HCV Rapid Test Device
Principle
The HCV Rapid Test Device (Whole Blood /Serum/Plasma) has been designed to detect antibodies to HCV through visual interpretation of color development in the internal strip. The membrane was immobilized with protein A on the test region. During the test, the specimen is allowed to react with colored recombinant HCV antigens colloidal gold conjugates, which were precoated on the sample pad of the test. The mixture then moves on the membrane by a capillary action, and interacts with reagents on the membrane. If there were enough HCV antibodies in specimens, a colored band will from at the test region of the membrane. Presence of this colored band indicates a positive result, while its absence indicates a negative result. Appearance of a colored band at the control region serves as a procedural control. This indicates that proper volume of specimen has been added and membrane wicking has occurred.
Procedure
Bring tests, specimens, buffer and/or controls to room temperature (15-30°C) before use.
1. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the device with patient or control identification. To obtain a best result, the assay should be performed within one hour.
2. For Serum or Plasma specimen: Hold the dropper vertically and transfer 2 drops of serum or plasma (approximately 50 μl ) and 1 drop buffer to the specimen well (S) of the test device, and start the timer.
For Venipuncture Whole Blood specimen: Hold the dropper vertically and transfer 2 drops of venipuncture whole blood (approximately 50 μl) to the specimen well (S) of the test device, then add 2 dropsof buffer and startthe timer.
For FingerstickWhole Bloodspecimen:
To use a capillary tube: Fill the capillary tube and transfer approximately 50μl of fingerstick whole blood specimen to the specimen well (S) of the test device, hen add 2 drops of buffer and startthetimer.
To use hanging drop: Allow 2 hanging drop of fingerstick whole blood specimen (approximately 50 μl ) to fall into the center of the specimen well (S) on the test device, then add 2 dropsof buffer and startthe timer.
3. Wait for the red line(s) to appear. The result should be read at 10 minutes. Do not interpret the result after 20 minutes.
Interpretation Of Results
POSITIVERESULT:
* A colored band appears in the control band region (C) and another colored band appears in the T band region.
NEGATIVERESULT:
One colored band appears in the control band region (C). No band appears in the test band region (T).
INVALID RESULT:
Control band fails to appear. Results from any test which has not produced a control band at the specified reading time must be discarded. Please review the procedure and repeat with a new test.
If the problem persists, discontinue using the kit immediately and contact your local distributor.
NOTE:
1. The intensity of the color in test region (T) may vary depending on the concentration of aimed substances present in the specimen. Therefore, any shade of color in the test region should be considered positive. Besides, the substances level can not be determined by this qualitative test.
2. Insufficient specimen volume, incorrect operation procedure, or performing expired tests are the most likely reasons for control band failure.
