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MEDICAL ASSISTANCE THYROID TSH TEST Description Rapid immunochromatographic test for the qualitative detection of TSH in human whole blood at a cut-off concentration of 5 mcIU/mL. The Thyroid TSH Test is a qualitative, membrane-based immunoassay for the detection of Thyroid Stimulating Hormone (TSH) in whole blood specimens. In this assay procedure, anti-TSH antibody is immobilized in the test region and coated particles. After the sample is added to the sample well of the cassette, it reacts with the anti-TSH antibody-coated particles in the assay. The mixture migrates chromatographically across the test region and interacts with the immobilized anti-TSH antibody. Positive samples react with the particles coated with specific anti-TSH antibodies to form a colored line in the test region of the membrane. The absence of a colored line suggests a negative result. For procedural control purposes, a colored line will always appear in the control region to indicate that an adequate volume of sample has been added and that capillary penetration of the membrane has occurred. This test provides a preliminary diagnostic result and can be used for TSH screening. How to use Wash your hands with soap and rinse with warm water. Allow the bag to come to room temperature before opening. Open the foil bag and remove the cassette. Carefully remove the lancet cap and discard. Use the alcohol swab provided to clean the tip of your middle or ring finger as the puncture site. Press the lancet, on the side from which the cap was removed, onto the tip of your finger (using the ring finger is recommended). The tip automatically and safely retracts after use. Keeping your hand pointing downwards, massage the pricked end to obtain a drop of blood. Place the bulb of the capillary pipette in contact with the blood, without squeezing the bulb. The blood will flow into the pipette up to the indicated line. If the line is not reached, you can massage your finger again to obtain more blood. Avoid air bubbles. Pour the collected blood into the collection well of the cassette by squeezing the bulb of the pipette. Wait until the blood has completely flowed into the well. Unscrew the cap of the buffer solution bottle and add two drops of buffer solution to the collection well of the cassette. Wait for the colored lines to appear. Read the result after 10 minutes. Do not interpret the result after 20 minutes. Reading the results POSITIVE: Two colored 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 mcIU/ml) and that a doctors consultation is necessary. NEGATIVE: One colored line appears. Only the control line (C) appears. This result means that the TSH level is outside the range of values that determine hypothyroidism. INVALID: Control line does not appear. The most likely reasons for control line failure are insufficient sample volume or incorrect procedural techniques. Review the procedure and repeat the test with a new test strip. If the problem persists, discontinue use of the test kit immediately and contact your local distributor. warnings Please read all the information in this leaflet before performing the test. For in vitro self-diagnostic use only. Do not eat, drink, or smoke in the area where specimens or kits are being handled. If the foil packaging is damaged or has been opened, do not use it. This test kit should only be used as a preliminary test, and repeated abnormal results should be discussed with your doctor or a clinical specialist. Strictly adhere to the indicated deadlines. Use the test only once. Do not disassemble or touch the test window of the cassette. The kit should not be frozen or used after the expiration date printed on the package. Keep out of reach of children. The used test should be disposed of according to local regulations. The test should only be used for the detection of TSH in whole blood samples. This qualitative test does not allow the determination of either the quantitative value or the rate of increase in TSH concentration. The rapid test is only used for screening primary hypothyroidism in the adult population, not in newborns. As with all diagnostic tests, all results must be interpreted in conjunction with other clinical information available to the physician. A positive test must be confirmed using a quantitative laboratory test for TSH. False positive results may occur due to heterophilic (unusual) antibodies. In certain clinical conditions, such as central hypothyroidism, TSH levels may be normal/low despite hypothyroidism. A medical consultation is recommended for evaluation of such cases. For central/secondary hypothyroidism, TSH is not a reliable biomarker, appearing in 1 in 1,000 cases of hypothyroidism. Conservation Store in a dry place between 2-30°C (36-86°F), avoiding areas with excessive humidity. Do not freeze. The test is stable until the expiration date printed on the sealed pouch. The test should remain in the sealed pouch until use. Do not use after the expiration date. Shelf life in intact packaging: 24 months. Format The kit contains: - test cassette; - capillary pipette; - buffer; - alcohol swab; - hand; - the prospectus. 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. et al., JAMA 291:228, 2004. Daniel, GH, Martin, JB, Neuroendocrine regulation and diseases of the anterior pituitary and hypothalamus in Wilson, JD, Braunwald, E., Isselbacher, KJ, et al., Harrisons Principles of Internal Medicine, 12th ed., McGraw-Hill, Inc., New York, NY, 1991, p. 1666). Code MM-OTS-402H
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