Clinical Performance of Abbott RealTime Hepatitis C Virus (HCV) Genotype II Test

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00979979

Collaborator

Abbott Diagnostics Division (Industry), National Science Council, Taiwan (Other), Department of Health, Executive Yuan, R.O.C. (Taiwan) (Other)

255

Enrollment

Locations

Duration (Months)

63.8

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C

Detailed Description

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).

Study Design

Study Type:

Observational

Actual Enrollment :

255 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

Clinical Performance of Abbott RealTime HCV Genotype II Test

Study Start Date :

Jul 1, 2009

Actual Primary Completion Date :

Oct 1, 2013

Actual Study Completion Date :

Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
HCV patients HCV patients with detectable viremia; all sera are tested both by Abbott RealTime HCV genotype II test and by direct HCV sequencing both at 5'UTR and NS5B
Non-HCV patients Patient without evidence of HCV infection (negative both for anti-HCV and HCV RNA); all sera are both tested by Abbott RealTime HCV genotype II test and by direct HCV sequencing at 5'UTR and NS5B

Outcome Measures

Primary Outcome Measures

Diagnostic accuracy for HCV genotype testing [7 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	Country
1	National Taiwan University Hospital, Yun-Lin Branch	Douliou	Taiwan
2	Far Eastern Memorial Hospital	Taipei	Taiwan
3	National Taiwan University Hospital	Taipei	Taiwan
4	Taipei Municipal Hospital, Ren-Ai Branch	Taipei	Taiwan

Sponsors and Collaborators

National Taiwan University Hospital
Abbott Diagnostics Division
National Science Council, Taiwan
Department of Health, Executive Yuan, R.O.C. (Taiwan)

Investigators

Study Chair: Chen-Hua Liu, MD, National Taiwan University Hospital
Study Director: Jia-Horng Kao, MD, PhD, National Taiwan University Hospital
Principal Investigator: Chun-Jen Liu, MD, PhD, National Taiwan University Hospital
Principal Investigator: Cheng-Chao Liang, MD, BS, Far Eastern Memorial Hospital
Principal Investigator: Chih-Lin Lin, MD, BS, Taipei Municipal Hospital, Ren-Ai Branch
Principal Investigator: Chen-Hua Liu, MD, National Taiwan University Hospital, Yun-Lin Branch