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Updated: Nov 19, 2025
A Protocol for Analyzing Hepatitis C Virus Replication
Published on: June 26, 2014
The performance of HCV GT plus RUO reagent in determining Hepatitis C virus genotypes in Taiwan
Ying-Chou Huang1, Chung-Feng Huang1,2,3, Shu-Fen Liu1
1Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan.
Insights
The Abbott HCV RealTime Genotype Plus assay improves Hepatitis C virus (HCV) genotyping, especially for difficult-to-classify genotype 1 subtypes and indeterminate samples. This advancement aids in accurate epidemiological studies and treatment decisions.
Area of Science:
- Hepatology
- Virology
- Clinical Diagnostics
Background:
- Hepatitis C virus (HCV) genotyping is crucial for epidemiology and treatment guidance.
- Accurate identification of HCV genotype 1 subtypes and indeterminate genotypes presents a challenge.
- The Abbott HCV RealTime Genotype Plus RUO assay was developed to address these limitations.
Purpose of the Study:
- To evaluate the performance of the Abbott HCV RealTime Genotype Plus RUO assay.
- To compare the assay's results with 5' UTR sequencing in clinical samples.
- To assess the assay's utility in identifying challenging HCV genotypes.
Main Methods:
- The study enrolled 100 viremic chronic hepatitis C patients in Taiwan.
- Samples previously genotyped as genotype 1 without subtype or indeterminate by Abbott RealTime HCV GT II were re-tested.
- All results were validated against 5' UTR sequencing as the reference standard.
Main Results:
- The HCV GT Plus assay detected 93.7% of genotype 1 samples and 62.2% of indeterminate samples.
- 5' UTR sequencing confirmed the HCV GT Plus results for 84.7% of genotype 1 and 65.2% of indeterminate samples.
- High concordance was observed for specific subtypes (1a, 1b, and genotype 6).
Conclusions:
- The Abbott HCV RealTime HCV GT Plus RUO assay demonstrates enhanced performance in Hepatitis C virus genotyping.
- The assay shows promise in improving the detection rates for challenging HCV genotypes.
- This tool can aid in more precise epidemiological surveillance and patient management.
Background And Aims:
Hepatitis C virus (HCV) genotyping is a pivotal tool for epidemiological investigation, guiding management and antiviral treatment. Challenge existed in identifying subtypes of genotype-1 (G-1) and genotype (GT) of indeterminate. Recently, the Abbott HCV RealTime Genotype Plus RUO assay (HCV GT Plus) has been developed aiming to overcome the limitations. We aimed to evaluate the performance of the assay compared with 5' UTR sequencing in clinical samples.
Materials And Methods:
Eligible individuals were treatment chronic hepatitis C patients that were enrolled consecutively in a medical center and two core regional hospitals in southern Taiwan from Oct 2017 through Aug 2018. The patient with genotype 1 without subtype and indeterminate previously genotyped by Abbott RealTime HCV GT II will further determinate by Abbott HCV RealTime HCV GT Plus. All of the genotype results were validated by 5' UTR sequencing as a reference standard.
Results:
A total of 100 viremic CHC patients were recruited, including 63 G-1 patients (male: 28), and 37 patients (male: 15) of indeterminate genotyped by Abbott RealTime HCV GT II assay (HCV GT II), respectively. The detection rate of 63 GT1 samples without subtype were 93.7% (59/63), 37 indeterminate samples without genotype were 62.2 (23/37) by HCV GT Plus. 5' UTR sequencing confirmed HCV GT Plus characterized results for 84.7% (50/59) of type1, with 100% (4/4), 82.8 (24/29) and 84.6% (22/26) for 1a, 1b and type6; 65.2% (15/23) of indeterminate with 100% (3/3) and 60% (12/20) for 1b and type 6 samples, respectively.
Conclusions:
The Abbott RealTime HCV GT Plus RUO assay provides additional performance in GT detection.
