【Product name】 TT4.pdf

Total Thyroxine(TT4)Rapid Quantitative Test(Fluorescence immunoassay)

【Intended use】

This kit is used for quantitative determination of TT4 in human whole blood, plasma and serum.

The hormone thyroxine (T4) is the main product secreted by the thyroid gland and incorporated into the regulatory system in the axis hypothalamus-pituitary-thyroid gland. The metabolism of the anabolic effects. Thyroxine is produced in the coupling reaction two molecules of 3,5-dijodthyrosinu in the thyroid gland. Is stored in bound form on thyroglobulin in thyroid follicle lumens and is secreted under the influence of TSH. A substantial proportion (> 99%) of total thyroxine (T4) in serum is bound to proteins. The concentration of transport proteins in serum is subject to endogenous and exogenous factors, and therefore the status of these binding proteins should be taken into account when assessing levels of thyroid hormones in serum. Apart from the that changes in protein binding may be such that metabolic status of thyroid gland evaluate incorrectly.

Determination of TT4 may have the following indications: Evaluation of hyperthyroidism, Primary and secondary hypothyroidism and TSH suppression therapy monitoring.

【Test principle】

The TT4 Rapid Test is a one-step chromatographic sandwich immunoassay designed for the quantitative measurement of TT4. The T4 antigen in the sample was first bound with the conjugated compound of fluorescent labeled T4 monoclonal antibody, then moved and combined with another T4 monoclonal antibody fixed on the nitrocellulose membrane, and the double antibody sandwich complex was formed at the detection line of the cellulose nitrate membrane. The quantitative detection results were obtained by NIR-1000 dry fluoroimmunoassay analyser.

【Storage conditions and validity】

The kit should be stored at 4℃~30℃, out of direct sunlight. It is valid for 18 months. The test card should be used within 15 minutes after unsealing under the environment of 15℃~30℃ and 20% ~ 90% relative humidity.

The production date, batch number and expiration date are shown in the outer package of the product.

【Applicable instruments】

NIR-1000 dry fluoroimmunoassay analyser produced by WWHS Biotech. Inc.

Note

1) Any variation in operator, pipetting and washing technique, incubation time or temperature, and kit age can cause variation in
result. Each user should obtain their own standard curve.
2) If samples have been diluted, the concentration read from the standard curve must be multiplied by the dilution factor.

3) If specimens generate values higher than the highest standard, dilute the specimens and repeat the assay