NEW YORK (360Dx) – A World Health Organization panel has approved Atomo Diagnostics' HIV self-test, making it eligible for procurement by organizations that can access Global Fund and Unitaid resources, Atomo announced today.
The Atomo HIV Self Test was approved by WHO's Expert Review Panel for Diagnostics (ERP-D), a process to accelerate access to diagnostic products in advance of approvals through the WHO prequalification process. As a result, the test can be procured by organizations accessing Global Fund and/or Unitaid funding HIV self-test pilot programs, Atomo said.
The test recently received CE marking, and the ERP-D approval will further expand commercialization of the test in low- and middle-income countries, the company added.
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.