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CE-marked HIV rapid tests are in vitro diagnostic medical devices that comply with European Union (EU) health, safety, and environmental protection standards, allowing them to be sold in the European Economic Area. These tests are highly sensitive, often designed for both professional use and at-home self-testing, and can detect HIV antibodies (3rd generation) or antibodies and antigens (4th generation) within 1 to 20 minutes.
Top CE-Marked HIV Self-Tests (At-Home)
These tests are authorized for purchase by lay users for private, at-home testing:
- INSTI HIV Self Test: Known for rapid results in under 60 seconds using a finger-prick blood sample.
- OraQuick HIV Self-Test: An oral fluid swab test that provides results in 20 minutes.
- SURE CHECK HIV Self-Test: A finger-prick blood test, often marketed with integrated safety features.
- Autotest VIH: A widely available CE-marked self-test in Europe.
- Atomo HIV Self-Test: An integrated blood-based test.
- Newfoundland HIV Test: A self-test kit with results in 15 minutes.
Key CE-Marked Professional Rapid Tests
These tests are primarily used in clinics, hospitals, and community-based testing sites:
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Web results
World's Fastest HIV Home Test Kit - INSTI
insti.com
https://insti.com › hiv-self-test
insti.com
https://insti.com › hiv-self-test
INSTI HIV Self Test is the world's fastest HIV home test kit. Highly accurate. CE Marked. One drop of blood. Instant results. No waiting. Learn more here.
Determine HIV Early Detect
Abbott Point of Care
https://www.globalpointofcare.abbott › Home › Products
Abbott Point of Care
https://www.globalpointofcare.abbott › Home › Products
Determine HIV Early Detect provides accurate results in just 20 minutes and can be run using fingerstick whole blood, venipuncture whole blood or ...
STAT-VIEW HIV 1/2 Assay (CE Marked)
CLIAwaived Inc.
https://www.cliawaived.com › stat-view-hiv-1-2-assay-c...
CLIAwaived Inc.
https://www.cliawaived.com › stat-view-hiv-1-2-assay-c...
A CE-Marked, rapid point-of-care test that detects antibodies to HIV-1 and HIV-2 in fingerstick whole blood, venous whole blood, serum and plasma specimens.Read more
2–8 day delivery10-day returns
How accurate are rapid, point-of-care tests for HIV?
Aidsmap
https://www.aidsmap.com › about-hiv › how-accurate-a...
Aidsmap
https://www.aidsmap.com › about-hiv › how-accurate-a...
Mar 15, 2022 — Rapid tests are usually reliable for long-standing infections, but are sometimes unable to detect recent HIV infections acquired in the past ...Read more
HIV rapid screening tests and self-tests: Be aware of ... - PMC
PubMed Central (PMC) (.gov)
https://pmc.ncbi.nlm.nih.gov › articles › PMC6284408
PubMed Central (PMC) (.gov)
https://pmc.ncbi.nlm.nih.gov › articles › PMC6284408
by T Mourez2018Cited by 31 — HIV rapid tests are unitary assays used in clinical and non-clinical settings; they facilitate screening of HIV infection due to their technical simplicity and ...Read more
SURE CHECK® HIV Self-Test Europe
Chembio Diagnostics, Inc.
https://chembio.com › Products
Chembio Diagnostics, Inc.
https://chembio.com › Products
One Drop of Blood is All You Need · A CE Marked single-use in-vitro diagnostic self-test that detects antibodies to HIV-1 and HIV-2 in fingerstick whole blood.Read more
HIV SELF-TEST
OraQuick
https://uk.oraquick.com › media › wysiwyg › O...
OraQuick
https://uk.oraquick.com › media › wysiwyg › O...
PDF
In this study, the OraQuick ADVANCE® HIV-1/2 Antibody Test detected seroconversion, on average, at approximately the same time as the CE marked EIA. TABLE 2.Read more
Wholesale CE-marked HIV Rapid Tests ...
InTec PRODUCTS, INC.
https://www.intecasi.com › ce-marked-hiv-rapid-tests_sp
InTec PRODUCTS, INC.
https://www.intecasi.com › ce-marked-hiv-rapid-tests_sp
HIV lateral flow rapid test kit. One Step Anti-HIV (1&2) Test. WHO Pre-qualified CE-Marked. Sensitivity: 100%. Specificity: 100%.Read more
HIV Self-tests
Paul-Ehrlich-Institut
https://www.pei.de › newsroom › hiv-self-tests-node
Paul-Ehrlich-Institut
https://www.pei.de › newsroom › hiv-self-tests-node
Nov 20, 2023 — The CE mark of the listed HIV self-tests comes from the Eudamed database or from pieces of information provided to the Paul-Ehrlich-Institut ( ...Read more
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