HCV Hepatitis C Virus Ab Rapid Test
【INTENDED USE】
Chronic hepatitis C is a primarily blood-borne disease that results from infection with the hepatitis C virus (HCV). Infection with HCV can lead to chronic inflammation, necrosis and fibrosis of the liver, and some patients may develop cirrhosis or even hepatocellular carcinoma (HCC). The detection of anti-HCV antibodies is suitable for high-risk population screening and can also be used for primary screening of HCV infected people.
This product is used for qualitative detection of hepatitis C virus antibodies in human serum and plasma samples, and can be used for auxiliary diagnosis of clinical hepatitis C virus infection.
【TEST PRINCIPLE】
This product is composed of genetically engineered recombinant hepatitis C virus antigen and sheep anti-rabbit IgG fixed in nitrocellulosic membrane, and coated with colloidal gold labeled recombinant hepatitis C virus antigen and gold labeled rabbit IgG and other reagents. Double antigen sandwich method was used to detect hepatitis C virus antibodies in human serum/plasma by colloidal gold immunochromatography.
During the test, the blood sample is added to the sample hole of the kit. The sample is first mixed with immunocolloidal gold on the glass fiber paper, and then eluted to the nitrate cellulose membrane. If the sample contains antibodies to hepatitis C virus, these antibodies are first bound to colloidal gold coated with recombinant antigen, so that when the mixture is eluted to the nitro fiber membrane, it will be captured by the detection line (T-line) fixed to hepatitis C virus antigen to form colloidal gold labeled HCV antibody-HCV antigen immune complex. Therefore, a red line appears on the T-line, indicating a positive result. If no antibodies to hepatitis C virus are present in the blood of the subject, a red line will not form on the test line (T-line), which is a negative result. The quality control line (C line) on the kit is covered with sheep anti-Rabbit IgG, and in any case, a red line should appear on the quality control line during testing to prove that the kit is working properly.
【Reagents And Materials Supplied】
|
Component Name |
1T/box |
20T/box |
25T/box |
50T/box |
|
Test Card |
1 |
20 |
25 |
50 |
|
Sample Diluent |
0.5ml |
4 ml |
5 ml |
10 ml |
|
Disposable Dropper |
1 |
20 |
25 |
50 |
Model: Test Card, Test Strip
【SHELF LIFE AND STORAGE】
1. The original packaging should be stored in a dry place at 2-30°C and protected from light.
2. The shelf life of the test kit is 2 years from date of manufacture. Refer to the product labels for stated expiration date.
3. The original packaging can be transported at 2-37℃ for 20 days.
4. After opening the inner package, the test card will become invalid due to moisture absorption, please use it within 1 hour.
【Test procedure】
Step1: Allow the test device, buffer, specimen to equilibrate to room temperature (15-30℃) prior to testing.
Step2: Remove the test device from the sealed pouch. Place the test device on a clean, flat surface.
Step3: Label the device with specimen number.
Step4: Using a Disposable Dropper, transfer serum, plasma or whole blood. Hold the dropper vertically and transfer 1 drop of specimen (approximately 40μl) to the specimen well(S) of the test device, and immediately add 2 drops of test buffer (approximately 70-100μl). Make sure there are no air bubbles.
Step5: Set up a timer. Read the results in 15 minutes.
Do not interpret the result after 20 minutes. To avoid confusion, discard the test device after interpreting the result. If you need to store it for a long time, please take a photo of the result.
【INTERPRETATION OF ASSAY RESULT】
1.NEGATIVE RESULT:
If only the C line develops, the test indicates that no detectable hepatitis C virus is present in the specimen. The result is negative or non-reactive.
2. POSITIVE RESULT:
In addition to the presence of the C line, if the T line develops, the test indicates the presence of hepatitis C virus. The result is hepatitis C virus positive or reactive.
3. INVALID
If the C line does not develop, the assay is invalid regardless of color development of the T line as indicated below. Repeat the assay with a new device.
