Clinical Performance of BioCLIA Ro60

Withdrawn

• Conditions: Systemic Lupus Erythematosus; Sjogren's Syndrome
• Interventions: Device: BioCLIA Ro60

• Registration Number: NCT03204448
• Lead Sponsor: HOB Biotech Group

Brief Summary

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

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 Timeline

• Study Start: 2017-05-08
• Study First Submitted: 2017-06-28
• Study First Submitted QC: 2017-06-28
• Study First Posted: 2017-07-02
• Primary Completion: 2020-04-16
• Study Completion: 2020-04-16
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-01
• Last Update Posted: 2020-08-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Relevant Disease Samples	BioCLIA Ro60	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	BioCLIA Ro60	Samples are tested on BioCLIA Ro60 instrument with Ro60 assay reagents, also as comparison, tested on BioFLASH instrument with QUANTA Flash Ro60 reagents

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

CRM Biotech; 🇺🇸 Irvine, California, United States