Humman Anti HCV Elisa Test Kit Hepatitis C Virus Rtk Test

Humman Anti-HCV ELISA Kit Elisa Test Kits

1. INTRODUCTION

• Hepatitis C virus (HCV), which was formerly described as the parenterally transmitted form of non-A, non-B hepatitis (NANBH)1, becomes a chronic disease in 50% of the cases.
• This is an enzyme linked immunosorbent assay using recombinant proteins derived from core regions of HCV virus to detect the presence of HCV antibodies in human sera.

2. PRINCIPLE OF THE ASSAY

• Multiple epitopes of HCV proteins(Core, NS3, NS4 and NS5) are bound to the microtiter wells.
• When antibodies to HCV are present in the test sample, they react with recombinant proteins and attach to the solid-phase. Non-reactive antibodies are removed with the wash buffer.
• Human IgGs bound to the antigen are reacted with anti-human IgG peroxidase conjugate and visualized by subsequent reactions with a chromogenic substrate. Positive sample generates a medium to dark blue color.
• No color or very pale blue color indicates a negative reaction. The intensity of the reaction is photometrically quantitated.

3. REAGENTS

Materials provided with the kits:

4. Materials required but not provided:

1. Precision pipettes: 0.02, 0.05, 0.10, 0.15, 0.20, and 1.0 ml.

2. Disposable pipette tips.

3. Distilled water.

4. Humidified Box capable of maintaining 37°C

5. Absorbent paper or paper towel.

6. Microtiter plate or strip-well washer

7. Microtiter plate reader.

5. PRECAUTION FOR USERS

All human source material used in the preparation of this product was found to be negative for the presence of HIV-1/HIV-2 antibodies, as well as for the hepatitis B surface antigen, using a commercial licensed method. Nevertheless, because no test method can offer complete assurance of the absence of infectious agents, this product should be handled with caution.

1. Avoid contact of reagents with the eyes and skin. If that occurs, wash thoroughly with water.

2. Wear gloves.

3. Do not pipette by mouth.

4. Do not smoke.

5. Dispose all used materials in a suitable biohazardous waste container. Remains of samples, controls, aspirated reagents and pipette tips should be collected in a container for this purpose and autoclaved 1-hour at 121°C or treated with 10% sodium hypochlorite (final concentration) for 30 min before disposal. (Remains containing acid must be neutralised prior addition of sodium hypochlorite).

6. Adjust washer to the plate used (flat bottom) in order to wash properly.

7. Do not mix reagents from different lots.

8. Do not use reagents after expiration date.

9. Extreme care should be taken to avoid microbial contamination and cross contamination of reagents.

10. Use a new pipette tip for each specimen and each reagent.

11. Soaps and/or oxidising agents remaining in containers used for the substrate-TMB solution can interfere with the reaction.

Biovantion Inc is independent from international department of Bioneovan Co., Ltd., which established in 2 0 0 5, is an in vitro diagnostic reagents manufacturer engaged in the research, development, production, and focus on clinical testing for infectious diseases, such as Hepatitis virus, Noro virus, Parvo virus test kits, our products include rapid test cassette and Elisa kits.

All our products have been registered in National Medical Products Administration of China, in year 2020 we get Certificate of ISO 13485:2016 – QUALITY MANAGEMENT SYSTEMS FOR MEDICAL DEVICES from SGS. More importantly, we have awarded the registration certificate from National Medical Products Administration for Diagnostic Kit for IgM Antibody to COVID-19 and IgG antibody to COVID-19 during the outbreak in China, and also we developed COVID-19 Antigen test ; Neutralizing Antibody Test, these products selling well all overthe world