TEST PROCEDURE:

1. Bring the pouched test device to room temperature(15-30℃) prior to testing. Do not open the pouch until ready to perform the assay.
2. Remove the test device from the sealed pouch. Lay it on a flat, clean and dry surface.
3. Use the pipette packed in the pouch to draw and slowly add 1 drop of whole blood specimen to the sample well. Hold the buffer bottle vertically and add 1 drop to the sample well. / If using a pipette, change a new one to avoid cross-contamination. Draw and transfer 2 drops of buffer to the sample well.
4. Wait for 10-15 minutes and read results. Do not read results after 20 minutes. Caution: The above interpreting time is based on room temperature range of 15-30℃. If your room temperature is significantly lower than 15℃, then the interpreting time should be properly increased to 30 minutes.

INTERPRETATION OF RESULTS:

INTENDEDUSE:
Positive:Two colored lines should be observed in the result window, one in the test region and another one in the control region.
Negative:Only the control line appears in the result window.
Invalid:No line appears in the control region regardless of the presence or absence of the line in the test region.
NOTE: Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for the control line failure. Review the procedure and repeat the test with a new device. If problem persists, please contact your local distributor.
SPECIFICATION:

Description	Specimen	Format	Catalog No.	Sensitivity	Package Size	Strip Width	Certificate
(HCV) Hepatitis C Virus Test	Serum/Plasma	Strip	B20-11	99.53%	50 Tests	3.0 mm	CE2265
		Cassette	B20-20		25 Tests	4.0 mm
	Whole Blood		B20-21		25 Tests	4.0 mm	——