Tsh - blood tsh rapid test

Product Description

In vitro diagnostic medical device CE 0123.

Indications

Rapid test for the qualitative detection of Thyroid-Stimulating Hormone (TSH) in human blood.

For in vitro self-diagnostic use only.

Directions for use

1. Wash your hands with soap and rinse with clean, warm water.
2. Bring the package to room temperature before opening. Open the sealed package and remove the device.
3. Gently pull and discard the protective cap from the lancet.
4. Use the alcohol swab provided to clean the tip of your middle finger, where you pricked it.
5. Press the lancet, from the side where the cap was removed, against the tip of your finger (the side of your ring finger is recommended). The tip automatically and safely retracts after use.
6. Holding your hand facing down, massage the puncture site to obtain a drop of blood.
7. Without squeezing 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 obtain more blood if the line is not reached. Try to avoid the formation of air bubbles as much as possible.
8. Dispense the collected blood into the sample well of the device by squeezing the bulb of the dropper.
9. Wait until the blood has completely flowed 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 after 10 minutes. Do not interpret results after 20 minutes.

Warnings

1. For in vitro self-diagnostic use only.
2. Do not eat, drink, or smoke in the area where specimens or kits are handled.
3. Store in a dry place at 2-30°C (36-86°F), avoiding areas of excessive humidity. If the sealed pouch is damaged or opened, 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 physician or healthcare professional.
5. Strictly follow the indicated timing.
6. Use the test only once. Do not disassemble or touch the test window on the holder.
7. The kit should not be frozen or used beyond the expiration date printed on the pouch.
8. Keep out of reach of children.
9. The used test should be disposed of according to local regulations.

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 either the quantitative value or the rate of rise of TSH concentration.
2. The TSH Rapid Test (Whole Blood) is only for primary screening of hypothyroidism in adults; it is not suitable for neonates.
3. As with all diagnostic tests, all results should be evaluated in conjunction with other clinical information available to the physician.
4. A positive test should be confirmed using another quantitative laboratory test for TSH.
5. False-positive results may occur due to heterophile antibodies (rare). In some specific clinical conditions, such as central hypothyroidism, TSH levels may be normal/low despite hypothyroidism. A medical consultation is always recommended to rule out such cases.
6. TSH is not a reliable marker for central/secondary hypothyroidism, which occurs in 1 in 1,000 cases of hypothyroidism.

Storage

Store in its original packaging at room temperature or refrigerated (2-30°C). The test is stable until the expiration date printed on the sealed pouch or unopened box. The test must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.

Format

Pack containing 1 piece.