Atomo Diagnostics’ HIV Self Test Receives Approval From Kenya Ministry of Health

 Medical device innovator Atomo Diagnostics said its pioneering HIV self test product has been approved for sale in Kenya, Africa.


 
Following successful product evaluations and in-field studies conducted in Kenya by investigators from the Kenya Medical Research Institute (KEMRI), Nairobi, Atomo HIV Self Test has received certification of registration from the Kenya Ministry of Health, Pharmacy and Poisons Board (PPB). 

In-field evaluations focused on test performance and product ease-of-use for self-testers. In the hands of untrained lay users the Atomo HIV Self Test was able to detect 100 percent of HIV infections in two separate studies. KEMRI has since recommended that the product be introduced to the Kenyan market to enable the national HIV testing program to benefit from its superior usability and in-field performance.
 
“We are extremely pleased that our Atomo HIV Self Test has been approved in Kenya. We passionately believe that self-testing has an important role to play in tackling HIV worldwide,” said Atomo Founder and Group CEO John Kelly. “In the independent studies carried out in Kenya with self test users, Atomo HIV Self Test successfully detected all the HIV positive samples. We believe that makes it the best performing HIV self test in the world.”
 
Kenya is at the forefront of HIV self-testing in Africa and formally launched its HIV self-testing campaigns last month. There are in the region of 1.5 million people living with HIV in Kenya, with an estimated 400,000 being unaware that they have the virus. There is high prevalence of new infections, particularly amongst young people and key populations. 

Further, it is believed that 8 million adults in Kenya have not been tested for HIV, with most seeking healthcare services in the private sector where HIV testing is not routine. They are a key focus for Kenya’s HIV self-testing initiatives.
 
Improving HIV testing rates among high risks groups is central to controlling the spread of HIV infection, and early diagnosis enables faster access to life-saving treatments. HIV self-testing is not only a means of increasing testing and detection rates, but also a tool for empowering individuals who test negative to take control of their sexual health to help them remain HIV negative.

 The Atomo HIV Self Test is a single-use, third-generation, rapid in-vitro diagnostic test (RDT) for the detection of antibodies to both human immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2) in whole blood. The all-in-one test has been designed for convenience, with a built-in safety lancet and a unique blood collection and delivery system that make it easy to use and help to eliminate errors common with traditional multi-component RDT kits. The Atomo HIV Self Test requires only a small drop of blood (10uL) from the fingertip and gives the result in just 15 minutes.
 
Atomo Diagnostics is a medical device design and manufacturing company based in Sydney, Australia, with corporate offices in the United Kingdom and South Africa. The company specializes in developing rapid diagnostic test (RDT) platform devices for capillary blood samples, including the Atomo HIV Self Test. Atomo’s user-centered approach to design and willingness to reimagine what has gone before has led it to create products that are simpler to use and that help prevent common user errors associated with standard RDT kits. Atomo’s all-in-one platform devices put the end user first and make it easy to test and screen for a range of infectious diseases and chronic conditions. As well as commercializing products in its own brand, Atomo provides OEM product development services to specialist diagnostic companies worldwide.