BERKELEYHEALTH THYROID TSH RAPID TEST 1TEST

Product Description: • A rapid test for the qualitative detection of human Thyroid Stimulating Hormone (TSH) in human whole blood. For self-testing in vitro diagnostic use only. • The Thyroid Stimulating Hormone Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of TSH in human whole blood at a cut-off concentration of 5 μIU/mL. This assay provides a preliminary diagnostic test result and can be used to screening for TSH. • 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. 2, 3 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. 1 Testing of thyroid stimulating hormone* levels in the blood is considered the best initial test for hypothyroidism. 4 It is important to note the statement from the Subclinical Thyroid Disease Consensus Panel: “There is no single level of 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). • ” 5 The Thyroid Stimulating Hormone Rapid Test Cassette (Whole Blood) is a rapid test that qualitatively detects the presence of TSH in whole blood specimen at the sensitivity of 5 μlU/mL. • The Thyroid Stimulating Hormone Rapid Test Cassette (Whole Blood) is a simple test that utilizes a combination of monoclonal antibodies to selectively detect elevated levels of TSH in whole blood. Product Features: • The Thyroid Stimulating Hormone Rapid Test Cassette (Whole Blood) is a qualitative membrane based immunoassay for the detection of Thyroid Stimulating Hormone (TSH) in whole blood. • In this test procedure, anti-TSH antibody is immobilized in the test line region and coated particles. After specimen is added to the specimen well of the cassette, it reacts with anti-TSH antibody coated particles in the test. • This mixture migrates chromatographically along the length of the test and interacts with the immobilized anti-TSH antibody. • Positive specimens react with the specific anti-TSH antibody coated particles to form a colored line at the test line region of the membrane. • Absence of this colored line suggests a negative result. • To serve as a procedural control, a colored line will always appear in the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred. How to use: • . Wash your hands with soap and rinse with clear warm water. • 2. Bring the pouch to room temperature before opening it. Open the foil pouch and get out the cassette. • 3. Carefully pull off and dispose the released cap of the lancet. • 4. Use the provided alcohol pad to clean the fingertip of the middle or ring finger as the puncture site. • 5. Press the lancet, on the side from where the cap was extracted; against the fingertip (Side of ring finger is advised). The tip retracts automatically and safely after use. • 6. Keeping the hand down massage the end that was pricked to obtain a blood drop. • 7. Without squeezing the capillary dropper bulb, put it in contact with the blood. The blood migrates into the capillary dropper to the line indicated on the capillary dropper. You may massage again your finger to obtain more blood if the line is not reached. Avoid air bubbles. • 8. Put the blood collected into the sample well of the cassette, by squeezing on the dropper bulb. • 9. Wait for the blood to be totally dispensed in the well. Unscrew the cap of the buffer bottle and add 2 drops of buffer into the sample well of the cassette. • 10.Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 20 minutes. Caution & Warnings: • Please read all the information in this package insert before performing the test. • For self-testing in vitro diagnostic use only. • Do not eat, drink or smoke in the area where the specimens or kits are handled. • Store in a dry place at 2-30°C (36-86°F), avoiding areas of excess moisture. If the foil packaging is damaged or has been opened, please do not use. • This test kit is intended to be used as a preliminary test only and repeatedly abnormal results should be discussed with doctor or medical professional. • Follow the indicated time strictly. • Use the test only once. Do not dismantle and touch the test window of the test cassette. • The kit must not be frozen or used after the expiration date printed on the package. • Keep out of the reach of children. • The used test should be discarded according to local regulations. Ingredients: • MATERIALS PROVIDED: • Test cassette • Capillary dropper • Buffer • Alcohol pad • Lancet • Package insert • MATERIALS REQUIRED BUT NOT PROVIDED: