Self-diagnostic for iron test

Product Description

Rapid test for the qualitative determination of ferritin in human blood from fingersticks for iron deficiency anemia.

Indications

The Munus Medical self-test for iron deficiency is a rapid test for the qualitative determination of ferritin in human blood from fingersticks 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 present on the membrane, generating a colored line.

If the ferritin level exceeds the cut-off 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 area to indicate that an adequate volume of specimen has been added and capillary penetration into the membrane has occurred.

Directions for Use and Dosage

• Bring the pouch to room temperature before opening;
• Open the pouch 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 the puncture site;
• Press the lancet from the side from which the cap was removed against the tip of your finger (it is recommended to do this on the ring finger);
• The tip automatically and safely retracts after Use;
• Holding your hand down, massage the pricked tip to release a drop of blood;
  Without squeezing the bulb of the capillary dropper, bring it into contact with the blood;
• The blood will migrate in the capillary dropper up to the line indicated on the dropper;
• You can massage your finger to obtain more blood if the line is not reached;
• Avoid air bubbles as much as possible;
• Put the collected blood into the sample well of the cassette, squeezing the bulb of the dropper;
• Wait until the blood is 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 results after 5 minutes;
• Do not interpret results after 10 minutes.

Warnings

Read all information in this package insert carefully before performing the test. For in vitro diagnostic self-testing only. Do not eat, drink, or smoke in the area where the specimens or kits are handled. This kit is intended for use only as a preliminary test and repeatedly abnormal results should be discussed with a physician or healthcare professional. Strictly follow the indicated timing. Use the test only once. Do not disassemble or touch the test window of the test 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 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 errors in the test method, may cause a false positive result. 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 testing is necessary.

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, the control line (C), appears. This result means that the ferritin concentration in the blood is too low. A physician should be consulted because there may be an iron deficiency.

Invalid: The control line does not appear. Insufficient sample volume or incorrect 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.

Storage

Store in the pouch 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 if unopened: 24 months.

Format

The kit contains: test cassette, capillary dropper, buffer, alcohol swab, lancet, and package insert.