Alltest Hypothyroidism (TSH) Rapid Test for Home Use (1 pc/box)

• The price includes 5% VAT.

Under the applicable legislation, Carbon Web Kft. may sell IVD tests intended for self-testing to private individuals online in accordance with Decree No. 7/2004 (XI. 23.) of the Minister of Health, and may have the order delivered to the customer’s home by parcel delivery after the order is placed. Please note that by placing your order you waive your right to receive professional information on the use of the self-test. For the correct performance of the test, we enclose detailed instructions for use in Hungarian, which you can find in the test box and on our website.

Hypothyroidism rapid test

TSH (thyroid stimulating hormone) is an important hormone produced by the pituitary gland. The role of TSH is to stimulate the function of the thyroid gland and the production of thyroid hormones (T3 and T4).

An elevated TSH level (which is referred to as hyperthyreosis) indicates that the thyroid gland is less active and does not produce a sufficient amount of thyroid hormone. This phenomenon can often be traced back to the following causes:

1. Hypothyroidism (underactive thyroid): This is the most common cause of an elevated TSH level. The thyroid gland functions insufficiently, which results in low levels of the T3 and T4 hormones. In response, the pituitary gland increases TSH production in order to stimulate the thyroid gland.
2. Hashimoto’s thyroiditis: This is an autoimmune disease in which the immune system attacks the body’s own thyroid cells. As a result, thyroid function decreases and the TSH level rises.
3. Medicines: Certain medicines, for example those used to treat low thyroid function or other health problems, may affect the TSH level and thyroid function.
4. Thyroid surgery or radioiodine therapy: If someone’s thyroid gland is treated by surgery or with radioactive iodine, this removes or damages the cells of the thyroid gland, and as a result thyroid hormone production decreases. In response, the pituitary gland increases TSH production.
5. Pregnancy: During pregnancy the body needs more thyroid hormone, so the TSH level may rise slightly.

It is important to note that an increase in the TSH level generally indicates insufficient thyroid function, and the exact cause must be determined by further examinations and medical evaluation. The hypothyroidism (TSH) rapid test is designed for home use and detects a possible elevated TSH level from a fingertip blood sample.

Hypothyroidism rapid test specification

Product name: Alltest TSH rapid test cassette for self-testing
Sample: whole blood
Pack size: 1 pc/box
Format: cassette test
Manufacturer: Hangzhou Alltest Biotech Co., Ltd., Ltd., 550 Yinhai Street, Hangzhou Economic and Technologic Development Area, 310018, Zhejiang, China; Telephone: +86-571-56267891; info@alltests.com.cn
EC REP: MedNet GmbH, Hansestraße 91, 48165 Münster, Germany; +49 251 32266-0; info@medneteurope.com
Expiry date: 31/07/2028

Contents of the hypothyroidism rapid test kit

• 1 test cassette
• 1 capillary dropper
• 1 buffer solution
• 1 alcohol wipe
• 1 fingertip lancet
• 1 instructions for use in Hungarian

Test procedure

Read the Instructions for Use carefully before performing the test!

1. Wash your hands with soap and rinse them with clean warm water.
2. Before opening, bring the pouch to room temperature. Open the foil pouch and take out the cassette.
3. Carefully twist off and discard the released cap of the lancet.
4. Clean the area to be pricked, which is the tip of the middle or ring finger, with the enclosed alcohol wipe.
5. Press the lancet, on the side from which you removed the cap, against the fingertip (the side of the ring finger is recommended). After use, the tip retracts automatically and safely.
6. Holding your hand downwards, massage the end of the pricked finger to obtain a drop of blood.
7. Without squeezing the bulb of the capillary dropper, touch it to the blood. The blood will move into the capillary dropper up to the line marked on it. If the blood does not reach the line, massage your finger a little to bring out more blood. Avoid air bubbles.
8. By squeezing the bulb of the dropper, transfer the collected blood into the sample well of the cassette.
9. Wait until the blood has completely flowed into the sample well. Unscrew the cap of the buffer bottle and add 2 drops of buffer solution to the sample well of the cassette.
10. Wait for the coloured line(s) to appear. Read the results after 10 minutes. After 20 minutes the result can no longer be interpreted.

Interpretation of results

Positive

Two coloured lines appear. Both the (T) test line and the (C) control line appear. This result means that the TSH level is higher than normal (5 μIU/ml) and you should consult a doctor.

Negative

Only the control line (C) appears. This result means that the TSH level is not in the range indicating thyroid insufficiency.

Invalid

The control line does not appear. The most likely reasons for the absence of the control line are an insufficient sample volume or an incorrect procedure. Review the procedure again and repeat the test using a new test. If the problem persists, stop using that test kit and contact your local distributor.

Reliability of the TSH rapid test

A clinical evaluation was performed in which the results obtained with the TSH test and with ELISA were compared. In the in-house clinical study, 220 whole blood samples were tested. The results showed a specificity of 98.2% and a sensitivity of 98.2%, with an overall accuracy of 98.2%.