The HIV home test is a home test to detect HIV (the virus that causes AIDS) in a fingertip blood sample. The test can detect HIV infection that occurred more than 3 months earlier. The test is a single-use home in vitro diagnostic kit.

PRINCIPLE AND CHARACTERISTICS OF THE TEST
The HIV DETECTION test at home is an immunochromatographic test that detects antibodies produced after HIV infection in human blood.

Sensitivity: The sensitivity of this test was rated as 100% with a confidence interval of 99.1% to 100%. In all tested persons who were actually seropositive, the virus was detected. There were no cases of false negative results.

Specificity: The specificity of this test was estimated to be 99.8% with a confidence interval of 99.5% to 100%. 0.2% of seronegative people were misdiagnosed, i.e. 0.2% of false positive cases.

Reliability: The study showed that 99.2% of patients who self-administered this home test obtained an interpretable result, and over 98.1% of home tests were interpreted correctly. Positive home tests are interpreted correctly 100% of the time.

Interference: Testing of samples containing substances or pathologies that could influence the results of this test revealed no significant interference.

RECOMMENDATIONS AND WARNINGS
- The home test is intended only for self-diagnosis of HIV for private use and under no circumstances may it be intended for other diagnostics or other purposes.
- The home test can only be used for freshly collected capillary blood according to the given technique and cannot be used for serum or plasma.
- The home test is for single use and cannot be reused under any circumstances.
- The home test is not intended for therapeutic monitoring of patients receiving antiretroviral therapy.
- The user of the home test should not make medical decisions without first consulting a doctor, regardless of whether the result is positive or negative.
- There may be false positive results (0.2% according to the specificity test) as well as false negative results in cases of: suspected exposure to HIV 3 months before the test (serological window), in situations of severe immune deficiency or infection through a rare variant also for HIV-positive people receiving antiretroviral treatment.
- Storage other than recommended or use after the expiration date may lead to incorrect test results.
- The home HIV test is an additional way to detect HIV, the test only detects HIV infection, but does not detect other sexually transmitted diseases.

READING THE RESULTS
NEGATIVE TEST
- a visible line: the control line (the line can be light or dark).

YOUR TEST IT'S NEGATIVE FROM HOME, YOU'RE PROBABLY SERONEGATE

If the result is negative, you must make sure that you are not in the so-called serological window (seroconversion*) and consult a doctor. If you have been infected with HIV in the past 3 months, you cannot be sure that you are HIV negative. You should test again 3 months after a risky event that may have caused HIV infection.

* Seroconversion is the period from the time of infection until the appearance of an adequate amount of detectable antibodies.

POSITIVE TEST

- two visible lines: the control line and the test line (one of these lines may be lighter or darker than the other).

YOUR TEST IS POSITIVE AT HOME, YOU ARE PROBABLY HIV-positive
1. CONSULT YOUR DOCTOR ASAP and explain that you tested positive for HIV at home.
2. YOU MUST DO A CONTROL TEST IN THE LABORATORY TO VERIFY IF THE RESULT OF THE TEST AT HOME IS CONFIRMED.
3. PROTECT YOURSELF AND OTHERS.

PACKAGING INCLUDED
- Self-test
- Support
- Instructions for use
- Dose of diluent
- The plaster
- Lancet
- disinfectant wipe
- Compress

CE 0459

Important information about the medical device.

This is a medical device.

Use it according to the directions for use or the label.

A medical device intended for self-monitoring – has the CE mark.

It has an EU declaration of conformity.

Includes user manual in Polish.