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Clinical trial of anti-MDA5 Antibody assay kit (chemiluminescence immunoassay)

Clinical trial of anti-MDA5 Antibody assay kit (chemiluminescence immunoassay)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300068103
Enrollment
Unknown
Registered
2023-02-07
Start date
2023-02-08
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ermatomyositis, polymyositis

Interventions

Gold Standard:BlueDot Myositis12 IgG of D-tek s.a.
Index test:MDA5 antibody resistance measurement kit (chemiluminescence immunoassay)

Sponsors

Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Samples of patients clinically diagnosed or suspected to be dermatomyositis or polymyositis (patients before, after, or at different periods during treatment); 2. Samples from patients with dermatomyositis, polymyositis combined with interstitial lung disease or dermatomyositis-specific rash (positive for anti-MDA5 antibodies by any of the available methods); 3. No relevant autoimmune disease samples; 4. Specific interference samples, such as RF and ANA positive; Hemolysis, jaundice, lipid blood samples; 5. Samples from other common rheumatic patients, such as rheumatoid arthritis, scleroderma, systemic lupus erythematosus, connective tissue disease, etc.

Exclusion criteria

Exclusion criteria: 1. The sample information is not complete so that the traceability of the sample cannot be guaranteed; 2. The sample size is not enough to guarantee the test; 3. Improperly stored samples; 4. Other samples that did not meet the inclusion criteria according to the researchers.

Design outcomes

Primary

MeasureTime frame
Coincidence rate;Kappa consistency test;

Countries

China

Contacts

Public ContactDai Lie

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

liedai2004@163.com+86 136 8227 7618

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026