| Customization: | Available |
|---|---|
| Type: | IVD Reagent |
| Pack Formats: | Strip: 50 Tests/Box Cassette: 20 Tests/Box |
|
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INTRODUCTION
Infection caused by HBV has brought serious public health problems. Mother-to-child transmission, sexual transmission and blood transmission are the most common routes of transmission. Early detection of infection can effectively reduce the spread of disease.
Commonly used methods to determine the HBsAg include enzyme-linked immunosorbent assay, colloidal gold, radioimmunoassay, fluorescence quantitative PCR diagnosis, etc.
INTENDED USE
HBsAg Test kit (Colloidal Gold) is used for the in vitro qualitative detection of hepatitis B virus surface antigen (HBsAg) in human serum and plasma samples.
HBsAg is the coat protein of hepatitis B virus. It is not infectious, only antigenic. But its presence is often accompanied by the presence of hepatitis B virus, so it is a sign of hepatitis B virus infection.
PACK FORMATS
Strip: 50 tests/box
Cassette: 20 tests/box
MATERIALS SUPPLIED
HBsAg Test Strip/Cassette
Instruction for use
Dropper(for Cassette only)
STORAGE AND STABILITY
The kit can be stored at room temperature or refrigerated (4-30°C). The test device is stable through the
expiration date printed on the sealed pouch. The test device must remain in the sealed pouch until use.
Do not freeze.
Do not use beyond the expiration date.
After opening the sealed pouch, use the test as soon as possible within 60 minutes.
SPECIMEN COLLECTION
1. Serum and plasma can be used for testing. Among them, plasma samples of commonly used clinical
anticoagulants (EDTA, heparin, sodium citrate) do not affect the test results.
2. Collect intravenous serum and plasma under sterile conditions and avoid hemolysis of the sample.
3. If the serum or plasma sample is tested within 7 days after collection, the sample must be stored at 2-8°C, if it is longer than 7 days,
it must be frozen.
4. If specimens are to be shipped, they should be packaged in accordance with local regulations regarding the transportation of pathogens.
TEST PROCEDURE
Allow test cassette/strip, specimen and/or controls to equilibrate to room temperature (15-30°C) prior to testing.
1. Remove the test cassette from the sealed foil pouch and use it as soon as possible.
2. Place the test device on a clean and level surface.
3. Use the provided dropper to draw the serum/plasma sample, and then add 3 drops(80μl) of the serum/plasma sample into the
sample well (avoid air bubbles). Then start the timer.
4. Wait for the result. The result should be read in 15 minutes. Do not interpret the result after 20 minutes.
INTERPRETATION OF RESULTS
NEGATIVE:
If only the C band is present, the absence of any burgundy color in the T band indicates that no HBsAg is detected in the specimen.
The result is negative.
POSITIVE:
In addition to the presence of C band, if T band is developed, the test indicates for the presence of HBsAg in the specimen.
The result is HBsAg positive.
INVALID:
Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
WARNINGS AND PRECAUTIONS
1. For professional In Vitro diagnostic use only. Do not use after expiration date.
2. These instructions must be strictly followed by a trained healthcare professional to achieve accurate results. All users
have to read the instruction prior to performing a test.
3. Do not use it if the tube/pouch is damaged or broken.
4. Wear protective gloves while handling specimens and wash hands thoroughly afterwards.
5. Avoid splashing or aerosol formation of specimen and buffer.
6. Clean up spills thoroughly using an appropriate disinfectant.
7. Decontaminate and dispose of all specimens, reaction kits and potentially contaminated materials (i.e. dropper, test device) in
a biohazard container as if they were infectious waste and dispose according to applicable local regulations.
8. Do not mix or interchange different specimens.
9. Do not mix reagent of different lots or those for other products.
10. Do not store the test kit in direct sunlight.
11. To avoid cross-contamination, do not reuse the dropper for specimen collection.
12. Test is for single use only. Do not re-use under any circumstances.
13. Do not perform the test in a room with strong air flow, ie. electric fan or strong air-conditionin.
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