PRIMA IRON Fer Test Instruction Manual

: June 12, 2024
: PRIMA

Table of Contents

PRIMA IRON Fer Test
IRON AND ANAEMIA
TEST PRINCIPLE
REFERENCES
PACKAGE CONTENT
PRECAUTIONS
TEST PROCEDURE
RESULTS INTERPRETATION
SYMBOLS
F.A.Q. QUESTIONS AND ANSWERS
References
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PRIMA IRON Fer Test

PRIMA-IRON-Fer-Test-PRIMA-IRON-Fer-Test-product

IRON AND ANAEMIA

Iron is an essential metal for our bodies and is crucial for transporting oxygen in the blood, for cell multiplication and to build the structure of tissues and organs. However, in excessively high levels it is toxic for the body. For this reason, every one of us has a system for taking up iron from the external environment (e.g. via a diet rich in iron-containing foods) and storing it in cells in a way that is not excessive (and therefore not toxic). Ferritin is the protein responsible for this storage function. The level of ferritin is an excellent indicator of the amount of iron available to the body. Low levels of this protein in the blood are an indication of depleted iron stores, a condition that precedes the development of anaemia. A decrease can be caused by anaemia, pregnancy, haemorrhages, alterations in iron uptake, or tuberculosis.

TEST PRINCIPLE

Iron FER Test is an immunochromatographic assay that detects the protein Ferritin thanks to special monoclonal gold-conjugate antibodies embedded to test strip.

REFERENCES

Wick M, Pingerra W, Lehmann P, Iron metabolism: diagnosis and therapy of anaemias, 5th ed, Vienna, New York: Springer Verlag, 2003; p. 151.
Worwood M. The laboratory assessment of iron status – an update. Clin Chim Acta 1997; 259: 3-23.
Kaltwasser JP, Werner E. Diagnosis and clinical evaluation of iron overload. Baillieres Clin Haematol 1989; 2; 363-89.
Baynes RD, Cook JD. Current issues in iron deficiency. Curr Opin Hematol 1996; 3:145-9.
Lee MH, Means RT Jr. Extremely elevated serum ferritin levels in a university hospital: associated diseases and clinical significance. Am J Med 1996; 98: 566-71.

PACKAGE CONTENT

The number of testing devices of the kit may vary. For the exact number of tests contained, please refer to the “content” section on the external box.

$PRIMA-IRON-Fer-Test-fig- $1$$

Material required but not supplied: cotton wool, a device to measure time (i.e. timer, watch).
Do not open the sealed aluminium bag until just before performing the test. Take care to open it as marked.
The desiccant packet must not be used. Dispose of it with household waste without opening it.

PRECAUTIONS

Read these instructions for use carefully before performing the test. The Test is reliable only if all the instructions are followed correctly.
Keep the Test out of the reach of children.
Do not use the Test after the expiry date or if the package has been damaged.
Follow the procedure exactly, using only the specified quantities of blood and diluent.
Store the Test components at a temperature between +4°C and +30°C. Do not freeze.
Use the test and lancing device once only.
The test is for external use only. DO NOT SWALLOW.
In vitro diagnostic device for individual use.
Not recommended for people who take anti-coagulant medications (blood thinners) or people suffering from haemophilia.
After using, please dispose of all components according to your local waste disposal laws. Ask your pharmacist for advice.

TEST PROCEDURE

Wash hands with soap and warm water, rinse with clean water and allow to dry. If this is not possible, use the provided gauze as an alternative.
Note: The use of warm water facilitates capillary blood collection as it induces vasodilation.
Prepare the necessary material as follows: open the aluminium pouch, take out only the test cassette and throw away the desiccant bag. Open the plastic packet containing the pipette. – fig. A
Carefully rotate the protective cap of the sterile lancet 360° without pulling it. Extract and discard the released cap. – fig. B
Carefully massage the finger chosen for the puncture (the side of the ring finger is recommended). It is important that the massage is done from the palm of the hand to the phalanx, to improve blood flow. Press the open end of the lancet (the side the cap has been extracted from), against the fingertip – fig. C The tip of the lancet automatically retracts after use. If the lancet does not work properly, discard it and use the second one supplied. If the second one is not required, it can be disposed of without special precautions.
Holding the hand down, massage the finger until a large drop of blood forms. It is important to massage from the palm of the hand to the phalanx to improve blood flow. – fig. D
Take the pipette without pressing the bulb. Two sampling methods are suggested:
- Fig. E1: Hold the pipette horizontally without pressing the bulb and place it in contact with the drop of blood, it will enter the pipette by capillarity. Move the pipette away when the black line is reached. If there is not enough blood, continue to massage the finger until the black line is reached.
- Fig. E2: Place the pipette on a clean, flat surface with the tip protruding from the shelf, then place the drop of blood in contact with the pipette, it will enter by capillarity. If blood is not sufficient, continue massaging the finger until the blood has reached the black line.
- Avoid, as far as possible, to continuously move the tip of the pipette away from the finger in order to prevent the formation of air bubbles.
Place the blood collected with the pipette into the well indicated on the cassette (S) by pressing the pipette bulb. – fig. F
Unscrew the blue cap from the dropper vial (leave the white cap tightly screwed on). Deposit 2 drops into the well indicated on the cassette (S), and wait for 5 seconds between the first and second drops. – fig. G
Wait 5 minutes and read the results referring to the next section for result interpretation.

RESULTS INTERPRETATION

READ THE RESULT AFTER EXACTLY 5 MINUTES
The intensity of the line colours is not relevant for the purposes of interpretation of the Test’s results.

NEGATIVE RESULT

Two coloured bands appear in the reading window by the T (test) and C (control) signs. The T band may be less intense (lighter) than the C line.
This result means the levels of ferritin in the blood are above 30 ng/ml. In some cases, samples with ferritin levels just below this value (between 27 ng/ml and 29 ng/ml) can yield a result of this type.

POSITIVE RESULTS

A coloured band appears only under the C (control) sign.
This means the value of ferritin is below normal levels and medical advice is needed. Consult a physician.

NON VALID RESULT

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

SYMBOLS

In vitro diagnostic device
Read the instructions before use
Sterilised using irradiation
Authorised Representative in the European Community
Temperature limits
Do not reuse
Sufficient for tests
Expiry date (last day of the month)
List number
Lot number
CE marking
Legal manufacturer

F.A.Q. QUESTIONS AND ANSWERS

HOW DOES THE IRON FER TEST WORK?
Ferritin is a protein responsible for storing iron in cells. A positive result means that the concentration of ferritin is ≤ 30 ng/ml. The Test was calibrated on the 3rd International Standard NIBSC 94/572. In some cases, samples with ferritin concentrations between 27 ng/ml and 29 ng/ml can yield a negative result.

WHEN CAN THE TEST BE USED?
The Iron Fer Test can be performed in the presence of symptoms such as paleness, tiredness, frequent migraines and widespread pain, palpitations and occasionally increased heart rate, lack of muscle strength. The Test can be carried out at any time of the day, but must not be performed in the case of illness, acute inflammation, liver or spleen problems. In these cases, there may be positive results even in the absence of an actual iron deficiency.

CAN THE RESULT BE INCORRECT?
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 being used, if part of the diluent is accidentally spilt, if the amount of blood is not enough or the number of drops dispensed in the well is more than 3. The plastic pipette supplied allows users to be sure they have collected the right amount of blood.

HOW DO I INTERPRET THE TEST IF THE COLOUR AND INTENSITY OF THE TEST AND CONTROL BANDS ARE DIFFERENT?
The colour and the intensity of the bands are not important for the interpretation of the result. The bands must be full and homogeneous. The test is negative regardless of the intensity and the colour of the test band.

IS THE RESULT RELIABLE IF READ AFTER 10 MINUTES?
No. The test must be read 5 minutes after the procedure is completed.

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

WHAT SHOULD I DO IF THE RESULT IS NEGATIVE?
If the result is negative, the concentration of ferritin 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) can yield a result of this type. If symptoms persist, seek medical advice in any case.

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, falsely positive or falsely negative results are possible.

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