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Thyroid TSH Test

Ref. 800021-1

Self-test for the determination of thyroid-stimulating hormone (TSH) levels in whole blood samples

Thyroid TSH Test

THYROID DISEASES & TSH

Thyroid stimulating hormone, TSH (also known as thyrotropin or thyrotropic hormone) is a hormone secreted by the adenohypophysis and controls the secretory activity of the thyroid.

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The adenohypophysis, under TSH stimulation, produces and releases thyroxine (T4) and triiodothyronine (T3), intended to regulate the body’s consumption and storage of energy. When thyroid hormone levels are below physiological values, the pituitary gland reacts by producing higher levels of TSH to stimulate the thyroid. Therefore, an increase in the concentration of TSH hormone in the blood usually indicates a reduction in thyroid activity – a condition better known as hypothyroidism.

WHO IS THIS TEST FOR?

THYROID TSH TEST is useful to check TSH levels in the blood, especially in women over 60 years of age or in the presence of symptoms related to hypothyroidism.

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Hypothyroidism is the most common thyroid disease, with higher incidence in women and family predisposition. Symptoms of hypothyroidism include: tiredness, weight gain, dry skin, depression and persistent constipation.

TECH SPECS

THYROID TSH TEST is an immunochromatographic device that detects TSH levels in blood above the cut-off of 5 μIU/mL.

Specificity 96.6%
Sensitivity 92.5%
Accuracy 95%

CONTENT

  • 1 test cassette
  • 1 vial with dropper containing the diluent
  • 2 sterile lancets
  • 1 pipette for blood sampling
  • 1 cleanser gauze
  • instructions for use

USE PROCEDURE

  1. Draw a blood sample by using the sterile lancet provided;
  2. Collect the sample indicated with the black line by using the capillary pipette provided;
  3. Deposit the collected specimen into the sample well (S) indicated on the test cassette;
  4. Add 2 drops of the diluent and wait 10 minutes before reading the result.

RESULTS INTERPRETATION

Negative TSH values are normal.
Positive TSH values are equal to or greater than the 5 μIU/mL cut-off. It is necessary to check with a specialist.

BIBLIOGRAPHY

1. Yasaman Pirahanchi1; Ishwarlal Jialal2. Physiology, Thyroid Stimulating Hormone (TSH). StatPearls Publishing; 2018 Jan-.
2. Simon H.S. Pearce,a,b,* Georg Brabant,c Leonidas H. Duntas,d Fabio Monzani,e Robin P. Peeters,f Salman Razvi,a,gand Jean-Louis Wemeauh ‘’ 2013 ETA Guideline: Management of Subclinical Hypothyroidism’’. Eur Thyroid J. 2013 Dec; 2(4): 215-228.
3. De Groot L, Abalovich M, Alexander EK, Amino N, Barbour L, Cobin RH, Eastman CJ, Lazarus JH, Luton D, Mandel SJ et al. Management of thyroid dysfunction during pregnancy and postpartum: an Endocrine Society clinical practice guideline. Journal of Clinical Endocrinology and Metabolism 2012 97 2543–2565. (doi:10.1210/jc. 2011-2803)
4. Nat Rev Endocrinol. 2018 May;14(5):301-316. doi: 10.1038/nrendo. 2018.18. Epub 2018 Mar 23.’’Global epidemiology of hyperthyroidismand hypothyroidism.’’Taylor PN1, Albrecht D2, Scholz A1, Gutierrez-Buey G3, Lazarus JH1, Dayan CM1, Okosieme OE1.

F.A.Q.

The test has been carried out correctly when the instructions for use are followed. It includes the reading time and the interpretation of the results shown at the "RESULTS INTERPRETATION" section of the instructions for use.


A colored line will appear at the control region (C) on the test device, showing that the test performed correctly. The absence of the colored line suggests to repeat the test with a new device and a new sample.


The color and intensity of the lines do not affect the interpretation of the result. The test has to be considered positive regardless of the color intensity of the test line (T).