One step test for Antibody to Hepatitis C Virus - Hepatitis C Virus

One step test for Antibody to Hepatitis C Virus

Intended Use:

This test is used for the qualitative detection of antibody to Hepatitis C Virus (HCV) in serum /plasma samples. It can be used to screen for HCV in the scene for blood donation and for in vitro diagnostic use.



The Test Strips contain:

Sample pad, colloidal gold pad (sprayed by the colloidal gold-labelled recombinant HCV antigen), chromatography membrane (T-line coated with recombinant HCV antigen, C-line coated with anti-HCV monoclonal antibodies), absorbent paper and lining.

Kit contains:

1. Foil bag contains one test card, one pipette and one desiccant 25

2. Manual 1



Storage Requirements:

1. Store the strip at 4oC~30oC within 12 months.

2. Use the test card within 1 hour once the foil bag is opened.



Sample Material and Volume:

Serum/plasma 60 μl



Specimen Collection and Preparation:

1. A serum or plasma specimen is required for testing by this product.

2. The plasma specimen is suggested to use heparin as anticoagulant.

3. Transport specimens at room temperature or chilledly and avoid extreme temperatures.

4. It is recommended to avoid using severely hemolyzed specimens whenever possible. If a specimen appears to be severely hemolyzed, another specimen should be obtained and tested.

5. Test blood specimens on the strips immediately or within 6 hours after collected, if testing can’t be completed within 6 hours, the serum or plasma specimen can be stored at -20oC until it can be tested.

6. The blood specimens must be restored to room temperature before testing.



Test Procedure:

1. Open the pouch and label the strip with the patient specimen number.

2. Use pipette to transfer blood from a sample collection tube.

3. Release the bulb slowly, dropping 2 to 3 drops (or 60 μl) of the sample.

4. Read the results within 10-20 mins.