Thyroid Stimulating Hormone (TSH) Rapid Test, primary hypothyroidism, Health Rapid Test

A rapid test for the qualitative detection of human thyroid stimulating hormone (TSH) CE certified

Applications:

The TSH Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of thyroid stimulating hormone (TSH) in whole blood, serum, or plasma to aid in the screening an ambulatory adult population for primary hypothyroidism by medical professionals. This test is intended to detect TSH at concentrations > 5μlU/ml. It is not indicated for use screening meonates for hypothyroidism.

Description:

Thyroid stimulating hormone (TSH), or thyrotropin, is the primary regulator of the functional state of the thyroid gland. Its production and release is stimulated by the hypothalamic thyrotropin-releasing hormone (TSH) and is controlled by levels of the thyroid hormones (thyroxine and triodothyronine) at the pituitary gland and possibly the hypothalamus. Serum TSH levels are raised in cases of primary hypothyroidism.

The diagnosis of hypothyroidism is made by finding a low total or free T4 value and is confirmed by a raised TSH level. Mild primary hypothyroidism may be more difficult to diagnose by just measuring the level of total and free T4, because the total and free T4 value can sometimes be within the normal range. In these cases, TSH assays are useful for diagnosis since the levels of TSH are raised. In hyperthyroidism, levels of T3 and T4 are raised and TSH level is reduced.

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 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, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.

1. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it as soon as possible.
2. 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 25 mL) to the specimen well then add 1 drop of buffer (approximately 40 mL), and start the timer. See illustration below.

For Venipuncture Whole Blood specimen:

• Hold the dropper vertically and transfer 2 drops of whole blood (approximately 50 mL) to the specimen well, then add 1 drop of buffer (approximately 40 mL), and start the timer. See illustration below.

For Fingerstick Whole Blood specimen:

• To use a capillary tube: Fill the capillary tube and transfer approximately 50mL of fingerstick whole blood specimen to the specimen area of test cassette, then add 1 drop of buffer (approximately 40 mL) and start the timer. See illustration below.
• To use hanging drops: Allow 2 hanging drops of fingerstick whole blood specimen (approximately 50 mL) to fall into the specimen area of test cassette, then add 1 drop of buffer (approximately 40 mL) and start the timer. See illustration below.
• 3.Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 20 minutes.

INTERPRETATION OF RESULTS

(Please refer to the illustration above)

POSITIVE:* Two distinct colored lines appear. One colored line should be in the control region (C) and another colored line should be in the test region (T). A positive result means that the TSH level is above the cut-off level of 5mlU/L.

*NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of TSH present in the specimen. Therefore, any shade of color in the test region (T) should be considered positive.

NEGATIVE: One colored line appears in the control region (C). No apparent colored line appears in the test region (T). A negative result means that the TSH level is below the cut-off level of 5mlU/L.

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

QUALITY CONTROL

A procedural control is included in the test. A colored line appearing in the control region (C) is the internal procedural control. It confirms sufficient specimen volume and correct procedural technique. Control standards are not supplied with this kit; however, it is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance.

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