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HBeAg Rapid Test Cassette
INTENDED USE
Rapid HBeAg test is an immunochromatography based one step in vitro test. It is designed for qualitative determination of HBeAg in human serum, plasma or whole blood specimens.
TEST PRINCIPLE
Rapid HBeAg test is a sandwich immunoassay. When specimen is added to sample pad, it moves through the conjugate pad and mobilizes gold anti-HBeAg conjugate that is coated on the conjugate pad. The mixture moves along the membrane by capillary action and reacts with anti-HBeAg antibody that is coated on the test region. If HBeAg is present at levels of 1 ng/ml or greater, the result is the formation of a colored band in the test region. If there is no HBeAg in the sample, the area will remain colorless.
The sample continues to move to the control area and forms a pink to purple color, indicating the test is working and the result is valid.
MATERIAL PROVIDED
1. Rapid HBeAg Test device
2. Package insert
3. Disposable transfer pipet
MATERIALS REQUIRED BUT NOT SUPPLIED
1. Whole blood or plasma: Vacutainer tube, or other appropriate tube, containing heparin or EDTA as an anticoagulant
2. Serum: Vacutainer tube, or other appropriate tube, without anticoagulant
3. Timer or clock
STORAGE
Store the test device at 4 to 30oC. Do Not Freeze.
PRECAUTIONS
1. For in vitro diagnostic use only.
2. Do not use product beyond the expiration date.
3. Handle all specimens as potentially infectious.
SPECIMEN COLLECTION AND PREPARATION
1. The serum, whole blood or plasma specimen should be collected under standard laboratory conditions.
2. Heat inactivation of specimens, which may cause hemolysis and protein denaturation, should be avoided.
3. Patient samples performed best when tested immediately after collection. If specimans are to be stored, the red blood cells should be removed to avoid hemolysis. If the sample cannot be tested within 24 hours, serum or plasma should be frozen until the test can be performed. Whole blood samples should be refrigerated at 2–8oC in stead of being frozen. Allow sample to reach room temperature before proceeding.
4. Sodium azide can be added as a preservative up to 0.1% without effecting the test results.
PROCEDURE
For HBeAg Test Strip
1. Bring all materials and specimens to room temperature.
2. Remove the test strip from the sealed foil pouch.
3. Label the test strip with specimen identity by writing the ID on the top label of the strip.
4. Place the test strip on a flat horizontal surface.
5. Using the transfer pipet to draw up the sample.
6. Hold the transfer pipet in a vertical position over the sample pad and dispense 2 drops (80-100 ml) of sample onto the sample pad.
7. Read the result at 20 minutes after adding the sample.
For HBeAg Test Card
1. Bring all materials and specimens to room temperature.
2. Remove the test card from the sealed foil pouch.
3. Label the test card with specimen identity on the “ID ____ ” area of the cassette.
4. Place the test card on a flat horizontal surface.
5. Using the transfer pipet to draw up the sample.
6. Hold the transfer pipet in a vertical position over the sample well and dispense 2 drops (80-100 ml) of sample into the sample well.
7. Read the result at 20 minutes after adding the sample.
Note: 1.Some positive samples may show positive results before 20 minutes. Results after 30 minutes may not be accurate.
2. Occasionally some whole blood samples are too sticky to move on the device. If it happens, re-test the sample by adding one drop of the blood sample and followed by adding one drop of the chasing buffer (15 mM phosphated buffered saline, PBS).
Span Biotech Ltd. is a research based company for rapid tests, with strong support from National Key Laboratory of Technology Projects of 10th and 11th Five-Year Plan and Faculty of Life Sciences of HuBei University. SpanBio also housed a R&D team that is developing gene recombination, cell cultivation and protein purification techniques. SpanBio pays strict attention on rapid tests for human being, animal diseases and food safety detection. It provides a number of customized services to professional distributors and partnering affiliates with excellent quality, competitive prices and super service.
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Contact Person: Ms. Anna Lee
Tel: +86-755-89589611
Fax: 86-755-89580096