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

NCT01582594 | Terminated

• 1 other identifier: OCD-200902
• Study Type: observational
• Target: 795
• Locations: 1 country
• Sites: 4

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

Conditions

Hepatitis C

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• the effect and applicability of different sample types on RIBA test results

  up to 30 weeks

• potential interference in RIBA

  up to 30 weeks

Eligibility Criteria

• Age: 1 Year - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johnson & Johnson Medical, China: lead

Study Sites (4)

302 military hospital of China

Beijing, Beijing Municipality, 100039, China

Location

National institues for Food and Drug control

Beijing, Beijing Municipality, 100050, China

Location

Chinese PLA general hospital

Beijing, Beijing Municipality, 100852, China

Location

Ruijin hospital Shanghai Jiaotong University school of medicine

Shanghai, 200027, China

Location

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.

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Yuanli Mao, Professor

  Beijing 302 Hospital

  PRINCIPAL INVESTIGATOR

• Yanping Luo, Professor

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

• Xinxin Zhang, Professor

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

• Tai Guo, Director

  National Institites of Food and Drug control

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2012
• First Posted: April 20, 2012
• Study Start: February 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: January 1, 2013
• Last Updated: June 28, 2013

Record last verified: 2012-05

Locations

CN (4)