Why do I need this anaemia test?

Anaemia is a common and potentially dangerous condition of the blood brought about when the body does not produce enough red blood cells. You should do this test if you think you may be anaemic. The following are common symptoms of anaemia:

• You feel tired most of the time.
• You look pale.
• You don’t have as much energy as you used to.
• Your nails break easily.
• Dizziness
• You feel the cold all the time.
• You find you are short of breath.
• Your ankles tend to swell up.
• Numbness or tingling in the hands or feet.

What is anaemia?

Anaemia is a reduced level of haemoglobin in the blood. Haemoglobin, (contained in the red blood cells) obtains oxygen from the lungs and carries it to all the bodys’ cells. Here it is used as fuel in the metabolism of sugar and fat to produce energy, so, when the level of oxygen in the blood is reduced, tiredness and other symptoms of anaemia result. To produce red blood cells, the body needs (among other things) iron, vitamin B12 and folic acid. If there is a lack of one or more of these ingredients, anaemia will develop.

What symptoms does anaemia cause?

The first symptoms will be:

• Tiredness and poor concentration.
• Palpitations (awareness of the heartbeat).
• Shortness of breath and dizziness.

If anaemia is severe, angina chest pain), headaches and leg pains can occur.

How accurate is this test?

Comparison between methods showed the anaemia metre has an accuracy of over 96% and is more than 97% specific for identifying anaemia as identified by a low haemoglobin level. Both the accuracy and specificity of the anaemia metre compare favourably with laboratory based tests.

Before you start the test:

Contents:

1 sealed aluminium pouch containing:

• 1 device for the test,
• 1 pipette and desiccant,
• 1 dropper vial containing 1 ml of diluent,
• 1 painless sterile lancet for blood sampling,
• instructions for use.

How is this test carried out

The Iron Test – FER is a rapid immunodiagnostic test for the assessment of ferritin (a protein capable of storing iron in cells) from finger prick whole blood sample. Therefore the Test can be used for the screening of potential iron deficiency. The cut-off is calibrated at 30 ng/mL according to the international standard.

The sample is a blood drop taken with the painless sterile lancet contained in the box.

Obtain a drop of blood by squeezing the finger and use the capillary tube to collect the blood.

Put the drop of blood on the indicated point on the device.

Add the diluent, wait for 10 minutes and read the result.

Test Results

	Negative Result Two coloured lines appear in the window under the marks T (Test) and C (Control). The intensity of the line T may be clearer than the intensity of the line C. This result means that the ferritin concentration in blood is normal and that there is no potential iron deficiency.
	Positive Result Only one coloured line appears under the C mark (Control). This result means that the ferritin concentration in blood is too low. Reserves are insufficient. You should consult a doctor because it may be an iron deficiency.
	NON Valid Result No line appears or a coloured line appears under the mark T (Test) without any line under the mark C (Control). In this case, it is not possible to interpret the test, which must be considered as non valid. It is recommended to repeat the test with a new test device and 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 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 positive 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.

To download the instructions for use please click on the links below;

Instructions for use – English

Istruzioni per l’uso – Italiano

Notice d’utilisation – Français

Brugsanvisning – Dansk

Instructions of use – Arab

Instructions of use – Greek