| Customization: | Available |
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| Type: | IVD Reagent |
| Sample Type: | Serum/Plasma |
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INTENDED USE
HBeAg Test Kit is a lateral flow chromatographic immunoassay for the qualitative detection of Hepatitis B envelope antigen (HBeAg) in human serum, plasma, or whole blood. This assay provides only a preliminary result. Clinical expertise and professional judgment should be sought to further evaluate the result of the test.
INTRODUCTION
HBeAg is the "soluble" or extractable part of the "core" antigen of the hepatitis B virus (HBV). The presence of HBeAg indicates that the virus is actively multiplying and is highly contagious. HBeAg appears in the blood shortly after HBsAg. It stays in the blood for about 3 to 6 weeks after the acute (symptomatic) phase of the disease and may persist for a long time or reappear in the case of active chronic hepatitis. Therefore, the HBeAg test is most often used to indicate the level of contagiousness. It is also useful in monitoring the efficacy of a treatment. A positive (reactive) HBeAg result combined with a negative (non-reactive) anti-HBe result confirms a high degree of contagiousness. When the anti-HBe is also reactive, this means the individual is in the process of healing and is less contagious. A non-reactive HBeAg result (with a reactive anti-HBe result) in a person with hepatitis B indicates that the infection is in its initial phase, before peak replication of the virus. If the anti-HBe is reactive, it may indicate that viral replication is now very low.
MAIN CONTENTS
• Rapid test cassette with desiccant.
• Disposable pipettes
• Buffer
• Package insert
STORAGE AND STABILITY
• Store at 2 ~ 30 º C in the sealed pouch for 24 months.
• Keep away from direct sunlight, moisture and heat.
• DO NOT FREEZE.
SAMPLE COLLECTION
• The HBeAg Test is intended for use with human whole blood, serum or plasma specimens only.
• Only clear, non-hemolyzed specimens are recommended for use with this test. Serum or plasma should be separated assoon as possible to avoid hemolysis.
• Perform testing immediately after specimen collection. Do not leave specimens at room temperature for prolonged periods. Serum and plasma specimens may be stored at 2-8°C for up to 3 days. For long term storage, specimens should be kept below -20°C.
• Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Avoid repeated freezing and thawing of specimens.
• If specimens are to be shipped, pack them in compliance with all applicable regulations for transportation of etiological agents.
• Icteric, lipemic, hemolysed, heat treated and contaminated sera may cause erroneous results.
DIRECTION OF US
Bring tests, specimens, and/or controls to room temperature (15-30°C) before use.
1. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the device with patient or control identification. For best results, the assay should be performed within one hour.
2. Using the provided disposable pipette, transfer 1 drop of whole blood, serum or plasma, then add 1 drop of buffer and start the timer. Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result window. As the test begins to work, color will migrate across the membrane.
3. Wait for the colored band(s) to appear. The result should be read in 15 minutes. Do not interpret the result after 20 minutes.
INTERPRETATION OF RESULTS
POSITIVE: The presence of two lines as control line (C) and test line (T) within the result window indicates a positive result.
NEGATIVE: The presence of only control line (C) within the result window indicates a negative result.
INVALID: If the control line (C) is not visible within the result window after performing the test, the result is considered invalid. Some causes of invalid results are because of not following the directions correctly or the test may have deteriorated beyond the expiration date. It is recommended that the specimen be re-tested using a new test.
For further operation or performance details, please refer to final instruction manual.
1.Are you a Manufacturer?
Yes,we are manufacturer based in Foshan,China with 100 workers,more than 5000 square meter non-dust workshop,advanced automate machines and professional R&D team ensure the high quality,speedy delivery and large production capacity.
2.Can we put our logo/text om the product or package?
Yes,we can do OEM or even ODM.All of our products can be customized.
3.Can you provide free samples?
Yes, free sample are available.
4.How long is your production time?
Our production time is usually two weeks after receiving the deposit and four weeks for one contaoner order quantity.
5.How to make the payment?
By T/T,L/C,Paypal,Western union and made in China is also acceptable.
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