Clinical Performance of BioCLIA Ro60

HOB Biotech Group

Status: Withdrawn

Conditions: Sjogren's Syndrome; Systemic Lupus Erythematosus

Treatments: Device: BioCLIA Ro60

Study type: Observational

Funder types: Industry

Identifiers

NCT03204448

CRM CSP 001

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

0 participants in 2 patient groups

Relevant Disease Samples

Description:

Samples are tested on BioCLIA Ro60 instrument with Ro60 assay reagents, also as comparison, tested on BioFLASH instrument with QUANTA Flash Ro60 reagents

Treatment:

Device: BioCLIA Ro60

Control Disease Samples

Description:

Samples are tested on BioCLIA Ro60 instrument with Ro60 assay reagents, also as comparison, tested on BioFLASH instrument with QUANTA Flash Ro60 reagents

Treatment:

Device: BioCLIA Ro60