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SCREEN VERIFICATION TEST Ferritin Description In vitro diagnostic medical device CE 0123. The rapid ferritin test is a test for the qualitative detection of ferritin in human digital puncture blood for iron deficiency anemia. For in vitro self-diagnostic use only. Precautions 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. Procedure 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 a drop of buffer solution to the sample well of the device. 10. Wait for the colored line(s) to appear. Read the results after 5 minutes. Do not interpret results after 10 minutes. Interpretation of results NORMAL: Two lines appear, both the T (Test) line and the C (Control) line. This result indicates that the ferritin concentration in the blood is normal and that there is no potential iron deficiency. ABNORMAL: Only one line appears, the control line (C). This result indicates that the ferritin concentration in your blood is too low. You should consult a doctor as you may have an iron deficiency. 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 rapid ferritin test provides only a qualitative analytical result. An additional analytical method is required to obtain a confirmatory result. 2. Technical or procedural errors may occur, as well as interference from other substances in the blood sample, which could lead to erroneous results. 3. As with all diagnostic tests, all results should be evaluated in conjunction with other clinical information available to the physician. 4. Additional available clinical tests are required if equivocal results are obtained. Conservation Store in the sealed pouch 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 should remain in the sealed pouch until use. DO NOT FREEZE. Do not use after the expiration date. Format Package containing 1 piece. BIBLIOGRAPHY: 1. Kryger MH, Otake K, Foerster J (March 2002). “Low body iron stores and restless legs syndrome: a correctable cause of insomnia in adolescents.” Sleep Med. 3(2): 127–32. 2. Mizuno S, Mihara T, Miyaoka T, Inagaki T, Horiguchi J (14 March 2005). “CSF iron, ferritin and transferrin levels in restless legs syndrome.” J Sleep Res 1:43–7
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