Abstract
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. 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. 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. The Abbott RealTime HCV GT Plus RUO assay provides additional performance in GT detection.
Highlights
Hepatitis C virus (HCV) is a 30–60 nm diameter, lipid-coated RNA virus and carries continuously a huge impact on liver-related events and hepatocellular carcinoma (HCC) globally [1]
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
A total of 100 viremic chronic hepatitis C (CHC) patients were recruited, including 63 G-1 patients, and 37 patients of indeterminate genotyped by Abbott RealTime HCV GT II assay (HCV GT II), respectively
Summary
Hepatitis C virus (HCV) is a 30–60 nm diameter, lipid-coated RNA virus and carries continuously a huge impact on liver-related events and hepatocellular carcinoma (HCC) globally [1]. According to the World Health Organization (WHO), there are 1.75 million new-infected cases annually, and still 75 million people have been suffering from chronic hepatitis C (CHC) worldwide. 399,000 people die directly due to CHC-related cirrhosis and HCC each year. The prevalence of anti-HCV seropositivity among adults in Taiwan was about 4.4%, much larger than other countries [2–4]. Geographic difference of prevalence exists and it could reach to 15–20% in some hyperendemic areas in South Taiwan [5–7]. 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
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