| Customization: | Available |
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| Type: | IVD Reagent |
| Specimen: | Whole Blood, Serum, Plasma |
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INTENDED USE
The HIV 1/2 & Syphilis(TP) Rapid Test is a rapid visual immunoassay for the qualitative, presumptive detection of antibodies to HIV- 1/HIV-2 and antibodies to Treponema Pallidum (TP) in human whole Blood, serum or plasma specimens. This kit is intended for use as an aid in the diagnosis of HIV infection.
MAIN CONTENTS
• Rapid test cassette
• Buffer
• Disposable dropper
• Package insert
DIRECTION OF USE
Bring tests, specimens, and/or controls to roomtemperature(15-30°C) before use.
1. Remove the test from its sealed pouch, and placeit onaclean,level surface. Label the test with patient or control identification.For best results, the assay should be performedwithinonehour.
2. Using the provided disposable dropper:
Serum/Plasma
HIV: Transfer 1 drop of serum/plasma to the specimen well (S) of the device with the provided disposable pipette, then add 1 drop of buffer and start the timer.
Syphilis: Transfer 2 drops of serum/plasma to each specimen well (S) of the cassette, then start the timer.
OR
Whole Blood
HIV and Syphilis: Transfer 1 drop of whole blood specimen to each specimen well (S) of the cassette, then add 1 drop of each buffer and start the timer.
Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area.
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 10 minutes. Do not interpret the result after 20 minutes.
INTERPRETATION OF RESULTS
HIV 1/2:
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.
Syphilis:
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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