Hepatitis virus type C immune body chemiluminescence method diagnostic reagent kit and its producing method

Abstract

The invention relates to a diagnostic reagent kit for testing the hepatitis c virus (HCV) and the preparation and test method, which is to add the HCV recombinant antigen used for peridium into the buffer solution, blend it, move into the luminous microplate, make incubation for 18 hours under 4DEG.C, wash the luminous microplate, add into the confining liquid, leave the liquid after incubation and fully dry the luminous microplate to complete the preparation of the pre-peridium luminous microplate; combine the anti-human IgG used for marking and the horse radish peroxidase by improving the sodium periodate to complete the preparation of the enzyme marker; prepare the chemical luminous substrate solution A with luminal, Tween20 and luminous intensifier and prepare the chemical luminous substrate solution B with the hydrogen peroxide. The reagent kit also comprises the sample diluent and concentrated scrub solution. The negative corresponds to the normal human serum while the positive corresponds to the people with serum of pooled serum with HCV antibody. The reagent kit provided in the invention has much higher detection sensitivity than the ELISA, which is safe and reliable, easy to operate with low cost, and without any expensive full-automatic chemical luminous measuring apparatus required.

Description

technical field

[0001] The invention relates to a hepatitis C virus (HCV) antibody diagnostic kit (chemiluminescent method) and a preparation method thereof, as well as a detection method using the kit. Background technique

[0002] Hepatitis C virus (HCV) is a linear single-stranded positive-sense RNA virus belonging to the Flavivirus genus. HCV is distributed all over the world. According to the CDC survey, the incidence of HCV is about 7.1 / 100,000. At present, there are more than 170 million HCV infected people in the world, of which my country accounts for more than 40 million. The main routes of transmission of HCV are: 1. Intravenous drug injection, shared needles and syringes (>40%); 2. Sexual contact and close contact with family members (10%); 3. Blood transfusion or blood products (4%); 4. . Nosocomial transmission (3%); 5. Vertical transmission; 6. Unknown cause (45%). The route of HCV infection in my country is mainly through blood transfusion or blood produ...

Examples

Embodiment Construction

[0043] 1. The present invention detects the hepatitis C virus antibody diagnostic kit component embodiment:

[0044] (1), pre-coated luminescent plate coated with HCV antigen

[0045] (2), enzyme-labeled anti-human IgG conjugate labeled with horseradish peroxidase

[0046] (3), HCV sample diluent containing indicator

[0047] (4), washing solution containing Tween20 phosphate buffer

[0048] (5), chemiluminescent substrate solution A containing luminol, Tween20 and its enhancer benzofluoranthene

[0049] (6), chemiluminescent substrate solution B containing hydrogen peroxide

[0050] (7) Negative control for normal human serum

[0051] (8), the positive control that is the newborn bovine serum dilution HCV antibody positive human serum

[0052] 2, the present invention detects the preparation method embodiment of hepatitis C virus antibody diagnostic kit:

[0053] I. Preparation of pre-coated chemiluminescent plates coated with HCV antigens

[0054] Add HCV recombinant ...

technical field

[0001] The invention relates to a hepatitis C virus (HCV) antibody diagnostic kit (chemiluminescent method) and a preparation method thereof, as well as a detection method using the kit. Background technique

[0002] Hepatitis C virus (HCV) is a linear single-stranded positive-sense RNA virus belonging to the Flavivirus genus. HCV is distributed all over the world. According to the CDC survey, the incidence of HCV is about 7.1 / 100,000. At present, there are more than 170 million HCV infected people in the world, of which my country accounts for more than 40 million. The main routes of transmission of HCV are: 1. Intravenous drug injection, shared needles and syringes (>40%); 2. Sexual contact and close contact with family members (10%); 3. Blood transfusion or blood products (4%); 4. . Nosocomial transmission (3%); 5. Vertical transmission; 6. Unknown cause (45%). The route of HCV infection in my country is mainly through blood transfusion or blood produ...

Examples

Embodiment Construction

[0043] 1. The present invention detects the hepatitis C virus antibody diagnostic kit component embodiment:

[0044] (1), pre-coated luminescent plate coated with HCV antigen

[0045] (2), enzyme-labeled anti-human IgG conjugate labeled with horseradish peroxidase

[0046] (3), HCV sample diluent containing indicator

[0047] (4), washing solution containing Tween20 phosphate buffer

[0048] (5), chemiluminescent substrate solution A containing luminol, Tween20 and its enhancer benzofluoranthene

[0049] (6), chemiluminescent substrate solution B containing hydrogen peroxide

[0050] (7) Negative control for normal human serum

[0051] (8), the positive control that is the newborn bovine serum dilution HCV antibody positive human serum

[0052] 2, the present invention detects the preparation method embodiment of hepatitis C virus antibody diagnostic kit:

[0053] I. Preparation of pre-coated chemiluminescent plates coated with HCV antigens

[0054] Add HCV recombinant ...

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