Beijing Tigsun Diagnostics Co,.Ltd.

Detection Kit for hepatitis b virus pre-s2 antigen

An instruction manual

Product introduction
【Product Name】 Detection Kit for hepatitis b virus pre-s2 antigen (enhanced chemiluminescence immunoassay)

【registration certificate number】国械注准20163401107

【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 the qualitative detection of hepatitis B virus pre-S2 antigen in human serum in vitro.

Hepatitis B virus (HBV) outer membrane proteins include S, pre-S1 and pre-S2. The pre-S2 antigen (PreS2) is a hepatitis B virus (HBV) capsid protein that has been found and identified in recent years and coexists with the hepatitis B virus surface antigen (HBsAg) on the outer capsid of HBV. Some studies have shown that Pre-S2 antigen can appear in the serum of patients with acute hepatitis B and disappeared before the disappearance of HBsAg, which can indicate the patient's intrahepatic HBV replication and the highly contagious of serum.
Detection principle
The kit uses double antibody sandwich method. Microplate was pre-coated with Hepatitis B virus pre-S2 monoclonal antibody, add the sample to be tested, then add horseradish peroxidase-labeled anti-HBS monoclonal antibody, if there are antigen to be detected, the complex antibody - antigen -enzyme labeled 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
Typical Symptoms:

1.Systemic performance: Patients often feel fatigue, fatigue, may be accompanied with mild fever and so on. Insomnia, dreams. may be related to this disease.

2. Gastrointestinal manifestations: abnormal liver function, reduced bile secretion, often appear loss of appetite, nausea, tired of the oil, abdominal discomfort, bloating and so on.

3. Jaundice: bilirubin excreted from the urine, urine color turns yellow, is the earliest performance of jaundice. Bilirubin concentration in the blood continues to increase, can cause eye, skin yellow dye.

4. Liver pain: chronic hepatitis B generally do not have severe pain. Some patients may have discomfort, pain, tenderness or percussion pain of right upper or right quarter rib.

5.Hepatosplenomegaly: due to inflammation, congestion, edema, cholestasis, patients often have hepatomegaly. Early acute hepatitis or chronic hepatitis, spleen has no significant enlargement, portal hypertension, splenic congestion, can cause splenomegaly.

Other Symptoms:

Men may have erectile dysfunction; women may appear symmetrical or asymmetrical breast hyperplasia, swelling and breast development, even misdiagnosed as breast cancer, menstrual disorders, amenorrhea, loss of libido and so on.
Clinical symptoms
Clinical laboratory, physical examination center.