INTENDED USE:
One Step HBsAg Test is used for the qualitative determination of Hepatitis B surface antigen (HBsAg) in human whole blood, serum or plasma. This test is intended for the screening of blood and blood products to be used for transfusion and an aid for the diagnosis of existing or previous hepatitis B infection.
TEST PROCEDURE:

1. Let the pouched test come to room temperature (15-30℃).Remove the test device from the foil pouch, and place it on a flat, dry surface.
2. Use the pipette to draw and slowly add 1 drop of whole blood/serum/plasma to the sample well.
3. Hold the buffer bottle vertically and add 1 dropof buffer to the sample well./ If using pipette, change a new one to avoid cross-  contamination. Draw and transfer 2-3 drops of buffer to the sample well.
4. Wait for colored bands to appear. Depending on the concentration of HBsAg, positive results may be observedin as short as 60 seconds. Read result within 20 minutes. However, to confirm negative results，the complete reaction time, 30 minutes is required. Do not interpret result after 30 minutes.

INTERPRETATION OF RESULTS：
POSITIVE:  Two colored lines appear. One in the test region (T) and another one in the control region (C). The color intensity of the test line may be weaker or stronger than that of the control line.
NEGATIVE:  Only one colored line appears in the control region (C). No line is visible in the test region (T).
INVALID:  Control Line fails to appear.
NOTE:  Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test device. If the problem persists, please contact your local distributor.
SPECIFICATION:

Description	Specimen	Format	Catalog No.	Sensitivity	Package Size	Strip Width	Certificate
(HBsAg) Ultra Hepatitis B Surface Antigen Test	Serum/Plasma	Strip	B11-11	2ng/mL	50 Tests	3.0 mm	CE2265
		Cassette	B11-20		25 Tests	4.0 mm
	Whole Blood		B11-21		25 Tests	4.0 mm	——