| Customization: | Available |
|---|---|
| Type: | IVD Reagent |
| Transport Package: | Cartons |
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INTENDED USE
The Hepatitis B Virus (HBV) Combo Test is a rapid chromatographic immunoassay for the qualitative detection of HBsAg, HBsAb, HBeAg, HBeAb and HBcAb in whole blood, serum or plasma.
MAIN CONTENTS
• Rapid test cassette with desiccant.
• Disposable pipettes
• Buffer
• Package insert
DIRECTION OF USE
Bring tests, specimens, and/or controls toroomtemperature (15-30°C) before use.
1. Remove the test from its sealed pouch, andplaceitonaclean, level surface. Label the cassette with patient or control identification. For best results, the assay should be performed within one hour.
2. Using the provided disposable pipette, transfer 2 drops of serum or plasma specimen to each specimen well (S) of the cassette and start the timer. OR Transfer 1 drop of whole blood specimen to each specimen well (S) of the cassette with the provided disposable pipette, 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. 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 at 15 minutes. Do not interpret the result after 20 minutes.
INTERPRETATION OF RESULTS
HBsAg, HBsAb, HBeAg
POSITIVE: Two red lines appear. One line should be in the control line region (C) and another line should be in the test line region (T).
NEGATIVE: One red line appears in the control line region (C). No apparent red or pink line appears in the test line region (T).
*NOTE: The intensity of the red color in the test line region (T) will vary depending on the concentrations of HBsAg, HBsAb, and HBeAg present in the specimen. Therefore, any shade of red in the test line region (T) should be considered positive.
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. the Review 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.
HBeAb, HBcAb
POSITIVE: One red line appears in the control line region(C), No apparent red or pink line appears in the test region (T).
NEGATIVE: Two red lines appear. One line should be in the control line region (C) and another line should be in the test line region (T).
*NOTE: The shade of red in the test line region (T) may vary, but it should be considered negative whenever there is even a faint pink line.
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.
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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