Hepatitis C virus RNA assays: current and emerging technologies and their clinical applications

Abstract

Molecular diagnostic assays represent a cornerstone in the management of hepatitis C virus (HCV) patients. Qualitative and quantitative HCV molecular assays are used for the diagnosis of acute and chronic HCV infections, viral genotyping, viral-load determination, treatment monitoring and prognosis. Reverse-transcription PCR, transcription-mediated amplification and branched DNA amplification are commonly employed for detection of HCV RNA. Recently, new HCV molecular assays that employ nanostructures have emerged and have been proposed as suitable for both low- and high-resource settings, without sacrificing sensitivity and specificity. This article will present current and future HCV molecular diagnostic assays with a focus on their clinical applications.

Performance of the Abbott RealTime and Roche Cobas TaqMan Hepatitis C Virus (HCV) Assays for Quantification of HCV Genotypes

“…Treatment of HCV infection typically consists of pegylated interferon plus ribavirin or pegylated interferon, ribavirin, and a direct-acting antiviral (DAA) protease inhibitor (triple therapy) for non-genotype 1 and genotype 1, respectively (11,12,13). Depending on the particular treatment regimen and the genotype of HCV, treatment success as measured by failure to detect viral replication 24 weeks after cessation of treatment can be achieved in 50 to 80% of patients (12).Measurement of HCV viral load (VL) for the different HCV genotypes is crucial to clinical management of HCV-infected patients, both treated and not, for disease staging, decisions regarding treatment initiation, and individualization of treatment strategy (i.e., dosage and duration based on response kinetics) (1,6,7,13). Furthermore, with the advent of DAAs, VL monitoring may help prevent protease inhibitor resistance development by allowing for switching or stopping therapy if VL does not decrease or returns while on treatment.…”

“…Measurement of HCV viral load (VL) for the different HCV genotypes is crucial to clinical management of HCV-infected patients, both treated and not, for disease staging, decisions regarding treatment initiation, and individualization of treatment strategy (i.e., dosage and duration based on response kinetics) (1,6,7,13). Furthermore, with the advent of DAAs, VL monitoring may help prevent protease inhibitor resistance development by allowing for switching or stopping therapy if VL does not decrease or returns while on treatment.…”

“…There are currently several commercially available HCV VL assays; real-time PCR assays are generally preferred because of their wide dynamic ranges and good sensitivities (1,3). Two commercial real-time PCR platforms are available, the Cobas AmpliPrep/Cobas TaqMan HCV assay version 1.0 (CAP-CTM; Roche Molecular Systems, Pleasanton, CA) and the Abbott RealTime HCV assay (ART; Abbott Molecular, Des Plaines, IL).…”

Evidence-based consensus on the diagnosis, prevention and management of hepatitis C virus disease

“…Gold nanoparticles and quantum dots (QDs) are the most commonly used nanoparticles [25] . QDs are composed of semiconductor substances that upon excitation give off light at different spectra [26] . Using biochipbased assay 1 ng/mL was obtained.…”

Can the Abbott RealTime hepatitis C virus assay be used to predict therapeutic outcomes in hepatitis C virus-infected patients undergoing triple therapy?

“…Real-time polymerase chain reaction (PCR) assays are generally preferred because of their wide range of detection and sensitivity to low quantities of viral RNA (13,14). Two commercial real-time PCR platforms are the CO-BAS AmpliPrep/COBAS TaqMan HCV assay version 1.0 (CAP/ CTM v1.0) (Roche Molecular Systems, Inc., Pleasanton, CA, USA) and the Abbott RealTime HCV assay (ART) (15)(16)(17).…”