Descrizione Clinica
SCREEN
CHECK TEST
Tiroid hormoneTSH
Description
CE 0123 in vitro diagnostic medical device.
Quick test for qualitative detection of Tyroid-Stimulating Hormone (TSH) in human blood.
Only for auto-diagnostic use in vitro.
Precautions
In vitro diagnostic device for individual use. Do not use beyond the expiry date.
1. Only for auto-diagnostic use in vitro.
2. Do not eat, drink or smoke in the sample handling area or kits.
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 open, 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 indicated timings.
6. Use the test only once. Do not disassemble or touch the test window on the support.
7. The kit should not be frozen or used over the printed expiration date on the package.
8. Keep away from the reach of children.
9. The test used must be disposed of according to local regulations.
Mode of use
1. Wash your hands with soap and rinse with warm clean water.
2. Bring the packaging to room temperature before opening it. Open the sealed package and extract the device.
3. Gently pull and throw the protective cap of the hand.
4. Use the tampon with alcohol provided to clean the tip of the middle finger, seat of the puncture.
5. Press the hand, on the side where the cap was removed, against the finger tip (we recommend the side of the ring). The tip is automatically and safely after use.
6. Keeping your hand turned down, massage the puncture seat to get a drop of blood.
7. Without pressing the capillary dropper bulb, put it in contact with the blood. The blood will migrate into the capillary dropper to the line indicated on the dropper. You can massage your finger again to get more blood if you do not reach the line. As far as possible, try to avoid the formation of air bubbles.
8. Put the blood collected in the well for device samples, pressing the dropper bulb.
9. Wait until the blood is completely poured into the well. Unscrew the buffer bottle cap and add 2 drops of buffer in the cockpit for device samples.
10. Wait for the appearance of the colored line/e. Read the results 10 minutes. Do not interpret the results after 20 minutes.
Reading results
POSITIVO: two lines appear, both the line T (Test) and the C (Control). This result indicates that the level of TSH is higher than normal (5 microIU/mL) and that it is necessary to consult a doctor.
NEGATIVE: only one line appears, the control line (C). This result indicates that the level of TSH is not in the range of hypothyroidism.
NULLO: no control line appears. The most probable reasons for the failure of the control line are an insufficient sample volume or incorrect procedural techniques. Review the procedure and repeat the test with a new kit. If the problem persists, stop using the kit immediately and contact your local distributor.
Limitation
1. The TSH (Full Blood) quick test is only for in vitro diagnostic use. The test should only be used to detect TSH in whole blood samples. This qualitative test cannot determine either the quantitative value or the growth rate of the TSH concentration.
2. The TSH rapid test is only for primary control of hypothyroidism in the adult population, it is not suitable for infants.
3. As with all diagnostic tests, all results are to be evaluated together with other clinical information available to the doctor.
4. A positive test must be confirmed using another quantitative laboratory test for TSH.
5. It is possible that false positive results occur due to heterophilic antibodies (rare). In some particular clinical conditions such as central hypothyroidism, TSH levels can 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, which occurs in 1 every 1,000 cases of hypothyroidism.
Conservation
Store packed at room or refrigerated temperature (2-30°C).
The test is stable until the expiry date printed on the sealed package or on the closed box. The test must remain in the sealed package until the time of use. DON'T CONGEL.
Do not use beyond the expiry date.
Format
Pack of 1 piece.
BIBLIOGRAPHY:
1. Merck Manual of Diagnosis and Therapy, Thyroid glans disorders.
2. The American Heritage Dictionary of the English Language, Fourth Edition. Houghton Mifflin Company. 2006. ISBN 0-395-82517-2.
3. Sacher R, Richard A. McPherson (2000). Widmann's Clinical Interpretation of Laboratory Tests, 11th ed. F.A. Davis Company. ISBN 0-8036-0270-7.
4. So, M; MacIsaac, RJ; Grossmann M (August 2012). "Hypothyroidism. Australian Family Physician 41 (8): 556–62.
5. Surkset. al.,JAMA 291:228, 2004.
6. Daniel,GH, Martin, JB, Neuroendocrine Regulation and Diseases of the Anterior Pituitary and Hypothalamus in Wilson, JD, Braunwald, E., Isselbacher, KJ, et. al., Harrison's Principles of Internal Medicine, 12th Edition, McGraw-Hill, Inc., New York, NY, 1991, p. 1666)
CE 0123 in vitro diagnostic medical device.
Quick test for qualitative detection of Tyroid-Stimulating Hormone (TSH) in human blood.
Only for auto-diagnostic use in vitro.
Precautions
In vitro diagnostic device for individual use. Do not use beyond the expiry date.
1. Only for auto-diagnostic use in vitro.
2. Do not eat, drink or smoke in the sample handling area or kits.
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 open, 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 indicated timings.
6. Use the test only once. Do not disassemble or touch the test window on the support.
7. The kit should not be frozen or used over the printed expiration date on the package.
8. Keep away from the reach of children.
9. The test used must be disposed of according to local regulations.
Mode of use
1. Wash your hands with soap and rinse with warm clean water.
2. Bring the packaging to room temperature before opening it. Open the sealed package and extract the device.
3. Gently pull and throw the protective cap of the hand.
4. Use the tampon with alcohol provided to clean the tip of the middle finger, seat of the puncture.
5. Press the hand, on the side where the cap was removed, against the finger tip (we recommend the side of the ring). The tip is automatically and safely after use.
6. Keeping your hand turned down, massage the puncture seat to get a drop of blood.
7. Without pressing the capillary dropper bulb, put it in contact with the blood. The blood will migrate into the capillary dropper to the line indicated on the dropper. You can massage your finger again to get more blood if you do not reach the line. As far as possible, try to avoid the formation of air bubbles.
8. Put the blood collected in the well for device samples, pressing the dropper bulb.
9. Wait until the blood is completely poured into the well. Unscrew the buffer bottle cap and add 2 drops of buffer in the cockpit for device samples.
10. Wait for the appearance of the colored line/e. Read the results 10 minutes. Do not interpret the results after 20 minutes.
Reading results
POSITIVO: two lines appear, both the line T (Test) and the C (Control). This result indicates that the level of TSH is higher than normal (5 microIU/mL) and that it is necessary to consult a doctor.
NEGATIVE: only one line appears, the control line (C). This result indicates that the level of TSH is not in the range of hypothyroidism.
NULLO: no control line appears. The most probable reasons for the failure of the control line are an insufficient sample volume or incorrect procedural techniques. Review the procedure and repeat the test with a new kit. If the problem persists, stop using the kit immediately and contact your local distributor.
Limitation
1. The TSH (Full Blood) quick test is only for in vitro diagnostic use. The test should only be used to detect TSH in whole blood samples. This qualitative test cannot determine either the quantitative value or the growth rate of the TSH concentration.
2. The TSH rapid test is only for primary control of hypothyroidism in the adult population, it is not suitable for infants.
3. As with all diagnostic tests, all results are to be evaluated together with other clinical information available to the doctor.
4. A positive test must be confirmed using another quantitative laboratory test for TSH.
5. It is possible that false positive results occur due to heterophilic antibodies (rare). In some particular clinical conditions such as central hypothyroidism, TSH levels can 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, which occurs in 1 every 1,000 cases of hypothyroidism.
Conservation
Store packed at room or refrigerated temperature (2-30°C).
The test is stable until the expiry date printed on the sealed package or on the closed box. The test must remain in the sealed package until the time of use. DON'T CONGEL.
Do not use beyond the expiry date.
Format
Pack of 1 piece.
BIBLIOGRAPHY:
1. Merck Manual of Diagnosis and Therapy, Thyroid glans disorders.
2. The American Heritage Dictionary of the English Language, Fourth Edition. Houghton Mifflin Company. 2006. ISBN 0-395-82517-2.
3. Sacher R, Richard A. McPherson (2000). Widmann's Clinical Interpretation of Laboratory Tests, 11th ed. F.A. Davis Company. ISBN 0-8036-0270-7.
4. So, M; MacIsaac, RJ; Grossmann M (August 2012). "Hypothyroidism. Australian Family Physician 41 (8): 556–62.
5. Surkset. al.,JAMA 291:228, 2004.
6. Daniel,GH, Martin, JB, Neuroendocrine Regulation and Diseases of the Anterior Pituitary and Hypothalamus in Wilson, JD, Braunwald, E., Isselbacher, KJ, et. al., Harrison's Principles of Internal Medicine, 12th Edition, McGraw-Hill, Inc., New York, NY, 1991, p. 1666)
