When a person is infected with HIV, their immune system is attacked. In the absence of screening, these people develop opportunistic diseases and can go on to develop AIDS (Acquired Immunodeficiency Syndrome). Therapeutic advances demonstrate that infected persons receiving treatment now have a normal life expectancy with a much lower risk of transmission(2).
In the United Kingdom, several HIV screening facilities are available: GUM (Genito Urinary Medicine) clinics, as well as Sexual Health Clinics offer HIV testing for free. It is also possible to undergo HIV screening through a medical analysis laboratory. The HIV self-test screening is a new alternative that has been available since 2015.
A positive result with the EXACTO® TEST HIV Self-test must be confirmed with a test performed by a laboratory. A biologist and a doctor must confirm the result; they will then manage the patient ‘s care by offering them suitable antiretroviral treatment (ART). Indeed, the earlier an infection is identified, the higher a person’s life expectancy, as compared to that of the general population(2).
Finally, a person who has tested positive and is receiving treatment sees their viral load disappear, that is to say, that the presence of the virus in the blood and the sperm is undetectable. These treated people have a much lower risk of causing infection with the virus.
A negative result with the EXACTO® TEST HIV Self-test indicates that the person is probably not infected with the HIV virus, subject to their last possible exposure being more than 3 months’ prior to testing.
(2) 2010 report by Prof. Patrick Yeni, Medical care of persons infected with HIV.
Ease of use
The EXACTO® TEST HIV Self-test is an immunochromatography test which requires a droplet of blood to be drawn from the fingertip. It is important to carefully read the user instructions before completing the self-test.
The box contains the accessories (lancet and inverted cup/capillary tube) to carry out the fingertip blood sampling; only a chronometer is necessary. As with any self-test kit, the EXACTO® TEST HIV Self-test should be carried out in your home in total privacy.
The EXACTO® TEST HIV Self-test is designed to detect the presence of anti-HIV1 and anti-HIV2 antibodies. The result appears in the form of a coloured band in the result window, in the C (Control) and T (Test) areas. If there is any doubt about the result, please do not hesitate to contact a doctor or attend a screening centre.
The lancet included in the EXACTO® HIV Screening Test kit is safe thanks to its retractable needle. It is intended for single use only. After having been used once, it is impossible to use it again. It should be disposed of in accordance with the current legislation applicable in the EU.
Questions / Answers
Infection with HIV due to high-risk behaviour (unprotected sex, a condom ripping during sexual relations with a person infected with HIV or whose HIV status is unknown, sharing injection material) or accidental exposure (ripped condom, blood contact, etc.) less than 3 months prior to testing cannot be screened with the EXACTO® Test HIV Self-test, as it could give a false negative result.
In this case, you are advised to undergo screening with a 4th generation ELISA test, which is available through medical laboratories.
After the 3-month seroconversion window, the EXACTO® Test HIV Self-test is able to detect an HIV infection if the test is properly performed and interpreted.
In the event of a possible exposure less than 48 hours prior to testing, the individual concerned must go to A&E for a consultation and possible post-exposure prophylaxis (PEP) treatment.
Fasting is not required in order to complete the test. It can be used at any time of the day so long as the user is not under the influence of alcohol or drugs, to ensure the correct use and interpretation of the EXACTO® Test HIV Self-test.
To help with completing the test and interpreting the reading, ensure that optimum lighting conditions are available.
An HIV self-test is not something to be undertaken lightly. Its use requires the user to be fully informed. The EXACTO® Test HIV Self-test must be undertaken willingly by the concerned party. It is important to remember that no one should be forced to undergo an HIV test. Any medical test requires the informed consent of the individual who is undergoing the test.
Before using an HIV self-test kit, it is important to reflect on what you will do once the result is available, whether this is positive or negative. Using an HIV self-test kit is different to having a consultation with a healthcare professional who can advise about the test, provide psychological support and facilitate access to biological tests to confirm the diagnosis.
The user may seek advice from their doctor, pharmacist or an HIV support organisation.
The EXACTO® Test HIV Self-test is designed using antigens that enable the detection of anti-HIV1 and anti-HIV2 antibodies from a droplet of blood. In the event of a positive result, the EXACTO® Test HIV Self-test is not able to differentiate between an HIV-1 or HIV-2 type infection.
The EXACTO® Test HIV Self-test should not be used by an HIV-positive person who is on ART. The EXACTO® Test HIV Self-test is designed to detect anti-HIV1 and anti-HIV2 antibodies in persons who have been infected and not yet treated. The EXACTO® Test HIV Self-test does not track the therapeutic efficacy of ART.
Please refer to the current EU rules on waste disposal.
The well marked “BLOOD” must be completely red before adding the buffer solution. This first control enables the user to ensure that they have deposited the right amount of blood to complete their EXACTO® Test HIV Self-test.
A second control appears during the migration. The “C” control band enables the user to ensure that the migration of the sample took place correctly. This C control band is visible so that the result of the EXACTO® Test HIV Self-test can be interpreted.
Yes, a minor (aged under 18) can use an EXACTO® Test HIV Self-test.
The EXACTO® Test HIV Self-test should not be used for a newborn aged under 18 months. Indeed, the child of an HIV-positive mother, whether or not infected, cannot be screened with a self-test kit because the maternal IgG antibodies that have crossed the placental barrier still remain.
No, like all diagnostic tests, the EXACTO® Test HIV Self-test must be used before the expiry date indicated on the packaging. After this date, the reliability of the components and the test are no longer guaranteed.
The EXACTO® Test HIV Self-test is designed for single use. Its components can only be used once. To see what the components look like and what they are for, it is important that you read the user instructions in full before unpackaging the components for the EXACTO® Test HIV Self-test.
If you have any doubts about using the EXACTO® HIV Screening Test, please consult a doctor or an HIV support organisation. It will be necessary to undergo a further HIV screening test with the help of a RTD (rapid diagnostic test) or a laboratory test to confirm the result.
To ensure you have collected the right amount of blood, the square well marked “BLOOD” must be completely red. As regards the interpretation of the EXACTO® Test HIV Self-test, it is important that the C control band is present. In the absence of this C control band, your self-test kit has not functioned correctly and you must do another EXACTO® Test HIV Self-test or a different screening test. The reading from the EXACTO® Test HIV Self-test must take place within 10 to 20 minutes. You should not attempt to interpret a self-test after this time period.
It is important to read the user instructions in full before starting to use your EXACTO® Test HIV Self-test.
If no band appears or if the C control band is absent, you are advised to repeat the self-test with another kit or to undergo screening at a laboratory with a 4th generation ELISA test.
Considering the reliability of the EXACTO® Test HIV Self-test, a positive result indicates a likely infection with the HIV virus.
Any positive result from a self-test must be confirmed with a 4th generation Elisa test, performed in a laboratory. A person with a positive result must be immediately referred either to a service that provides care to persons living with HIV or a GP. The importance of early treatment in the case of a confirmed HIV infection must be underlined.
If the result of the EXACTO® Test HIV Self-test is negative, and in the absence of possible risks or accidental exposure within the last 3 months, this means that the user is not infected. There is no need to perform a confirmation test, unless there is reason to believe that the test was incorrectly performed or interpreted.
If the result of the EXACTO® Test HIV Self-test is negative, but a possible exposure occurred during the last 3 months, the result cannot be considered negative due to the seroconversion window. The user must therefore be advised to undergo screening with an Elisa 4th generation test at a laboratory, for which the seroconversion window is only 6 weeks. The pharmacist can invite the user to undergo a second EXACTO® Test HIV Self-test, 3 months after this last possible exposure.
A negative test does not necessarily mean that the partner(s) of the person tested is/are not infected with HIV. It is important to ensure that you do not use your EXACTO® Test HIV Self-test during the seroconversion window (three months following the risk of a possible exposure). To be certain of an HIV-negative result, you will need to do an EXACTO® Test HIV Self-test three months after the last possible exposure). During this period, it is important to protect yourself and to protect your partners by using condoms.
For any further questions, or if you require specific advice, please contact SIDA INFO SERVICE 24 hours, 7 days a week on 0.800.840.800.
The EXACTO® Test HIV Self-test is only designed to detect an HIV infection.
Other sexually transmitted infections, such as syphilis, chlamydia, gonorrhoea or viral hepatitis cannot be detected with the EXACTO® Test HIV Self-test. To undergo screening for these infections, please make an appointment with your GP or attend a GUM or sexual health clinic.
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Precautions for use
- This test must not be frozen, it must be stored in a dry place between 2 °C and 30 °C.
- Remove the test cassette from its sealed bag and use it within the hour.
- The test must be used at a temperature of between 15 °C and 30 °C.
- This test must be used immediately after the blood has been collected from the fingertip.
- This test is intended for single use only.
- Ensure that the bottom of the square well labelled “BLOOD” is completely red before adding the buffer solution to the round well marked “DILUENT”.
- Keep the self-test kit and its components out of the reach of children; the buffer solution can present a danger in the case of ingestion and the lancet a risk of injury.
- This test is intended for the screening of persons who do not know their HIV status and must not be used for monitoring antiretroviral treatments in HIV-positive patients who are undergoing treatment.
- For persons who are undergoing PEP (post-exposure prophylaxis) treatment, there is the risk of a false negative result. Medical follow-up with regular screening is therefore recommended.
- Negative results can appear in infected persons, who have been infected less than 3 months before completing the test.
- If you think you have been exposed to the risk of infection during the last 3 months, you must consult your doctor so you can undergo a laboratory test (ELISA 4th generation test) or repeat a self-test three months after the last possible exposure. During this period, use condoms to protect yourself and protect others.
- A positive result must be confirmed by a laboratory analysis. Please consult your doctor.
- The diagnosis of an HIV infection can only be confirmed by a doctor on the basis of biological examinations performed at a clinical laboratory. The EXACTO® Test HIV Self-test is only an additional tool aimed at encouraging HIV screening.
- The EXACTO® Test HIV Self-test does not detect other infections (sexually transmitted or others).
- Erroneous results can be obtained if:
– the test has not be used in accordance with the user instructions.
– the foil pouch is damaged or if the test is not performed immediately after opening the foil pouch.
– if the storage conditions are not respected or if the test is performed after the expiry date indicated on the foil pouch.
- Product Name: EXACTO® Test HIV Self-test (ref: 855164 – 855169)
- Correct usage: this self-test is reliable for detecting an HIV infection having occurred more than 3 months prior to testing.
- Intended use: Test designed for detecting infection with the HIV1 or HIV2 virus within a private setting, carried out by the general public.
- Manufactured and distributed by:
22 Boulevard Sébastien Brant
- Instructions: carefully read the user instructions before use. In case of any doubts about the result obtained, please consult your doctor.
- This medical device is a regulated health product bearing the 0123 CE mark.
- Reference pages: WEB_855164 – 855169_FR_V01201803R03
- Date of amendment: 07/2018
- ANSM [French National Agency for Medicines and Health Products Safety] marketing reference number: 18/04/EXHIVINT/GP/003