1. Project Background

Thyrotropin (TSH) is a hormone secreted by the pituitary gland that regulates thyroid function. Human TSH is a glycoprotein, a hormone secreted by the anterior pituitary gland. It consists of 211 amino acids, with sugars accounting for approximately 15% of the entire molecule. The molecule is composed of two peptide chains—the alpha and beta chains—and has a molecular weight of 28,000 Daltons. TSH secretion is stimulated by thyrotropin-releasing hormone (TRH) and is secreted in pulsatile fashion around the clock. In normal individuals, TSH secretion is rhythmic, peaking at 2-4 a.m. and gradually decreasing, reaching its lowest point at 6-8 p.m. Insomnia can elevate its peak, while sleep can attenuate its pulsatility. Additionally, there are seasonal variations in TSH secretion.

TSH causes cells to proliferate in a tall columnar shape, thereby enlarging the glands. Its secretion is regulated by the hypothalamic-pituitary-thyroid axis, mediated by the hypothalamus’s release of TRH and the negative feedback loop of thyroid hormones. These regulatory mechanisms are antagonistic, maintaining a balance in thyroid function.

Changes in thyroid function lead to rapid and significant fluctuations in TSH levels, making it a sensitive indicator of the hypothalamic-pituitary-thyroid axis’s function. Clinical measurement of TSH is crucial for diagnosing various thyroid disorders, including hyperthyroidism and hypothyroidism, monitoring L-T4 replacement therapy, diagnosing Euthyroid Sick Syndrome (ESS), and identifying central hypothyroidism or inappropriate TSH secretion syndromes.

Linear range: 0.005μIU/mL to 100μIU/mL;

Lowest detection limit: 0.005μIU/mL.

No high-dose hook effect (HOOK effect) observed within 1000 μIU/mL sample concentration.

Linear range: 0.1μIU/mL to 100μIU/mL;

Lowest detection limit: 0.1μIU/mL.

No high-dose hook effect (HOOK effect) observed within 1000 μI U/mL sample concentration.

3. Clinical Relevance

3.1 Chemiluminescence (Acridinium Ester) Platform:

The luminescence value of the low-concentration part of the Seebio TSH antibody pairing (≤2μIU/mL) shows a clinical correlation coefficient greater than 0.95 with the Roche TSH reagent.

The luminescence value of the high-concentration part of Seebio TSH antibody pairing (<100μIU/mL) also exhibits a correlation coefficient greater than 0.95 with the Roche TSH reagent.

The clinical correlation between the T/C ratio of the low-value part of Seebio TSH antibody pairing (<6μIU/mL) and the Roche TSH reagent is R>0.95;

The clinical correlation R value between T/C ratio and Roche TSH reagent for the high-value part of Seebio TSH antibody pairing (<100μIU/mL) is >0.95.

4.1 Chemiluminescence (Acridinium Ester) Platform:

Antigen to be tested: Thyrotropin antigen (Cat. No.: EDD0518B)

Sample/calibrator: Volume to be added: 100 ul;

Thyroid-stimulating hormone antibody (TSH) (Cat. No.: EKY0908A) Reagent 1: Coated magnetic bead dilution, dosage 50 ul/test;

Thyroid-stimulating hormone antibody (TSH) (Cat. No.: EKY0907A) Reagent 2: Labeled acridinate dilution, dosage 50 ul/test;

Reaction conditions:

Step 1: Mix 100 ul sample with 50 ul reagent 1, incubate at 37°C for 9 minutes, and wash;

Step 2: Add 50 ul of reagent 2, mix, incubate at 37°C for 9 minutes, and wash;

Step 3: Add pre-excitation solution and excitation solution, and conduct the test.

Luminescence instrument used in the test: Cosmai SMART 500S; chemiluminescence instrument compatible with various acridinium ester systems (such as Sichuan Maccura, Shandong Kanghua Bio and Getein Bio.)

4.2 Fluorescence Immunochromatography (Lanthanide Eu Chelate Filling) Platform:

Dry type (TSH antibody-labeled fluorescent microspheres are sprayed on the release pad)

Antigen to be tested: Thyroid stimulating hormone antigen (catalog number: EDD0518B), sample/calibrator: volume to be added: 80 ul;

Reaction conditions: Mix sample with diluent (the sample is diluted 2 times this time), load sample, reaction time (10 min-15 min).

5. Product List