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World’s Only Atomo HIV Self Test Receives CE Marking From European Union Notified Body

Oct 25, 2017

Atomo Diagnostics, a world leader in innovative point-of-care, rapid diagnostic devices, announced today that its Atomo HIV Self Test has been granted CE Marking by a European Union Notified Body.

The Atomo HIV Self Test is the world’s only integrated self-test device, providing greater convenience, ease-of-use, and infield diagnostic performance when compared to other multi-component HIV test kits. Atomo Diagnostics is now actively engaging with commercialization and distribution partners to make the test widely available in European and other global markets during 2018 via retail, e-commerce and public health channels.

Designed as an at-home self-test, the Atomo HIV Self Test is a rapid, lateral flow in vitro qualitative immunoassay for the detection of antibodies to Human Immunodeficiency Virus Type 1 and Type 2 in human whole blood.

The Atomo HIV Self Test needs only a single drop of blood, obtained from the fingertip using the built-in safety lancet. The test device also incorporates a unique blood collection and delivery system to further simplify the test procedure and eliminate user errors common to other test kits. An accurate result is provided in minutes.


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