ASSAY PROCEDURE
Do not open foil pouch until ready to begin test, Refrigerated test devices should be allowed to reach room temperature (15- 28°C)before opening the pouch.1. Remove the device from the protective pouch and label the device with specimen identification. After opening the package ,the test device should be used immediately.
2. Place the test device on a clean and level surface Hold the dropper vertically and transfer 1 drop of whole blood or serum or plasm (approx. 25μl )to the specimen well of test cassette, then
add 2-3 drop of buffer (75-100 μl )
3. Start the timer.
4. Read the result exuactly at 15-20 minutes.
IMPORTANT:
In order to prevent an incorrect reading, do not read the test results after 20 minutes.
INTERPRETATION OF RESULTS
POSITIVE: Presence of two visible, pink colored bands, one in the control region (C) and one in test region (T), indicates
presence of HCV antibodies in sample. NEGATIVE: Presence of a single colored band in the control region (C) indicates the absence of HCV antibodies or that the concentration of antibodies in sample is below the detection cut-off level. INVALID: Results are invalid if no band appears in the control region, or a band appears only in the test region after 10 minutes. An invalid result may be due to improper assay procedures or damage to the device. The assay is in-conclusive and the specimen should be re-tested using a new test device.