A Registration Study to Evaluate the Performance of CHIRON® RIBA® HCV 3.0 SIA in HCV Antibody Detection
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
To evaluate the accuracy of the CHIRON® RIBA® HCV 3.0 (RIBA, Investigational Product) test using known anti-HCV seropositive and seronegative specimens.
Registration for license application
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | A Registration Study to Evaluate the Performance of CHIRON® RIBA® HCV 3.0 SIA in HCV Antibody Detection |
- To evaluate the accuracy of the CHIRON® RIBA® HCV 3.0 [ Time Frame: up to 30 weeks ] [ Designated as safety issue: No ]To evaluate the accuracy of the CHIRON® RIBA® HCV 3.0 (RIBA, Investigational Product) test using known anti-HCV seropositive and seronegative specimens.
- the effect and applicability of different sample types on RIBA test results [ Time Frame: up to 30 weeks ] [ Designated as safety issue: No ]To evaluate the effect and applicability of different sample types on RIBA test results through the tests of the investigational product on serum and plasma collected from the same donors.
- potential interference in RIBA [ Time Frame: up to 30 weeks ] [ Designated as safety issue: No ]The specimens with HAV IgG positive, or HBsAg positive, or HEV IgG positive, or anti-HIV positive will be collected and tested for potential interference in the investigational product when used for testing the specimens infected by viruses other than HCV
Biospecimen Retention: Samples With DNA
A minimum of 1000 qualified specimens shall be collected, including at least 350 anti-HCV seropositive specimens.
To further evaluate RIBA test specificity in HAV IgG positive, HBsAg positive, HEV IgG positive and anti-HIV positive specimens, approximately 30 specimens of each viral infection will be included in the study.
A minimum of 60 matched plasma and serum specimens will be collected to evaluate the applicability of the investigational product on different types of samples, including at least 30% of anti-HCV seropositive specimens.
| Estimated Enrollment: | 1000 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
To evaluate the accuracy of the CHIRON® RIBA® HCV 3.0 (RIBA, Investigational Product) test using known anti-HCV seropositive and seronegative specimens.
To evaluate the effect and applicability of different sample types on RIBA test results through the tests of the investigational product on serum and plasma collected from the same donors.
The specimens with HAV IgG positive, or HBsAg positive, or HEV IgG positive, or anti-HIV positive will be collected and tested for potential interference in the investigational product when used for testing the specimens infected by viruses other than HCV.
This clinical trial is for registration purpose, the study data will be submitted to Regulatory Authority (SFDA) for license application for CHIRON®RIBA®HCV 3.0 SIA reagent.
Eligibility| Ages Eligible for Study: | 1 Year to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
The specimens used for this study will be pre-tested by licensed anti-HCV screening methods and / or Nucleic acid test (NAT) in combination with the past history and will be classified as either seronegative or seropositive.
Inclusion Criteria:
- Residual serum or plasma specimens after routine clinical testing; fresh specimens or frozen specimens stored at -20°C or lower within 2 years after collection, with sufficient volume (≥0.5 mL) to complete all the study tests ; 2) Residual serum or plasma specimen is acceptable; matched serum and plasma with EDTA, heparin or citrate used as the anticoagulant. The collection and preparation of the specimens should comply with the standard laboratory operation procedures and the instruction for use (IFU).
Exclusion Criteria:
- Severely hemolytic or turbid specimens; 2) Bacterial contaminated specimens; 3) Specimens that are improperly collected, prepared, or stored or not in accordance with package insert instructions.
Elimination criteria:
- Errors arising during testing in which the specimen cannot be repeated shall be excluded;
- Test results that do not pass routine quality control will not be used
- Any specimen in which the case report form has incomplete data, or the case report form is missing the principal investigator's signature will not be used in the study. Case report forms with missing data will have an explanation for the missing data and should be signed by the principal investigator.
- Use of unqualified reagents for specimen testing.
Contacts and Locations| China, Beijing | |
| 302 military hospital of China | Recruiting |
| Beijing, Beijing, China, 100039 | |
| Contact: Lin Chen, technician 010-66933114 ext 6245 chenmedic@163.com | |
| Principal Investigator: Yuanli Mao, professor | |
| Chinese PLA general hospital | Not yet recruiting |
| Beijing, Beijing, China, 100852 | |
| Contact: Gang Chen, technician 13699205949 chen_gang326@163.com | |
| Principal Investigator: Yanping Luo, professor | |
| National institues for Food and Drug control | Recruiting |
| Beijing, Beijing, China, 100050 | |
| Contact: Yan Liu, technician 13520557682 94670465@qq.com | |
| Principal Investigator: Tai Guo, Director | |
| China, Shang hai | |
| Ruijin hospital Shanghai Jiaotong University school of medicine | Recruiting |
| Shang hai, Shang hai, China, 200027 | |
| Contact: Gendi Jin, physician 13501806326 JinGD690@163.com | |
| Contact: Deqi Qiu, technician 13636304153 RJQDQ@126.com | |
| Principal Investigator: Xinxin Zhang, Professor | |
| Principal Investigator: | Yuanli Mao, Professor | 302 military hospital of China |
| Principal Investigator: | Yanping Luo, Professor | Chinese PLA General Hospital |
| Principal Investigator: | Xinxin Zhang, Professor | Ruijin hospital Shanghai Jiaotong University school of medicine |
| Principal Investigator: | Tai Guo, Director | National Institites of Food and Drug control |
More Information
No publications provided
| Responsible Party: | Johnson & Johnson Medical, China |
| ClinicalTrials.gov Identifier: | NCT01582594 History of Changes |
| Other Study ID Numbers: | OCD-200902 |
| Study First Received: | April 19, 2012 |
| Last Updated: | June 20, 2012 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Johnson & Johnson Medical, China:
|
1000 residual serum/plasma samples anti-HCV seronegative or seropositive |
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 Hepatitis C Antibodies Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013