On 10 July 2024, the World Health Organization (WHO) prequalified the first self-test for hepatitis C. The disease is caused by the hepatitis C virus (HCV) which affects the liver.
To overcome barriers to testing, WHO’s prequalification programme for in vitro diagnostics has prequalified the first self-test for hepatitis C.The OraQuick HCV self-test is an extension of the OraQuick HCV Rapid Antibody Test, which WHO prequalified for professional use in 2017.
The ability to test in non-medical contexts will expand access to testing and diagnosis and accelerate global efforts to eliminate hepatitis C.Lack of diagnosis is a glaring barrier to eliminationTo date, global efforts to eliminate hepatitis C have not been as effective as hoped.
GlobalData estimates that there are more than 31.2 million cases of hepatitis C across the nine major markets (9MM: Brazil, China, France, Germany, Japan, Italy, Spain, the UK and the US), only nine million of which are diagnosed.
Treatment supply chains must keep up with demand, and it remains to be seen if improving testing access through self-testing will lead to improved outcomes for people with hepatitis C in the varying contexts found worldwide.
On 10 July 2024, the World Health Organization (WHO) prequalified the first self-test for hepatitis C. The disease is caused by the hepatitis C virus (HCV) which affects the liver. The virus can cause acute or chronic hepatitis ranging in severity from mild illness to lifelong serious illness including cancer and liver cirrhosis. It is bloodborne, and most infections occur through exposure to blood due to unsafe injection practices, unsafe health care, blood transfusions, injection drug use and sexual contact that leads to exposure to blood.
There is no vaccination against HCV, but antiviral medications can cure 95% of infections. As a result, accurate diagnosis is crucial to timely treatment and cure. To overcome barriers to testing, WHO’s prequalification programme for in vitro diagnostics has prequalified the first self-test for hepatitis C.
The OraQuick HCV self-test is an extension of the OraQuick HCV Rapid Antibody Test, which WHO prequalified for professional use in 2017. This self-test provides non-medical users with a single kit containing all the components needed to perform a self-test for HCV, which gives results from a fingerstick in 20 minutes with above 98% accuracy. The ability to test in non-medical contexts will expand access to testing and diagnosis and accelerate global efforts to eliminate hepatitis C.
Lack of diagnosis is a glaring barrier to elimination
To date, global efforts to eliminate hepatitis C have not been as effective as hoped. WHO estimates that 50 million people are living with the condition, but only around one-third of these are diagnosed, according to Dr Meg Doherty, WHO’s director for the Department of Global HIV, Hepatitis and STI Programmes. GlobalData estimates that there are more than 31.2 million cases of hepatitis C across the nine major markets (9MM: Brazil, China, France, Germany, Japan, Italy, Spain, the UK and the US), only nine million of which are diagnosed. This illustrates the gap in diagnostics – a glaring barrier to eliminating the disease.
The new self-test will also extend crucial access to safe and affordable testing options to low and middle-income countries. High-quality health products such as the OraQuick HVC self-test will allow for improved case finding and draw attention to this disease, but testing is only half of the battle. Treatment supply chains must keep up with demand, and it remains to be seen if improving testing access through self-testing will lead to improved outcomes for people with hepatitis C in the varying contexts found worldwide.
