Clinical Performance of BioCLIA Ro60

NCT ID: NCT03204448

Last Updated: 2020-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-08

Study Completion Date

2020-04-16

Brief Summary

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

Detailed Description

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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

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Systemic Lupus Erythematosus Sjogren's Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

BioCLIA Ro60

Intervention Type DEVICE

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

BioCLIA Ro60

Intervention Type DEVICE

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

Interventions

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BioCLIA Ro60

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HOB Biotech Group

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Polly Chan, PhD

Role: PRINCIPAL_INVESTIGATOR

CRM Biotech

Locations

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CRM Biotech

Irvine, California, United States

Site Status

Countries

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United States

Other Identifiers

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CRM CSP 001

Identifier Type: -

Identifier Source: org_study_id

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