Beijing Tigsun Diagnostics Co,.Ltd.

Hepatitis B virus core antibody IgM

An instruction manual

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

【registration certificate number】国械注准20163401103

【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 B virus core antibody IgM in human serum in vitro.

This product is suitable for clinical assistant diagnosis of hepatitis B virus infection. The hepatitis B virus core antigen is not detected in the serum (it is rapidly lysed), but it is antigenic and stimulates the body's immune system to produce a specific antibody, called core antibody (HBcAb). Therefore, detectction of HBcAb can know whether the human body had stimulation of core antigen, that is, whether had hepatitis B virus infection. So anti-HBcAb is a sign of hepatitis B virus infection. Hepatitis B core antibody IgM usually appears in the early stage of hepatitis B virus infection and is often used clinically for the early diagnosis of acute hepatitis B. However, a small number of chronic hepatitis B patients also appear core antibody IgM positive. Anti-HBc is often the only marker to detect the HBV during the window of HBV infection.
Detection principle
This kit uses capture method. Microplate is pre-coated with anti-human IgM μ chain antibody, add the sample to be tested, then add the hepatitis B virus core antigen, horseradish enzyme-labeled hepatitis B virus core antibody, if there are antibodies to be detected, antibodies (μ chain) HBcAb IgM antibody - Hepatitis B core antigen - ELISA anti-hepatitis B core antigen antibody can be form. Add luminescent substrate and HRP 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
No obvious symptoms, no morbidity. Hepatitis B (Hepatitis B) is a contagious disease with a high incidence and great harm to humans. The core antibody-IgM (anti-HBc IgM) and acute hepatitis B are closely related. After acute infection with hepatitis B virus (HBV), the concentration of HBsAg and HBeAg in the blood is undetectable and the protective antibody anti-HBs has not yet appeared during this period, the early recovery after acute infection is called " Window period ", at this time, anti-HBc is the only specific HBV marker that can be detected.
Clinical symptoms
Clinical laboratory, physical examination center.