The Wondfo Whole Blood/Serum/Plasma Hepatitis C Virus Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of hepatitis C virus antibodies.
Use for in vitro diagnostic use only and by healthcare professionals only
The hepatitis C virus (HCV) is an RNA-containing virus with a very strong pathogenic factor. HCV has six major genotypes (subtypes): 1a, 1b, 2a, 2b, 3, 4, 5, and 6. Genotypes 1a and 1b are the most common and more difficult to treat.
You can get infected with the hepatitis C virus despite a healthy immune system. The virus enters the body through contact with blood. The virus attacks the liver cells where it replicates (reproduces). HCV causes liver inflammation and kills liver cells. Approximately 80%~85% of people who are infected with the hepatitis C virus develop a chronic infection, meaning the infection does not go away within six months. Most people with chronic hepatitis C do not have symptoms. In 10%~25% of people with chronic hepatitis C, the disease progresses within 10~40 years, and can lead to severe liver damage, liver cirrhosis, and liver cancer.
PRINCIPLE OF OPERATION
When a sample is introduced into the test device, it is absorbed by the pad by capillary action, mixed with the antibody-dye conjugate, and passed through the pretreated membrane.
When the levels of anti-HCV antibodies equal or exceed the threshold values (test detection limit), the anti-HCV antibodies in the sample bind to the antibody-dye conjugate and are then fixed with the antigen immobilized in the test zone (T) of the device. This results in a colored band, indicating a positive result.
If HCV antibody levels are zero or below the detection limit of the test, no color band appears in the test zone (T). This indicates a negative result.
If the test procedure is performed correctly, a colored band will appear in the control zone (C).
PRECAUTIONARY MEASURES
1. This test kit is for in vitro use only. Do not swallow.
2. All specimens should be considered as potential vector-borne disease agents.
3. Blood samples taken from patients with jaundice, with lipemia; hemolyzed, heat-treated, or contaminated blood samples may give erroneous results.
4. After the first use, the test system is discarded. It can only be used once.
5. Do not use the test kit after the expiration date.
6. Do not use the test kit if the soft pack is damaged or poorly sealed.
7. Keep out of the reach of children.
8. DISPOSAL OF THE DIAGNOSTIC TEST: The used device is infectious. The disposal process of the used test system should be carried out in accordance with local laws or laboratory regulations on infection.
STORAGE AND STABILITY
1. Store at 2°C ~ 30°C in sealed soft packaging until the expiration date.
2. Keep away from direct sunlight, moisture. Keep away from sources of heat.
3. DO NOT FREEZE.
SPECIMEN COLLECTION AND PREPARATION
1. Use whole blood immediately, or separate serum or plasma from blood cells as soon as possible to avoid hemolysis. Only uncontaminated and non-hemolyzed samples may be used.
2. Testing should be done immediately after sample collection. Do not leave samples at room temperature for long periods of time. Samples can be stored at 2○C~8○C for 3 days. For longer storage, samples should be stored below -20°C. Whole blood samples that have been stored at 2°C -8°C for more than 7 days should not be tested.
3. Before testing, samples should take room temperature (10ºC~30ºC). Frozen specimens should be completely thawed and mixed thoroughly before the procedure. Samples should not be repeatedly frozen and thawed.
TEST PROCEDURE
Before testing, the device and the sample must take room temperature (10°C ~30°C).
1. Remove the test device from the foil sachet by tearing it along the notch and place it on a flat surface.
2. For whole blood testing:
Holding the pipette vertically, add two drops of whole blood (approximately 50 µl) to the sample well (up to the mark line). Add two drops (approximately 50 µl) of diluent buffer directly from the vial to the sample well.
For testing serum/plasma:
Holding the sample pipette upright, add four drops (80-100 µl) of serum or plasma to the sample well.
3. Leave for 15 minutes, then fix the results. Do not read results after 30 minutes.
INTERPRETATION OF THE RESULTS
Positive (+)
Pale pink streaks are visible in both the control zone and the sample application zone. This indicates a positive result for the presence of anti-HCV antibodies in the sample.
Negative (-)
A pale pink band is visible in the control zone. The color bar does not appear in the test area. This indicates that the concentration of antibodies to HCV is equal to zero, or it is less than the sensitivity threshold of the test system.
Invalid
There are no visible bands, or there is such a band only in the test zone, but not in the control zone. Repeat the procedure with a new test kit. If the test fails, contact the distributor or store where you purchased the product with the lot number.
Note: Color intensity or line width does not matter.
LIMITATIONS OF THE TEST PROCEDURE
1. This test is designed to test whole blood/serum/plasma samples only. There is no evidence that this test system will work with other samples.
2. This test is a qualitative immunological screening procedure. It is not intended to quantify the concentration of anti-HCV antibodies.
