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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.

Moreover, recommendations on HIV testing in France made in 2009 by the Haute Autorité de Santé (HAS) state that all members of the general population from the ages of 15 to 70 years should be offered an HIV test at least once in their lifetime regardless of risk of exposure to infection.

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 from French departments in the Americas;
• 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 for a consultation and possible prescription for post-exposure prophylaxis treatment (PEP).

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 %(4)

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 are HIV self-tests?

No HIV self-test is 100% reliable. False positive results (a specimen known to be negative for the target marker and mistakenly classified as positive by the test) or false negative results (a specimen known to be positive for the target marker and mistakenly classified as negative by the test) are possible. Failure to store as directed or to respect the limits of use could cause the test result to be incorrect.

In comparison to lab tests (Elisa – 4th generation), HIV self-tests are less sensitive to detecting new infections (infection occurred less than 3 month). In fact, different markers appear successively during HIV infection. According to the target marker and the method used, delays of first positivities are different. Negativity of autotest VIH^® can only be certified after a precautionary period of 3 months(*).

Other tests exist but are not allowed in France, including oral HIV self-tests.

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(5). 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 practicability study of the use of the autotest VIH^® test by laypersons has shown that more than 99.2% of participants correctly used the self-test and succeeded to obtain an interpretable result and more than 98.1% self-tests are correctly interpreted. 100% of positive self-tests are correctly interpreted(**).

^*Les TROD – tests rapides d’orientation diagnostique de l’infection à VIH, Dossier de synthèse documentaire bibliographique, Le CRIPS, septembre 2013

^**Excellente praticabilité de l’Autotest Santé SURE CHECK® VIH sur sang capillaire par une population de profanes concernée par le VIH. S. Karon et al. Octobre 2014.

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.

In France, where do you go to get an autotest VIH^® test?

autotest VIH^®, an in vitro diagnostic test with the CE Marking, is only available in pharmacies and can be obtained without a medical prescription. The self-test can be obtained over the counter or on the pharmacy’s website. A list of pharmacy websites licensed for the online sale of medication can be found at:
http://www.ordre.pharmacien.fr/Le-patient/Vente-de-medicaments-sur-Internet-en- France

Is the cost of purchasing an autotest VIH^® test covered by Social Security?

At the moment, autotest VIH^® is not covered by Social Security and individuals who use the test must assume its cost. autotest VIH^® is only available in pharmacies (or on their websites) and can be obtained without a medical prescription.

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 at a Centre de Dépistage Anonyme et Gratuit (CDAG - free, anonymous testing centre); at a Centre d'information, de dépistage et de diagnostic des infections sexuellement transmissibles (CIDDIST - centre for information, testing, and diagnosis of sexually transmitted infections); or at a lab.

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 and possible prescription for post-exposure prophylaxis treatment (PEP).

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

or 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 speaking to a pharmacist or by calling the toll-free Sida Info Service number (0 800 840 800, 24/7, all calls are free and anonymous). It is also possible to contact a CDAG, a CIDDIST (or CeGIDD), or 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?

The autotest VIH^® test 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, call the toll-free Sida Info Service number (0 800 840 800, 24/7 free and anonymous call) or speak to your pharmacist for advice. It is also possible to contact a CDAG, a CIDDIST (or CeGIDD), or 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 by 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^®?

The safety lancet in the kit is secured, the needle is retractable. Nevertheless in France, the lancet has to be returned to the pharmacy and eliminated in the yellow boxes given by the pharmacist (more information on dastri.fr). 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 purchased from a pharmacy or go to a lab, a CDAG, or a CIDDIST (or CeGIDD) for a 4^th generation Elisa test.

What does does it mean if I get a positive result? What should I do?

The autotest VIH^® test result is positive if two pink or red lines (one control line and one test line) appear on the self-test after 15 minutes.

Given limits to the reliability of the autotest VIH^® test, a positive result does not necessarily mean that a person is infected with HIV.

All positive autotest VIH^® test results must be verified by having a confirmatory 4th generation Elisa test at a CDAG, a CIDDIST (or CeGIDD), or a lab.

If your self-test result is positive, it is essential to consult your family doctor or go to CDAG/CIDDIST (or CeGIDD) that provides care and treatment for HIV-positive people.

For confirmed cases of HIV infection, starting treatment as early as possible is very important.

For questions regarding a positive HIV self-test result, call Sida Info Service: 0 800 840 800, 24/7, all calls are free and anonymous.

What does does it mean if I get a negative result? What should I do ?

The autotest VIH^® test result is negative if only one pink or red line (the control line) appears on the self-test after 15 minutes. If the result is negative and there have not been any at-risk practices or accidental risk of exposure within the past three months, this means that the person who used the test is not infected. It is not necessary to get a confirmatory lab test unless you think you made an error in performing the test or interpreted the test result incorrectly.

If the result is negative but you have had practices that put you at risk of exposure to HIV in the past 3 months, the test result is not considered to be reliable because of the window period. It is recommended that you have a 4th generation Elisa test at a CDAG, a CIDDIST (or CeGIDD), or a lab.

If a person gets a negative test result, this does not mean that his or her sexual partner or partners are uninfected with HIV.

For questions regarding a negative HIV self-test result or if you need support, call Sida Info Serivce: 0 800 840 800, 24/7, all calls are free and anonymous.

Can information about the autotest VIH^® test be obtained by phone?

Sida Info Service can provide information about HIV and about the use and interpretation the autotest VIH^® test (0 800 840 800, 24/7, all calls are free and anonymous). You can also speak to you pharmacist for advice or contact an AIDS service organization.

Where can I find a list and contact information for the various agencies that provide advice, support, medical care, and psychological counseling?

A list of the following types of organizations can be found on the Sida Info Service website www.sida-info-service.org:

• CDAG;
• CIDDIST;
• hospital HIV departments;
• PASS and other agencies that provide services to individuals in need;
• agencies set up by COREVIH;
• AIDS service organizations.

Information for Metropolitan France as well as for overseas departments (DOM) is provided.

Can autotest VIH^® be used to test for other sexually transmitted infections or for viral hepatitis?

No, autotest VIH^® can only be used to test for infection with HIV. It cannot be used to test for other sexually transmitted infections such as herpes, syphilis, chlamydia, gonorrhea or viral hepatitis.

Doing an HIV test implies that there has been a risk of exposure (unprotected sex, sharing injection equipment, having sex with a partner who is infected with an STI, etc.) that can lead to more than one type of infection. On its own, having an HIV test may not be enough.

It is important to go to an agency such as a CDAG or CIDDIST to get tested for other infections.

If the result of my HIV self-test is negative, does this mean can I stop using condoms?

No, a negative autotest VIH^® result does not mean that condoms are no longer necessary.

In the case of a couple getting tested to know whether it is safe to stop using condoms, a negative autotest VIH^® result is not enough. Getting information about contraception and getting tested for other STIs are also advised.

Both partners will need to get tested for HIV and other STIs. Getting the results for just one partner is not enough to prevent the transmission of HIV or other STI within the couple.

For couples who to stop using condoms, a time frame of sufficient length must be take into account.

Because of the window period (both for self-tests and for all 4^th generation HIV tests), a negative result does not mean a person is not infected, but rather that the individual was not infected 3 months ago. If an infection occurred less than 3 months ago, the autotest VIH^® result can be negative. The risk of transmitting HIV to another person is highest at the start of an infection.

Unprotected sex is risky for the transmission of other STIs. The risk of HIV transmission is also higher if a sexual partner is infected with another STI. STIs are often asymptomatic.

Can the fact that I am taking a medication have an effect on the autotest VIH^® result?

An autotest VIH^® result can be false negative for individuals who are infected with HIV, who are taking antiretroviral therapy, and whose viral load is undetectable. This can be explained by a decrease in the production of anti-HIV antibodies due to inhibition of viral replication by the antiretroviral therapy.

No other medications have been observed to have an affect on an autotest VIH^® result.

Can I use the HIV self-test to monitor the effectiveness of my antiretroviral therapy?

No, autotest VIH^® should not be used by individuals taking antiretroviral therapy to monitor the effectiveness of the treatment.

Could someone else be infected handling a used HIV self-test?

autotest VIH® is a blood test performed using a retractable safety lancet. If basic rules for good hygiene and the Instructions for Use are followed, the risk of infection is practically non-existent.

A negligible risk of infection is present if the person using the self-test is HIV-positive and another person handles the test and has a wound that comes directly in contact with the test.