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The challenges of hepatitis C diagnosis and the potential role of Stimmunology™ to address them

Tamar Jehuda-Cohen, Serhat Unal

Corresponding author name: Tamar Jehuda-Cohen
Corresponding author e-mail: tamar@smartube-bio.com

Citation: Antiviral Therapy 2012; 17:1415-1422
doi: 10.3851/IMP2472

Date accepted: 23 May 2012
Date published online: 07 December 2012

Abstract

The diagnosis of HCV infection is hindered by the long seronegative window period, the high rate of false-positives and the need to differentiate between current and cleared infection. Stimmunology™ is a technology by which antibody production can be stimulated, even in a whole blood sample, in vitro. Such stimulation leads to an increase in HCV antibody levels in the blood sample, enabling the detection of HCV infection prior to seroconversion. This increase in the levels of the HCV antibodies, which can be achieved within days of infection, practically resolves the window period problem. The detection of the infection, even at its seronegative stage, translates to increased diagnostic sensitivity and the concomitant dilution of ‘noise’ in the sample leads to a >96% reduction in the false-positive rate. The stimulation step acts upon HCV-primed lymphocytes in the blood sample; therefore, only in the presence of infection would the increased antibody levels be detected, thus differentiating between current and cleared infection. Clinical diagnostic data have been collected to provide insight as to how the diagnosis of HCV infection may be improved using this technology.

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