HBsAg strip

INTENDED USE

This is a one step HBsAg rapid test strip and a direct binding test for the visual detection of hepatitis B Antigen (HBsAg) used as an aid in the diagnosis of hepatitis B infection. This one step test is very sensitive and only takes about 15 to 20 minutes, test results can be read visually without any instrument.

SPECIMEN COLLECTION

For the serum, collect the blood into a container without anticoagulant, if the specimen cannot be tested on the day of collection; then store it in a refrigerator or freezer. Bring it to the room temperature before testing.

TEST PROCEDURE

• Open the sealed pouch and remove the test strip from it.

• Immerse the test strip into the sample with the arrow end pointing towards the sample. Do not immerse it past the MAX (maximum) line. Take out the strip after 8 to 10 seconds and lay it on a horizontal, clean, dry and nonabsorbent surface.

• Take 0.1ml (about 3 drops) sample into the pipette, and dispense it into the sample well on the cassette.

• Wait for 15 to 20minutes and read the results. Do not read it after 30 minutes.

INTERPRETATION OF RESULTS

• Negative: If only one colored line appears on the control (C) region and no apparent band on the test (T) region.

• Positive: In addition to a pink colored control (C) line, a distinct pink colored line also appears in the test (T) region.

• Invalid: Absence of colored line in both the regions is an indication of procedural error and/or the test reagent has deteriorated.

STORAGE AND STABILITY

The test kit can be stored at room temperature (4 to 30℃) in a sealed pouch until the date of expiration. It should be kept away from direct sunlight, moisture, and heat.

PRECAUTION

• For in vitro diagnostic use only

• Do not use the test kit beyond its expiry date

• The test device should not be reused