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SCREEN VERIFICATION TEST Thyroid hormone TSH Description 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-diagnostic use only. Precautions In vitro diagnostic device for individual use. Do not use after the expiry date. 1. For in vitro self-diagnostic use only. 2. Do not eat, drink or smoke in the sample or kit handling area. 3. Store in a dry place between 2-30°C (36-86°F), avoiding areas with 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 specialist. 5. Strictly adhere to the indicated deadlines. 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 after the expiration date printed on the package. 8. Keep out of reach of children. 9. The used test should be disposed of according to local regulations. How to use 1. Wash your hands with soap and rinse with clean warm water. 2. Allow the packaging to reach room temperature before opening. Open the sealed packaging 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 the sting occurred. 5. Press the lancet, from the side where the cap was removed, onto the tip of your finger (using your ring finger is recommended). The tip automatically and safely retracts after use. 6. Holding your hand down, massage the puncture site to obtain a drop of blood. 7. Without squeezing the bulb of the capillary pipette, place it in contact with the blood. The blood will flow into the capillary pipette up to the line indicated on the pipette. You can massage your finger again to get more blood if the line is not reached. Try to avoid air bubbles as much as possible. 8. Insert the collected blood into the sample well of the device by pressing the pipette bulb. 9. Wait until the blood has completely flowed into the well. Unscrew the cap of the buffer solution bottle and add 2 drops of buffer solution to the sample well of the device. 10. Wait for the colored line(s) to appear. Read results after 10 minutes. Do not interpret results after 20 minutes. Reading the results POSITIVE: Two lines appear, both the T (Test) line and the C (Control) line. This result indicates that the TSH level is higher than normal (5 microIU/ml) and that a doctors consultation is necessary. NEGATIVE: Only one line appears, the control line (C). This result indicates that the TSH level is not in the hypothyroid range. NULL: Control line does not appear. The most likely reasons for the control line not appearing are insufficient sample volume or incorrect procedural techniques. 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. limitation 1. The TSH Rapid Test (Whole Blood) is for in vitro diagnostic use only. The test should only be used for the detection of TSH in whole blood specimens. This qualitative test cannot determine the quantitative value or rate of increase in TSH concentration. 2. The TSH rapid test (whole blood) is intended only for primary screening for hypothyroidism in the adult population, it is not suitable for newborns. 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 will need to be confirmed using another quantitative laboratory test for TSH. 5. False positive results may occur due to heterophilic antibodies (rare). In certain 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. Conservation Store packaged at room temperature or in a refrigerator (2-30°C). The test is stable until the expiration date printed on the sealed pouch or unopened box. The test should remain in the sealed pouch until use. DO NOT FREEZE. Do not use after the expiration date. Format Pack of 1 piece. BIBLIOGRAPHY: 1. Merck Manual of Diagnosis and Therapy, Thyroid Disorders. 2. American Dictionary of the English Language, Fourth Edition. Houghton Mifflin Company. 2006. ISBN 0-395-82517-2. 3. Sacher R, Richard A. McPherson (2000). Widmanns Clinical Interpretation of Laboratory Tests, 11th edition. FA Davis Company. ISBN 0-8036-0270-7. 4. Deci, M; MacIsaac, RJ; Grossmann M (August 2012). “Hypothyroidism”. Australian Family Physician 41(8): 556–62. 5. Surkset. al., JAMA 291:228, 2004. 6. Daniel, G.H., Martin, J.B., Neuroendocrine regulation and diseases of the anterior pituitary gland and hypothalamus in Wilson, J.D., Braunwald, E., Isselbacher, K.J. et al., Harrisons Principles of Internal Medicine, 12th ed., McGraw-Hill, Inc., New York, NY, 1991, p. 1666)
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