| 製品概要: |
Introduction
One step HBV cassette test is a rapid direct binding test for the visual detection of hepatitis B surface(core) antigen/ant in serum as an aid in the diagnosis of hepatitis B infection, test results are read visually without any instrument.
One step HBV cassette test is based on the principle of double antibody sandwich immunoassay for determination of HBV in serum. Monoclonal and polyclonal antibodies were employed to specifically identify HBV with high sensitivity. This one step test only takes about 10-20 minutes. The sensitivity of the test can reach to 5-10ng/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 can not be tested on the day of collection, store the serum specimen in a refrigerator or freezer. Bring the specimen to normal room temperature 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 70μl ). Dispense entire contents into the sample well. Alternatively, hold the pipette in a straight up and down position- not at an angle. Dispense 2 drops (approximately 70μl ) of the specimen or control into the sample well for each sample or control, use a separate pipettor and device.
4. Wait for 10-15 minutes and read results. And do not read results after 30 minutes.
Package:
Panel25T Brochure
Interpretation of results for HbsAg, HbsAb, HbeAg:
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.
Interpretation of results for HbeAb, HbcAb:
Positive: Only one pink colored band appears on the control region. No apparent band on the test region
Negative: In addition to a pink colored band, a distinct pink colored band will also appear in the test region.
Invalid: A total absence of color in both regions is an indication of procedure error and/or that test reagent deterioration has occurred.
Sensitivity: SAg≥2ng eAg≥2ncu sAb≥30mIU eAb≥4ncu cAb≥4ncu
Expiry date: 18months
Temperature: 4-30
Attention:
1. For in-vitro diagnostic use only.
2. Read result within 15 minutes.
3. The dryers in the aluminium foil package are not victuals.
Company:
Hangzhou Yikang Biotech Co., Ltd. |
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