1 - autotest VIH^® – How does it works ?

In relation to other types of testing, where does the autotest VIH® self-test fit in?

autotest VIH® is a rapid diagnostic orientation test. It is described as a unitary, subjective visual reading test that is easy to use and quickly provides a result (in under 20 minutes). It must be used with a sample of freshly collected capillary blood. Rapid tests are now able to detect both HIV-1 and HIV-2 antibodies. Some healthcare professionals and trained staff are able to use rapid tests in the course of their work. A negative result cannot be considered conclusive if the most recent risk of exposure to HIV occurred within the past 3 months. A positive result obtained using a rapid test must be confirmed by a laboratory test (4th generation Elisa test).

Who should do an HIV test and how often ?

Anyone who has reason to believe they may have been exposed to a risk of HIV infection should get tested. Getting tested is the only way to know whether you are HIV-positive.

Certain groups of people are more at risk of exposure to HIV because they come from a region with high prevalence or because of practices that can put them at risk of infection. Individuals from the following groups should get tested on a regular basis:

men who have sex with men (MSM);
heterosexuals who have had more than one sexual partner in the past 12 months;
people who use injection drugs;
people from regions where the prevalence of HIV is high, in particular Sub-Saharan Africa and the Caribbean;
people who engage in sex work;
people whose partners are HIV-positive.

The following individuals are advised to get tested at least once a year:

MSM who have multiple sex partners;
people who use injection drugs;
people from Sub-Saharan Africa or the Caribbean who have multiple sex partners.

HIV testing should always be offered, in lab, in the following situations regardless of population:

suspicion or diagnosis of an STI or hepatitis B or C;
suspicion or diagnosis of tuberculosis;
when planning or attempting to get pregnant;
voluntary interruption of pregnancy;
prescribing contraceptives for the first time;
sexual assault;
incarceration;
in the event of signs that suggest the presence of an HIV infection.

It’s important to note that if a risk of exposure happened in the past 48 hours, a person should immediately go to a hospital emergency room.

Starting at what age can the autotest VIH® test be used?

A minor can use an autotest VIH® test without parental consent.

autotest VIH® should not be used by children younger than 18 months. Whether they are infected or not, all infants whose mothers are HIV-positive are also “HIV-positive” at birth due to a passive transfer of maternal IgG antibodies through the placenta. Regardless of the HIV-status of the child, a baby’s blood serum remains positive until these maternal antibodies disappear (in approximately 15 to 18 months). If the child is not infected, the blood serum becomes negative after this period. It will remain positive if the child is infected.

What are the technical features that characterize the test?

Packaging: single-use kit

Contents of kit: 1 package insert with instructions for use, 1 test stand, 1 sterile pad, 1 disinfectant wipe, 1 foil pouch containing 1 test device, 1 buffer cap, 1 safety lancet, 1 bandage.

Storage: 8 to 30°C
Sample type: capillary blood
Sensitivity: 100 %(*)
Specificity: 99,8 %(*)

Test principle: immunochromatographic assay that detects antibodies in human blood produced after infection with HIV (anti HIV-1 and anti HIV-2 antibodies)

*Studies of 503 people (sensitivity) and 2051 people (specificity) from the United States and the European Union.

How reliable is autotest VIH® ?

The window period for the autotest VIH® test (referring to the period of time required for HIV antibodies to develop in sufficient quantity to become detectable by the test) can be as long as three months. Therefore, a negative result can only be considered reliable if there has been no risk of exposure to HIV within the past 3 months.

A study with autotest VIH® has shown that:

- 99.8% of uninfected individuals have been correctly detected
- 100% of infected individuals have been correctly detected

Is autotest VIH® capable of detecting both HIV-1 and HIV-2?

Yes, because autotest VIH® is able to detect both HIV-1 and HIV-2 antibodies in the blood.

How long do I have to wait after a risk of exposure to HIV before my autotest VIH® result can be considered reliable?

An HIV infection that has occurred as a result of high-risk practices (unprotected sex or condom failure during sex with a partner who is HIV-positive or whose HIV status is unknown, sharing of injection equipment) or accidental exposure (condom rupture, blood contact, etc.) within the past 3 months will not be detected by autotest VIH®. In such cases, a false negative result is possible and it is strongly recommended that you get tested with a 4th generation Elisa test if risk-taking occured at least 6 weeks ago.

After the 3-month window period, autotest VIH® is considered reliable for detecting an HIV infection.

If a risk of exposure happened in the past 48 hours, a person should immediately go to a hospital emergency room for a consultation.

What are the optimal conditions for using the autotest VIH® test?

For the result to be reliable, all of the directions included in the Instructions for Use should be carefully followed.

It is not necessary to have fasted before using the autotest VIH® test. The test can be used at any time of the day.

Good lighting is required in order to perform the test and read the result.

Use of the autotest VIH® test should not be taken lightly. Individuals who use the test need to be fully informed. The autotest VIH® test must only be used by person making a free and independent choice to do so. It is important to remember that no one should be forced to use the autotest VIH® test. All medical tests require the free and informed consent of the person being tested.

Before doing an autotest VIH® test, it is important to think about what you will do when you get the result, whether positive or negative. Using the autotest VIH® test is clearly different from getting tested by a healthcare professional who available to give advice and support and facilitate access to a confirmatory lab test.

Information and advice can be obtained by send an email to Sida Info Service : autotest-vih@sis-association.org (7/7 – 8h00 23h00 GMT+1). It is also possible to contact an AIDS service organization for immediate support.

After opening the foil pouch containing the test device, how long can I wait before using the autotest VIH® test?

autotest VIH® must be used as soon as you open the foil pouch. Moreover, the storage information that appears on the packaging and in the Instructions for Use is valid up to the expiry date only if the test remains sealed in its original foil pouch.

Can I use an autotest VIH® test if it has passed the expiry date printed on the packaging?

No HIV self-test should ever be used used if the expiry date has passed. The performance of the autotest VIH® test is only valid until the expiry date printed on the packaging.

How can I be sure that I have handled the test properly and that there is no error that has affected the result?

The test kit must be stored and the test must be used in accordance with the conditions specified on the autotest VIH® packaging.

During the time that the test takes to develop, a coloured line must appear (the “control line”). If the control line does not appear, this means the test was used incorrectly or did not work and the result is inconclusive. You will need to do another autotest VIH®.

It is important to read the test result within the time period specified in the Instructions for Use (between 15 and 20 minutes). A result may be false if it is read before or after this period of time.

What can I do if I have problems when using an autotest VIH® test?

If you have difficulties using the autotest VIH® test once you have read the Instructions for Use, contact the association Sida Info Service by send an email: autotest-vih@sis-organisation.org. It is also possible to contact an AIDS service organization for immediate support.

If you are unsure whether you are using an autotest VIH® test properly, you are advised to start again with another test kit or go to a testing centre to have a 4th generation Elisa test.

I just bought my autotest VIH®, do I need additional materials or equipment?

Except for a timing device (watch, clock, or other timer), everything is provided. Prior to using the autotest VIH® test, be sure to have a timepiece conveniently at hand to keep track of the test development time.

Can the same autotest VIH® test be used more than once ?

No, the autotest VIH® test is for single-use only, and for use only by one person. It is not possible to use the same test more than once or for it to be used by more than one person. All of the contents of the test kit are for single-use only.

When the test is finished, what should I do with my used autotest VIH®?

Used safety lancets might be classified as medical waste by health authorities in your area. To reduce the risk of injury from a used lancet, please follow local requirements for its disposal. Other components can be eliminated with household waste.

What should I do if my test result is inconclusive?

If no line appears or if the control line is missing, you should either do another autotest VIH® using a new test kit.

2 -  Shipping & Delivery / Payment / Ordering

What are the shipping costs ?

Shipping cost 5€ (European Union countries). Different shipment cost may apply for other countries.

How long does it take for an order to be delivered ?

You will receive your order within four to ten working days. Deliveries are scheduled during office hours from Monday until Friday (except on holidays).

 During the month of December (World AIDS Day) the delivery period can be extended by cause of high demand.

During the month of August, the delivery period is extended by 1 week.

I ordered several tests but I only received one package. What should I do ?

Each test can be shipped in a single package and all of your tests may not be delivered the same day. If you have not received all your packages after several days, please contact us.

What if I am not at home when my ordered is delivered ?

If you are not at home when the postman comes, he will leave you a delivery notification in your letterbox, request you to go to the post office to collect your order.

I haven't received my order, what should I do ?

If you have not received all the items you ordered, please contact our Customer Service department.

Can I make changes to my order?

No, unfortunately, as we start to process your order as soon as we receive it, we cannot cancel or change your order.

What happens if I notice that my personal details are incorrect after I have completed the ordering process?

If you realize your personal details are incorrect once you have completed the ordering process, please get in touch with our Customer Service Team by visiting our Contact us page (please be aware that all of our e-mails are conducted in English). We cannot guarantee that we will be able to rectify the issue; however, we can assure you that we will do all we can to amend your order.

How do I know if you have received my order?

When you place an order you will receive an e-mail from us acknowledging your order, which will contain your order number for reference. Please note that this is only to acknowledge that your order has been received and is not confirmation that your purchase has been successful. When your goods have been picked and despatched to you, your card will be charged and we will send you an order despatch email including details of the parcel tracking information.

Return & refunds ?

As the autotest VIH® is a medical device, we can’t accept the return.

Is it safe to shop on our website ?

Shopping on autotest-vih.eu is very safe. We use the secure 3-D Secure. This means that your personal information is encrypted and cannot be read by third parties.

We comply with all the privacy regulations and other legal requirements. We will never share your personal information with third parties without your permission. Read more about security and privacy.

How can I pay on autotest-vih.eu ?

The following payment methods are available on autotest-vih.eu :

1. Credit cards. We accept Visa and Mastercard

2. Paypal

How long does it take before my payment has been processed ?

The time required to process your payment depends on the payment method. If you pay using a credit card, the amount will be charged to your credit card when your order is dispatched.

If you pay by PayPal, it will depend on the setting of your account: if Paypal charge on your credit card, the delay is approximately two days. If Paypal charge on your bank account, the delay is approximately ten days.

Can I have a different billing adress to my delivery adress ?

Yes, the billing and shipping address can be different.

Payment information ?

To place your order you will need to enter you debit/credit card number, expiry date, start date and CVV number (security number; which can be found on the back of your card).

What is a CVV number ?

A CVV number ("Card Verification Value") is a 3 digit number found the back of VISA®, MasterCard® and Discover® branded credit and debit cards and on the front of American Express® branded credit or debit cards. This is also known as the security number.