HBSAG RAPID TEST STRIP

INTRODUCTION:

One Step HBsAg Rapid Screen Test is a lateral flow, immunochromatographic screening test for HBsAg of hepatitis B. The test is based on the principle of sandwich immunoassay for determination of HBsAg in serum .Two Monoclonal antibodies are employed to identify HBsAg specifically.This one step test is very sensitive and only takes about 15-20 minutes. Test results are read visually without any instrument.

TEST PROCEDURE:

1. When you are ready to begin testing, open the sealed pouch by tearing along the notch. Remove the test from the pouch.
2. Immerse the strip into the container with the arrow end pointing towards the container. Do not immerse past the MAX (maximum) line. Take the strip out after 8-10 seconds and lay the strip flat on a clean, dry, nonabsorbent surface (e.g., mouth of the serum container).
3. Wait 10-20 minutes and read result. Do not read results after 30 minutes.

INTERPRETATION OF RESULTS:
1. Negative: Only one color band appears on the control region. No apparen band on the test region. This indicates that there is no detectable HBsAg in the serum.
2. Positive: Distinct color bands appears on the control and regions test Both test line and control line indicate that the specimen contains detectable amount of HBsAg.
3. Invalid: No visible bang at all or only one colored band appears on test region, this is an indication of a possible error in performing the test. The test should be repeated using a new device.

PRECAUTION:
1, Must use fresh specimen and avoid repetitive freezing, the result will be invalid.
2, Use it before expiry date.
3, The package of kit should not be opened until it reaches the room temperature if it taken out from the refrigerator.
4, Old Serum can not be used. If the serum is thick, it can be used only after being separated.

LIMITATIONS:
1, The test is for in-vitro diagnostic use only.
2, The test is qualitative filter detection, it can not be used as the final test for blood donor.

STORAGE AND STABILITY:
1. The test kit can be stored at room temperature (2 to 30C) in the sealed pouch to the date of expiration.
2. The test kit should be kept away from direct sunlight, moisture and heat.