HIV Test (Self test)

HIV Self Test (CE-Marked Self Test)

About the HIV Self Test

The HIV Self Test is a CE-marked at-home test for the qualitative detection of antibodies to both HIV-1 and HIV-2 using a small finger-prick blood sample. It is designed for private testing at home with a clear result in 10 minutes when read at the correct time. The test is intended as a screening tool and does not detect other sexually transmitted infections.

What does the test measure?

This HIV home test detects anti-HIV-1 and anti-HIV-2 antibodies in whole blood. A control line confirms that the test has operated correctly.

Because the test detects antibodies, timing matters. After a potential exposure, antibodies may take time to reach detectable levels (the “window period”).

When can the test be used?

The test can be performed at any time of day. However, antibody tests may require time after exposure to become positive. Antibodies can take approximately 23–90 days to be detectable. Testing too early may lead to a negative result even if infection has occurred. This self test is not intended for emergency situations.

How does it work?

If HIV-1 and/or HIV-2 antibodies are present, they bind to test components in the cassette and a coloured line may appear in the Test (T) region. A coloured line in the Control (C) region indicates the test ran correctly.

How to use the test (overview)

You collect a small blood sample from your fingertip, combine it with the provided solution, and add drops to the test cassette. For a reliable reading, the result must be interpreted at the correct time.

A brief overview:
Wash hands (warm water may help blood flow), clean the puncture site, use the sterile lancet, collect blood with the pipette to the marked line, add the sample to the vial and mix, then add 3 drops to the cassette.

Read the result at exactly 10 minutes. Do not read after 10 minutes, as late readings may be incorrect.

Result interpretation (read at 10 minutes)

Positive: Two coloured lines appear (one at C and one at T). Any visible line in the test region should be considered positive. A positive result indicates antibodies to HIV-1 and/or HIV-2 may be present and should be followed by confirmatory testing via healthcare services.

Negative: One coloured line appears at C only, and no line at T. This means no HIV-1/HIV-2 antibodies were detected, or antibodies are present at levels below the detection limit (including early testing during the window period).

Invalid: No control line at C, or a line appears only at T. The result cannot be interpreted—repeat with a new device and a new blood sample.

Accuracy (reported performance)

Evaluation reports show a sensitivity of 99.3% (95% CI: 98.2–99.7%), specificity of 99.7% (95% CI: 99.2–99.9%), and overall accuracy of 99.6% (95% CI: 99.2–99.8%) compared to a laboratory standard test.

Important information

Store the test components between +4°C and +30°C. Do not freeze. Do not use after the expiry date or if packaging is damaged. The test and sterile lancet are single-use only.

Not recommended for individuals taking blood-thinning medication (anticoagulants) or with haemophilia problems. The test is not intended for therapeutic follow-up in patients receiving antiretroviral therapy.

This test detects HIV antibodies only and cannot be used to detect other STIs.

What’s included

Each kit contains 1 HIV 1/2 test cassette, 1 diluent vial with dropper tip, 2 sterile lancets, 1 blood collection pipette, 1 alcohol cleansing gauze, and instructions for use.