PreventID TSH. Additional information Manual Medical information

Transcription

1 Additional information Manual Medical information

2 Manual (for professional use) PreventID TSH (KST72116) The PreventID TSH is a rapid test for the determination of TSH in capillary blood, serum or whole blood. The test sensitivity is 5 µ IU/ml. For professional use only. Explanation of the Test A thyroid stimulating hormone (TSH) test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone in whole blood. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. Symptoms of hypothyroidism: Vague symptoms Thyroid deficiency Sluggishness Cold sensitivity Depression Forgetfulness Dry hair Dry skin Constipation Increased menstrual flow Weight gain Materials provided One PreventID TSH test kit contains the following items: PreventID TSH test device 1 Blood sample dropper Manual Test Procedure 1. Remove the test disk from the foil pouch, and place it on a flat, dry surface. 2. Collect capillary blood as described below or provide serum or whole blood samples. 3. As the test begins to work, you will see purple color move across the Result Window in the center of the test disk. 4. Interpret test results at 10 minutes. Do not interpret the test after 15 minutes. Specimen Collection and Application (capillary blood) 1. Prick fingertip with a sterile lancet. 2. Massage near the site to obtain blood flow. 3. Place the tip of the blood sample dropper into the blood sample and make sure the blood sample dropper is slightly lower than the blood sample so that the blood will automatically flow into the dropper. 4. Fill the dropper with blood sample so that you can yield 3 drops of blood (Fig. A). If insufficient blood sample, massage near the site again to obtain more blood flow and fill the blood sample dropper. 5. Holding the sample dropper above the test disk (Fig. B) and add one hanging drop into the sample well. After the drop is absorbed into the sample well, add two further hanging drops the same way. If specimen drops are added too quickly, especially for blood specimen, it may cause clogging of the sample well. 6. Interpret test results at 10 minutes. Do not interpret the test after 15 minutes. Materials required but not provided: Alcohol pad, sterile lancet, clock. Reagent Storage The PreventID TSH test kit should be stored at 4-30 C (40-86 F). Precautions 1. If the test device or the extraction buffer were stored at lower temperatures make sure they are at room temperature before starting the test. 2. The test device is sensitive to humidity as well as to heat. Perform the test immediately after removing the test device from the foil pouch. 3. Do not use it beyond the expiration date. 4. For in vitro diagnostic use only. 5. Do not eat or smoke while handling specimens. 6. Wear protective gloves while handling specimens. Wash hands thoroughly afterwards. 7. Avoid splashing or aerosol formation. 8. Clean up spills thoroughly using an appropriate disinfectant. 9. Decontaminate and dispose of all specimens, reaction kits and potentially contaminated materials, as if they were infectious waste, in a biohazard container. 10. Do not use the test kit if the pouch is damaged or the seal is broken. Fig. A: Filling the dropper with blood Fig. B: Expelling the blood sample into the sample well Specimen Application (serum, whole blood) For a TSH analysis in serum, 2 drops of the sample are added to the sample well. For a TSH analysis in whole blood, 3 drops of the sample are added to the sample well.

3 Manual (for professional use) Test Interpretation A purple band will appear at the left section of the Result Window. This shows that the test is working properly. This band is the Control Band (C). The right section of the Result Window indicates the test results. If another color band appears at the right section of the Result Window, this band is the Test Band (T). Positive Result: The presence of two color bands ( T band and C band) within the result window regardless of which band appears first indicates a positive result (Figure 2). Note: Generally, the higher the analyte level in the specimen, the stronger the T band color will be. When the specimen analyte level is close to but still within the sensitivity limit of the test, the color of the T band will be very faint. Negative Result: The presence of only one color band within the Result Window indicates a negative result (Figure 3). Invalid Result: If after performing the test no purple color band is visible within the Result Window, this result is considered invalid (Figure 4). Not following the procedures correctly or using a test kit that has deteriorated can cause invalid results. It is recommended that the specimen be retested. Limitations of the Test Although the PreventID TSH Test is very accurate in detecting TSH, a low incidence of false results can occur. Some serum specimens with a high rheumatoid factor concentration may yield a nonspecific positive result. Other clinically available tests are required if questionable results are obtained. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated. Short instructions for the PreventID TSH Remove the test disk from the foil pouch and place it on a flat, dry surface. Prepare sample (serum or whole blood), or obtaina capillary blood sample, using a sterile lancet and the sample dropper. Apply 2 drops of serum or 3 drops of whole blood into the sample well. Alternatively, squeeze capillary blood from the dropper into the sample well. Interpret test result at 10 minutes. Do not interpret the test after 15 minutes Status: Used symbols Storage temperature In vitro diagnostic device Catalogue number Read instruction before use Manufacturer Lot number Expiry date Do not reuse Contains sufficient for <n> tests Note: A positive result will not change once it has been established at 10 minutes. However, in order to prevent any incorrect results, the test result should not be interpreted after 10 minutes. Sensitivity and Specificity The PreventID TSH Test sensitivity is 5 µ IU/ml TSH. The ability of the test to specifically detect TSH was challenged through cross-reaction studies on specimens containing known quantities of structurally and physiologically related hormone. Serum specimens spiked with 500 miu/ml LH (Human Leuteinizing Hormone), 1000 miu/ml FSH (Follicle Stimulating Hormone), 200,000 miu/ml hcg (human Chorionic Gonadotropin) show negative results. US: all products: Research Use Only. Not for use in diagnostic procedures. Distributed by: Preventis GmbH Wiesenstr Bensheim, Germany Phone: +49 (0) Fax: +49 (0) info@preventis-online.de MPC INTERNATIONAL S.A. 26, Boulevard Royal 2449 Luxembourg, Luxembourg

4 Medical information Hypothyroidism? PreventID TSH Rapid test for the determination of TSH in blood (diagnosis of hypothyroidism) PreventID TSH is a rapid test for the determination of thyroid stimulating hormone (TSH) in capillary blood, serum, or whole blood. The test sensitivity is 5 µ IU/ml. For professional use. A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in blood. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. Simple Handling of the PreventID TSH Remove the test disk from the foil pouch, and place it on a flat, dry surface Apply capillary blood from the sample dropper, 2 drops of serum or 3 drops of whole blood samples into the sample well Interpret test result at 10 minutes Symptoms of hypothyroidism: Vague symptoms Thyroid deficiency Sluggishness Cold sensitivity Depression Forgetfulness Dry hair Dry skin Constipation Increased menstrual flow Weight gain Interpretation of the Test Positive Result: The presence of two color bands ( T band and C band) within the result window regardless of which band appears first indicates a positive result (Figure 2). Note: Generally, the higher the analyte level in the specimen, the stronger the T band color will be. When the specimen analyte level is close to but still within the sensitivity limit of the test, the color of the T band will be very faint. Negative Result: The presence of only one purple color band within the Result Window indicates a negative result (Figure 3). Invalid Result: If after performing the test no purple color band is visible within the Result Window, this result is considered invalid (Figure 4). Not following the procedures correctly or using a test kit that has deteriorated can cause invalid results. It is recommended that the specimen be retested. Sensitivity and Specificity The PreventID TSH test sensitivity is 5 µ IU/ml TSH. The ability of the test to specifically detect TSH was challenged through cross-reaction studies on specimens containing known quantities of structurally and physiologically related hormone. Serum specimens spiked with 500 µ IU/ml LH (Human Leuteinizing Hormone), 1000 µ IU/ml FSH (Follicle Stimulating Hormone), 200,000 µ IU/ml hcg (human Chorionic Gonadotropin) show negative results.

5 Medical information Fax Reply Preventis GmbH +49 (0) We will gladly send further information about this test and our other point-of-care diagnostics on request Please send me more informative material about (please mark): PreventID TSH (Determination of hypothyroidism) PreventID CC (Early detection of bowel cancer) PreventID Haemo/HaptOccult (Early detection of bowel cancer) PreventID Micro-Albumin (Detection of microalbuminuria) PreventID CalDetect (Differentiation between IBD and IBS) PreventID CalScreen (Differentiation between IBD and IBS) PreventID CalDetect 50/200 (Differentiation between IBD and IBS & Therapy monitoring) PreventID CRP 1/3 (Prediction of first and recurrent cardiovascular events) Name: Address: Date: August 2013* US: all products: Research Use Only. Not for use in diagnostic procedures. Preventis GmbH Wiesenstr Bensheim, Germany Phone +49(0)6251/ Fax +49(0)6251/ info@preventis-online.de