Self-Test
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ConfiSign HIV Self-Test
A qualitative, single-use in vitro diagnostic self-test for the detection of HIV-1/2 antibodies (IgG, IgM) in capillary (fingerstick) whole blood. Designed for untrained lay users in a private setting.
Key Features
- 1 Test / Kit
- For Self-Testing
- Result in 15–25 min
- Sensitivity 99–100%
- Specificity 99.9–100%
- Store 1–30°C
How to Use
Product Specification
ConfiSign HIV Self-Test is a qualitative, single-use, manual in vitro diagnostic self-test for the detection of antibodies (IgG, IgM) to Human Immunodeficiency Virus Types 1 and 2 (HIV-1/2) in capillary (fingerstick) whole blood. It is intended for use by untrained lay users in a private setting to aid the diagnosis of HIV infection. It can be used by anyone who believes they may have been exposed to HIV; those under 14 should be tested with a guardian present.
A rapid, qualitative immunochromatographic assay. The membrane is immobilized with HIV-1 antigens (gp41 + gp120) and HIV-2 antigen (gp36) at the test line, with recombinant HIV antigens conjugated to colloidal gold. If the specimen contains antibodies to HIV-1 or HIV-2, a red line appears at the HIV test line within 15 minutes. A control line confirms the test ran correctly.
Provided: test device, assay solution (0.24 mL), sterile safety lancet, alcohol pad, desiccant, plastic disposal bag, and Instructions for Use.
Required but not provided: bandage, watch or timer, tissue.
Required but not provided: bandage, watch or timer, tissue.
Store the kit as indicated on the package. Bring all components to room temperature 15–30 minutes before testing. After opening, the test device may be kept at 10–35°C for up to 8 hours, but immediate use is recommended. Refer to the package for the expiration date.
Read between 15 and 25 minutes after the test starts.
- Reactive (Positive): two red lines (HIV line + Control). Possible HIV infection — visit a healthcare facility for confirmatory testing.
- Non-reactive (Negative): one red line at Control only.
- Invalid: no Control line — repeat with a new kit.
Performance characteristics are described in the Instructions for Use.
For use outside the body only; single use; do not reuse. May not detect infections acquired within the last 3 months (window period). A reactive result must be confirmed by a healthcare professional. PrEP or antiretroviral therapy may affect results. Treat used kit and specimen as biohazardous and dispose of per local regulations.
Clinical Performance
99–100%
Sensitivity
99.9–100%
Specificity
15 min
Time to Read
Clinical evaluation across Germany, South Korea, Kenya and Uganda (n = 5,091). Reference methods incl. Abbott ARCHITECT HIV Ag/Ab, INNO-LIA, Bioline HIV 1/2. Full data in the Instructions for Use.
Frequently Asked Questions
General HIV Self-Testing
HIV self-testing allows a person to collect their own sample, perform the test, and read the result themselves in a private setting. HIV self-testing is a simple and convenient way to help individuals know their HIV status and access further care or support when needed.
ConfiSign HIV Self-Test is a single-use HIV self-test designed to help individuals test themselves privately and confidentially. The kit includes the materials required to perform the test and provides a result within the time specified in the Instructions for Use.
Knowing your HIV status is important for your health and wellbeing. Early testing can help people access treatment, care, support, and prevention services as early as possible. Many people living with HIV can live healthy lives when diagnosed early and linked to appropriate care.
Yes. HIV self-testing is private and confidential. You can perform the test in a place where you feel comfortable. Your result does not need to be shared unless you choose to do so or unless further care is required.
When used correctly and according to the Instructions for Use, HIV self-tests are reliable screening tests. It is important to carefully follow all instructions provided with the test kit. A reactive result is not a final diagnosis and must be confirmed by a healthcare facility, clinic, or approved testing service according to national HIV testing guidelines.
Preparing the Kit
Before starting, carefully read the Instructions for Use provided inside the kit. The test involves collecting a fingerstick blood sample, applying the sample as instructed, inserting the device into the assay solution tube, waiting for the required time, and reading the result at the specified time.
No. Before starting the test, the handle of the device should be separated from the transparent cassette and positioned in the “CORRECT” position, as shown in the Instructions for Use. If the handle is pushed down and appears to be in the “WRONG” position, gently pull the top of the handle upward to place it in the “CORRECT” position before starting the test.
No. Do not use the test if the assay solution has been spilled. The correct volume of assay solution is required for the test to work properly. If the assay solution is spilled, the test result may be inaccurate or invalid. Use a new test kit.
Do not use the test if the kit is expired, the pouch is damaged or already opened, any component is missing, or the test has not been stored as instructed. In these cases, use a new test kit.
No. ConfiSign HIV Self-Test is for single use only. Do not reuse the test device, lancet, assay solution, or any other single-use component.
Blood Collection & Procedure
The test is generally quick and causes only minimal discomfort. When collecting a fingerstick blood sample, you may feel a small pinch for a few seconds.
No. After pricking your finger with the lancet, wipe away the first drop of blood with a clean tissue. Then gently squeeze your finger to form a new drop of blood. Use this second drop of blood to fill the sampling tip as instructed.
Press the top of the device firmly and completely downward until you hear a “click.” The device must be fully inserted into the assay solution tube for the test to start properly. When the device is correctly inserted, the red line on the device should no longer be visible from the outside.
The liquid should begin to move upward within 2 minutes after the device is inserted. If the liquid does not move, the device may not have been fully inserted. Press the device downward again firmly until it is completely inserted. Start timing the test when the coloured liquid begins to move. If the liquid still does not move, do not interpret the result. Use a new test kit or seek assistance from a healthcare provider or approved support service.
Yes. ConfiSign HIV Self-Test is designed to be used by individuals in a private setting. However, if you would like support, you may ask a healthcare worker, counsellor, trained provider, or other approved support service for guidance.
Understanding Results
Read the test result between 15 and 25 minutes after the test has started. Do not read the result before 15 minutes or after 25 minutes. Reading the result too early or too late may lead to an incorrect interpretation, including a false non-reactive or false reactive result.
A non-reactive result means that HIV antibodies were not detected by the test at the time of testing. However, a non-reactive result does not always exclude HIV infection, particularly if the exposure was recent or if other factors may affect the immune response. If you think you may have been recently exposed to HIV, follow national guidance on repeat testing or consult a healthcare provider.
A reactive result means that HIV antibodies may have been detected by the test. A reactive result is not a final diagnosis. You should visit a healthcare facility, clinic, or approved testing service for confirmatory testing and further support according to national HIV testing guidelines.
An invalid result means that the test did not work properly or the result cannot be interpreted. If the result is invalid, repeat the test using a new kit or seek assistance from a healthcare provider or approved support service.
If your result is non-reactive, continue to protect yourself and repeat testing when recommended according to national guidance.
If your result is reactive, visit a healthcare facility, clinic, or approved testing service for confirmatory testing and linkage to care.
If your result is invalid, repeat the test using a new kit or seek assistance from a healthcare provider.
If your result is reactive, visit a healthcare facility, clinic, or approved testing service for confirmatory testing and linkage to care.
If your result is invalid, repeat the test using a new kit or seek assistance from a healthcare provider.
Medical Limitations & Follow-up
ConfiSign HIV Self-Test detects antibodies produced by the body in response to HIV infection. HIV antibodies may not be detectable immediately after exposure. This period is known as the window period. If you think you may have been exposed to HIV recently, a non-reactive result may not exclude HIV infection. Repeat testing after the window period, for example 3 months after the possible exposure, may be recommended depending on national guidance. You should also consult a healthcare provider or approved testing service for advice.
Yes. Use of antiretroviral medicines, including PrEP or HIV treatment, may affect HIV test results in some cases. These medicines may delay or reduce the antibody response, which could lead to a false non-reactive result. If you are taking PrEP, are receiving HIV treatment, or think you may have been recently exposed to HIV, consult a healthcare provider and follow national testing guidance.
No. A reactive result from an HIV self-test is not a final diagnosis. If your result is reactive, you must visit a healthcare facility, clinic, or approved testing service for confirmatory testing according to the national HIV testing algorithm.
If you are unsure whether the test was performed correctly, do not rely on the result. Use a new test kit and carefully follow the Instructions for Use, or seek assistance from a healthcare provider, counsellor, trained provider, or approved support service.
Support & Additional Questions
Where permitted by national policy and with appropriate support, HIV testing can help young people make informed decisions about their health, access care or prevention services early, and help reduce the risk of HIV transmission in their communities.
It is normal to feel nervous or afraid before testing. Knowing your HIV status is an important step in protecting your health and wellbeing. Support services, healthcare providers, and counsellors may be available to help you before and after testing.
Yes. Questions can be asked confidentially through approved healthcare providers, counsellors, helplines, or digital support platforms linked to the program or campaign.
Regulatory Status & References
ConfiSign Self-Test products are manufactured under an MFDS (Republic of Korea) export-only manufacturing approval. Additional international authorizations are in progress.
MFDS — Export-only
Manufacturing approval, Republic of Korea
EU Regulation 2022/1107
Referenced common specifications (in progress)
WHO TSS-1
HIV RDT for self-testing — technical specification
Customer Support
As part of our post-market surveillance commitment for self-test products, our support team is available to help with product use, results guidance, and feedback.
Mon–Fri 08:00–17:00 (KST) · For a reactive or unclear result, please consult a healthcare facility for confirmatory testing.
TEL
Call +82-41-523-8993
WA
WhatsApp +82-10-2689-4618
EMAIL
contact@genbody.co.kr
