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Medical Devices / Regulatory Affairs

The Biotiytical INSTI HIV Test Self-Test Approved in Kenya

May 5, 2017

Canadian manufacturer BioLytical Laboratories has received a validation certificate from the Kenya Technical Laboratory Technologists and Technicians Board of the Kenyan Ministry of Health, following a successful field study in western Kenya by researchers from the Kenya Medical Research Institute, Nairobi.

The self-administered test is designed to identify individuals who may be infected with HIV, so they can follow up with additional testing at a clinic.

The test produces results in 60 seconds or less. — Cynthia Jessup

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