NCT03204448

Clinical Performance of BioCLIA Ro60

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

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: HOB Biotech Group · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Systemic Lupus Erythematosus
• Sjogren's Syndrome

Interventions

Type	Name	Description
DEVICE	BioCLIA Ro60	BioCLIA Ro60 is a Chemiluminescent Immuno Assay (CLIA) as a fully automated testing process, reporting with arbitrary units, RU/mL

Timeline

• Start date: 2017-05-08
• Primary completion: 2020-04-16
• Completion: 2020-04-16
• First posted: 2017-07-02
• Last updated: 2020-08-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study