【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
| Assay list | Thyroid Hormone | | | | |
| cat#. | Product Item | Specimen | Reaction Time | Measure Range | Clinical Range | Intended Use |
| 15 | TSH | Serum/Plasma | 15min. | 0.3-100mU/L | 0.35-5mU/L | hyperthyroidism and hypothyroidism |
| 16 | TT3 | Serum/Plasma | 15min. | 0.5-10nmol/L | 1.3-3.1nmol/L | thyroid dysfunction |
| 17 | TT4 | Serum/Plasma | 15min. | 5-300nmol/L | 66-181nmol/L | thyroid dysfunction |
| 18 | FT3 | Serum/Plasma | 15min. | 1-100pmol/L | 4-10pmol/L | thyroid dysfunction |
| 19 | FT4 | Serum/Plasma | 15min. | 5-300pmol/L | 19-39pmol/L | thyroid dysfunction |
