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WHO prequalifies rapid HCV test
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For the first time, WHO has prequalified a rapid diagnostic test for hepatitis C virus infection, according to a press release.
WHO anticipates that the new test, SD BIOLINE HCV (Standard Diagnostics Inc.), will improve HCV diagnosis in low- and middle-income countries and expand access to treatment.
“The fact that we now have very effective new medicines for [hepatitis C virus (HCV)] needs to be bolstered by effective and affordable diagnostics,” Suzanne Hill, PhD, director of WHO’s Essential Medicines and Health Products, said in the release. “This new quality-assured test is good news for the many people awaiting diagnosis and treatment.”
According to WHO, the rapid test resembles a pharmacy pregnancy test and can be performed by health care professionals with limited training. The test, which is only validated for adults, detects HCV antibodies in serum, plasma or whole blood. Samples are tested on a pre-coated nitrocellulose membrane strip that forms into a visible line when results are positive for HCV. A control line should always appear to indicate the test is performed properly. Results are ready in 20 minutes or less.
WHO reported that the new prequalified test is more accurate and affordable than the few rapid HCV tests that are available on the market. Agencies that purchase health care products for low-resource countries, including Médecins Sans Frontières and UNITAID, have been waiting for a safe, quality-assured test to improve diagnosis and treatment.
“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,” Lelio Marmora, executive director of UNITAID, said in the release. “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.”
Disclosure: Hill reports no relevant financial disclosures. Infectious Disease News was unable to confirm other financial disclosures at the time of publication.