Ferritin Assay

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Ferritin Assay

Reagent | Ferritin

The Most Sensitive and Specific Diagnostic Test for Iron Deficiency

Benefits of Ferritin

Exceptional correlation

A correlation coefficient of r=0.99 was displayed when the Randox ferritin assay was compared to commercially available methods.

Limited interference

The Randox ferritin assay has shown to have limited interference from bilirubin, haemoglobin and triglycerides.

Applications available

Applications available detailing instrument-specific settings for the convenient use of the Randox ferritin assay on a variety of clinical chemistry analysers.

Excellent stability

The Randox ferritin assay is stable to expiry when stored at +2oC to +8oC.

Calibrator and controls available

Calibrator and controls available offering a complete testing package.

Ordering Information

Cat NoSize
FN3452R1 1 x 40ml (L)
R2 1 x 20ml
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FN3888R1 3 x 20ml (L)
R2 3 x 11ml
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FN8037 R1 4 x 16.2ml
R2 4 x 10.2ml
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(L) Indicates liquid option

Instrument Specific Applications (ISA’s) are available for a wide range of biochemistry analysers.  Contact us to enquire about your specific analyser.

Diagnostic Uses

  • Physiological Significance
  • Iron Deficiency
  • Still's Disease
  • Sepsis
  • cHL
  • COVID-19

Ferritin is an iron storage protein. It is the primary iron storage mechanism and is critical to iron homeostasis. As an iron store, ferritin has two roles 1.

  1. Provides a reserve of iron, which can be transported for the synthesis of molecules such as cytochromes, haemoglobin and iron-sulphur compounds.
  2. Safe-guards cells, DNA, lipids and proteins from the potential toxic effects of iron.

Ferritin is a vital component of iron homeostasis. It acts as as a ferroxidase, converting Fe(II) to Fe(III) as iron is internalised and sequestered in the ferritin mineral core. Iron is toxic in cellular systems due to its capacity to generate reactive oxygen species (ROS) which directly damages cells, DNA, lipids and proteins 1.

Iron deficiency without anaemia is a diagnostic challenge, as it commonly goes unrecognised for a long period of time as the patient is asymptomatic. Ferritin is the most sensitive and specific test used in the diagnosis of iron deficiency, especially when a patient presents with symptoms of iron deficiency anaemia, but their full blood count is normal 2.

Adult onset Still’s Disease (AOSD) is a rare systemic inflammatory disorder characterised by arthritis, fever and a typical skin rash. Elevated ferritin levels have been observed in 89% of patients with AOSD, with five times the normal level observed in over half of patients 3.

Elevated ferritin levels is associated with a poor outcome in patients with sepsis and can be used as a predictive marker of mortality along with current prognostic scores 4. Elevations of both ferritin and CRP during hospitalisation was associated with the highest mortality, followed by elevations of either biomarker alone (fig. 1) 5.

Fig. 1. Risk contingency table for mortality and organ dysfunction based on cut-points for C-reactive protein and ferritin and patients’ maximum value for each biomarker 5
Fig. 1. Risk contingency table for mortality and organ dysfunction based on cut-points for C-reactive protein and ferritin and patients’ maximum value for each biomarker

Data is displayed as n / N (%) for mortality outcomes

*Significant difference in high/intermediate versus low risk quadrants; {<0.001 by Mann-Whitney test PELOD2, Pediatric Logistic Organ Dysfunction Score 2

Ferritin is the most important acute phase reactant in the prediction of classical Hodgkin lymphoma (cHL). Ferritin correlates with the inflammatory activity of the cHL microenvironment, which could explain its prognostic impact. Elevated ferritin levels are associated with clinical features of aggressive disease and poor prognosis in cHL patients 6.

As an acute phase reactant, ferritin levels increase during inflammation and infection. Several studies have indicated that elevated ferritins levels were confirmed in the majority of hospitalised patients with COVID-19, approximately 60%. In the critically ill COVID-19 patients, extremely elevated ferritin concentrations were recorded, which could be attributed to a cytokine storm and secondary haemophagocytic lymphohistiocytosis (a hyperinflammatory syndrome associated with multiorgan failure) 7.

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Iron Deficiency Anaemia during Pregnancy

On a global scale, 1.62 billion people are affected by anaemia which is equivalent to 24.8% of the population . According to a review carried out by WHO of various national surveys, anaemia affects approximately 42% of pregnant women worldwide and it is also estimated that at least 50% of all anaemia cases are due to iron deficiency.

Anaemia caused by iron deficiency is usually expected during pregnancy. This is due to several reasons: the increased demand for iron by a pregnant woman’s body from increased total blood cell volume, requirements of the foetus and placenta as well as mass blood loss during labour₂. Although iron cost is unbalanced by the lack of loss of menstrual blood during pregnancy, the net cost is still high enough that iron recommendations are higher than in non-pregnant women. Also, iron is critical during pregnancy considering its involvement in foetal growth: 600-800mg of iron is required during pregnancy with around 300mg needed just for the foetus, a minimum of 25mg for the placenta and almost 500mg due to the increase in volume of red blood cells. ₃

Iron deficiency is the most common micronutrient deficiency in pregnant women leading to iron deficiency anaemia if left untreated. However, iron deficiency can be difficult to measure in some populations due to the lack of availability of field-specific biomarkers. For example, anaemia can affect up to 56% of pregnant women in developing countries, which suggests a high prevalence of iron deficiency anaemia: around 25%. In settings with endemic malaria, such as certain countries in Africa, the number of pregnant women with anaemia is much higher: around 65%.

There are various factors that may increase the risks of iron deficiency anaemia. For example, a diet influenced by religious beliefs can cause a lack of iron in the diet, such as vegetarianism which is common in countries such as India where religious beliefs dictate this. Iron levels can also be affected by consumption of nutrients which inhibit proper absorption of iron, such as calcium or ones that promote iron absorption, such as vitamin C. Other circumstantial risks include infections, multiple pregnancies and adolescent pregnancy while socioeconomic factors and access to healthcare mean some women won’t have access to anaemia control programs, iron supplements or even access to information about iron deficiency anaemia during pregnancy.

To prevent iron deficiency, international guidelines state that iron supplementation to manage iron deficiency is recommended during pregnancy. ₄ However, this is not always available, especially in developing countries.

Iron deficiency anaemia during pregnancy can cause several complications for the mother including:

  • Increased fatigue
  • Short-term memory loss
  • Decreased attention span
  • Increased pressure on the cardiovascular system due to insufficient haemoglobin and blood oxygen levels
  • Lower resistance to infections
  • Reduced tolerance to significant blood loss and surgical implications during labour.

As expected, neonates with mothers who suffered from iron deficiency anaemia during pregnancy will also be confronted with risks and, even if iron deficiency is only mild to moderate, can result in a premature birth, complications with foetal brain development, low birth weight and even foetal death. Additionally, it has been proven that cognitive and behavioural abnormalities can be seen in children for up to ten years after iron insufficiency in the womb.

Randox Soluble Transferrin Receptor (sTfR) Reagent

Randox Reagents offer a Soluble Transferrin Receptor assay to expand upon our current iron testing offering.

In iron deficiency anaemia, soluble transferrin receptor levels are significantly increased, however, remain normal in acute phase conditions including: chronic diseases and inflammation.  As such, sTfR measurements are useful in the differential diagnosis of anaemia: anaemia of chronic disease or iron deficiency anaemia.

In iron deficiency anaemia, increased sTfR levels have also been observed in haemolytic anaemia, sickle cell anaemia and B12 deficiency.

The benefits of the Randox Soluble Transferrin Receptor (sTfR) Reagent include:

  • Latex enhanced immunoturbidimetric method facilitating testing on biochemistry analysers and eliminating the need for dedicated equipment.
  • Liquid ready-to-use reagents for convenience and ease-of-use
  • Stable to expiry date when stored at +2 to +8 °C
  • Excellent measuring range of 0.5 – 11.77mg/L, comfortably detecting levels outside of the normal health range of 0.65 – 1.88mg/L
  • Excellent correlation coefficient of r=0.977 when compared against other commercially available methods
  • Applications available detailing instrument-specific settings for a wide range of clinical chemistry analysers

Find out more at: https://www.randox.com/stfr/


  1. de Benoist B et al., eds.Worldwide prevalence of anaemia 1993-2005WHO Global Database on Anaemia Geneva, World Health Organization, 2008.
  2. Harvey et al, Assessment of Iron Deficiency and Anemia in Pregnant Women: An Observational French Study, Women’s Health, Vol 12 Issue 1, 2016
  3. Burke et al, Identification, Prevention and Treatment of Iron Deficiency during the First 1000 Days, Nutrients, Vol 6 Issue 10, 2014
  4. Guideline: Daily Iron and Folic Acid Supplementation in Pregnant Women. World Health Organization; Geneva, Switzerland: 2012

If you are a clinician or laboratory who are interested in running assays to test iron status, Randox offer a range of assays, including: Iron, Total Iron-Binding Capacity (TIBC), Transferrin and Ferritin .  These assays can be run on most automated biochemistry analysers.

Instrument Specific Applications (ISA’s) are available for a wide range of biochemistry analysers. Contact us to enquire about your specific analyser.

For more information, visit: https://www.randox.com/stfr / or email: reagents@randox.com