A Registration Study to Evaluate the Performance of CHIRON® RIBA® HCV 3.0 SIA in HCV Antibody Detection

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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A Registration Study to Evaluate the Performance of CHIRON® RIBA® HCV 3.0 SIA in HCV Antibody Detection

Conditions
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Hepatitis C

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the accuracy of the CHIRON® RIBA® HCV 3.0 | To evaluate the accuracy of the CHIRON® RIBA® HCV 3.0 (RIBA, Investigational Product) test using known anti-HCV seropositive and seronegative specimens. As the study early terminated,no evaluation performed. | up to 30 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the effect and applicability of different sample types on RIBA test results | 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.As the study early terminated,no evaluation performed. | up to 30 weeks | 
| potential interference in RIBA | 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. As the study early terminated,no evaluation performed. | up to 30 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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1000 residual serum/plasma samples, anti-HCV seronegative or seropositive