【Product Name】Detection Kit for free thyroxine (FT4)  (Enhanced chemiluminescence immunoassay)

【registration certificate number】 京食药监械（准）字2014第2400138号

【Packing】48 tests/box，96 tests/box.

【Storage conditions and validity】Storage at  2 ~ 8℃，validity for 6 months.

         This kit is mainly used for quantitative determination of free thyroxine (FT4) in human serum in vitro.

After the release of Thyroxine (T4) into the blood, most of it was combined with plasma protein, and only about 0.03% of T4 was in free state (FT4) in the blood. FT4 enters the target cell to play a role, and it is one of the most accurate indicators of thyroid function. Determination of the content of FT4 in serum is one of the most sensitive indicators for the thyroid function. For the diagnosis of hypothyroidism, FT4 is more sensitive than FT3. Thyroid function in pregnant women or in critical non-thyroid diseases such as cirrhosis and renal failure is of great value. In particular, the content of FT4 is more valuable when the function of central nervous thyroid is low.

This kit uses competitive approach. Microplates were coated with purified FT4 antibody to make a solid-phase antibody, in the competitive reaction, a certain amount of solid-phase antibody has competitive reaction with HRP-labeled FT4 and non-labeled FT4 (standard or test sample), the binding amount of antibody to HRP-labeled FT4 is inhibited by non-labeled FT4. The more non-labeled FT4, the less binding amount of antibody to HRP-labeled FT3, on the contrary the more binding. Unbound HRP-labeled T4 was removed after immunoreactivity. The luminescent substrate was added and the luminescence (RLU value) was measured with a photon counter.  With the increase of FT4 concentration, the value of RLU decreased gradually to a certain linear relationship. Instrument software will automatically calculate the FT4 content in the sample.

11. High Sensitivity: chemiluminescence immuno assay can detect the substance that 

1. Hyperthyroidism:

It is commonly in young women. Clinical manifestations are mainly caused by excessive circulation of thyroid hormone, the symptoms is irritability, insomnia, heart palpitations, fatigue, fear of heat, sweating, weight loss, bulimia, increased stool frequency or diarrhea, menstrual scarce. In physical examination, most patients have varying degrees of goiter, it is diffuse, medium texture and no tenderness. Some patients have exophthalmia.

2. Thyroid inflammation:

① Subacute thyroiditis is often secondary to upper respiratory tract infection, the incidence of spring and autumn are often more. Subacute thyroiditis most occurred in women aged 40-50 years, it is mainly manifested as neck pain, thyroid tenderness on one side, and may appear fever, joint pain and other systemic inflammatory response. Some patients may be hyperthyroidism. Most patients have a severe thyroid gland swelling on one side.

② Chronic lymphocytic thyroiditis, also known as Hashimoto's thyroiditis. It is commonly in women in 30-60 years old. Common symptoms are generalized weakness, most patients have no neck discomfort, but a small number of patients will have partial pressure and neck pain. The thyroid are mostly bilateral symmetry enlargement in examination and isthmus also increased. Tough texture, the surface is more smooth or nodular. A small number of patients may be accompanied by cervical lymph nodes, but soft.

3. Thyroid tumor:

①Thyroid benign tumor is mainly thyroid adenoma. It is mostly occurred in young adults. Clinical manifestations are mostly cervical anterior mass, slow growth and no conscious symptoms. The surface of the physical examination is smooth, soft or tough, the boundary is clear, and can be swallowed up and down. Such as adenoma hemorrhage, mass can be rapidly increased accompanied with local pain, these symptoms can generally disappear within 1-2 weeks.

②Thyroid malignancies with differentiated thyroid cancer are more common in women, it commonly occurs at age of 30-60 years old. Differentiated thyroid cancer develops slowly, the patient can find a painless mass that is gradually increasing in the neck, which has been unintentionally detected by themselves or by a physical examination, or found in B ultrasound examination. Physical examination of cancer more than hard quality, the surface can be smooth, border or clear. If the cancer is limited in the thyroid gland, it can swallow up and down activities; if the cancer is located in trachea or adjacent tissue, it's more fixed.

Clinical laboratory, physical examination center.