Clinical Performance of Abbott RealTime Hepatitis C Virus (HCV) Genotype II Test
Recruitment status was Recruiting
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Purpose
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 |
|---|
|
Hepatitis C |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Cross-Sectional |
| Official Title: | Clinical Performance of Abbott RealTime HCV Genotype II Test |
- Diagnostic accuracy for HCV genotype testing [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Patient stored serum with detectable HCV RNA levels
| Estimated Enrollment: | 198 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | October 2010 |
| Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
180 HCV patients both positive for anti-HCV and HCV RNA and 18 patients without ant-HCV and HCV RNA; all 198 patients were tested for Abbott RealTime genotype II test and direct HCV sequencing at 5'UTR and NS5B for the sensitivity, specificity, and the overall diagnostic accuracy.
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| Contact: Chen-Hua Liu, MD | 886-2-23123456 ext 63572 | jacque_liu@mail2000.com.tw |
| Contact: Jia-Horng Kao, MD, PhD | 886-2-23123456 ext 67307 | kaojh@ntu.edu.tw |
| Taiwan | |
| National Taiwan University Hospital, Yun-Lin Branch | Recruiting |
| Douliou, Taiwan | |
| Contact: Shih-Jer Hsu, MD | |
| Principal Investigator: Shih-Jer Hsu, MD | |
| Sub-Investigator: Chieh-Chang Chen, MD | |
| Sub-Investigator: Ming-Lun Han, MD | |
| Sub-Investigator: Ji-Yuh Lee, MD | |
| Sub-Investigator: Yu-Jen Fang, MD | |
| National Taiwan University Hospital | Recruiting |
| Taipei, Taiwan | |
| Contact: Chen-Hua Liu, MD | |
| Contact: Jia-Horng Kao, MD, PhD | |
| Principal Investigator: Chen-Hua Liu, MD | |
| Principal Investigator: Jia-Horng Kao, MD, PhD | |
| Principal Investigator: Chun-Jen Liu, MD, PhD | |
| Sub-Investigator: Ming-Yang Lai, MD, PhD | |
| Sub-Investigator: Pei-Jer Chen, MD, PhD | |
| Sub-Investigator: Ding-Shinn Chen, MD | |
| Far Eastern Memorial Hospital | Recruiting |
| Taipei, Taiwan | |
| Contact: Cheng-Chao Liang, MD, BS | |
| Principal Investigator: Cheng-Chao Liang, MD, BS | |
| Taipei Municipal Hospital, Ren-Ai Branch | Recruiting |
| Taipei, Taiwan | |
| Contact: Chih-Lin Lin, MD, BS | |
| Principal Investigator: Chih-Lin Lin, MD, BS | |
| 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: | Shih-Jer Hsu, MD | National Taiwan University Hospital, Yun-Lin Branch |
| Principal Investigator: | Cheng-Chao Liang, MD, BS | Far Eastern Memorial Hospital |
| Principal Investigator: | Chih-Lin Lin, MD, BS | Taipei Municipal Hospital, Ren-Ai Branch |
More Information
No publications provided
| Responsible Party: | Chen-Hua Liu, National Taiwan University Hospital |
| ClinicalTrials.gov Identifier: | NCT00979979 History of Changes |
| Other Study ID Numbers: | 200906047D |
| Study First Received: | September 16, 2009 |
| Last Updated: | March 25, 2010 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by National Taiwan University Hospital:
|
Hepatitis C Genotype Realtime PCR |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis C Liver Diseases Digestive System Diseases Hepatitis, Viral, Human |
Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections |
ClinicalTrials.gov processed this record on May 23, 2013