Ferri Check
Rapid self-test for the detection of iron deficiency in blood
Intended Purpose
FERRI-Check® is a manual qualitative immunochromatographic screening test for the assessment of ferritin level (a protein capable of storing iron) in finger prick whole blood sample. It can be used at home by lay users for self-testing for the detection of potential iron deficiency.
General Points
Anaemia due to iron depletion is widely held in children and women of all ages but mainly in women who still have their period (at least 20% suffer iron deficiency). Main signs as paleness, feeling tired, headaches, faster heartbeat or shortness of breath during exercise appear gradually and could go unnoticed. Therefore, it is important to determine if the available iron is sufficient for the body’s needs.
Iron deficiency occurs when blood does not contain enough red cells and thus low levels of haemoglobin which is a major protein involved in oxygen transport in whole body. An important component of haemoglobin is iron.
Depletion in iron, which can happen during pregnancy, growth, in case of insufficient iron intake, inadequate absorption or blood loss (periods, abnormal bleedings, ulcers…etc) have tremendous effects on health.
Caution: This test is not appropriated for patient suspected of or suffering from hemochromatosis.
Test Procedure
Prepare everything properly before starting the testing procedure. Place the content of the box on a clean, dry and flat surface (e.g. table). Then perform the test as follows:
- Wash your hands thoroughly. Use soap and warm water. Dry your hand with clean towel.
- Prepare the test device and capillary pipette: Take them out from the protective pouch (tear at the notch) and place them in the reach of your hands (you will need them later). Discard the desiccant bag.
- Prepare the lancet. Hold the lancet without touching the trigger button. Unlock the cap twisting it off ¼ turn until you feel it separates from the lancet and then continue twisting it (2-3 rotations). Don’t pull just twist and discard the cap when finished. ①②
- Clean the end of the middle or ring finger with cotton damped with alcohol. Massage the chosen finger towards the tip for 10 to 15 seconds to enhance the blood flow.
- Prick the finger: put the lancet firmly against the side of the previously cleaned finger, and press the release trigger button.③ The lancet will automatically retract into the body of the device. Gently massage the finger to create a nice round blood droplet.④
- Collect the blood with the capillary pipette: Gently touch the blood droplet with the open end of the capillary pipette. It must be filled until the line indicated on the capillary pipette. Do not press the bulb, it fills by itself. Make another blood droplet if the line is not reached. As far as possible, avoid air bubbles. ⑤
- Put the blood collected with the pipette into the sample well of the device, by pressing on the pipette bulb. ⑥
- Wait 30-40 sec for the blood being totally absorbed into the sample well.
- Add the diluent: Unscrew the blue cap of the diluent dropper vial (leave the white cap tightly screwed) and add the diluent as follows: Hold the diluent dropper vial vertically and slowly add exactly 4 drops in the sample well of the device with an interval of 2-3 seconds between each drop. ⑦
- Read the result after 10 minutes. Do not interpret after 15 minutes.
Results Interpretation
The intensity and the colour of the lines do not have any importance for the interpretation of the test results.
Analyze
Result
Summary
Positive result
Negative result
Invalid result
Questions and Answers
How does FERRI-Check® work?
FERRI-Check® test uses a couple of antibodies detecting specifically ferritin by producing a coloured test line under the T mark of the cassette. A control line capturing the reagent excess appears as a coloured line under the C mark of the cassette. In case only one line appears under the C mark, the test indicates that the level of ferritin is too low (value <20 ng/mL determined against W.H.O.* reference).
*World Health Organization
When should the test be performed?
FERRI-Check® test should be performed in case of symptoms like paleness, feeling tired, headaches, faster heartbeat or shortness of breath during exercise mainly when pregnant or in case of copious periods.
The test can be performed at any time of the day but must not be performed in case of diseases, acute inflammations, obesity or in case of spleen or liver injury. Positive results could be obtained even in case of no iron deficiency situation.
Can the result be incorrect?
The results are accurate as long as the instructions are carefully respected. Nevertheless, the results can be incorrect if FERRI-Check® test gets wet before test performing or if the quantity of blood dispensed in the sample well is not correct. The plastic pipette provided in the box makes sure the collected blood volume is correct.
How to interpret the test if the colour and the intensity of the lines are different?
The colour and intensity of the lines have no importance for result interpretation. The lines should only be homogeneous and complete. The test should be considered as negative regardless the colour intensity of the test line (T), even weak.
What is the line that appears under the mark C (Control) for?
When this line appears, it only means that the test has been performed well.
If I read the result after 15 minutes, will the result be reliable?
No. The test should be read 10 minutes after adding the diluent. The result is reliable up to 15 minutes.
What do I have to do if the result is positive?
If the result is positive, it means that the ferritin level in blood is lower than the norm (20 ng/mL) and that you should consult a doctor to show the test result. Then, the doctor will decide whether additional analysis should be performed.
What do I have to do if the result is negative?
If the result is negative, it means that the ferritin level is higher than 20 ng/mL and is within the norm. However, if the symptoms persist, it is recommended to consult a doctor.
What is the accuracy of FERRI-Check®?
The FERRI-Check® test is accurate and has been used for more than 20 years by professionals in the field. Evaluation reports show an overall agreement of 98% [92.58 – 100**] with reference methods. Although this test is reliable, false positive or false negative results could be obtained.
**CI 95%: 95% Confidence Interval.