HIV HOME TEST CARD
Rapid HIV I&II Test Card is a single use device,for qualitative detection of antibodies to Human Immunodeficiency Viruses I&II (HIV I&II) in human serum, plasma or whole blood. The Rapid HIV I&II Test Kit provides private at-home HIV testing with fast and reliable result, and at a time when you needed to know the most!
1. Tear open the alcohol prep ped.
2. Using the alcohol prep ped to clean your finger (usually the midius or the ring finger) from pulp to the surrounding.
3. Remove the cover as the arrow marks.
4. Twist and pull out the protection knob of the lancet.
5. Place the lancet at the finger pulp and press the trigger to sting the finger.
6. Using the transfer pipet to collect about 1 to 2 dropps of blood sample.
7. Place 1 drop of blood sample into the sample well marked as “S”.
8. Uncap the sample buffer bottle.
9. Add 1 drop of sample buffer into the sample well marked as “S”.
10. Read the result at 20 minutes. Reactive samples can be read as soon as distinct colored bands appear on both test zone and control zone. To confirm a negative result, please read the result at 20 minute after adding sample.
INTERPRETATION OF RESULTS
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.
If test area has no color band and the control area displays a colored band, the result is non-reactive or negative and valid.
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.
In a clinical evaluation of the performance of HIV I&II Test Card using 2567 confirmed negative and 510 positive samples, sensitivity was 99.6% (508/510) and specificity was 99.7% (2560/2567). The overall agreement with the reference ELISA tests is 99.7%.
HIV positive sera
HIV negative sera
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The precision of three lots tested with Chinese FDA QC panel showed 100% agreement.