NEW YORK (360Dx) – Atomo Diagnostics today said that it has received CE marking for the Atomo HIV Self Test.
The Australian firm is now in talks with commercialization and distribution partners to make the test widely available in Europe and other markets that recognize the CE mark.
The Atomo HIV Self Test is a lateral flow, in vitro qualitative immunoassay that detects human antibodies to HIV virus type 1 and type 2 in whole blood. It requires one finger prick of blood and can provide results in minutes, Atomo said, adding that in independent studies with untrained users, the test achieved 100 percent concordance to laboratory results.
In June Atomo said that the test received certification of registration from the Kenya Ministry of Health, Pharmacy, and Poisons Board.