The HCV Rapid Test Cassette (Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative delection of antibody to Hepatits C Virus in serum or plasma.
The HCV rapid Test Cassette (Serum/Plasma) in a quantitative, membrane based immunoassay for the detection of antibody to HCV in serum or plasma. The membrane is pre-coated with recombinant HCV antigen on the test line region of the cassette. During testinf, the serum or plasma specimen reacts with recombinant HCV antigen conjgated collid gold. The mixture migrates upward on the membrane chromatographically by capillary action to react with recombinant HCV antigen of the membrane and generate a colored line. Presence of this colored line indicates a positive result, while its absence indicates a negative result. To reserve as a procedural contro, a colored line will always appear at the control line region indicating that proper volum of specimen has been added and membrane wicking has occurred.
What is HCV?
Hepatitis C Virus (HCV) is a small, enveloped, positive-sense, single-strandend RNA Virus. HCV is now known to be the major cause of parenterally transmitted non-A, non-B hepatitis. Antibody to HCV in found in over 80% of patients with well-documented non-A, NON-b hepatitis.
The test cassette contains recombinant HCV antigen conjugated colloid gold and HCV antigen coated on the membrane.
Material Supplied HCV rapid test
- 1. Test cassettes
- 2. Droppers
- 3. Buffer
- 4. Instruction for use
Material Required but not provided
- Specimen collection containers
- Centrifuge ( for plasma only)
TEST Storage and stability
The Kit can be stored at room temperature or refrigerated (2-30 °C). The test cassette is stable through the expiration date printed on the sealed pouch. The test cassette must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.
Allow test cassette, spedimen, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.
- 1. Bring the pouch to room temeprature before opening it. Remove the last cassette from the sealed pouch and use it as soon sa possible. Best results will be obtained in the assay is performed within one hour.
- 2. Place the test cassette on a clean and level surface. Hold the dropper vertically and transfer 1 drop of serum or plasma (approximately 25 ul) to the specimen well of the test cassette, then add 2 drops of buffer (approximately 80 ul) and start the timer. Avoid trapping air bubbles in the specimen well. See the illustration below.
- 3. Wait for the colored line(s) to appear. The test result should be read at 10 minutes. Do not interpret the result after 20 minutes.
Intermpretation of results
Positive: Two distinct colored lineas appear. One colore line should be in the control region (C) and other color line shoud be in test region (T).
*NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of HCV antibodies present in the specimen. Therefore, any shade of red in the test region should be considered positive.
NEGATIVE: One color line appears in control region (C). no apparent red or pink line appears in the test region (T).
INVALID: Controlo line fails to appear. Insufficient specimen volum or incorrect procedural techniques are the most likely reasons fo control line failure. Review the procedure and repeat the test with a new test cassette. If the problem persists, discontinue usisng the test kit immediately and contact your local distributor.