Cassette Thyoid Stimulating Homone, One Step Rapid Test with Reader
CE Approved
| Product features | Parameters |
| Principle | Chromatographic Immunoassay |
| Format | Cassette |
| Specimen | WB/S/P |
| Certificate | CE |
| Reading Time | 10 minutes |
| Pack | 40 T |
| Storage Temperature | 2-30°C |
| Shelf Life | 2 Years |
| Sensitivity | 98.10% |
| Specificity | 98.20% |
| Accuracy | 98.20% |
| Cut-Off | 3-100 uIU/mL |
Application:
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.
Description:
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.[1] 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.
Order Information
| Cat. No. | Product | Specimen | Pack |
| OTS-R402 | Thyroid Stimulating Hormone (TSH) Rapid Test Cassette | WB/S/P | 10 T |
