Tg Assay kit CLIA

Primary DI

06974521001645

Basic UDI-DI Code

B-06974521001645

Reference

SUPM093072

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Shenzhen Superbio Technology Co.,Ltd.

This kit is used for in vitro quantitative detection of thyroglobulin(Tg) in human serum or plasma samples. Thyroglobulin (Tg) is a glycoprotein with a molecular weight of about 660 kDa that is abundantly synthesized by thyroid cells and released into the thyroid follicular lumen. TSH, iodine deficiency in the thyroid gland, and thyroid-stimulating hormone immunoglobulin can stimulate Tg production. Tg plays a decisive role in the synthesis of peripheral thyroid hormones T3 and T4. Tg detection is mainly used for follow-up of patients after total or subtotal thyroidectomy. Since the thyroid is the only known source of Tg, after total or subtotal thyroidectomy with radioactive iodine successful ablation of residual thyroid tissue, serum Tg concentrations will drop to extremely low or even undetectable levels. For patients with partial thyroidectomy, the level of Tg detected depends on the amount of thyroid tissue remaining after surgery. If Tg can still be detected after total thyroidectomy, it indicates the residual or recurrence of DTC. Therefore, a marked increase in Tg often indicates a recurrence of the disease. All Tg results should be evaluated in conjunction with the patient's presentation, including symptoms, clinical history, other tests (color ultrasonography of the neck, full body scan), and other appropriate information. Tg autoantibodies can affect Tg test results, making them falsely high or low. Therefore anti-Tg antibody detection is recommended for all Tg samples to rule out this interference.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).