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

NCT ID: NCT01582594

Last Updated: 2013-06-28

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 795 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2013-01-31

Brief Summary

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

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.

Conditions

Hepatitis C

Keywords

1000 residual serum/plasma samples; anti-HCV seronegative or seropositive

Study Design

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

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson & Johnson Medical, China

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yuanli Mao, Professor

Role: PRINCIPAL_INVESTIGATOR

Beijing 302 Hospital

Yanping Luo, Professor

Role: PRINCIPAL_INVESTIGATOR

Chinese PLA General Hospital

Xinxin Zhang, Professor

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Tai Guo, Director

Role: PRINCIPAL_INVESTIGATOR

National Institites of Food and Drug control

Locations

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

Countries

China

Other Identifiers

OCD-200902

Identifier Type: -

Identifier Source: org_study_id