Clinical Performance of BioCLIA Ro60

Systemic Lupus Erythematosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03204448
• Other study ID #: CRM CSP 001
• Status: Withdrawn
• Start date: May 8, 2017
• Est. completion date: April 16, 2020

Study information

• Verified date: August 2020
• Source: HOB Biotech Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 16, 2020
• Est. primary completion date: April 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Sjogren's Syndrome
• Systemic Lupus Erythematosus

Intervention

Device:
• BioCLIA Ro60
BioCLIA Ro60 is a Chemiluminescent Immuno Assay (CLIA) as a fully automated testing process, reporting with arbitrary units, RU/mL

Locations

Country	Name	City	State
United States	CRM Biotech	Irvine	California

Sponsors (1)

Lead Sponsor	Collaborator
HOB Biotech Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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