New Tools in HCV Diagnosis, in Light of the Enhanced Awareness and the New Drugs for Treatment: SMARTube and Stimmunology

Abstract

With improved HCV therapy, challenges regarding HCV diagnosis, such as seronegative window period, false positive readings, and differentiation between recent, chronic, and resolved infections, are of increasing importance. To address these challenges an innovative device—SMARTube HIV & HCV—was used. Blood samples were tested for anti-HCV antibodies before and after incubation in the SMARTube, which promotes the in vitro stimulation of in vivo HCV primed lymphocytes, thus enhancing levels of anti-HCV antibodies. Comparing antibody levels, in concordant samples before and after SMARTube, yielded the Stimulation Index (SI). Among 5888 fresh blood samples, from various populations and regions worldwide, 641 were seropositive using plasma, while SMARTube processing (yielding enriched plasma, termed SMARTplasma) enabled diagnosis of 10 additional carriers in high-risk cohorts, that is, earlier detection. Using SMARTplasma eliminated all false positive results, using the current assays. In addition we show that SI calculation may serve as an important tool for differentiating between those who recently seroconverted, carriers of long-term infection, and those who have cleared the virus. SMARTube and the SI could lead to better, more informative diagnosis of HCV infections and play an important role in changing the way we treat both the infected individuals and the epidemic as a whole.

Genetic Variations in Host Factors and their Critical Role on HCV Medication

“…An internal ribosome site (IRS) is located near the 5'-NTR, conducting the expression of a polyprotein precursor. Core E1 and E2 are structural proteins, originated from precursor polyprotein The main ways of HCV infection includ: 1) Blood transfusion from infected persons, 2) Organ transplant from infected persons; 3) Needlestick cases in hospitals or in health care units; 4) Injection drug users who used sharing syringe; 5) Being born to a hepatitis C-infected mother; 6) Through sex with infected persons; 7) Sharing personal items which were contaminated with infectious blood (4,22). The HCV infection usually has a different latency period which might take 2 weeks to 6 months; however, about 80% of persons present no symptoms in initial stages of infection (23).…”

“…Approximately, 170-200 million people 3-3.5% of the world population suffer from hepatitis C virus (HCV) infection with the risk of morbidity and mortality (1)(2)(3). Around 3-4 million persons are infected each year and more than 350,000 people die every year from hepatitis C-related liver diseases (4)(5)(6). Amongst different groups of the patients with acute HCV infection, only 15-30% could spontaneous clear the virus while the other patients have potential for promoting severe progressive liver damage (7,8).…”

Implications of grey zone results for routine hepatitis C virus screening with the ARCHITECT HCV‐Ag assay

“…As anti‐HCV and HCV‐Ag testing can be performed on the same platform, a reflex test for an anti‐HCV‐positive sample can confirm HCV infection within 40 min of a positive anti‐HCV test. It should be noted that a small proportion of HCV‐Ag nonreactive individuals may test positive for HCV‐RNA (Gorodin et al ; Alonso et al ). In addition, patients with low or undetectable HCV‐RNA levels may show values in the grey zone.…”