Description
The HIV 1/2 test is a self-test that can specifically detect the presence of antibodies to HIV 1 and/or 2 in a blood sample. If the drop of blood taken contains antibodies to HIV, 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). The absence of color in the test line region (T) is also possible when the levels of circulating antibodies 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) to confirm that the test is working correctly.
It is recommended that you do not make any medical decisions after taking this test without first consulting your doctor.

How to use
1. Prepare the necessary material as follows: open the aluminum bag, take only the cassette and throw away the desiccant sachet. Open the plastic bag containing the pipette and unscrew the white cap from the vial containing the diluent.
2. Wash your hands with warm water and soap, rinse with clean water and dry. Note: The use of warm water facilitates the collection of capillary blood because it induces vasodilation.
3. Use the gauze provided to clean the puncture site.
4. Carefully rotate the protective cap of the lancet 360° without pulling it. Remove 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 to massage from the palm of the hand to the phalanx, to improve blood flow. Press the lancet, on the side from which the cap was removed, against the fingertip.
The lancet tip automatically retracts safely after use. If the lancet does not work properly, use the second one provided. If the second one is not needed, it can be disposed of without special precautions.
6. Keeping your hand facing down, massage your finger until a large drop of blood forms. It is important to massage from the palm of your hand to the knuckle, to improve blood flow.
7. Take the pipette without squeezing the bulb. Two methods of sampling are suggested:
– hold the pipette horizontally without pressing the bulb and put it in contact with the drop of blood, it will enter by capillarity. Move the pipette away when you reach the black line. If the blood is not enough, continue to massage your finger until you reach that line;
– place the pipette on a flat, clean surface, making sure the tip sticks out, then put the drop of blood in contact with the pipette, it will enter by itself by capillary action. Move your finger away when you reach the black line. If there is not enough blood, continue massaging your finger until you reach that line. Avoid, as much as possible, interrupting the contact between the blood and the pipette to prevent the formation of air bubbles.
8. Deposit the blood collected with the pipette into the previously opened vial, pressing the bulb of the pipette itself. – Press the bulb of the pipette 2 or 3 times keeping the tip on the bottom of the bottle to ensure that all the blood sample is released into the diluent. Then screw the white cap together with the blue cap on the bottle and mix well.
9. Unscrew the blue cap from the dropper bottle (leave the white cap tightly screwed on).
10. Place 3 drops in the well indicated on the cassette (S).
Note: If the dispensed drop contains air bubbles, place a fourth drop in the well. Wait 3-5 seconds between dispensing each drop.
11. Read the result after 10 minutes.

Interpretation of results
POSITIVE: Two colored lines appear in the reading window corresponding to the C (Control) and T (Test) regions. This result means that the test has detected the presence of HIV 1 and/or HIV 2 antibodies in the blood sample.
Contact your doctor and report this result as you are probably HIV positive (i.e. specific antibodies have been detected in the blood sample, indicating 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. Therefore, any shade of color in the T-line region, even if fainter than 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 healthcare provider.
NEGATIVE: A colored line appears only under the C (Control) mark. No line appears under the T (Test) mark. This result means that HIV1 and HIV2 antibodies are not present or are present in very low concentrations, undetectable by this diagnostic test.
If your test result is negative, but you think you may have been exposed to HIV in the last 3 months, it is possible that your body has not yet produced antibodies (window period, the time it takes for a detectable amount of HIV antibodies to develop). In this case, it is recommended that you repeat the test 3 months after the possible exposure and avoid any activity that could cause you to transmit HIV to others. If you have symptoms that may be related to HIV, contact your doctor anyway.

INVALID: No bands are visible or there is a line only under the T (Test) mark and not under the C (Control) mark. In this case, the test result cannot be interpreted and should be considered invalid. Insufficient sample volume or incorrect procedural techniques are the most likely reasons for which the control line is not visible (invalid result). Review the procedure and repeat the test with a new device and a new blood sample.

Warnings
- The HIV 1/2 TEST is not intended for therapeutic follow-up for patients undergoing antiretroviral therapy.
- Read these instructions for use carefully before performing the test. The test is reliable if the instructions are followed carefully.
- Keep the test out of the reach of children.
- Do not use the test after the expiration date or if the package is damaged.
- Follow the procedure exactly, using only the specified amount of blood and thinner.
- Store test components at a temperature between +4°C and +30°C. Do not freeze.
- Use the test and sterile lancet only once.
- The test is for external use only. Do not ingest.
- It is not recommended for use by people taking drugs that thin the blood (anticoagulants) or people suffering from haemophilia.
- After use, dispose of all components in accordance with local regulations, ask your pharmacist for advice.
- This test can only detect HIV infection and cannot be used to detect other sexually transmitted infections.
- People using this self test should consult their doctor before making any medical decisions.
- If testing other people, treat blood samples as potentially infectious.
- In vitro diagnostic device for individual use.

Format
Content
- 1 hermetically sealed aluminum pouch containing: 1 HIV 1/2 TEST cassette, 1 desiccant sachet.
Open the sealed aluminum bag only before performing the Test, pay attention to the opening sign. The desiccant bag must not be used. Dispose of it with waste, without opening it.
- 1 dropper bottle containing HIV 1/2 TEST DILUENT sufficient for 1 test.
- 2 sterile lancets for self-pricking blood samples.
- 1 plastic bag containing 1 pipette for blood sampling.
- 1 antiseptic skin cleansing gauze.
- 1 instruction sheet for use.

Cod. SF014