，96 tests/box.

【Storage conditions and validity】Storage at 2 ~ 8℃，validity for 12 months.
Expected use
This product is used for qualitative detection of Hepatitis A virus IgM antibody (HAV-IgM) in human serum in vitro.

Hepatitis A virus (HAV) belongs to the Hepadnavirus in the Picornaviridae family, this family only has HAV species. AV is spherical in shape with diameter 27-32nm, it is not envelope and it has 20 symmetrical body particles composed of 32 sub-unit structure. Under the electron microscope, two kinds of solid and hollow particles were observed. The solid particles were intact HAV and contagious. The hollow particles were immature RNA-free particles, which were antigenic but not infectious. The HAV genome is a single-stranded linear RNA consisting of 7478 nucleotides in length. Either patients with acute hepatitis A virus can not be distinguished from other types of hepatitis virus in both clinical manifestations and liver function tests. Therefore, etiological examination is very important for the diagnosis of acute Hepatitis A virus infection.
Detection principle
This kit uses capture method. Microplate is coated with the anti-human IgM μ chain antibody, the sample to be tested is added, and then the HAVAg and HRP-HAVAb are added. If the sample to be tested contains the HAV-IgM antibody, it can bind to the coated anti-human IgM μ chain and form complexes with HAVAg and HRP-HAVAb. Luminescent substrate and HRP was added to generate luminescent signal.
Product advantage
1. High Sensitivity: chemiluminescence immuno assay can detect the substance that radioimmunoassay, enzyme-linked immunosorbent assay and other methods can not, early diagnosis of disease is of great significance.

2. Short Detection time: the optical signal measurement time of each sample is less than

a second, which is very necessary for emergency situations in medical and health work (such as rescue, blood transfusion, emergency surgery, remote treatment, etc.).

3. Excellent stability: the validity period is up to one year, which is conducive to the popularization and application.

4. Simple and fast operation: Chemiluminescence immunoassay is simple and fast, the test can be completed one hour and projects commonly used can print report one hour.

5. Fast, good security: chemiluminescence immunoassay does not involve harmful chemical composition for human, although there are also waste exclusion, no harmful pollution to the environment.
Clinical symptoms
1. Most infections are sub-clinical hepatitis A, that is, no symptoms. In severe cases, vomiting, do not want to eat, fatigue, greasy tired and yellow eyes and face, yellow urine.

2 Jaundice onset acute, chills, fever, malaise, loss of appetite, tired of oil, nausea, vomiting, abdominal pain, liver pain, diarrhea, bird color gradually deepened to the end of the current pattern of strong tea. A small number of cases has the main performance such as fever, headache, upper respiratory symptoms.

3. Jaundice symptoms can be improved, fever decreased, but the urine color is deeper, sclera, skin is yellow dye, it peaked in about 2 weeks. May have loose stool color, itchy skin, bradycardia and other obstructive jaundice performance. Liver enlargement to the ribs 1-3cm with a sense of fullness, tenderness and percussion pain. Some cases have mild splenomegaly.

4. Convalescent jaundice gradually retreat, symptoms alleviated or even disappear, liver and spleen retract, liver function gradually returned to normal.
Clinical symptoms
Clinical laboratory, physical examination center.