Clinical Performance of BioCLIA Ro60

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

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

Study Overview

• Status: Withdrawn
• Conditions: Systemic Lupus Erythematosus; Sjogren's Syndrome
• Intervention / Treatment: Device: BioCLIA Ro60

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 Type: Observational

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92618
      • CRM Biotech

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Multiple sites for clinically leftover samples accessed through Access Biologicals not confined to any demographic groups, general health status nor geographic locations

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: HOB Biotech Group
• Investigators: Principal Investigator: Polly Chan, PhD, CRM Biotech

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 8, 2017
• Primary Completion (ANTICIPATED): April 16, 2020
• Study Completion (ANTICIPATED): April 16, 2020

Study Registration Dates

• First Submitted: June 28, 2017
• First Submitted That Met QC Criteria: June 28, 2017
• First Posted (ACTUAL): July 2, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 4, 2020
• Last Update Submitted That Met QC Criteria: August 1, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Eye Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Stomatognathic Diseases; Mouth Diseases; Lacrimal Apparatus Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Lupus Erythematosus, Systemic; Sjogren's Syndrome
• Other Study ID Numbers: CRM CSP 001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No