Thyroid Stimulating Hormone (TSH) Test
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Description
Intended Use
Thyroid Stimulating Hormone Test is a lateral flow chromatographic immunoassay for the qualitative determination of human thyroid stimulating hormone (TSH) in whole blood/Plasma/Serum samples. This test is intended to detect TSH at concentrations >5 mlU/L. Thyroid Stimulating Hormone Test is intended for use by medical professionals to screen an ambulatory adult population for primary hypothyroidism. It is not indicated for use screening neonates for hypothyroidism
Introduction
Thyroid-stimulating hormone, also known as thyrotropin, is secreted from cells in the anterior pituitary called thyrotrophs, finds its receptors on epithelial cells in the thyroid gland, and stimulates that gland to synthesize and release thyroid hormones.
TSH is an important indicator of thyroid function, Used to monitor thyroid associated diseases. A high TSH level means that your thyroid gland is under-active. When your thyroid gland is under-active and not producing enough thyroid hormone, your body produces more TSH to stimulate the gland and increase its activity. A low TSH level means that your thyroid gland is over-active. When your thyroid gland is overactive and producing too much thyroid hormone, your body decreases the amount of TSH to slow production of thyroid hormone. And TSH levels can help determine whether hypothyroidism is due to a damaged thyroid gland or some other cause (such as a problem with the pituitary gland or the hypothalamus).
TSH test can keep track of treatment with thyroid replacement medicine for people who have hypothyroidism and thyroid gland function in people who are being treated for hyperthyroidism.
And TSH level test also can Double-check the diagnosis of an underactive thyroid gland in a newborn.
Procedure
Bring tests, specimens, and/or controls to room temperature (15-30°C) before use.
1. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the test with patient or control identification. For best results, the assay should be performed within one hour.
2. For Serum or Plasma specimens: Hold the dropper vertically and transfer 2 drops of serum or plasma (approximately 50 mL) to the specimen well (S) of the test device, then start the timer..
For Whole Blood specimens: Hold the dropper vertically and transfer 3 drops of whole blood (approximately 75mL) to the specimen well (S) of the test device, then add 1 drop of buffer(approximately 40mL) and start the timer.
Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area.
As the test begins to work, color will migrate across the membrane.
3. Wait for the colored band(s) to appear. The result should be read at 10 minutes. Do not interpret the result after 15 minutes.
Interpretation of Results
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POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T). A positive result indicates that the TSH concentration exceeds the detectable level. |
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NEGATIVE: Only one colored bands appears in the control region (C). No colored band appears in the test region (T). A negative result indicates that the TSH concentration is below the detectable level. |
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INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor. |
1) The intensity of color in the test region (T) may vary depending on the concentration of analytes present in the specimen. Therefore, any shade of color in the test region (T) should be considered positive. Please note that this is a qualitative test only, and cannot determine the concentration of analytes in the specimen.
2) Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for control band failure.
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