Clinical Performance of Abbott RealTime Hepatitis C Virus (HCV) Genotype II Test
Clinical Performance of Abbott RealTime Hepatitis C Virus (HCV) Genotype II Test
Hepatitis C virus (HCV) infection, a leading cause of cirrhosis, hepatocellular carcinoma
 (HCC) and liver transplantation, affects approximately 170 million individuals worldwide.
 Combination of peginterferon plus ribavirin therapy has become the current standard of care
 for chronic hepatitis C (CHC) patients, with an overall sustained virologic response (SVR)
 rate of 54-63% and more favorable response rates in patients with genotype 2/3 infection than
 those with genotype 1/4 infection. Therefore, accurate pre-treatment HCV genotype evaluation
 is of paramount importance to facilitate individualized therapy in the era of response guide
 therapy and specific-targeted antiviral therapy for HCV (STAT-C).

 Currently, direct HCV genetic sequencing for both the 5' untranslated terminal region (5'UTR)
 and non-structural 5B (NS5B) regions with subsequent phylogenetic tree analysis is considered
 the gold standard for determining HCV genotype and subtype. However, it is time-consuming and
 need special laboratory settings. Several commercial available reverse hybridization with
 type-specific probing assay (Inno-LiPA II) or simplified direct sequencing of the 5'UTR
 region were used to replace the two region sequencing method (Trugene HCV 5' NC genotyping
 kit). Nonetheless, data on the overall diagnostic accuracy varied.

 The Abbott RealTime HCV Genotype II is an in vitro reverse transcription-polymerase chain
 reaction (RT-PCR) assay for determining the genotype(s) of HCV in plasma and serum from
 HCV-infected individuals. Based on genetic similarity, HCV has been classified into six major
 genotypes (1-6) and numerous subtypes. HCV genotype is predictive of the response of
 HCV-infected patients to peginterferon plus ribavirin combination therapy. The Abbott
 RealTime HCV Genotype II assay uses the Abbott m2000sp instrument for processing samples and
 the Abbott m2000rt instrument for amplification and detection. Furthermore, the Abbott
 m2000sp provides automated sample transfer and reaction assembly of the assay reagents in the
 Abbott 96-Well Optical Reaction Plate.

 The investigators aimed to evaluate the overall diagnostic accuracy of the currently
 available commercial HCV genotype kits (Abbott RealTime HCV Genotype II) by using 5'UTR and
 NS5A gene amplification and direct sequencing as the gold standard.
Hepatitis C virus (HCV) infection, a leading cause of cirrhosis, hepatocellular carcinoma
 (HCC) and liver transplantation, affects approximately 170 million individuals worldwide.
 Therefore, prevention of HCV transmission and early intervention of HCV infection are
 urgently needed to reduce or halt the liver-related morbidity and mortality. Combination of
 peginterferon plus ribavirin therapy has become the current standard of care for chronic
 hepatitis C (CHC) patients, with an overall sustained virologic response (SVR) rate of 54-63%
 and more favorable response rates in patients with genotype 2/3 infection than those with
 genotype 1/4 infection. Therefore, accurate pre-treatment HCV genotype evaluation is of
 paramount importance to facilitate individualized therapy in the era of response guide
 therapy and specific-targeted antiviral therapy for HCV (STAT-C).

 Currently, direct HCV genetic sequencing for both the 5' untranslated terminal region (5'UTR)
 and non-structural 5B (NS5B) regions with subsequent phylogenetic tree analysis is considered
 the gold standard for determining HCV genotype and subtype. However, it is time-consuming and
 need special laboratory settings. Several commercial available reverse hybridization with
 type-specific probing assay (Inno-LiPA II) or simplified direct sequencing of the 5'UTR
 region were used to replace the two region sequencing method (Trugene HCV 5' NC genotyping
 kit). Nonetheless, data on the overall diagnostic accuracy varied.

 The Abbott RealTime HCV Genotype II is an in vitro reverse transcription-polymerase chain
 reaction (RT-PCR) assay for determining the genotype(s) of HCV in plasma and serum from
 HCV-infected individuals. Based on genetic similarity, HCV has been classified into six major
 genotypes (1-6) and numerous subtypes. HCV genotype is predictive of the response of
 HCV-infected patients to peginterferon plus ribavirin combination therapy. The Abbott
 RealTime HCV Genotype II assay uses the Abbott m2000sp instrument for processing samples and
 the Abbott m2000rt instrument for amplification and detection. Furthermore, the Abbott
 m2000sp provides automated sample transfer and reaction assembly of the assay reagents in the
 Abbott 96-Well Optical Reaction Plate.

 The investigators aimed to evaluate the overall diagnostic accuracy of the currently
 available commercial HCV genotype kits (Abbott RealTime HCV Genotype II) by using 5'UTR and
 NS5A gene amplification and direct sequencing as the gold standard.
Inclusion Criteria:

 -  HCV patients with both positive for anti-HCV and HCV RNA (Cobas Taqman, Roche
 Diagnostics, LOQ:25 IU/mL and LOD:10 IU/mL)

 -  Patients with signed informed consent

 Exclusion Criteria:

 -  Patients without signed informed consent

 -  HCV patients without detectable HCV RNA (Cobas Taqman, Roche Diagnostics)