Clinical Performance of BioCLIA Ro60

Study Overview
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Brief Summary
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The study is to evaluate the clinical performance of BioCLIA Ro60 for measuring the autoantibody in autoimmune disease patients.

Detailed Description
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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.

Official Title
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Evaluation of Clinical Performance of Serologic Anti-Ro60 Autoantibody Detection Kit on BioCLIA Platform

Conditions
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Sjogren's Syndrome, Systemic Lupus Erythematosus

Intervention / Treatment
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* Device: BioCLIA Ro60


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Relevant Disease Samples<br>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<br>* BioCLIA Ro60 is a Chemiluminescent Immuno Assay (CLIA) as a fully automated testing process, reporting with arbitrary units, RU/mL<br>|
| Control Disease Samples<br>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<br>* BioCLIA Ro60 is a Chemiluminescent Immuno Assay (CLIA) as a fully automated testing process, reporting with arbitrary units, RU/mL<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 2 months |