Clinical trial NCT01582594: A Registration Study to Evaluate the Performance of CHIRON® RIBA® HCV 3.0 SIA in HCV Antibody Detection
Official title: A Registration Study to Evaluate the Performance of CHIRON® RIBA® HCV 3.0 SIA in HCV Antibody Detection
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hepatitis C
Keywords: 1000 residual serum/plasma samples
anti-HCV seronegative or seropositive
Lead sponsor: Johnson & Johnson Medical, China
Sponsor class: INDUSTRY
First posted: 2012-04-20
Enrollment: 795
Sex: ALL
Minimum age (years): 1
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

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.

Primary outcomes:
measure: To evaluate the accuracy of the CHIRON® RIBA® HCV 3.0
timeFrame: up to 30 weeks
Secondary outcomes:
measure: the effect and applicability of different sample types on RIBA test results
timeFrame: up to 30 weeks
measure: potential interference in RIBA
timeFrame: up to 30 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: 302 military hospital of China
state: Beijing
city: Beijing
country: China
facility: National institues for Food and Drug control
state: Beijing
city: Beijing
country: China
facility: Chinese PLA general hospital
state: Beijing
city: Shang hai
country: China
facility: Ruijin hospital Shanghai Jiaotong University school of medicine
Study officials:
affiliation: Beijing 302 Hospital
name: Yuanli Mao, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Chinese PLA General Hospital
name: Yanping Luo, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Ruijin Hospital
name: Xinxin Zhang, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institites of Food and Drug control
name: Tai Guo, Director
role: PRINCIPAL_INVESTIGATOR
References: