This study was reviewed and approved by Institutional Review Board, Kaohsiung Medical University Hospital (KMUH/IRB/AF/2.8-01-11.0). The study was conducted in one medical centre and 2 regional hospitals in Southern Taiwan. We recruited those CHC patients with age and HCV viral loads criteria were over 20 years old above and over 500 IU/mL, respectively. All participants were informed of the research content and signed a written consent form. People with not detected for HCV RNA were suitable as negative control group. We also recruited the HCV genotype 1 with subtype 1a or 1b and genotype 6 previously genotyped by Abbott RealTime HCV GT II as positive control group. The patient’s serum samples were determinate for genotype from Oct 2017 through Aug 2018. All the eligible patients 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. The patients with other viral infections such as HIV or HBV were excluded.
Huang Y.C., Huang C.F., Liu S.F., Liu H.Y., Yeh M.L., Huang C.I., Hsieh M.H., Dai C.Y., Chen S.C., Yu M.L., Chuang W.L, & Huang J.F. (2021). The performance of HCV GT plus RUO reagent in determining Hepatitis C virus genotypes in Taiwan. PLoS ONE, 16(1), e0246376.
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