Beijing Taigekexin Biological Technology Co., Ltd.

Detection Kit for Hepatitis B virus pre-S1 antigen

(Enhanced chemiluminescence immunoassay)

An instruction manual

Product introduction
【Product Name】 Detection Kit for Hepatitis B virus pre-S1 antigen (enhanced chemiluminescence immunoassay)

【registration certificate number】国械注准20163401105

【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 pre-S1 antigen in human serum in vitro.

Hepatitis B virus (HBV) outer membrane proteins include S, pre-S2 and pre-S1. Pre-S1 protein plays an important role in the virus invasion of liver cells. Pre S1-containing proteins are found mainly on Dane particles and tube-type particles. Pre-S1 protein plays a very important role in the virus infection, assembly, replication and stimulate the body to produce immune response. The detection rate of pre-S1 antigen coincided with that of HBV-DNA, and the pre-S1 antigen was detected only in HBV-DNA positive serum. Pre-S1 protein disappears with the disappearance of HBeAg and was positively correlated with the time of negative conversion, so that the pre-S1 antigen can be used as an indicator of virus clearance and virus negative conversion. Pre-S1 antigen-positive hepatitis B patients are more at risk of transmitting hepatitis B virus than pre-S1 antigen-negative and asymptomatic HbsAg carriers, indicating that pre-S1 antigen may reflect hepatitis B virus replication and infectivity.
Detection principle
The kit uses double antibody sandwich method. Microplate was pre-coated with hepatitis B virus pre-S1 monoclonal antibody, add the sample to be tested, and then add horseradish peroxidase-labeled anti-HBS monoclonal antibody, if there are antigen to be detected, the complex antibody - antigen - enzyme labeling antibody will 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
Clinical laboratory, physical examination center.