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The study is to evaluate the clinical performance of BioCLIA Ro60 for measuring the autoantibody in autoimmune disease patients.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BioCLIA Ro60 | Device | BioCLIA Ro60 is a Chemiluminescent Immuno Assay (CLIA) as a fully automated testing process, reporting with arbitrary units, RU/mL |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Method comparison between BioCLIA Ro60 and BioFlash/QUANTA Flash Ro60 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Multiple sites for clinically leftover samples accessed through Access Biologicals not confined to any demographic groups, general health status nor geographic locations
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| Name | Affiliation | Role |
|---|---|---|
| Polly Chan, PhD | CRM Biotech | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRM Biotech | Irvine | California | 92618 | United States |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D012859 | Sjogren's Syndrome |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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Clinically leftover plasma/serum
| 2 months |
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D014987 | Xerostomia |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D015352 | Dry Eye Syndromes |
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |