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

NCT ID: NCT00979979

Last Updated: 2014-10-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 255 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2013-10-31

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.

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).

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.

Conditions

Hepatitis C

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Diagnostics Division

INDUSTRY

Sponsor Role: collaborator

National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role: collaborator

Department of Health, Executive Yuan, R.O.C. (Taiwan)

OTHER_GOV

Sponsor Role: collaborator

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

National Taiwan University Hospital

National Taiwan University Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chen-Hua Liu, MD

Role: STUDY_CHAIR

National Taiwan University Hospital

Jia-Horng Kao, MD, PhD

Role: STUDY_DIRECTOR

National Taiwan University Hospital

Chun-Jen Liu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Cheng-Chao Liang, MD, BS

Role: PRINCIPAL_INVESTIGATOR

Far Eastern Memorial Hospital

Chih-Lin Lin, MD, BS

Role: PRINCIPAL_INVESTIGATOR

Taipei Municipal Hospital, Ren-Ai Branch

Chen-Hua Liu, MD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital, Yun-Lin Branch

Locations

National Taiwan University Hospital, Yun-Lin Branch

Douliu, , Taiwan

Far Eastern Memorial Hospital

Taipei, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Taipei Municipal Hospital, Ren-Ai Branch

Taipei, , Taiwan

Countries

Taiwan

References

Liu CH, Liang CC, Liu CJ, Lin CL, Su TH, Yang HC, Chen PJ, Chen DS, Kao JH. Comparison of Abbott RealTime HCV Genotype II with Versant line probe assay 2.0 for hepatitis C virus genotyping. J Clin Microbiol. 2015 May;53(5):1754-7. doi: 10.1128/JCM.03548-14. Epub 2015 Mar 4.

Reference Type: DERIVED

PMID: 25740780 (View on PubMed)

Other Identifiers

200906047D

Identifier Type: -

Identifier Source: org_study_id