Clinical Performance of BioCLIA Ro60
Study Details
Study Description
Brief Summary
The study is to evaluate the clinical performance of BioCLIA Ro60 for measuring the autoantibody in autoimmune disease patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
100-200 clinically-diagnosed disease samples, as well as approximately 300 samples of various control diseases, will be used in the study. The specimen will be collected as the clinically leftover samples that have been used for routine clinical diagnosis purpose or research purpose, and with de-identification methods. Each set of samples will also be tested on a control serologic Anti-Ro60 detection kit, QUANTA Flash Ro60. Clinical sensitivity and clinical specificity will be analyzed for, also a method comparison conclusion will be drawn by comparing the two methods.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 |
Device: BioCLIA Ro60
BioCLIA Ro60 is a Chemiluminescent Immuno Assay (CLIA) as a fully automated testing process, reporting with arbitrary units, RU/mL
|
| 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 |
Device: BioCLIA Ro60
BioCLIA Ro60 is a Chemiluminescent Immuno Assay (CLIA) as a fully automated testing process, reporting with arbitrary units, RU/mL
|
Outcome Measures
Primary Outcome Measures
- Clinical performance of BioCLIA Ro60 [10 months]
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.
Secondary Outcome Measures
- Method comparison between BioCLIA Ro60 and BioFlash/QUANTA Flash Ro60 [2 months]
The same samples tested in BioCLIA Ro60 will be tested on-board with the automated BioFLASH instrument with QUANTA Flash Ro60 reagents. Result will be reported in the form of CU of antibodies in the samples. Clinical sensitivity of BioFLASH/QUANTA Flash Ro60 will be determined by dividing the number of Ro60 positives by the number of relevant disease samples. Clinical specificity of BioFLASH/QUANTA Flash Ro60 will be determined by dividing the number of Ro60 negatives by the number of control disease samples. Degree of agreement between BioCLIA Ro60 and BioFLASH/QUANTA Flash Ro60 will be calculated.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosed with relevant diseases, including Systemic lupus erythematosus (SLE) and Sjogren's syndrome (SS)
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Or diagnosed with other control diseases, including Rheumatoid arthritis (RA), Infectious diseases and others
Exclusion Criteria:
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Treatment with medicine that submerge the autoantibody concentration to non-detectable range
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Co-diagnosed with multiple relevant diseases (e.g., SLE / SS) and/or control diseases
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Hemolyzed sample.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CRM Biotech | Irvine | California | United States | 92618 |
Sponsors and Collaborators
- HOB Biotech Group
Investigators
- Principal Investigator: Polly Chan, PhD, CRM Biotech
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CRM CSP 001