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MUNUS MEDICAL IRON DEFICIENCY TEST Description Rapid test for the qualitative determination of ferritin in human blood from fingerstick for iron deficiency anemia. The membrane is coated with a polyclonal anti-ferritin antibody on the test line area. The gold particle is coated with a monoclonal anti-ferritin antibody and rabbit IgG. During the test, the sample reacts with the particle coated with monoclonal anti-ferritin antibodies. The mixture then migrates chromatographically upward on the membrane by capillary action and reacts with the polyclonal anti-ferritin antibody on the membrane, generating a colored line. If the ferritin level exceeds the cutoff level of 30 ng/mL, a colored line appears in the test region (T). If the ferritin concentration is less than 30 ng/mL, the colored line does not appear. For procedural control purposes, a colored line will always form in the control region to indicate that an adequate volume of sample has been added and capillary penetration into the membrane has occurred. How to use Bring the case to room temperature before opening. Open the case and remove the cassette. Wash your hands with soap and rinse with warm water. Carefully remove the lancet cap and discard it. Use the alcohol swab to clean the tip of your middle or ring finger, as this is the puncture site. Press the lancet on the side where the cap was removed against your fingertip (its recommended to do this on the ring finger). The tip automatically and safely retracts after use. Keeping your hand down, massage the pricked tip to draw a drop of blood. Without squeezing the bulb of the capillary dropper, place it in contact with the blood. The blood will flow into the capillary dropper up to the line indicated on the dropper. You can massage your finger to obtain more blood if the line isnt reached. Avoid air bubbles as much as possible. Place the collected blood into the sample well of the cassette by pressing the dropper bulb. Wait until the blood has completely transferred to the well. Unscrew the cap of the buffer bottle and add 1 drop of buffer to the sample well on the cassette. Wait for the colored line(s) to appear. Read the results after 5 minutes. Do not interpret results after 10 minutes. Reading the results Normal: Two colored lines appear. Both the T (test) and C (control) lines appear. This result means that the ferritin concentration in the blood is normal and that there is no potential iron deficiency. Abnormal: Only one colored line appears, the control line (C). This result means that the ferritin concentration in the blood is too low. It is necessary to consult a doctor because you may have an iron deficiency. Invalid: The control line does not appear. Insufficient sample volume or improper procedural techniques are the most likely causes of a missing control line. Review the procedure and repeat the test with a new test. 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 carefully before performing the test. For in vitro diagnostic self-testing only. Do not eat, drink, or smoke in the area where specimens or kits are being handled. This kit is intended for use as a preliminary test only and repeatedly abnormal results should be discussed with a physician or healthcare professional. Strictly follow the indicated timeframes. Use the test only once. Do not disassemble or touch the test window of the test cassette. The kit must not be frozen or used after the expiration date printed on the package. Keep out of reach of children. The used test must be disposed of according to local regulations. The test provides only a qualitative analytical result. A second analytical method must be used to confirm the result. Technical or procedural errors, as well as interfering substances in the whole blood sample, may cause erroneous results. As with all diagnostic tests, all results should be considered in conjunction with other clinical information available to the physician. If the results obtained are questionable, further clinical tests are necessary. Conservation Store in the original package at room temperature or refrigerated (2-30°C). Do not freeze. The test is stable until the expiration date. The test must 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 dropper; - buffer; - alcohol swab; - hand; - package leaflet. 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 and young adults.” SleepMed.3(2): 127-32. 2. Mizuno S, Mihara T, Miyaoka T, Inagaki T, Horiguchi J (March 14, 2005). “Cerebrospinal fluid iron, ferritin, and transferrin levels in restless legs syndrome.” J Sleep Res1: 43–7. Cod. MM-OFE-402H
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