2020-08-012024-05-17https://scholars.lib.ntu.edu.tw/handle/123456789/678307Hepatitis C virus (HCV) infection is a global health problem and it is estimated that about 71 million people are HCV carriers worldwide. Based on the excellent efficacy and safety, interferon (IFN)-free direct acting antiviral agents (DAAs) have become the standard of care (SOC) for the care of HCV. Currently, about 10 different DAA regimens have been approved by FDA and EMA for the treatment of HCV, including genotype (GT)-specific and pan-genotypic regimens. The pre-treatment HCV genotyping testing is mandatory for patients who will receive GT-specific DAA regimens. Although pan-genotypic DAA regimens can be applied to patients infected with different HCV genotypes, the HCV genotyping testing is still necessary to decide the treatment options. Furthermore, it is also mandatory to confirm the HCV genotyping for patients who fail to prior IFN-based or IFN-free DAA therapies. Therefore, accurate HCV genotyping before the initiation of DAA treatment is of paramount importance to secure the treatment effectiveness. Nowadays, the HCV genotyping can be classified into commercial kits and in-house testing. Generally speaking, commercial-based HCV genotyping tests are the preferred choices for health care providers because they have undergone repeated and public testing with superior consistency. Prior studies focusing on the two commercial HCV genotyping testing, the Abbott RealTime HCV Genotyping II and Roche Cobas HCV Genotyping, showed that the diagnostic accuracies were about 95%. Although the overall performance of these two commercial kits is good, about 5% to 10% of patients still have erroneous or indeterminate results, making the optimized treatment decision by the health care providers difficult. Recently, a novel HCV genotyping testing, the Abbott HCV Genotype plus RUO, is developed by Abbott Diagnostic Incorporation, which assists in improving the diagnostic accuracy for indeterminate results by Abbott RealTime HCV Genotyping II. Several studies indicated that the use of Abbott HCV Genotype plus RUO may improve the diagnostic accuracy and may assist Abbott RealTime HCV Genotyping II in terms of indeterminate results. Till now, the head-to-head comparison of Abbott RealTime HCV Genotyping II, Abbott HCV Genotype plus RUO with Roche Cobas HCV Genotyping Assays for hepatitis C virus genotyping is lacking. We aim to conduct a clinical study to compare the performance of the three commercial-based HCV genotyping, taking direct sequencing as the reference standard for those with inconsistent or indeterminate results, and try to assess the underlying mechanisms for the assay uncertainty.hepatitis C virusdirect acting antiviralsviral genotyping