IRON FER TEST – 1 Test

Description

GENERAL

IRON AND ANEMIA
Iron is an essential metal for our body and is crucial for the transport of oxygen in the blood, for cell division and for the construction of tissues and organs. However, in too high concentrations it is toxic to the body. Therefore, each of us has a system to absorb iron from the external environment (e.g. through a diet rich in iron-containing foods) and store it in the cells in a way that is not excessive (and therefore not toxic). ). Ferritin is the protein responsible for this storage function. Ferritin levels are an excellent indicator of the amount of iron available in the body. A low level of this protein in the blood is an indication of depleted iron stores, a condition that precedes the development of anemia. A decrease can be caused by anemia, pregnancy, bleeding, changes in iron absorption, tuberculosis.

TEST PRINCIPLE
Iron FER Test is an immunochromatographic test that detects the protein ferritin thanks to special monoclonal gold conjugate antibodies embedded in the test strip.

INSTRUCTION MANUAL
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TEST PROCEDURE

1. Wash hands with soap and warm water, rinse with clean water and allow to dry. If this is not possible, use the supplied gauze as an alternative.
   Note: The use of warm water facilitates capillary blood collection because it induces vasodilation.
2. Prepare the necessary material as follows: open the aluminum pouch, remove only the test cassette and discard the desiccant pouch. Open the plastic package containing the pipette. – . a
3. Gently rotate the protective cap of the sterile lancet 360° without pulling it. Remove the released cap and throw it away. – . b
4. Gently massage the finger chosen for the injection (the side of the ring finger is recommended).
   It is important that the massage is performed from the palm of the hand to the phalanx of the finger to improve blood circulation. Press the open end of the lancet (the side where the cap is pulled out).
   is) against the fingertip – .C The tip of the lancet automatically retracts after use. If the lancet does not work properly, throw it away and use the second lancet provided. If the second is not necessary, it can be removed without special precautions.
5. Hold the hand down and massage the finger until a large drop of blood forms. It is important to massage from the palm of the hand to the phalanx of the finger to improve blood circulation.
   – . D
6. Take the pipette without pressing the bulb. Two sampling methods are proposed:
   – . E: Hold the pipette horizontally without pressing the bulb and place it in contact with the
   drop of blood, which will end up in the pipette due to capillarity. Move the pipette away when the
   black line has been reached. If there is not enough blood, continue to massage the finger until the black line is reached.
   – . E: Place the pipette on a clean, flat surface with the tip out of the shelf, then place
   the drop of blood in contact with the pipette, it will enter by capillarity. If the blood is not enough, continue to massage the finger until the blood reaches the black line.
   As much as possible, avoid continuously moving the pipette tip away from the finger to prevent the formation of air bubbles.
7. Transfer the blood collected with the pipette into the well indicated on the cassette (S) and onto the bulb
   of the pipette. – . F
8. Unscrew the blue cap from the dropper bottle (leave the white cap firmly in place). Place 2 drops in the well indicated on the cassette (S), wait 5 seconds between the first and the second drop. –
   . G
9. Wait 5 minutes and read the results referring to the next section for interpretation of the results.

INTERPRETATION OF THE RESULTS:
READ THE RESULT AFTER EXACTLY 5 MINUTES
The intensity of the line colors is not relevant to the interpretation of the test results.

NEGATIVE RESULT
Two colored bands appear in the reading window at the characters T (test) and C (control). The T-band may be less intense (lighter) than the C-line. This result means that the ferritin level in the blood is higher than 30 ng/ml. In some cases, samples with ferritin levels just below this value (between 27 ng/ml and 29 ng/ml) may produce such a result.

POSITIVE RESULTS
A colored band appears only under the C (control) sign. This means that the value of ferritin is below normal levels and medical advice is needed. See a doctor.

INVALID RESULT
No bands appear or there is only a line under the T (test) mark and not under the C (control) mark.
In this case it is not possible to interpret the result of the test, which should be considered invalid. Repeat the test with a new blood sample.

HOW DOES THE IRON FER TEST WORK?
Ferritin is a protein responsible for storing iron in cells. A positive result means that the ferritin concentration is 30 ng/ml. The test is calibrated to the 3rd international standard NIBSC 94/572. In some cases, samples with ferritin concentrations between 27 ng/ml and 29 ng/ml may yield a negative result.

WHEN CAN THE TEST BE USED?
The Iron Fer Test can be performed for symptoms such as paleness, fatigue, frequent migraines and widespread pain, palpitations and sometimes increased heart rate, lack of muscle strength. The test can be performed at any time of the day, but should not be performed in case of illness, acute inflammation, liver or spleen problems. In these cases, results may be positive even if there is no actual iron deficiency.

COULD THE RESULT BE WRONG?
The result is correct if the instructions are followed carefully. However, the result may not be correct if: the device comes into contact with other liquids before use, if some of the diluent is accidentally spilled, if the amount of blood is not sufficient or if the number of drops delivered into the well is more than 3. With the supplied plastic pipette, the user can be sure that he has collected the correct amount of blood.

HOW SHOULD I INTERPRETE THE TEST IF THE COLOR AND INTENSITY OF THE TEST AND CONTROL BANDS ARE DIFFERENT?
The color and intensity of the bands are not important for the interpretation of the result. The bands must be complete and homogeneous. The test is negative regardless of the intensity and color of the test band.

IS THE RESULT RELIABLE IF IT IS READ AFTER 10 MINUTES?
No. The test should be read 5 minutes after completion of the procedure.

WHAT SHOULD I DO IF THE RESULT IS POSITIVE?
If the result is positive, the concentration of ferritin in the blood is lower than normal and you should consult a doctor, who will determine what to do next.

WHAT SHOULD I DO IF THE RESULT IS NEGATIVE?
If the result is negative, the ferritin concentration is at least 30 ng/ml. In some cases, samples with ferritin levels just below this value (between 27 ng/ml and 29 ng/ml) may produce such a result. Consult a doctor if symptoms persist.

HOW ACCURATE IS THE IRON FER TEST?
The test is very accurate. Assessment reports show a concordance rate of 96,6% (CI 95%: 93,4-99,8%) with reference methods. Despite the reliability of the test, false positive or false negative results are possible.