Cassette Thyoid Stimulating Homone, One Step Rapid Test with Reader CE Approved
The TSH Rapid Test Cassette (Whole Blood/ Serum/ Plasma) is a rapid chromatographic immunoassay for the quantitative detection of Thyroid Stimulating Hormone (TSH) in whole blood, serum, or plasma to aid in the screening the adult population for primary hypothyroidism that can be performed with the use of LF Reader. It is not indicated for use 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),”
The TSH Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid test that semi-quantitative detects the presence of TSH in whole Blood, serum or plasma specimen at the sensitivity of 5μlU/ml. The TSH Rapid Test Cassette (Whole Blood/Serum/Plasma) is a simple test that utilizes a combination of monoclonal antibodies to selectively detect elevated levels of TSH in whole blood, serum or plasma.
How to use?
Allow the test cassette, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.
1. Exact QR Code from the QR code card for specific information of the test. Use only QR code card provided inside the test kits.
2. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it as soon as possible.
3. Place the cassette on a clean and level surface.
For Serum or Plasma specimen:
· Hold the dropper vertically and transfer 1 drop of serum or plasma (approximately 25μL) to the specimen well then add 1 drop of buffer (approximately 40μL), and start the timer. See illustration below.
For Venipuncture Whole Blood specimen:
· Hold the dropper vertically and transfer 2 drops of whole blood (approximately 50μL) to the specimen well, then add 1 drop of buffer (approximately 40μL), and start the timer. See illustration below.
For Fingerstick Whole Blood specimen:
· To use a capillary tube: Fill the capillary tube and transfer approximately 50μL of fingerstick whole blood specimen to the specimen area of test cassette, then add 1 drop of buffer (approximately 40μL) and start the timer. See illustration below.
4. Wait for the colored line to appear. The result should be read with Citest LF Reader at 10 minutes.
5. Do not interpret test results visually
6. For LF Reader installation, start up and complete instructions refer to LF Reader User Manual. Operator must consult LF Reader User Manual prior to use and become familiar with the processes and quality control procedures.
Note: It is suggested not to use the buffer, beyond 30 days after opening the vial.
INTERPRETATION OF RESULTS
Results read by LF reader
The result of positive or negative for Thyroid Stimulating Hormone (TSH) is determined by the LF reader.
Result could be exported to excel.
|Thyroid Stimulating Hormone (TSH) Rapid Test Cassette