Study Stopped
Evaluation halted
Clinical Performance of BioCLIA Ro60
Evaluation of Clinical Performance of Serologic Anti-Ro60 Autoantibody Detection Kit on BioCLIA Platform
1 other identifier
observational
N/A
1 country
1
Brief Summary
The study is to evaluate the clinical performance of BioCLIA Ro60 for measuring the autoantibody in autoimmune disease patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 8, 2017
CompletedFirst Submitted
Initial submission to the registry
June 28, 2017
CompletedFirst Posted
Study publicly available on registry
July 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 16, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 16, 2020
CompletedAugust 4, 2020
August 1, 2020
2.9 years
June 28, 2017
August 1, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical performance of BioCLIA Ro60
About 500 μl or more of each de-identified sample, in the form of serum or plasma, will be tested on-board with the automated BioCLIA serologic antinuclear antibodies (ANA) assay. Result will be reported in the form or IU/ml of antibodies in the samples. Clinical sensitivity of BioCLIA Ro60 will be determined by dividing the number of Ro60 positives by the number of relevant disease samples. Clinical specificity of BioCLIA will be determined by dividing the number of Ro60 negatives by the number of control disease samples.
10 months
Secondary Outcomes (1)
Method comparison between BioCLIA Ro60 and BioFlash/QUANTA Flash Ro60
2 months
Study Arms (2)
Relevant Disease Samples
Samples are tested on BioCLIA Ro60 instrument with Ro60 assay reagents, also as comparison, tested on BioFLASH instrument with QUANTA Flash Ro60 reagents
Control Disease Samples
Samples are tested on BioCLIA Ro60 instrument with Ro60 assay reagents, also as comparison, tested on BioFLASH instrument with QUANTA Flash Ro60 reagents
Interventions
BioCLIA Ro60 is a Chemiluminescent Immuno Assay (CLIA) as a fully automated testing process, reporting with arbitrary units, RU/mL
Eligibility Criteria
Multiple sites for clinically leftover samples accessed through Access Biologicals not confined to any demographic groups, general health status nor geographic locations
You may qualify if:
- Diagnosed with relevant diseases, including Systemic lupus erythematosus (SLE) and Sjogren's syndrome (SS)
- Or diagnosed with other control diseases, including Rheumatoid arthritis (RA), Infectious diseases and others
You may not qualify if:
- Treatment with medicine that submerge the autoantibody concentration to non-detectable range
- Co-diagnosed with multiple relevant diseases (e.g., SLE / SS) and/or control diseases
- Hemolyzed sample.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CRM Biotech
Irvine, California, 92618, United States
Biospecimen
Clinically leftover plasma/serum
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Polly Chan, PhD
CRM Biotech
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2017
First Posted
July 2, 2017
Study Start
May 8, 2017
Primary Completion
April 16, 2020
Study Completion
April 16, 2020
Last Updated
August 4, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share