The World Health Organization (WHO) has just prequalified its first hepatitis C virus (HCV) rapid diagnostic test. The newly prequalified test, SD BIOLINE HCV (Standard Diagnostics, Inc., South Korea), is a rapid assay that detects antibodies to HCV in human serum, plasma, or whole blood.

SD BIOLINE HCV is a point-of-care diagnostic that resembles a pharmacy pregnancy test, making it easier to diagnose patients with HCV in low- and middle-income countries, where laboratories and trained personnel may be scarce.  The test can give results within 5 to 20 minutes, and since this is a visually read device, no instrument is required to interpret the test result.


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With direct-acting antivirals (DAAs) becoming more affordable and available in low- and middle-income countries, the prequalified test will scale up diagnosis and treatment, making the goal of eliminating HCV more achievable.

“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.” In addition, the new test will assist key affected populations like injection drug users, who have not been reached by HCV testing services that focus on blood screening.

Unlike the other HCV tests on the market, SD BIOLINE HCV is expected to be more affordable, as well as guarantee quality, safety, and performance.

SD BIOLINE HCV has not been validated for use in infants or children.

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Reference

First WHO prequalified hepatitis C rapid test opens the door to expanded treatment [news release]. Washington, DC: World Health Organization; Accessed December 14, 2016.