Genedrive® HCV ID Kit coming soon!
Based on proprietary technology, Genedrive® is an innovative and affordable system providing molecular diagnostics at the point of need. Genedrive® HCV ID Kit will provide rapid, accurate diagnosis of acute HCV infection from plasma within 90 minutes. The kit will consist of an ambient temperature stable, lyophilised PCR reagent packaged into a single-use, disposable cartridge.
Diagnostics for HCV are available in less than 1% of low and middle income countries (LMIC).1 The Foundation for Innovative New Diagnostics (FIND) published its HCV Strategy in 2015 stating that ‘rapid, inexpensive and accurate diagnostics are the critical bottleneck that must be addressed to eradicate Hepatitis C’.1 Current diagnostic pathways are complex and expensive, and although rapid HCV tests are available they show mixed performance, particularly in patients co-infected with Human Immunodeficiency Virus (HIV) or Hepatitis B (HBV).2 In addition, guidelines recommend a nucleic acid test for the detection of HCV RNA be performed to establish the diagnosis of chronic HCV infection.3 Existing molecular tests are expensive, however, and availability is limited to centralised settings, particularly in LMIC.4 There is a need for a rapid, accurate and qualitative molecular test that can be implemented in a decentralised setting, ideally to be used as a one-step solution.5
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1. Foundation for Innovative New Diagnostics (FIND) (2014) Strategy for Hepatitis C: 2015-2020. Available: http://www.finddx.org/wp-content/uploads/2016/02/HepatitisC_Strategy_WEB.pdf Last accessed: 9 November 2016.
2. Fisher, D.G., Hess, K.L., Erlyana, E., Reynolds, G.L., Cummins, C.A. and Alonzo, T.A. (2015) ‘Comparison of rapid point-of-care tests for detection of antibodies to hepatitis C virus’, Open Forum Infectious Diseases, 2(3), p. ofv101. doi: 10.1093/ofid/ofv101.
3. World Health Organization (WHO) (2016) Guidelines for the screening, care and treatment of persons with Hepatitis C Infection. Available: http://apps.who.int/iris/bitstream/10665/111747/1/9789241548755_eng.pdf?ua=1&ua=1 Last accessed: 9 November 2016.
4. Foundation for Innovative New Diagnostics (FIND) (2015) High-priority target product profile for hepatitis C diagnosis in decentralized settings: Report of a consensus meeting. Available: http://www.finddx.org/wp-content/uploads/2016/01/HCV-TPP-Report_17July2015_final.pdf.
5. World Health Organization (WHO). (2016). Key facts on hepatitis C treatment. Available: http://www.who.int/mediacentre/factsheets/fs164/en/. Last accessed 8th November 2016.