WHO has just prequalified its first HCV rapid diagnostic test, a tool that will aid diagnosis of HCV in low- and middle-income countries and improve access to treatment.

10 Apr 2017

“The fact that we now have very effective new medicines for HCV needs to be bolstered by effective and affordable diagnostics,” said Dr Suzanne Hill, WHO Director for Essential Medicines and Health Products. “This new quality-assured test is good news for the many people awaiting diagnosis and treatment.”

The newly prequalified test, SD BIOLINE HCV, by Standard Diagnostics, Inc. (South Korea), is a point-of-care diagnostic, which makes it particularly appropriate for low-resourced countries, where testing laboratories and trained personnel may be scarce. Resembling a pharmacy pregnancy test, it does not require hospital facilities or electricity and can be performed by health workers with limited training. The test gives a result within 20 minutes.

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WHO acceptance of the test comes at a time when direct acting antivirals (DAAs), new and highly effective medicines for HCV, are becoming increasingly affordable and available in low- and middle-income countries.

“The majority of people with chronic hepatitis C don’t know they have the infection and miss the opportunity to be cured,” said Dr Gottfried Hirnschall, WHO Director for the Department of HIV and Global Hepatitis Programme. “Making the first WHO prequalified test available in countries can greatly contribute to achieving the goal of eliminating hepatitis.”

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