A rapid test for measuring hyroid-stimulating hormone in Serum /Plasma with the use of Fiatest TM Go fluorescence Immunoassay Analyzer. For professional in vitro diagnostic use only.
TSH Test Cassette (Immunofluorescence Assay) is intended for in vitro quantitative determination of Thyroid Stimulating Hormone (TSH) in serum, plasma. Measurement of TSH is useful to aid in the screening the adult population for primary hypothyroidism by medical professionals. It could also be used in screening neonates for hypothyroidism.
Thyroid-stimulating hormone (also known as thyrotropin, thyrotropic hormone, TSH, or hTSH for human TSH) is a pituitary hormone that stimulates the thyroid gland to produce thyroxine (T4), and then triiodothyronine (T3) which stimulates the metabolism of almost every tissue in the body. It is a glycoprotein hormone synthesized and secreted by thyrotrope cells in the anterior pituitary gland, which regulates the endocrine function of the thyroid.
TSH (with a half life of about an hour) stimulates the thyroid gland to secrete the hormone thyroxine (T4), which has only a slight effect on metabolism. T4 is converted to triiodothyronine (T3), which is the active hormone that stimulates metabolism. About 80% of this conversion is in the liver and other organs, and 20% in the thyroid itself.  Laboratory testing of thyroid stimulating hormone* levels in the blood is considered the best initial test for hypothyroidism. It is important to note the statement from the Subclinical Thyroid Disease Consensus Panel: “There is no single level of serum TSH at which clinical action is always either indicated or contraindicated. The higher the TSH, the more compelling is the rationale for treatment. It is important to consider the individual clinical context (e.g. pregnancy, lipid profile, ATPO antibodies).
How to use?
Refer to Fiatest TM Go Fluorescence Immunoassay Analyzer Operation Manual for the complete instructions on use of the Test. The test should be in room temperature.
Allow the test, specimen, buffer and/or controls to reach room temperature (15-30 °C) prior to testing.
1. Turn on the Analyzer power. Then according to the need, select “Standard test” or “Quick test” mode.
2. Remove the ID card and insert it into the Analyzer port.
3. Serum or plasma: Pipette 75 μL serum or plasma into the buffer tube, mix the specimen and the buffer well.
4. Add diluted specimen with a Pipette: Pipette 75 μL diluted specimen into the sample well. Start the timer at the same time.
5. There are two test modes for Fiatest TM Go Fluorescence Immunoassay Analyzer, Standard Test mode and Quick Test mode. Please refer to the user manual of Fiatest TM Go Fluorescence Immunoassay Analyzer for details.
“Quick test” mode: Insert the test cassette into the Analyzer at 15 minutes after sample application click “QUICK TEST”, fill the test information and click "NEW TEST" immediately. the Analyzer will automatically give the test result after a few seconds.
“Standard test” mode: Insert the test cassette into the Analyzer immediately after sample application, click “STANDARD TEST”, fill the test information and click "NEW TEST" at the same time, the Analyzer will automatically counting down 15 minutes. After the countdown, the Analyzer will give the result at once.
INTERPRETATION OF RESULTS
Results read by Fiatest TM Go Fluorescence Immunoassay Analyzer.
The result of tests for TSH is calculated by FluroLit TM Fluorescence Immunoassay Analyzer and display the result on the screen. For additional information, please refer to the user manual of
FluroLit TM Fluorescence Immunoassay Analyze.
Working range of FluroLit TM TSH is 0.1-100 μIU/mL.
||TSH Test Cassette