Screen Test Thyroid Hormone TSH

In vitro diagnostic medical device CE 0123.
Rapid test for the qualitative detection of Thyroid Stimulating Hormone (TSH) in human blood.
For in vitro self-testing use only.

Precautions
In vitro diagnostic device for individual use. Do not use beyond the expiry date.
1. For in vitro self-test use only.
2. Do not eat, drink, or smoke in the specimen or kit handling area.
3. Store in a dry place at 2-30°C (36-86°F), avoiding areas with excessive humidity. If the sealed package is damaged or opened, please do not use the test.
4. This kit is intended for use as a preliminary test and repeated abnormal results should be discussed with a doctor or specialist.
5. Strictly follow the times indicated.
6. Use the test only once. Do not disassemble noré tap the test window on the media.
7. The kit should not be frozen or used beyond the expiration date printed on the package.
8. Keep out of reach of children.
9. The used test must be disposed of according to local regulations.

Mode of use
1. Wash your hands with soap and rinse with clean warm water.
2. Bring the package to room temperature before opening it. Open the sealed package and take out the device.
3. Gently pull and discard the lancet protective cap.
4. Use the alcohol swab provided to clean the tip of your middle finger where the sting occurred.
5. Press the hand on the side where it is the cap has been removed, against the tip of the finger (ring finger side is recommended). The tip retracts automatically and safely after use.
6. Keeping your hand facing down, massage the puncture site to obtain a drop of blood.
7. Without pressing the bulb of the capillary dropper, bring it into contact with the blood. The blood will migrate into the capillary dropper up to the line indicated on the dropper. You can massage your finger again to get more blood if you don't reach the line. As much as possible, try to avoid the formation of air bubbles.
8. Place the collected blood into the sample well of the device by squeezing the dropper bulb.
9. Wait until the blood is completely poured into the well. Unscrew the cap of the buffer bottle and add 2 drops of buffer to the sample well of the device.
10. Wait for the colored line(s) to appear. Read the results at 10 minutes. Do not interpret results after 20 minutes.

Reading the results
POSITIVE: two lines appear, both the T (Test) and the C (Control) lines. This result indicates that the TSH level is more higher than normal (5 microIU/mL) and which is necessary to consult a doctor.
NEGATIVE: only one line appears, the control line (C). This result indicates that the TSH level is not in the range of hypothyroidism.
NULL: the control line does not appear. The most important reasons Insufficient sample volume or incorrect procedural techniques are likely to cause the control line to fail to appear. Review the procedure and repeat the test with a new kit. If the problem persists, discontinue use of the kit immediately and contact your local distributor.

Limitations
1. The TSH rapid test (Whole blood) is for in vitro diagnostic use only. The test should be used only for the detection of TSH in whole blood specimens. This qualitative test cannot determine né the quantitative value né the growth rate of TSH concentration.
2. The TSH rapid test (Whole blood) is only for a primary control of hypothyroidism in the adult population, it is not suitable for newborns.
3. As with all diagnostic tests, all results should be evaluated together with other clinical information available to the doctor.
4. A positive test will have to be be confirmed using another quantitative laboratory test for TSH.
5. & False positive results may occur due to heterophile antibodies (rare). In some particular clinical conditions such as central hypothyroidism, TSH levels may be normal/low, despite hypothyroidism. A medical consultation is always recommended to exclude such cases.
6. TSH is not a reliable marker for central/secondary hypothyroidism, occurring in 1 in 1,000 cases of hypothyroidism.

Storage
Store wrapped at room temperature or refrigerated (2-30°C).
The test is stable until the expiry date printed on the sealed package or closed box. The test must remain in the sealed package until used. DO NOT FREEZE.
Do not use beyond the expiry date.

Format
Pack of 1 piece.