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One Step HBsAg test Cassette

Introduction         

 one step HBsAg cassette test is a rapid direct binding test for the visual detection of hepatitis b surface antigen in serum as an aid in the diagnosis of hepatitis b infection, test results are read visually without any instrument. One step hbsag cassette test is based on the principle of double antibody sandwich immunoassay for determination of hbsag in serum. Monoclonal and polyclonal antibodies were employed to specifically identify hbsag with high sensitivity . This one step test only takes about 10-20 minutes.the sensitivity of the test can reach to 2-5ng/ml.

Specimen collection

For serum, collect blood into container without anticoagulant. Allow the blood to clot and separate the serum from the clot. Use the serum for testing.

If the specimen cannot be tested on the day of collection, store the serum specimen in a refrigerator or freezer. Bring the specimen to normal room temperaure before testing. Do not freeze and thaw the specimen repeatedly.

　

Test procedure

1.review specimen collection instructions, test device, patients samples and controls should be brought to room temperature(18-30℃) prior to testing..

2.remove the test device from its protective pouch(bring the device to room temperature before opening of the pouch to avoid condensation of moisture on the membrane) .label the device with patient or control identifications.

3.draw sample to the line marked on the pipettor  (approximately 0.2ml ) . Dispense entire contents into the sample well . Alternatively, hold the pipette in a straight up and down position - not at an angle. Dispense 6 drops (approximately 0.2ml ) of the specimen or control into the sample well (diag. 1) for each sample or control , use a separate pipettor and device.

4.wait for 10-20 minutes and read results. And do not read results after 30 minutes.

　

　

　

Interpretation of results

　

Negative: only one colored band appears on the control region （c）no apparent band on the patient test region(t).

Positive: in addition to a pink colored control band , a distinct pink colored control band will also appear in the patient test region(t)

Invalid : a total absence of color in both regions is an indication of  procedure error and/ or that test reagent deterioration has  occurred.