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AUTOTEST VIH SCREENING HIV 1 TEST

  • MYLAN ITALIA Srl
  • 971268634

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

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AUTOTEST VIH SCREENING HIV 1 TEST

VIH self-test

HIV screening self-test

Instructions for Use
• VIH self-test is a screening test for HIV (the virus responsible for AIDS) that is performed on a sample of blood from the fingertip.
• This is a self-testreliable for the diagnosis of HIV infections that occurred at least 3 months earlier.
• VIH autotest is a single use in vitro diagnostic device.
• VIH self-test can be performed by non-expert people in a private setting.
• The test takes approximately 5 minutes to complete and the waiting time before reading the result is 15 minutes.
• You must have a clock or other timekeeping device.
• Read all of the following instructions carefully before testing.

Kit contents
TO.Aluminum sachet.
B.Test device.
C.Cap containing the solution.
D.Safety scalpel.
AND.Bandaid.
F.Moisture absorbent bag (to be eliminated).
G.Test tube holder.
H.Disinfectant wipe.
THE.Sterile gauze.

PHASE 1
1. Lay down the tube holderG.on a flat surface.
2. Gently pull the cap containing the buffer solutionC.to separate it from the test deviceB..
3. Slide it with your finger to the bottom of the tube holderG..

STEP 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 wipeH.and sterile gauzeTHE.
3. Wipe the disinfectant wipeH.on your fingertip and wait for it to dry.
4. Remove the clear cap from the safety scalpelD.. 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 gauzeTHE.
6. Without pressing too hard, gently squeeze your finger once more to form another large drop of blood.
7. With the test deviceB.directed downwards (90 ° angle), touch the blood drop with the tip of the device until the pointed end is filled with blood.

STEP 3
1. Verify the tube holderG.containing the cap with a buffer solutionC.is placed on a flat surface.
2. Holding the test deviceB.with the tip down, insert it firmly into the holderG.so as to pierce the aluminum membrane of the buffer solution capC..
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 patchANDon the finger.
The test is now in progress.
If the pink spot does not appear within one minute, push more firmly on the test deviceB.to insert it completely.
The test device should be held straight until Step 4 is complete.

STEP 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 its self-test is like example (1), the test is negative.
Appearance of 1 line: control line.
This line can be light or dark.
Responsive self-test:if its self-test is like example (2), the result is positive.
Appearance of 2 lines: control line and test line.
The two lines can be lighter or darker than the other.

You are probably HIV negative
It 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.

You are probably HIV positive
1.Contact a physicianas soon as possible informing him that he has just performed a self-test for HIV 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.
Using condoms to protect yourself and your sexual partnersuntil the 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.

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
By examining samples containing substances or which had 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.


Warnings and Precautions
• 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 usefor serum and plasma samples.
• Store the self-test in the original packaging in a cool and dry environment and 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 using the test (window period), advanced immunodeficiency or infection with 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 self-test offers an additional modality of HIV testing 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 liability with regard to 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 indications and limits of use specified in the instructions for use.
971268634
12 Items