The THYRO-Check® is a manual qualitative immunochromatographic screening test for the detection of increased TSH (Thyroid Stimulating Hormone) level in finger prick whole blood sample. It can be used at home by lay users for self-testing for the detection of possible hypothyroidism.
Thyroid disorders are one of the most prevalent medical conditions in the world, particularly for women, with an increasing rate of the population suffering under active thyroid (hypothyroidism).
The symptoms of hypothyroidism include feeling tired and lethargic, weight gain, dry skin and brittle hair, becoming forgetful and sometimes depressed, feeling cold and enduring constipation as well as menstrual irregularities in women.
Thyroid stimulating hormone (TSH), which is secreted by pituitary, regulates and controls the activity of the thyroid gland. Therefore, a raised TSH level indicates an under active thyroid and this is the principle on which Thyro-Check® is based for the detection of the hypothyroidism condition.
Caution: THYRO-Check® should not be performed in case of hormonal thyroid medical treatment.
In early pregnancy, the level of TSH is generally lowered and therefore could lead to underestimated result.
Prepare everything properly before starting the testing procedure. Place the content of the box on a clean, dry and flat surface (e.g. table). Then perform the test as follows:
The intensity and the colour of the lines do not have any importance for the interpretation of the test results.
Positive result
Negative result
Invalid result
THYRO-Check® test uses a couple of antibodies detecting specifically TSH hormone by producing a coloured test line under the T mark of the cassette.
A control line capturing the reagent excess appears as a coloured line under the C mark of the cassette. In case both lines appear, the test indicates that the level of TSH is higher than normal (>5µIU/mL determined against W.H.O.* reference).
*World Health Organisation
In case of hypothyroidism symptoms such as feeling tired, depressed or cold regularly, weight gain, dry skin, brittle hair, enduring constipation or menstrual cycle irregularities in women, it is recommended to perform THYRO-Check® screening test. THYRO-Check® test can be used any time of the day.
The results are accurate as long as the instructions are carefully respected. Nevertheless, the result can be incorrect if THYRO-Check® test gets wet before test performing or if the quantity of blood dispensed in the sample well is not correct. The plastic pipette provided in the box makes sure the collected blood volume is correct.
The results of THYRO-Check® may also be incorrect in the following cases:
– Pregnancy
– New Born
– Obesity
– Primary adrenal insufficiency
– Taking certain drugs such as anti-thyroid agent, rifampicin and amiodarone
– Isolated ACTH (Adreno Cortico Tropic Hormone) deficiency
The colour and intensity of the lines have no importance for result interpretation. The lines should only be homogeneous and complete. The test should be considered as positive regardless of the colour intensity of the test line is (T) even weak.
When this line appears, it only means that the test has been performed well.
No. The test should be read 10 minutes after adding the diluent. The result is reliable up to 15 minutes.
If the result is positive, it means that the TSH level in blood is higher than the norm (5µIU/mL) and that you should consult a doctor to show the test result. Then, the doctor will decide whether additional analysis should be performed.
If the result is negative, it means that the TSH level is below 5µIU/mL and is within the norm. However, if the symptoms persist, it is recommended to consult a doctor.
The THYRO-Check® test is accurate and has been used for more than 20 years by professionals (hospitals, laboratories) in the field. Evaluation reports show an overall agreement of 99.2% [95.2-100.0**] with reference method. Although this test is reliable, false positive or false negative results could be obtained.
** CI 95%: 95% Confidence Interval.