Legal & Regulatory

WHO Prequalifies Rapid Diagnostic Test For Hepatitis C Virus

December 7
5:08 AM 2016

The World Health Organization prequalified the first diagnostic test for hepatitis C virus (HCV) - the SD BIOLINE HCV. This diagnostic tool will aid in the diagnosis of HCV in low and middle-income countries.

 "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."

SD BIOLINE HCV of South-Korea's Standard Diagnostics, Inc. is a point-of-care diagnostic, making it suitable for low-resourced countries where there is no immediate access for testing laboratories and trained personnel.

"One of the chief obstacles to effective testing and treatment of HCV has been a lack of suitable diagnostic tests, with the result that only a small minority of people infected with HCV are aware of their status," said UNITAID Executive Director, Lelio Marmora.

"We are therefore greatly encouraged by the news that a WHO-prequalified rapid diagnostic test for HCV can now be made available to those most in need."

The prequalified HCV test resembles a pharmacy pregnancy test, so it does not necessitate any hospital facilities or electricity. The test can also be conveniently performed by health workers even if they only have limited training. It gives result within 20 minutes.

Dr. Gottfried Hirnschall, WHO Director for the Department of HIV and Global Hepatitis Programme, said that most of the people with chronic hepatitis C are not even aware that they have the infection, therefore missing the opportunity to be cured.

"Making the first WHO prequalified test available in countries can greatly contribute to achieving the goal of eliminating hepatitis."

The prequalification of the rapid diagnostic test comes as the direct acting antivirals and other effective medicines have become affordable and available in low and middle-income countries like Argentina, Brazil, Indonesia, Philippines, Nigeria, Pakistan, and Thailand, among others.

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