Beijing Kinghawk CO.,LTD

Human Immunodeficiency Virus (1+2) Antibodies Rapid Test

A rapid test for the qualitative detection of antibodies to human immunodeficiency virus-1+2 in whole blood or serum or plasma.
For professional in vitro test use only

Intended use
Human Immunodeficiency Virus Antibodies Diagnostic Kit is a rapid chromatographic immunoassay for the qualitative detection of antibody to Human Immunodeficiency Virus (HIV) type-1 and/or type-2 in whole blood or serum or plasma.

Principle
The membrane is coated with recombinant HIV antigens on the test line region of the device. When a whole blood or serum or plasma specimen is applied at one end of the membrane, it reacts with recombinant antigens labeled with colloidal gold particle that has already been applied to the specimen pad at the same end .The mixture then migrates chromatographically towards the other end of membrane and reacts with the recombinant HIV antigens on the membrane in the test line region, showing a positive result. The absence of the colored line indicates that the whole blood or serum or plasma does not contain the anti-HIV antibodies, showing a negative result. To serve as a procedural control, a colored line will always appear at the control line region if the test has been performed properly.

Package:
50 Test strips
2 bottle of sample solution
1user's guide

Materials Required But Not Provided
Timer, Tube, Sterilized cotton ball

Safety
Please treat the used strip as POSITIVE contamination.
Don't use after expiration date.
Do not eat, drink or smoke in the area where the specimens and kits are handled.
Do not mix reagents with different lot numbers.
Do not touch the membrane of the strip.
Ensure the blood taking needle, tube, sterilized cotton ball be used only once.
Avoid microbial contamination on your finger.
Humidity and temperature can adversely affect results.

Storage and Stability
Store as packaged in the sealed pouch at 4-25ºC.
The test devie must remain in the sealed pouch until use.
The buffer should be stored at 2-8ºC.DO NOT FREEZE.

Shelf life: 12 months

Sample collection and Preparation
This kit can be performed using either whole blood or serum or plasma.
Only clear, non-hemolyzed specimens can be used.
Testing should be performed immediately after the specimens have been collected or prepared.
Specimens may be stored at 2-8ºC for up to 3 days. For long term storage, specimens should be kept below -20ºC.
Bring specimens to room temperature prior to testing.
Frozen specimens must be completely thawed and mixed well prior to testing.
Specimens should not be frozen and thawed repeatedly.

Directions of use
Equilibrate the kit to room temperature (15-30ºC) prior to testing.
Remove the strip from the foil pouch and use it as soon as possible. Place the device on a clean and level surface. Get some blood as what is showed in Pic. A.Hold the dropper vertically and transfer 1 full drop of whole or serum or plasma (approx.40-50ul) to the sample well. (See Pic. B)Then add 1 full drops of buffer from the dropper bottle to the sample well of the device and start the timer. Avoid trapping air bubbles in the sample well. (See Pic. C) Wait for the red line(s) to appear .The line should be read at 25 to 30 minutes. It is important that the background is clear before the result is read.
Interpretation of result
POSITIVE: Two distinct red lines appear. One line should be in the control region (C) and another line should be in the test region (T).
NEGATIVE: one red line appears in the control region (C), No apparent red or pink line appears in the test region (T).
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 repeated the test with a new test device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

NOTE: Low titers of anti-HIV 1/2 antibodies might result in a faint line appearing in the region (T) after a prolonged time The intensity of the red color in the test line region (T) will vary depending on the concentration of anti-HIV 1/2 antibodies present in the specimen. However, neither the quantitative value nor the rate of increase in anti-HIV 1/2 antibodies can be determined by this qualitative test.