SoFarma Description The HIV 1/2 test is a self-test that can specifically detect the presence of HIV 1 and/or 2 antibodies in a blood sample. If the blood sample contains HIV antibodies, they are captured by the test, producing a red 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 detection limit, leading to false negative results, especially for HIV-1 Group O (worldwide prevalence of HIV-1 Group O: 1%). A red line always appears in the control line region (C) to confirm that the test is working properly. 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 materials as follows: open the aluminum bag, remove only the cassette and discard the desiccant sachet. Open the plastic bag containing the pipette and unscrew the white cap from the bottle containing the diluent. 2. Wash your hands with warm water and soap, rinse with clean water and dry. Note: Using warm water facilitates capillary blood collection as it induces vasodilation. 3. Use the provided tablet to clean the puncture site. 4. Carefully rotate the lancet protective cap 360° without pulling it. Remove and discard the released cap. 5. Gently massage the joint chosen for the puncture (the side of the ring finger is recommended). It is important to massage from the palm towards the joint to improve blood flow. Press the lancet, on the side from which the cap was removed, onto the tip of the finger. The lancet tip automatically retracts safely after use. If the lancet malfunctions, use the second lancet provided. If the second lancet is not needed, it can be discarded without any special precautions. 6. Holding your hand down, massage your finger until a large drop of blood forms. It is important to massage from the palm of your hand towards the knuckle to improve blood flow. 7. Lift the pipette without squeezing the bulb. Two sampling methods are recommended: – Hold the pipette horizontally, without pressing on the bulb, and place it in contact with the drop of blood; the blood will flow naturally by capillary action. Remove the pipette when it reaches the black line. If there is not enough blood, continue massaging the finger until it reaches that line; – Place the pipette on a clean, flat surface with the tip facing out. Then, place the drop of blood in contact with the pipette; it will flow naturally by capillary action. Remove your finger when you reach the black line. If there is not enough blood, continue to massage your finger until you reach that line. Avoid breaking the contact between the blood and the pipette whenever possible to prevent air bubbles from forming. 8. Pour the collected blood with the pipette into the previously opened vial by pressing the pipette tip. – Press the pipette tip 2 or 3 times, keeping the tip at the bottom of the vial, to ensure that all the blood sample is released into the diluent. Then, screw the white cap back onto the vial together with the blue cap and mix well. 9. Unscrew the blue cap from the pipette bottle (leave the white cap tightly screwed on). 10. Place 3 drops in the well indicated on the cassette (S). Note: If the released drop contains air bubbles, place a fourth drop in the well. Wait 3-5 seconds between releasing 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 it is likely that you are 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 in the sample. Therefore, any color in the T-line region, even if it is paler than that shown in the images, should be considered positive. It is recommended that you do not make any medical decisions after performing this test without first consulting your physician. NEGATIVE: A colored line appears only under the C (Control) mark. No line appears under the T (Test) mark. This result means that HIV-1 and HIV-2 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 past three months, your body may not have yet produced antibodies (this is the window period, the time it takes for detectable HIV antibodies to develop). In this case, it is recommended to repeat the test three months after the possible exposure and avoid any activity that could lead to HIV transmission. If you experience symptoms that suggest HIV, contact your doctor. INVALID: No bands appear 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 why 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 monitoring of patients undergoing antiretroviral therapy. - Read these instructions for use carefully before performing the test. The test is reliable if the instructions are strictly followed. - Keep out of reach of children. - Do not use the test after the expiration date or if the packaging is damaged. - Follow the procedure exactly, using only the specified amount of blood and diluent. - 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 swallow. It is not recommended for use by people taking blood-thinning medications (anticoagulants) or by people suffering from hemophilia. - 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 you are testing other people, treat blood samples as potentially infectious. - In vitro diagnostic device for individual use. Format Content - 1 hermetically sealed aluminum bag containing: 1 HIV TEST 1/2 cassette, 1 desiccant sachet. Open the sealed aluminum pouch only before performing the test; pay attention to the opening mark. The desiccant sachet should not be used. Discard it unopened in the trash. - 1 vial with pipette containing HIV TEST DILUENT 1/2, sufficient for 1 test. - 2 sterile lancets for self-lancing blood sample collection. - 1 plastic bag containing 1 pipette for blood collection. - 1 antiseptic gauze for cleaning the skin. - 1 instruction sheet. Code SF014