Description
Self test HIV 1/2 is a self-test able to specifically detect the presence of anti-HIV 1 and/or 2 antibodies in a blood sample. If the drop of blood taken contains anti-HIVé antibodies, these are captured by the test, producing a red colored line in the test line region (T). Otherwise, if the sample does not contain such antibodies, no color will appear in the test line region (T). Absence of color in the test line region (T) is also possible when circulating antibody levels are below the limit of detection, leading to false negative results, especially for HIV-1 Group O (prevalence of HIV 1 Group O in the world: 1%). A red colored line will always appear in the control line region (C) confirming that the test is working properly.

How to use
Open the sealed aluminum bag only before carrying out the test, pay attention to the opening sign.
Bring all test components to room temperature (15-30°C) before carrying out the test if the kit has been stored in the refrigerator.
1. Prepare the necessary materials as follows: open the foil bag and take only the cassette and throw away the desiccant bag. Open the plastic bag containing the pipette and unscrew the white cap from the vial containing the diluent.
2. Wash your hands with soap and warm water, rinse with clean water and dry.
Note: the use of hot water facilitates capillary blood sampling as it induces vasodilation.
3. Use the gauze provided to clean the puncture site.
4. Carefully turn the protective cap of the lancing device 360° without pulling it. Pull out and discard the released cap.
5. Carefully massage the phalanx chosen for the puncture (the side of the ring finger is recommended). It is important that the massage is done from the palm of the hand to the phalangeé to improve blood flow. Press the lanceté on the side from which the cork was removedé against the fingertip.
The lancet tip automatically retracts safely after use. If the hand does not work properly, use the second hand provided. If, on the other hand, the latter is not necessary, it can be disposed of without particular precautions.
6. Keeping the hand pointing downwards, massage the finger until a large drop of blood forms. It is important that the massage is done from the palm of the hand to the phalangeé to improve blood flow.
7. Take the pipette without pressing the bulb. Two withdrawal methods are suggested:
– hold the pipette horizontally without pressing the bulb and put it in contact with the drop of blood, it will enter autonomously by capillarity. Remove the pipette when reaching the black line. If the blood is not enoughé continue to massage the finger until it reaches that line;
– place the pipette on a flat and clean surface making the tip protrude, at this point bring the drop of blood into contact with the pipette, it will enter autonomously by capillarity. Move your finger away when you reach the black line. If there is not enough blood, continue massaging the finger until that line is reached.
Avoid, as far as possible, breaking the contact between the blood and the pipette to prevent the formation of air bubbles.
8. Deposit the blood collected with the pipette in the previously opened vial by pressing the bulb of the pipette itself. Press the bulb of the pipette 2 or 3 times while keeping the tip at the bottom of the bottle to ensure that all blood sample is released into the diluent. Then screw the white cap back together with the blue cap on the bottle and mix well.
9. Unscrew the blue cap from the dropper vial (leave the white cap tightly closed).
10. Deposit 3 drops in the well indicated on the cassette (S).
Note: If the dispense drop contains air bubbles, place a fourth drop in the well. Wait 3–5 seconds between dispensing one drop and the next.
11. Read the result at 10 minutes.

Interpretation of results
POSITIVE*
Two colored lines appear in the reading window at the C (Control) and T (Test) regions.
Contact your doctor and report this result as you are probably HIV positive (specific antibodies have been detected in your blood sample which indicate the presence of the virus).
*NOTE: The intensity of the color in the test line regions may vary depending on the concentration of HIV 1 and/or HIV 2 antibodies present in the specimen (as seen in the images). Therefore, any shade of color in the T-line region, even if it is dimmer than in the images shown, should be considered positive. It is recommended that you do not make any medical decisions after performing this test without first consulting your doctor.
NEGATIVE
A colored band is displayed only under the C (Control) mark. No line is displayed at the T (Test) mark.
If the result is negativeé but you think you have been exposed to HIV in the last 3 monthsé it is possible that the antibodies have not yet been produced by the body (window periodé or time required for the development of a detectable amount of anti-HIV antibodies HIV). In this case it is recommended to repeat the test 3 months after possible exposure and to avoid any activity that could cause transmission of HIV to others. If you have symptoms that could be traced back to HIV, you should still contact your doctor.
INVALID
No bands appear or there is a line only under the T (Test) sign and not under the C (Control) sign.
In this case it is not possible to interpret the test result and it should be considered invalid. Insufficient sample volume or incorrect procedural techniques are the most likely reasons why the control line is not visible (invalid result). Review the procedure and retest with a new device and blood sample.

Warnings
- The HIV 1/2 Self Test is not intended for therapeutic follow-up for patients undergoing antiretroviral therapy.
- Read these instructions for use carefully before carrying out the test. The test is reliable if the instructions are followed accurately.
- Keep the test out of the reach of children.
- Do not use the test after the expiry date or if the package is damaged.
- Follow the procedure exactly using only the specified amount of blood and diluent.
- Use the test and the sterile lancet only once.
- The test is for external use only. Do not swallow.
- It is not recommended for use by people taking medicines that thin the blood (anticoagulants) or people suffering from haemophilia.
- After use, dispose of all components in accordance with local regulations in force, ask your pharmacist for advice.
- This test can only detect HIV infection and cannot be used for the detection of other sexually transmitted infections.
- People using this self test should consult their doctor before making any medical decisions.
- If you are testing other people, treat blood samples as potentially infectious.
- In vitro diagnostic device for individual use.

storage
Store test components at temperatures between 4°C and 30°C. Do not freeze.

Format
Contents: hermetically sealed aluminum pouch containing 1 HIV 1/2 TEST cassette, 1 desiccant sachet, 1 dropper vial containing HIV 1/2 TEST DILUENT sufficient for 1 test 2 sterile lancets for self-puncture for blood collection blood 1 plastic bag containing 1 pipette for blood sampling 1 antiseptic cleansing gauze for the skin 1 leaflet of instructions for use.

CodeREF 800062-1