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

Johnson & Johnson Medical, China795 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

795

Conditions

Hepatitis C

Eligibility

Sex: ALLMin age: 1 YearMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

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: 1. Errors arising during testing in which the specimen cannot be repeated shall be excluded; 2. Test results that do not pass routine quality control will not be used 3. 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. 4. Use of unqualified reagents for specimen testing.

Locations (4)

302 military hospital of China

Beijing, Beijing Municipality, China

National institues for Food and Drug control

Beijing, Beijing Municipality, China

Chinese PLA general hospital

Beijing, Beijing Municipality, China

Ruijin hospital Shanghai Jiaotong University school of medicine

Shanghai, China

Outcomes

Primary Outcomes

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.

Time frame: up to 30 weeks

Secondary Outcomes

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.

Time frame: 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.

Time frame: up to 30 weeks

Data from ClinicalTrials.gov

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