Kimmi: What does the Iron FER Test measure?

Jase: It screens a finger-prick blood sample for ferritin below a 30 ng/mL cut-off.

Kimmi: Does that diagnose iron-deficiency anaemia?

Jase: No. Ferritin is one part of an iron assessment, and the result needs clinical context.

Prima Iron FER Test is a single-use ferritin screening test. In this test’s terminology, a “positive” result means ferritin is below the stated cut-off and medical advice is recommended; a “negative” result means it was not detected below that threshold. The test does not diagnose anaemia, identify the cause of low iron stores or assess iron overload.

The supplied technical specifications state specificity of 100%, sensitivity of 85.2% and accuracy of 96.6%. These figures do not guarantee an individual result, and the supplied interpretation notes that values around 27–29 ng/mL may produce a result similar to one above the cut-off. Seek clinical advice if symptoms or concerns continue regardless of the result, and do not begin high-dose iron solely on a self-test result.

Contents:

• 1 test cassette
  
• 1 vial with dropper containing the diluent
  
• 2 sterile lancets
  
• 1 pipette for blood sampling
  
• 1 cleanser gauze
  
• Instructions for use
  

Directions

USE PROCEDURE

1. Draw a blood sample by using the sterile lancet provided;
2. Collect the sample indicated with the black line by using the capillary pipette provided;
3. Deposit the collected specimen into the sample well (S) indicated on the test cassette;
4. Add 2 drops of the diluent and wait 5 minutes before reading the result.

RESULTS INTERPRETATION

Negative: Ferritin levels in the blood are above 30 ng/mL. Cases where the ferritin concentration is just below this value (27 ng/mL-29 ng/mL) can give a similar result.

Positive: Ferritin value in blood is lower than the cut-off, it is necessary to consult your doctor.

F.A.Q.

What happens if the results reading time is not met?


The test has been carried out correctly when the instructions for use are followed. It includes the reading time and the interpretation of the results shown at the "RESULTS INTERPRETATION" section of the instructions for use.

How to prove that the test worked correctly?


A colored line will appear at the control region (C) on the test device, showing that the test performed correctly. The absence of the colored line suggests to repeat the test with a new device and a new sample.


How to interpret the test if the control and test lines have different intensities?


The color and intensity of the lines do not affect the interpretation of the result. The test has to be considered positive regardless of the color intensity of the test line (T).


BIBLIOGRAPHY

1. Wick M, Pingerra W, Lehmann P, Iron metabolism: diagnosis and therapy of anemias, 5th ed, Vienna, New York: Springer Verlag, 2003; p. 151.
2. Worwood M. The laboratory assessment of iron status – an update. Clin Chim Acta 1997; 259: 3-23.
3. Kaltwasser JP, Werner E. Diagnosis and clinical evaluation of iron overload. Baillieres Clin Haematol 1989; 2; 363-89.
4. Baynes RD, Cook JD. Current issues in iron deficiency. Curr Opin Hematol 1996; 3:145-9.
5. 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.