Superior Performance & Unique Tests

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Specialty Reagents Designed to Expand Your Routine Testing Panel

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Superior Performance & Unique Tests – Innovating clinical diagnostics and enhancing laboratory testing!

In vitro diagnostics is the heart and soul of the healthcare system as healthcare professionals not only rely on diagnostic tests to diagnose and treat patients, but also to rule out the different contributing causes of a disease state. The implementation of superior performance & unique tests can aid in the early and accurate diagnosis of disease states, enabling the appropriate and effective implementation of a personalised treatment plan ¹.

Benefits of the Randox Superior Performance & Unique Tests

Superior Performance Offering

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Offering a range of assays with superior methodologies, delivering more accurate and specific results compared to traditional methods.

Unqiue Offering

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Offering a range of unique assays meaning that Randox are one of the only manufacturers to offer these tests in an automated biochemistry format.

Reduce Labour

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Reduce time spent running tests with liquid ready-to-use formats, automated methods and our easy-fit options.

Reduce Costs

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Creating cost-savings for your laboratory through excellent reagent stability; by eliminating costly re-runs, as a result of high quality of products and the availability of a range of kit sizes (including smaller kits for unique tests, reducing wastage).

Confidence in Patient Results

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All our superior performance & unique diagnostic reagents are validated against gold-standard methods, offering low CV’s and excellent precision giving you the confidence that you are sending out accurate patient results.

Applications Available

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Applications are available detailing instrument-specific settings for the convenient use of the Randox superior performance & unique assays on a wide variety of clinical chemistry analysers.

The in vitro diagnostics market is continuously adapting to the changes in laboratory testing. Consequently, Randox have continued to reinvest in R&D to produce superior performance & unique tests offering laboratories choice, quality and innovation.

Lipoprotein(a) [Lp(a)]

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The Randox Lp(a) assay is calibrated in nmol/l and traceable to the WHO/IFCC reference material (IFCC SRM 2B) and provides an acceptable bias compared with the Northwest Lipid Metabolism Diabetes Research Laboratory (NLMDRKL) gold standard. A five-point calibrator with accuracy-based assigned target values (in nmol/l) is available, accurately reflecting the heterogeneity of the apo(a) isoforms.

5th Generation Total Bile Acids

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The Randox bile acids test utilises an advanced enzyme cycling method which displays outstanding sensitivity and precision when compared to traditional enzymatic based tests. The Randox 5th Generation Bile Acids test is particularly useful in paediatrics where traditional bile acids tests are affected by haemolytic and lipaemic samples.

Vanadate Oxidation Bilirubin

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A superior assay from Randox, the vanadate oxidation method offers several advantages over the diazo method, including less interference by haemolysis and lipaemia, which is particularly evident for infant and neonatal populations.

Adiponectin

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Adiponectin has been identified as having pleiotropic functions widely associated with anti-atherogenic, anti-diabetic, cardioprotective and anti-inflammatory effects. Adiponectin levels inversely correlate with insulin levels, BMI, triglyceride levels, insulin resistance (IR), glucose, and most importantly, visceral fat accumulation.

sTfR

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Soluble transferrin receptor (sTfR) is a marker of iron status. In iron deficiency anaemia, sTfR levels are significantly increased, however remain normal in the anaemia of inflammation. Consequently, sTfR measurement is useful in the differential diagnosis of microcytic anaemia.

Fructosamine

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The Randox Fructosamine assay utilises the enzymatic method which offers improved specificity and reliability compared to conventional NBT-based methods. The Randox enzymatic method does not suffer from non-specific interferences unlike other commercially available fructosamine assays.

Current Challenges

Cardiovascular Disease (CVD)
CVD accounts for 45% of all deaths in europe and 37% of all deaths in the EU. Atherogenesis is a circulatory disease whereby atheromas are formed (plaque build-up) within the artery. Plaque is a combination of cholesterol, fat, calcium, lipids and other substances within the blood stream. As time progresses, the plaque hardens, narrowing the arteries. This is known as atherosclerosis. Consequently, blood flow through the narrowed artery is reduced, limiting the supply of blood to vital organs and bodily tissues. As atherogenesis can affect any artery within the body, different diseases may develop based on the artery that is affected. Such diseases include: coronary heart/artery disease, carotid artery disease, peripheral artery disease and chronic kidney disease ^{2, 3, 4}.

Type 2 Diabetes Mellitus (T2DM)
425 million people are living with type 2 diabetes mellitus (T2DM) and 352 million are at risk of developing T2DM. T2DM is a serious condition whereby blood glucose levels are elevated (hyperglycaemia). T2DM is characterised by insulin resistance or insulin deficiency. T2DM is the most common form of diabetes, accounting for 90% of cases. The key to T2DM is control. Implementing lifestyle changes, oral medication and in more severe cases, insulin, a diabetic can take control of their disease, keeping glucose levels stable. When glucose levels are not monitored and controlled, associated complications may arise including: diabetic nephropathy, CVD and renal impairment ^{5, 6}.

Chronic Kidney Disease (CKD)
Worldwide 1/5 of men and 1/4 of women between 65 and 74 years of age have Chronic kidney disease (CKD). CKD is an umbrella term encompassing a wide range of renal conditions from commonly prevalent sub-clinical, asymptomatic to rare end-stage renal disease requiring dialysis or a transplant to sustain life. Kidney disease is ranked in stages from stage 1 (very mild damage) through to stage 5 (kidney failure) ⁷. Symptoms are commonly expressed in the later stages of renal impairment, however, at this point dangerous levels of fluid, electrolytes and waste products can build up inside the body. The aim of CKD treatment is to slow the progression of the disease, thus early intervention is vital ⁸.

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Related Products

On a global scale, 1.62 billion people are affected by anaemia which is equivalent to 24.8% of the population ₁. 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/

References:

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

Adiponectin	Cholesterol (sdLDL)	Glutathione Peroxidase (Ransel)	Microalbumin
Aldolase	Copper	Glutathione Reductase	Non-Esterified Fatty Acids (NEFA)
Apolipoprotein C-II	Creatinine (Enzymatic)	H-FABP (AKI)	Soluble Transferrin Receptor (sTfR)
Apolipoprotein C-III	Cystatin C	H-FABP (Cardiac)	Superoxide Dismutase (Ransod)
Apolipoprotein E	D-3-Hydroxybutyrate (Ranbut)	Homocysteine	Total Antioxidant Status (TAS)
Bile Acids (5th Generation)	Fructosamine (Enzymatic)	IgE	Zinc
Bilirubin (Vanadate Oxidation)	G6PDH	Lipoprotein (a)