Rapid self-test for the qualitative detection of antibodies against human immunodeficiency virus 1 and 2 (HIV1/HIV2) in whole blood
Human immunodeficiency virus, or HIV, is a pathogen that attacks and suppresses the immune system by specifically affecting white blood cells.
The virus can be transmitted (a) sexually – through unprotected sex, (b) with blood – for example through the exchange of syringes – and (c) vertically – from mother to child during pregnancy, at birth and, more rarely, through breastfeeding.
Without specific treatment, the virus weakens the subject’s immune system to the point of inducing the development of acquired immunodeficiency syndrome, or AIDS. It is a syndrome that can occur in people with HIV even several years after the infection, when the immune system’s efficiency dramatically falls, and the body loses its ability to fight even the most common infections.
The onset of AIDS can be prevented by taking appropriate antiretroviral therapy at an early stage.
WHO IS THIS TEST FOR?
HIV 1/2 SELF-TEST can be performed by anyone who has been, or suspects to have been, exposed to the virus, people with HIV symptoms or anyone who wants to check a possible ongoing infection.
Among the most common HIV symptoms there are: fever, rash, sore throat and/or oral candidiasis, swollen glands, headache, joint and/or muscle pain.
HIV 1/2 SELF-TEST is an immunochromatographic assay, able to detect anti-HIV antibodies in human blood samples.
1 test cassette
1 vial with dropper containing the diluent
2 sterile lancets
1 pipette for blood sampling
1 cleanser gauze
instructions for use
Draw a blood sample by using the sterile lancet provided;
Collect the sample indicated with the black line by using the capillary pipette provided;
Deposit the collected specimen into the vial, previously open, then screw it;
Add 3 drops of the obtained liquid into the sample well (S) indicated on the test cassette and wait 10 minutes before reading the result.
no antitoxin antibodies have been detected in the sample or their concentration is below the cut-off. If you doubt having been exposed to the virus in the past 3 months, it is possible that the antibodies have not yet been produced by the body. In this case it is recommended to repeat the test 3 months after possible exposure.
HIV antibodies have been detected in the sample and thus a possible seropositivity condition. It is necessary to check with a specialist.
2. European Centre for Disease Prevention and Control, HIV/AIDS surveillance in Europe
The test has been carried out correctly when the instructions for use are followed. It includes the reading time and the interpretation of the results shown at the "RESULTS INTERPRETATION" secrion of the instructions for use.
A colored line will appear at the control region (C) on the test device, showing that the test performed correctly. The absence of the colored line suggests to repeat the test with a new device and a new sample.
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