WHO prequalifies first Hepatitis C rapid diagnostic test (5 December 2016)

The World Health Organization (WHO) has prequalified its first Hepatitis C rapid diagnostic test.

Background information:

WHO prequalification is conducted in accordance with international standards of quality, safety and performance of in vitro diagnostic medical devices.

Once a product has been prequalified by WHO, it is eligible for procurement by UN agencies. Countries and non-governmental organizations also rely on the WHO list of prequalified health products to guide their purchasing and procurement practices.

The SD BIOLINE HCV is a rapid assay that detects antibodies to HCV in human serum, plasma or whole blood.

The assay is used as an aid to diagnosis of HCV infection; reactive specimens require additional testing to identify current HCV infection.

The test contains a pre-coated nitrocellulose membrane strip; when the serum, plasma or whole blood specimen is applied, it moves along the membrane to the test region and forms into a visible line, which indicates a reactive result.

The control line should always appear if the test procedure is performed properly and the reagents in the control line are working.

The test result can be read between 5 and 20 minutes; as this is a visually-read device, no instrumentation is required to interpret the test result.

The product has not been validated for infants or children.

Key Messages:

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.

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 newly prequalified test is expected to be more affordable, as well as guaranteeing quality, safety and performance.

Agencies that procure or purchase health products for low-resource countries, such as Médecins Sans Frontières and UNITAID, have been waiting for such a test in order to scale up diagnosis and treatment.

WHO has recently released normative guidance on care and treatment of viral hepatitis. DAAs have an over 90% cure rate and now provide the opportunity for addressing the HCV public health crisis.

The emergence of DAAs has stimulated renewed interest in the establishment and expansion of testing services for HCV after a long period of stagnation.

In addition, the new test will help key affected populations (e.g. injecting drug users), who have not been reached by existing HCV testing services that focus on blood screening.

Useful Links:

Link to the WHO news release:

http://www.who.int/medicines/news/prequal_hvc/en/

Link to WHO Guidelines for the Screening, Care and Treatment of persons with chronic Hepatitis C infection (Updated April 2016) (English) [PDF]:

http://apps.who.int/iris/bitstream/10665/205035/1/9789241549615_eng.pdf?ua=1

Link to WHO’s Global Report on Access to Hepatitis C Treatment (October 2016) (English) [PDF]:

http://apps.who.int/iris/bitstream/10665/250625/1/WHO-HIV-2016.20-eng.pdf

Link to Key facts on Hepatitis C Treatment (from the Global Report above) (English) [HTML]:

http://www.who.int/medicines/areas/access/hepCtreat_key_facts/en/

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