PRINCIPLES
The invisible anti-CHW antibody (T line) and secondary antibody (C line) are immobilized on a nitrocellulose membrane in result window.
Another anti-CHW antibody is conjugated with colloidal gold particle and immobilized on glass fiber as conjugate pad.
When specimen is applied into the sample well on device, CHW antigen will bind to the gold conjugate and migrate on the surface of test strip by passive diffusion,and a visible T line will appear in result window after 10 minutes.
The C line has to appear every time when a test is properly performed.
MATERAILS PRAVIDED
1. Test Devices: 10 pieces test devices individually pouched.
2. Assay diluent bottle:1 unit
3. Droper:10 units
4. Instructions For Use: 1 copy attached.
TEST PROCEDURE
1. The test device, specimen, assay diluent should be brought to room temperature (15~30°C) prior to use.
2. Remove the test device from the foil pouch, and place it on a flat and dry surface.
3. Using a dropper, add 1 drop of specimen into sample well on the test device.
4. Add 2 drops of assay diluent into sample well vertically.
5. Read the results at 10~15 minutes. Any results after 15 minutes are no longer valid.
INTERPRETATION OF THE RESULT
Positive result:
Test line (T) and control line (C) within the result window indicate the presence
of CPL antigen.
Negative result:
Only control (C) line appears in the result window indicating that CPL antigen
has not been detected.
Invalid result:
If the control (C) line does not appear, the result might be considered invalid.
The specimen should be retested.
