Description
HIV self-test
Description
Screening test for HIV (the virus that causes AIDS) performed on a blood sample taken from the fingertip.
This is a reliable self-test for diagnosing HIV infections that occurred at least three months ago.
Autotest VIH is a single-use in vitro diagnostic device.
Self-test VIH can be performed by non-experts in a private setting.
The test takes approximately 5 minutes to complete and the waiting time before reading the result is 15 minutes.
You will need a clock or other time-keeping device.
How to use
1. Place the test tube holder on a flat surface. Gently pull the cap containing the buffer solution to separate it from the self-test. Slide it with your finger to the bottom of the test tube holder.
2. Wash your hands, preferably with warm water, and dry them. Open the bags containing the disinfectant wipe and sterile gauze. Rub the disinfectant wipe on your fingertip and wait for it to dry. Remove the cap from the safety scalpel. Place the red end of the scalpel on your fingertip and push down firmly to pierce the skin with the needle.
Gently squeeze your finger to form a first large drop of blood. Wipe away the drop with sterile gauze. Without applying too much pressure, gently squeeze your finger again to form another large drop of blood. With the self-test pointing down, touch the tip of the device to the drop of blood until the tip fills with blood.
3. Make sure the test tube holder containing the buffer solution cap is placed on a flat surface. Hold the self-test with the tip pointing down, firmly in the test tube holder so as to pierce the aluminum membrane of the buffer solution cap.
Push down firmly (you will hear a 3-time click). Look for a pink spot that should begin to appear less than a minute after the test device and buffer cap are inserted into each other. Apply the patch to your finger.
4. Check the time and wait 15 minutes before reading the result.
Non-reactive self-test: one line appears: control line (HIV negative).
Reactive self-test: two lines appear: control line and test line (probably HIV positive).
If positive:
- contact a doctor as soon as possible and inform him that you have just performed a self-test for HIV and that the result was positive;
- the result of the self-test must be confirmed by an examination carried out at an analysis laboratory;
- protect yourself and protect others.
Warnings
If you think you may have been exposed to HIV in the past 3 months, a negative test result is not certain at this time. Therefore, avoid any activity that could cause transmission of HIV to others. Use condoms to protect yourself and your partners. You will need to repeat the self-test 3 months after your most recent risk of exposure to HIV.
- The self-test is intended for strictly private use as a self-test for HIV and must not be used for other diagnoses or other purposes under any circumstances.
- The self-test should only be used with a freshly drawn capillary blood sample following the instructions in this document. Do not use for serum or plasma samples.
- The self-test is a single-use device. Do not reuse.
- Do not open the foil pouch containing the self-test until you are ready to perform the test.
- This self-test should not be used in the follow-up of patients on antiretroviral therapy.
- Anyone using this self-test should consult their doctor before making any therapeutic decisions, regardless of whether the result is positive or negative.
- False positive (0.2% in studies on test specificity) or false negative results may be due to the following circumstances: exposure to HIV in the three months prior to using the test (window period), situations of advanced immunodeficiency or infection by a rare variant or testing performed on HIV-positive subjects undergoing antiretroviral therapy.
- The test result may also be incorrect if the product is not stored as directed or if the limitations of use are not respected.
- Do not use the self-test if the package or foil pouch has been opened or damaged.
- Do not use the self-test if the expiry date indicated on the package has passed.
- If you have difficulty understanding the explanations on the packaging or the instructions for use, contact Mylan immediately at: +39 02 61246462.
- Keep the self-test and all contents of the package out of the reach of children. The components of the VIH self-test can be dangerous if swallowed and may cause irritation.
- Autotest VIH offers an additional HIV testing modality that can be used as a complement to other existing options. Autotest VIH can only diagnose HIV infection and cannot be used to test for other sexually transmitted diseases.
- AAZ-LMB expressly declines any responsibility relating to the use or distribution of the VIH self-test or any of its components, which occurs without strict observance of the indications and limits of use specified in the instructions for use.
Conservation
Store the self-test in the original packaging in a cool, dry place at a temperature between 8°C and 30°C. Keep away from sunlight.
Format
- 1 aluminium sachet containing: 1 self-test, 1 cap containing the buffer solution, 1 safety scalpel, 1 patch;
- 1 test tube holder;
- 1 sterile gauze;
- 1 disinfectant wipe;
- 1 instruction sheet.
Screening test for HIV (the virus that causes AIDS) performed on a blood sample taken from the fingertip.
This is a reliable self-test for diagnosing HIV infections that occurred at least three months ago.
Autotest VIH is a single-use in vitro diagnostic device.
Self-test VIH can be performed by non-experts in a private setting.
The test takes approximately 5 minutes to complete and the waiting time before reading the result is 15 minutes.
You will need a clock or other time-keeping device.
How to use
1. Place the test tube holder on a flat surface. Gently pull the cap containing the buffer solution to separate it from the self-test. Slide it with your finger to the bottom of the test tube holder.
2. Wash your hands, preferably with warm water, and dry them. Open the bags containing the disinfectant wipe and sterile gauze. Rub the disinfectant wipe on your fingertip and wait for it to dry. Remove the cap from the safety scalpel. Place the red end of the scalpel on your fingertip and push down firmly to pierce the skin with the needle.
Gently squeeze your finger to form a first large drop of blood. Wipe away the drop with sterile gauze. Without applying too much pressure, gently squeeze your finger again to form another large drop of blood. With the self-test pointing down, touch the tip of the device to the drop of blood until the tip fills with blood.
3. Make sure the test tube holder containing the buffer solution cap is placed on a flat surface. Hold the self-test with the tip pointing down, firmly in the test tube holder so as to pierce the aluminum membrane of the buffer solution cap.
Push down firmly (you will hear a 3-time click). Look for a pink spot that should begin to appear less than a minute after the test device and buffer cap are inserted into each other. Apply the patch to your finger.
4. Check the time and wait 15 minutes before reading the result.
Non-reactive self-test: one line appears: control line (HIV negative).
Reactive self-test: two lines appear: control line and test line (probably HIV positive).
If positive:
- contact a doctor as soon as possible and inform him that you have just performed a self-test for HIV and that the result was positive;
- the result of the self-test must be confirmed by an examination carried out at an analysis laboratory;
- protect yourself and protect others.
Warnings
If you think you may have been exposed to HIV in the past 3 months, a negative test result is not certain at this time. Therefore, avoid any activity that could cause transmission of HIV to others. Use condoms to protect yourself and your partners. You will need to repeat the self-test 3 months after your most recent risk of exposure to HIV.
- The self-test is intended for strictly private use as a self-test for HIV and must not be used for other diagnoses or other purposes under any circumstances.
- The self-test should only be used with a freshly drawn capillary blood sample following the instructions in this document. Do not use for serum or plasma samples.
- The self-test is a single-use device. Do not reuse.
- Do not open the foil pouch containing the self-test until you are ready to perform the test.
- This self-test should not be used in the follow-up of patients on antiretroviral therapy.
- Anyone using this self-test should consult their doctor before making any therapeutic decisions, regardless of whether the result is positive or negative.
- False positive (0.2% in studies on test specificity) or false negative results may be due to the following circumstances: exposure to HIV in the three months prior to using the test (window period), situations of advanced immunodeficiency or infection by a rare variant or testing performed on HIV-positive subjects undergoing antiretroviral therapy.
- The test result may also be incorrect if the product is not stored as directed or if the limitations of use are not respected.
- Do not use the self-test if the package or foil pouch has been opened or damaged.
- Do not use the self-test if the expiry date indicated on the package has passed.
- If you have difficulty understanding the explanations on the packaging or the instructions for use, contact Mylan immediately at: +39 02 61246462.
- Keep the self-test and all contents of the package out of the reach of children. The components of the VIH self-test can be dangerous if swallowed and may cause irritation.
- Autotest VIH offers an additional HIV testing modality that can be used as a complement to other existing options. Autotest VIH can only diagnose HIV infection and cannot be used to test for other sexually transmitted diseases.
- AAZ-LMB expressly declines any responsibility relating to the use or distribution of the VIH self-test or any of its components, which occurs without strict observance of the indications and limits of use specified in the instructions for use.
Conservation
Store the self-test in the original packaging in a cool, dry place at a temperature between 8°C and 30°C. Keep away from sunlight.
Format
- 1 aluminium sachet containing: 1 self-test, 1 cap containing the buffer solution, 1 safety scalpel, 1 patch;
- 1 test tube holder;
- 1 sterile gauze;
- 1 disinfectant wipe;
- 1 instruction sheet.
