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World’s solely Atomo HIV Self Take a look at receives CE Marking from European Union Notified Physique

Atomo Diagnostics, a world chief in revolutionary point-of-care, speedy diagnostic gadgets, introduced immediately that its Atomo HIV Self Take a look at has been granted CE Marking by a European Union Notified Physique.

The Atomo HIV Self Take a look at is the world’s solely built-in self-test gadget, offering larger comfort, ease-of-use, and infield diagnostic efficiency when in comparison with different multi-component HIV check kits. Atomo Diagnostics is now actively participating with commercialization and distribution companions to make the check extensively accessible in European and different world markets throughout 2018 by way of retail, e-commerce and public well being channels.

Designed as an at-home self-test, the Atomo HIV Self Take a look at is a speedy, lateral circulation in vitro qualitative immunoassay for the detection of antibodies to Human Immunodeficiency Virus Sort 1 and Sort 2 in human entire blood.

The Atomo HIV Self Take a look at wants solely a single drop of blood, obtained from the fingertip utilizing the built-in security lancet. The check gadget additionally incorporates a singular blood assortment and supply system to additional simplify the check process and get rid of consumer errors frequent to different check kits. An correct result’s offered in minutes.

When utilized by untrained customers within the discipline, the Atomo HIV Self Take a look at demonstrated 100% concordance to laboratory ends in unbiased research, making it the perfect performing self-test authorized to this point. Moreover, as a threerd era check, the Atomo HIV Self Take a look at can detect HIV antibodies sooner than established 2nd era competitor assessments.

“Self-testing is facilitating larger entry to HIV testing for beforehand hard-to-reach and high-burden teams. Research have additionally proven that our check has a excessive diploma of acceptance and take-up amongst the younger, which could possibly be central to stemming an infection charges and rising entry to remedy,” mentioned John Kelly, Chief Govt Officer of Atomo Diagnostics. “CE Marking signifies that the Atomo HIV Self Take a look at can now be made accessible to anybody who needs a protected, handy, correct and personal option to discover out their HIV standing in minutes,” he added.

HIV self-testing is more and more seen as very important if the worldwide well being group is to attain the targets of the 90-90-90 initiative of the Joint United Nations Program on HIV/AIDS (UNAIDS). The intention of the initiative is to make sure that by 2020 90% of these dwelling with HIV will know their standing, 90% of these people shall be on antiretroviral remedy (ART), and 90% of people on ART shall be virologically suppressed. To attain even the primary 90% is a serious endeavor: UNAIDS estimates that, as of July 2017, solely 70% of the 36.7 million folks dwelling with HIV knew their standing.

“HIV self-testing has the potential to be a game-changer in attaining the UNAIDS formidable purpose of 90% of all HIV constructive folks understanding their standing by 2020,” mentioned Linda-Gail Bekker, President of the Worldwide AIDS Society, and a member of Atomo’s Scientific Advisory Board.

Atomo is proud to be taking part in its half in serving to to attain the primary 90-90-90 milestone, additionally saying immediately that it has obtained CE approval for the threerd era model of its established skilled use speedy diagnostic check, AtomoRapid HIV (1&2). Approval of this extra delicate threerd era check will additional help early detection of HIV infections and facilitate more practical interventions.

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