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.
THYRO Check is a rapid immunodiagnostic test for the detection of increased TSH levels and therefore for hypothyroidism screening from a finger prick blood sample.
The box contains the material necessary to perform a test:
– 1 sealed aluminium pouch containing:
1 test device, 1 plastic pipette and 1 desiccant bag.
Only open the protective pouch when you are ready to use the test. The desiccant bag should not be used.
– 1 sterile lancet for blood sampling.
– 1 diluent vial containing 1 ml of diluent.
– 1 instruction leaflet.
- This test is exclusively intended to in vitro diagnostic. External use only. DO NOT SWALLOW.
- Carefully read the instructions before performing the test. The test is only interpretable if the instructions are carefully respected. Follow strictly the indicated time, blood and diluent quantities.
- Store between +4°C and +30°C. Do not freeze.
- Do not use after the expiry date printed on the label and on the protective pouch or if the pouch is damaged.
- Do not re-use THYRO Check test.
- Keep out of the reach of children.
- After use, all components can be discarded in a dustbin.
Testing procedure always starts with a good preparation. Place the content of the box on a clean, dry and flat surface (e.g. table). Then the testing follows:
- Wash your hands thoroughly. Use soap and warm water. Dry your hand with clean towel.
- Prepare the test device and the pipette. Take them out from the protective pouch (tear at the notch) and place them in the reach of your hands (you will need them later). Dispose the small dessicant bag.
- Prepare the lancet. Hold the lancet without touching the trigger button. Unlock the lancet cap twisting it off ¼ turn until you feel it separates from the lancet and then continue twisting it (2-3 rotations). Don’t pull just twist and discard the cap when finished.
- Clean the end of the forefinger or of the middle finger with cotton damped with alcohol.
Rub the chosen finger towards the tip to later on enhance the blood stream.
- Press platform firmly against the previously cleaned finger, and press the release trigger button.
- The tip will automatically retract into the body of the device.
- Rub the finger’s end to obtain enough whole blood sample.
- Without pressing the bulb, put in contact the plastic pipette with the blood sample. The blood migrates into the pipette through capillarity to the line indicated on the pipette. You may rub again your finger to obtain more blood if the line is not reached. As far as possible, avoid air bubbles.
- Put the blood collected with the pipette into the sample well of the device, by pressing on the pipette bulb.
- Wait 30-40 sec for the blood being totally absorbed into the sample well. Unscrew the blue cap of the diluent vial (leave the white cap tightly screwed) and add the diluent as follows:
Hold the diluent vial vertically and slowly add exactly 4 drops in the sample well of the device with an interval of 2-3 seconds between each drop.
- Read the result after 10 minutes. Do not interpret after 15 minutes.
The intensity of the line colour does not have any importance for the interpretation of the test result.
- Positive result
Two coloured lines appear in the window under the marks T (Test) and C (Control). The intensity of the line T may be clearer than the intensity of the line C. This result means that the TSH level is higher than the norm and therefore hypothyroidism so you should consult a doctor.
- Negative result
Only one coloured line appears under the mark C (Control). This result means that the TSH level is normal and the thyroid is functioning correctly.
- Non valid result
No line appears or a coloured line appears under the mark T (Test) without any line under the mark C (Control). In this case, it is not possible to interpret the test, which must be considered as non-valid. It is recommended to repeat the test with another THYRO Check and a fresh whole blood sample.
QUESTIONS AND ANSWERS
How does THYRO Check work?
The thyroid stimulating hormone (TSH) is activating thyroid gland. Therefore a TSH level over 5 µIU/mL in case of a positive result, indicates most probably an under active thyroid (hypothyroidism).
When should the test be used?
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. However, Thyro Check should not be performed in case of hormonal thyroid medical treatment.
Can the result be incorrect?
The results are accurate as far 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 sufficient. The plastic pipette provided in the box allows making sure the collected blood volume is correct.
How to interpret the test if the colour and the intensity of the lines are different?
The colour and intensity of the lines have no importance for result interpretation. The lines should only be homogeneous and clearly visible. The test should be considered as positive whatever the colour intensity of the test line (T) is.
What is the line that appears under the mark C (Control) for?
When this line appears, it only means that the test was performing well.
If I read the result after 15 minutes, will the result be reliable?
No. The result should be read within 10 minutes after adding the diluent. The result is reliable up to 15 minutes.
What do I have to do if the result is positive?
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.
What do I have to do if the result is negative?
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.