Rapid Test over 99% Accuracy HIV Rapid Test With CE

Rapid Test over 99% Accuracy HIV Rapid Test With CE
Product Description
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Specification
For in vitro diagnostic use only
INTENDED USE
Rapid HIV 1+2 Test Card is a single use, rapid test device, double antigen sandwich immunoassay for qualitative detection of antibodies to Human Immunodeficiency Viruses or HIV1+2 in serum. It is intended for medical institution as the aid for the diagnosis of possible HIV infection. The product may be used for the quick screening of blood donors and blood products.
PRINCIPLE
Rapid HIV 1+2 Test Card employs chromatographic lateral flow device in a cassette format. Colloidal gold conjugated recombinant antigens (Au-Ag) corresponding to HIV-1 gp120, gp41 and HIV-2 gp-36 are dry-immobilized at the end of nitrocellulose membrane strip. HIV 1+2 antigens are bond at the Test Zone (T) and rabbit anti-HIV 1+2 antibodies are bond at the Control Zone (C). When the sample is added, it migrates by capillary diffusion rehydrating the gold conjugate. If there are HIV1 or HIV 2 antibodies in sample, they will bind with the gold conjugated antigens forming particles. These particles will continue to migrate along the strip until the Test Zone (T) zone where they are captured by the HIV 1+2 antigens generating a visible red line. If there are no HIV 1 or HIV 2 antibodies in sample, no red line is formed in the Test Zone (T).The gold conjugate will continue to migrate alone until it is captured in the Control Zone(C) by the rabbit anti-HIV 1+2 antibodies aggregating in a red line, which indicates the validity of the test.
INTERPRETATION OF RESULTS
Reactive: Positive
If two colored bands are visible within 20 minutes, the test result is reactive or positive and valid. The test result can be read as soon as a distinct colored band appears in the test area.
Non-reactive: Negative
If test area has no color band and the control area displays a colored band, the result is non-reactive or negative and valid.
Invalid result:
The test result is invalid if a colored band does not form in the control region. The sample must be re-tested, using a new test device.
FEATURE:
1) Simple: simply add specimen and dilution(if necessary) into sample well
2) Rapid: results come out at 20 minutes
3) Visually interpreted: don't need any equipment
4) Stable: more than 24 month period of validity
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