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Evaluation and Comparative Analysis of Reference Intervals and Diagnostic Performance of Different TRAb Detection Kits

Evaluation and Comparative Analysis of Reference Intervals and Diagnostic Performance of Different TRAb Detection Kits

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500112087
Enrollment
Unknown
Registered
2025-11-10
Start date
2025-11-10
Completion date
Unknown
Last updated
2025-11-24

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

Conditions

Graves’ disease

Interventions

Patients with Graves’ Disease:None
Patients with Hashimoto’s Thyroiditis:None
Patients with Subacute Thyroiditis:None
Patients with Thyroid Nodules:None

Sponsors

Guangdong Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria Patients aged >=18 years, excluding pregnant women, with complete and traceable background information. 1. Patients with Graves' Disease (GD): (1) Elevated serum thyroid hormone levels and decreased TSH levels; (2) Diffuse enlargement of the thyroid gland; (3) At least one of the following: 1) Eyelid retraction and other clinical signs suggestive of Graves' ophthalmopathy (GO); 2) Dermal mucinosis, such as pretibial myxedema or acropachy; 3) Increased radioactive iodine uptake on thyroid scintigraphy; (4) Negative or low-titer TPOAb and TgAb. 2. Patients with Hashimoto's Thyroiditis: (1) Serum TPOAb > 500 IU/mL and diffuse heterogeneous echotexture on thyroid ultrasound; (2) Normal or reduced thyroid hormone levels at present. 3. Subacute Thyroiditis: Meeting at least 4 of the following 6 criteria: (1) Acute onset, often accompanied by symptoms and signs of upper respiratory tract infection; (2) Painful, enlarged, and firm thyroid gland; (3) Accelerated erythrocyte sedimentation rate (ESR); (4) Dissociation between elevated serum thyroid hormone levels and reduced thyroid iodine uptake; (5) Transient thyrotoxicosis; (6) Negative or low-titer TgAb and TPOAb. 4. Thyroid Nodules: (1) Normal thyroid function at present; (2) Negative TgAb and TPOAb; (3) Ultrasound shows focal echogenic changes consistent with thyroid nodules (not diffuse abnormalities), with size >5 mm. 5. Healthy Individuals: (1) Normal thyroid function; (2) Negative TgAb and TPOAb; (3) Ultrasound shows normal thyroid size and nearly normal echotexture; (4) No use of medications affecting thyroid function.

Exclusion criteria

Exclusion criteria: 1. Samples with incomplete information that cannot be traced. 2. Samples with insufficient volume for testing. 3. Samples that do not meet the requirements for collection and storage. Healthy individuals should be excluded if they have had recent surgery, hospitalization, drug abuse, or other potential confounding factors.

Design outcomes

Primary

MeasureTime frame
Thyroid Stimulating Hormone Receptor Antibody;Diagnostic Performance of the TRAb Assay Kit;

Countries

China

Contacts

Public ContactGuan Haixia

Guangdong Provincial People's Hospital

1461886137@qq.com+86 185 8535 1941

Outcome results

None listed

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