Descrizione Clinica
SoFarma
Description
The HIV 1/2 test is an autotest that specifically detects the presence in a blood sample of anti-HIV 1 and/or 2. If the blood drop taken contains anti-HIV antibodies, these 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 region of the test line (T). The absence of color in the region of the test line (T) is also possible when the levels of circulating antibodies are below the detection limit, leading to negative false results, especially for HIV-1 Group O (prevalence of HIV 1 Group O in the world: 1%). A red line will always appear in the region of the control line (C) to confirm the correct functioning of the test.
It is recommended not to make any medical decision after performing this test without first consulting your doctor.
Mode of use
1. Prepare the necessary material as follows: open the aluminum envelope, take only the cassette and throw away the drying bag. Open the plastic bag containing the pipette and unscrew the white cap from the vial containing the diluent.
2. Wash hands with hot water and soap, rinse with clean water and dry. Note: the use of hot water facilitates the withdrawal of capillary blood since it induces vasodilation.
3. Use the gauze provided to clean the puncture site.
4. Rotate 360° carefully the protective cap of the pointed hand without pulling it. Extract and eliminate the released cap.
5. Carefully massage the chosen falange for puncture (it is advisable the side of the ring). It is important that the massage takes place from the palm of the hand to the falange, to improve the blood flow. Press the hand, on the side from which the cap was extracted, against the fingertip.
The tip of the pointed hand is automatically portrayed safely after use. If the hand does not work properly, use the second hand. If the latter is not necessary, it can be disposed of without special precautions.
6. Keeping your hand turned down, massage your finger until a large drop of blood is formed. It is important that the massage takes place from the palm of the hand to the falange, to improve the 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 independently for capillarity. Remove the pipette from the black line. If the blood is not enough, continue to massage your finger until you reach that line;
– put the pipette on a flat and clean surface by protruding the tip, at this point to contact the drop of blood with the pipette, it will enter independently for capillarity. Remove the finger from the black line. If the blood is not enough, continue to massage your finger until you reach that line. Avoid, as far as possible, interrupting contact between blood and pipette to prevent the formation of air bubbles.
8. Deposit the blood collected with the pipette in the previously opened vial, pressing the pipette bulb itself. – Fig. F Press 2 or 3 times the pipette bulb while keeping the tip on the bottom of the bottle to ensure that all the blood sample is released in the diluent. Then reboot the white cap along with the blue cap on the falcon and mix well.
9. Avoid the blue cap from the dropper bottle (leave the tightly screwed white cap).
10. Deposit 3 drops in the well indicated on the cassette (S).
Note: if the delivered drop contains air bubbles, deposit a fourth drop in the well. Wait 3-5 seconds between the dispensation of a drop and the next.
11. Read the result 10 minutes.
Interpretation of results
POSITIVE: Two coloured lines appear in the reading window at the C (Control) and T (Test) regions. This result means that the test has identified 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 seropositive (i.e. specific antibodies have been detected in the blood sample, indicating the presence of the virus).
*NOTE: Color intensity in test line regions may vary depending on the concentration of HIV 1 and/or HIV 2 antibodies in the sample (as seen in images). Therefore, any color tones in the T-line region, even if lighter than the images shown, must be considered positive. It is recommended not to make any medical decision after performing this test without consulting your physician first.
NEGATIVE: a colored band is only displayed under the C sign (Control). No line is displayed at the T sign (Test). This result means that HIV1 and HIV 2 antibodies are not present or present in very low concentrations, not detectable by this diagnostic test.
If the result is negative, but it is thought to have been exposed to HIV in the last 3 months, it is possible that the antibodies have not yet been produced by the body (window period, i.e. time necessary for the development of a detectable amount of anti-HIV antibodies). In this case it is recommended to repeat the test 3 months after possible exposure and to avoid any activity that can cause HIV transmission to others. If there are symptoms that can be traced back to HIV, please contact your doctor.
INVALIDO: bands are not displayed or there is only a line under the T sign (Test) and not under the C sign (Control). In this case it is not possible to interpret the test result, which must be considered invalid. Insufficient sample volume or incorrect procedural techniques are the most likely reasons for which the control line is not visible (result invalid). Review the procedure and repeat the test with a new device and a new blood sample.
Warnings
- TEST HIV 1/2 is not intended for therapeutic follow-up for patients with anti-retroviral therapy.
- Carefully read these instructions for use before testing. The test is reliable if the instructions are carefully followed.
- Keep the test out of the reach of children.
- Do not use the test after the expiry date or if the packaging is damaged.
- Follow exactly the procedure, using only the specified amount of blood and diluent.
- Store the test components at a temperature between +4°C and +30°C. Don't freeze.
- Use the sterile test and hand only once.
- The test is only for external use. Don't swallow.
- It is not recommended to use by people taking medications that make fluid blood (anti-agulants) or people suffering from hemophilia.
- After use, dispose of all the components according to current local standards, ask for advice to the pharmacist.
- 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 physician before taking any medical decision.
- If you test other people, treat blood samples as potentially infected.
- In vitro diagnostic device for individual use.
Format
Content
- 1 airtight sealed aluminium envelope containing: 1 HIV box 1/2 TEST, 1 drying bag.
Open the sealed aluminum envelope only before the test execution, pay attention to the opening sign. The drying bag should not be used. Eliminate it by clearing it along with the waste, without opening it.
- 1 dropper bottle containing the HIV diluent 1/2 TEST DILUENT sufficient for 1 test.
- 2 sterile stinged hands for self-punture for blood sampling.
- 1 plastic bag containing 1 pipette for blood sampling.
- 1 antiseptic cleaning gauze for the skin.
- 1 sheet of instructions for use.
Cod. SF014
The HIV 1/2 test is an autotest that specifically detects the presence in a blood sample of anti-HIV 1 and/or 2. If the blood drop taken contains anti-HIV antibodies, these 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 region of the test line (T). The absence of color in the region of the test line (T) is also possible when the levels of circulating antibodies are below the detection limit, leading to negative false results, especially for HIV-1 Group O (prevalence of HIV 1 Group O in the world: 1%). A red line will always appear in the region of the control line (C) to confirm the correct functioning of the test.
It is recommended not to make any medical decision after performing this test without first consulting your doctor.
Mode of use
1. Prepare the necessary material as follows: open the aluminum envelope, take only the cassette and throw away the drying bag. Open the plastic bag containing the pipette and unscrew the white cap from the vial containing the diluent.
2. Wash hands with hot water and soap, rinse with clean water and dry. Note: the use of hot water facilitates the withdrawal of capillary blood since it induces vasodilation.
3. Use the gauze provided to clean the puncture site.
4. Rotate 360° carefully the protective cap of the pointed hand without pulling it. Extract and eliminate the released cap.
5. Carefully massage the chosen falange for puncture (it is advisable the side of the ring). It is important that the massage takes place from the palm of the hand to the falange, to improve the blood flow. Press the hand, on the side from which the cap was extracted, against the fingertip.
The tip of the pointed hand is automatically portrayed safely after use. If the hand does not work properly, use the second hand. If the latter is not necessary, it can be disposed of without special precautions.
6. Keeping your hand turned down, massage your finger until a large drop of blood is formed. It is important that the massage takes place from the palm of the hand to the falange, to improve the 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 independently for capillarity. Remove the pipette from the black line. If the blood is not enough, continue to massage your finger until you reach that line;
– put the pipette on a flat and clean surface by protruding the tip, at this point to contact the drop of blood with the pipette, it will enter independently for capillarity. Remove the finger from the black line. If the blood is not enough, continue to massage your finger until you reach that line. Avoid, as far as possible, interrupting contact between blood and pipette to prevent the formation of air bubbles.
8. Deposit the blood collected with the pipette in the previously opened vial, pressing the pipette bulb itself. – Fig. F Press 2 or 3 times the pipette bulb while keeping the tip on the bottom of the bottle to ensure that all the blood sample is released in the diluent. Then reboot the white cap along with the blue cap on the falcon and mix well.
9. Avoid the blue cap from the dropper bottle (leave the tightly screwed white cap).
10. Deposit 3 drops in the well indicated on the cassette (S).
Note: if the delivered drop contains air bubbles, deposit a fourth drop in the well. Wait 3-5 seconds between the dispensation of a drop and the next.
11. Read the result 10 minutes.
Interpretation of results
POSITIVE: Two coloured lines appear in the reading window at the C (Control) and T (Test) regions. This result means that the test has identified 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 seropositive (i.e. specific antibodies have been detected in the blood sample, indicating the presence of the virus).
*NOTE: Color intensity in test line regions may vary depending on the concentration of HIV 1 and/or HIV 2 antibodies in the sample (as seen in images). Therefore, any color tones in the T-line region, even if lighter than the images shown, must be considered positive. It is recommended not to make any medical decision after performing this test without consulting your physician first.
NEGATIVE: a colored band is only displayed under the C sign (Control). No line is displayed at the T sign (Test). This result means that HIV1 and HIV 2 antibodies are not present or present in very low concentrations, not detectable by this diagnostic test.
If the result is negative, but it is thought to have been exposed to HIV in the last 3 months, it is possible that the antibodies have not yet been produced by the body (window period, i.e. time necessary for the development of a detectable amount of anti-HIV antibodies). In this case it is recommended to repeat the test 3 months after possible exposure and to avoid any activity that can cause HIV transmission to others. If there are symptoms that can be traced back to HIV, please contact your doctor.
INVALIDO: bands are not displayed or there is only a line under the T sign (Test) and not under the C sign (Control). In this case it is not possible to interpret the test result, which must be considered invalid. Insufficient sample volume or incorrect procedural techniques are the most likely reasons for which the control line is not visible (result invalid). Review the procedure and repeat the test with a new device and a new blood sample.
Warnings
- TEST HIV 1/2 is not intended for therapeutic follow-up for patients with anti-retroviral therapy.
- Carefully read these instructions for use before testing. The test is reliable if the instructions are carefully followed.
- Keep the test out of the reach of children.
- Do not use the test after the expiry date or if the packaging is damaged.
- Follow exactly the procedure, using only the specified amount of blood and diluent.
- Store the test components at a temperature between +4°C and +30°C. Don't freeze.
- Use the sterile test and hand only once.
- The test is only for external use. Don't swallow.
- It is not recommended to use by people taking medications that make fluid blood (anti-agulants) or people suffering from hemophilia.
- After use, dispose of all the components according to current local standards, ask for advice to the pharmacist.
- 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 physician before taking any medical decision.
- If you test other people, treat blood samples as potentially infected.
- In vitro diagnostic device for individual use.
Format
Content
- 1 airtight sealed aluminium envelope containing: 1 HIV box 1/2 TEST, 1 drying bag.
Open the sealed aluminum envelope only before the test execution, pay attention to the opening sign. The drying bag should not be used. Eliminate it by clearing it along with the waste, without opening it.
- 1 dropper bottle containing the HIV diluent 1/2 TEST DILUENT sufficient for 1 test.
- 2 sterile stinged hands for self-punture for blood sampling.
- 1 plastic bag containing 1 pipette for blood sampling.
- 1 antiseptic cleaning gauze for the skin.
- 1 sheet of instructions for use.
Cod. SF014
