INTENDED USE
The PocTell® HCV Rapid Test Device (Whole Blood /Serum/Plasma) is a rapid visual immunoassay for the qualitative presumptive detection of antibodies to HCV in human whole blood, serum or plasma specimens. This kit is intended to be used as an aid in the diagnosis of HCV infection. .
Ordering Information
|
Test Item |
Format |
Specimen |
Reaction Time |
Shelf life |
Kit Size |
|
HCV |
Cassette |
S / P / WB |
10 mins |
24 months |
25 T/Kit |
TEST PRINCIPLE
The PocTell® 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 HCV antigen on the test region. During the test, the specimen is allowed to react with colored 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. .
DIRECTIONS FOR USE
Bring tests, specimens, buffer and/or controls to room temperature (15-30°C) before use.
1.Remove the Test Device from the sealed foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed immediately after opening the foil pouch.
2.For Serum or Plasma specimen: Transfer 2 drops (approximately 50 L) of serum/plasma and 1 drop of buffer(approximately 40 L) to the specimen well (S) of the test device, and start the timer.
3.For Venipuncture Whole Blood specimen: Place the Device on a clean, level surface. Hold the dropper vertically and transfer 2 drops of venipuncture whole blood (approximately 50 l) to the specimen well (S) of the test device, then add 1-2 drops of buffer (approximately 40-80 l) and start the timer.
4.For Fingerstick Whole Blood specimen:
- To use a capillary tube: Fill the capillary tube and transfer approximately 50 l of fingerstick whole blood specimen to the specimen well (S) of the test device,then add 1-2 drops of buffer(approximately 40-80 l) and start the timer.
- To use hanging drop: Allow 2 hanging drops of fingerstick whole blood specimen (approximately 50 l) to fall into the center of the specimen well (S) of the test device, then add 1-2 drops of buffer(approximately 40-80 l) and start the timer.
Wait for the red line(s) to appear. The result should be read at 10 minutes. Do not interpret the result after 20 minutes..
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