Beijing Tigsun Diagnostics Co,.Ltd.

Detection Kit for Hepatitis C virus (HCV) antibody

An instruction manual

Product introduction
【Product Name】Detection Kit for Hepatitis C virus (HCV) antibody (enhanced chemiluminescence immunoassay)

【registration certificate number】国械注准20163401104

【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 C virus (HCV) antibodies in human serum in vitro.

Hepatitis C virus (HCV) virosomes are spherical in shape with a diameter of less than 80nm (36-40nm in hepatocytes and 36-62nm in blood), it is a single-stranded positive-sense RNA virus, the nucleocapsid is surrounded by lipid-containing capsule with spike. The main source of HCV infection is acute clinical patients, asymptomatic subclinical patients, chronic patients and virus carriers. Patient before the onset of 12 days, the blood is infectious and can carry virus for more than 12 years. Clinical observation data showed that the human infected with HCV have poor protective immunity, they can be re-infected different diseases and some patients even can lead to cirrhosis or hepatocellular carcinoma.
Detection principle
This kit uses double antigen sandwich method. The microplate was pre-coated with high-purity recombinant HCV antigen, firstly, specimens to be tested were added, then horseradish peroxidase-labeled recombinant antigen was added, if there are antibodies to be detected, it is going to form a complex (antigen-antibody-enzyme labeled antigen). Added luminescent substrate and HRP would 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.Tired and weak: It mainly manifest as that they do not love activities for the light and keep bedridden for the heavy (even they do not love to wash their face or to eat), which mainly due to the loss of appetite, the disorder of digestion and absorption, leading to the lack of energy in the patient's body.

2.Patients with HCV have reduced appetite in the daily diet and often been accompanied by vomiting, nausea and other symptoms, they will feel fatigue and have no energy, the careful patient will find that they sometimes feel liver pain and often be accompanied by abdominal pain and diarrhea, the more serious symptoms are the phenomenon of bleeding.

3.Hepatitis C symptoms may appear varying degrees of fatigue, dizziness, loss of appetite, tired of oil, yellow urine, liver discomfort and poor sleep, they may have large liver, mild tenderness and mild splenomegaly. Some chronic hepatitis C cases have no obvious symptoms.
Clinical symptoms
Clinical laboratory, physical examination center.