Autotest VIH Mylan 1 HIV Screening Test

The VIH self-test is a screening test for HIV (the virus responsible for AIDS) that is performed on a fingertip blood sample from the comfort of home.

Indications

The VIH test proposed by Mylan is a reliable self-diagnosis test if the HIV infection occurred at least 3 months earlier. It is a single use in vitro diagnostic device to be performed by non-expert people in a private setting. The execution time takes about 5 minutes and the waiting time before reading the result is 15 minutes. You must have a watch or other time-measuring device.

The VIH self-test was designed to offer a practical and confidential method of checking your HIV status after possible exposure to the virus that occurred more than three months previously. In the event of a positive result, the test enables the person to contact the doctor and start treatment after having performed a confirmatory laboratory test.

If treatment for HIV infection is initiated promptly, the life expectancy of those affected is similar to that of the rest of the population. Indeed, the mortality of HIV-infected men treated with antiretroviral therapy for more than three years is comparable to that of the general population.

If the result is negative, it means that the person is likely not infected and their HIV status is of no concern, provided the most recent risk of exposure is at least three months earlier.

Features

It is a blood test based on immunochromatographic assay. The VIH self -test does not require the use of special materials or devices other than those contained in the package. In fact, by simply taking a drop of blood from the tip of a finger, it is possible to highlight the presence of anti-HIV-1 and / or anti-HIV-2 antibodies.

• Principles and performance: HIV self-test is an immunochromatographic assay for detecting antibodies in human blood that are produced after contracting HIV infection. The check line that appears when you run the test is to confirm correct operation.
• Sensitivity *: The sensitivity of the test was calculated at 100% with a confidence interval of 99.1% to 100%. All HIV-positive subjects included in the study achieved a correct result. No false negatives were observed **.
• Specificity *: The specificity of the test was calculated at 99.8%, with a confidence interval from 99.5 to 100%. 0.2% of seronegative subjects obtained an incorrect result, i.e. 0.2% of the results were false positives ***.
• Reliability: a feasibility study carried out on the execution of the test by people without specific skills showed that over 99.2% of the participants obtained an interpretable result and that over 98.1% correctly interpreted the result. Positive results were interpreted correctly in 100% of cases.
• Interferences: when examining samples containing substances or presenting some pathology, no significant interferences were found that could potentially affect the test result.

* Studies of 503 people (sensitivity) and 2051 people (specificity) in the United States and the European Union.
** False Negative: Sample tested positive for the target marker but incorrectly classified as negative by the test.
*** False Positive: Sample found negative for the target marker but incorrectly classified as positive by the test.

Technical features

The VIH self-test for HIV screening has the following technical characteristics:

• Packaged in disposable kit
• CE mark 0459 (French Notification Body: LNE / G-MED)
• Storage: between +8 and + 30 ° C. Keep away from sunlight
• Type of sample: 2.5 microliters of capillary blood

How to use the VIH Autotest for HIV screening?

Read all of the following instructions carefully before testing.

Phase 1

1. Place the tube holder on a solid surface.
2. Gently pull the cap containing the buffer solution to separate it from the test device.
3. Slide it with your finger to the bottom of the tube holder.

Phase 2

(steps 2 and 3 must be performed one after the other)
1. Wash your hands, preferably with warm water, and dry them.
2. Open the bags containing the disinfectant wipe and sterile gauze.
3. Rub the disinfectant wipe on your fingertip and wait for it to dry.
4. Remove the clear cap from the safety scalpel. Place the red tip of the scalpel on the tip of your finger and push down firmly to pierce the skin with the needle.
5. Gently squeeze the finger to form a first large drop of blood. Remove the drop with sterile gauze.
6. Without pressing too hard, gently squeeze your finger once more to form another large drop of blood.
7. With the test device pointing down (90 ° angle), touch the blood drop with the tip of the device until the tip and tip are filled with blood.

Phase 3

1. Verify that the tube holder containing the cap with a buffer solution is placed on a flat surface.
2. Holding the test device with the tip down, insert it firmly into the tube holder to pierce the aluminum membrane of the buffer cap.
3. Check for a pink spot that should begin to show less than a minute after the test device and solution cap are inserted into each other.
4 Apply the patch to your finger.

The test is now in progress.

If the pink car doesn't buy within a minute, push harder on the test device to fully insert it. The test device should be held straight until Step 4 is complete.

Phase 4

1. Check the time and wait 15 minutes before reading the result.

Step 5

(read the self-test result)

Non-reactive self-test: If your self-test shows a line: control line. This line can be light or dark.

You are probably HIV negative

The product is a reliable test, however: if the result is negative, it is important to check that you are not within the window period (seroconversion *) and to consult a doctor. If it is believed that HIV exposure may have occurred within the past 3 months, the negativity of the test is uncertain at this time. Therefore, avoid any activity that could cause HIV transmission to others. Using condoms to protect yourself and your partners. You will need to repeat the self-test after 3 months have elapsed from the most recent risk of HIV exposure.
* Seroconversion refers to the length of time it takes for antibodies to HIV to develop in sufficient quality to make them detectable.

Reactive self-test: If your self-test shows two lines: control line and test line. The two lines can be lighter or darker than the other.

You are probably HIV positive

1. See a doctor as soon as possible and tell him that you have just performed an HIV self-test and that the result was positive.
2. The result of the self-test must be confirmed by an examination carried out in an analysis laboratory.
3. Protect yourself to protect others. Use condoms to protect yourself and your sexual partners until confirmation test results arrive.

If its result does not look like any of the examples given above, the result is invalid (no line, or only 1 line, the test line). This means that the test did not work. It is not possible to draw conclusions from this result and it will be necessary to repeat the test. In case of repeated invalid tests, consult a doctor.

Warnings and contraindications

The product is intended for strictly private use as a self-test for HIV and should not be used for other diagnoses or other purposes under any circumstances.
The product should only be used with a freshly drawn capillary blood sample following the instructions contained in this document.
Do not use for serum and plasma samples.
Store the self-test in its original packaging in a cool, dry environment at a temperature between 8 ° C and 30 ° C. Keep away from sunlight.
The product is a single use device. Do not reuse.
Do not open the foil pouch containing the self-test until the test is performed.
This self-test should not be used as part of the follow-up of patients on antiretroviral therapy.
Anyone using this self-test should consult their physician before making any treatment decisions, regardless of whether they have obtained a positive or negative result.
False positive (0.2% in test specificity studies) or false negative results may be due to the following circumstances: HIV exposure in the three months prior to use of the test (window period), advanced immunodeficiency or infection situations from a rare variant or execution on HIV positive subjects receiving antiretroviral therapy.
The test result may also be wrong due to failure to store the product according to the instructions or failure to comply with the restrictions on use.
Do not use the self-test if the package or foil pouch has been opened or damaged.
Do not use if the expiry date indicated on the package has passed.
Keep the self-test and all package contents out of the reach of children. The components of the product can be dangerous if ingested and can cause irritation.
The product offers an additional HIV test modality that can be used as a complement to other existing operations. The product can only diagnose HIV infection and cannot be used as a test for other sexually transmitted diseases.
AAZ-LMB expressly disclaims any responsibility for the use or distribution of the product or any of its components, and for the consequences of direct, indirect, accidental or otherwise inaccuracies or errors deriving from any use of the product without strict observance of the instructions. and the limits of use specified in the instructions for use.

Packaging

• 1 sachet containing: 1 autotest, 1 cap containing the solution, 1 safety scalpel, 1 plaster
• 1 support
• 1 sterile gauze
• 1 disinfectant wipe
• 1 instruction sheet

More information about the product can be found on the website of the manufacturer Mylan