Could H-FABP Have Potential Benefits in Diagnostics Beyond Cardiac Health Problems?

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Could H-FABP Have Potential Benefits in Diagnostics Beyond Cardiac Health Problems?

14th March 2019

Could H-FABP Have Potential Benefits in Diagnostics Beyond Cardiac Health Problems?

To date, the most traditional diagnostic test for renal impairment is creatinine. However, although most commonly used, problems can arise when implementing this test as a number of factors are not considered. On this World Kidney Day, Randox will explore the potential utility of H-FABP as a clinical diagnostic marker for cardiac surgery-associated acute kidney injury.

Acute Kidney Injury (AKI) is defined as an acute decline in renal function that can lead to structural changes. It involves a sudden drop in kidney function that usually arises due to a complication of another serious illness such as impaired renal perfusion, exposure to nephrotoxins, outflow obstruction or intrinsic renal disease. As a result, a patient can experience effects such as impaired clearance and regulation of homeostasis, altered acid/base and electrolyte regulation and impaired volume regulation.1

The mortality rate associated with AKI varies depending on severity, patient related factors and setting including whether the patient is in intensive care (ICU) or not.2 In the UK, AKI has been found to affect 1 in 5 people admitted to hospital as an emergency and has been found to be deadlier than a heart attack, contributing to around 100,000 deaths each year. Conversely, in the US, age-standardized rates of acute kidney injury hospitalisations increased by 139% among adults with diagnosed diabetes and by 230% among those without diabetes.3, 4

The rising incidence of AKI comes at price. Patients tend to survive ICU but will be discharged with various degrees of chronic kidney disease (CKD), placing an increasing strain on the health care system. At present, the cost to the NHS is estimated to be between £434 and £620 million, which is more than the costs associated with breast cancer, or lung and skin cancer combined. However, this increased cost and strain could be unnecessary, as research has shown that 30% of the reported 100,000 deaths in the UK could have been prevented with the right care and treatment.3,4

These unfavourable statistics are the result of late detection of AKI, as to date, a superior method of detection has not been found.

Cardiac surgery-associated acute kidney injury (CSA-AKI)

CSA-AKI is a well-recognised postoperative complication of cardiac surgery and is the second most common cause of AKI in the intensive care unit, occurring in up to 30% of patients.5,6 Of these patients, an estimated 1% will require dialysis and the majority will remain dependent on dialysis leading to an increase in mortality. Certain patient groups are more susceptible to CSA-AKI and vulnerability can depend on age, sex, pre-existing cardiac dysfunction, pre-existing CKD, previous cardiac surgery or comorbidity.7

The pathogenesis of AKI involves multiple pathways including hemodynamic, inflammatory and nephrotoxic factors that overlap  leading to kidney injury.6 Figure 1 illustrates the pathophysiology of AKI following cardiac surgery. It shows that there are multiple physiological processes that are associated with the development of AKI as a result of cardiac surgery.8

Figure 1 Illustrates the pathophysiology of AKI following cardiac surgery and the various mechanisms that contribute.8

What is H-FABP?

Fatty acid-binding proteins (FABPs) are small cytoplasmic proteins that are abundantly expressed in tissues with an active fatty acid metabolism, with their primary function being the facilitation of intracellular long-chain fatty acid transport.9 Elevated FABP serum concentrations are related to a number of common comorbidities including heart failure, CKD, diabetes mellitus and metabolic syndrome, which represent important risk factors for postoperative AKI.10

H-FABP is most commonly associated with being a marker for acute coronary syndrome (ACS) as its concentrations peak at approximately 6-8 hours after symptom onset, making it easier to detect. Recently studies have highlighted H-FABP as a potential biomarker for the detection of AKI after cardiac surgery. This potential would mean earlier diagnosis of patients, reducing the mortality rate and costs to the health service.

Potential Mechanism for the release of H-FABP in AKI

There are a number of hypotheses regarding the release of H-FABP, with myocardial injury being considered the major reason for an increased level. The mechanisms involved in this increase have been found to differ depending on the severity of a patients ACS situation including whether they are in ICU.11

One possible explanation for the release of H-FABP is the effects of ischemic stress. Ischemic stress induced by non-cardiogenic shock is a type of mechanical stretching which can lead to the leakage of small amounts of macromolecules. This process would lead to the release of H-FABP into the blood. In non-cardiac patients, minor myocardial injury alone may not adequately explain this observed increase. Other factors such as a reduction in the amount of skeletal muscle tissue, lipid disorders, release of free radicals and an increase in free acids produced by the catabolism of glycogen could also contribute to a rise in H-FABP levels.11

One final process that could lead to increased H-FABP is the damage of vital organ functions which occurs in almost all non-surgical intensive care patients. The degree of leakage of H-FABP may vary depending on the severity of a patient’s condition and whether they have suffered from multiple organ failure or vital organ damage. AKI is a component of multiple organ failure suggesting that serum H-FABP levels may increase in AKI patients as a result. Also, serum H-FABP is excreted by renal tubular cells and patients with an acutely diminished renal function are unable to clear large amounts of H-FABP resulting in increasing levels. These potential mechanisms of H-FABP and its release during AKI provide further confirmation that the measurement of serum H-FABP is an effective biomarker in patients with AKI.11

Comparison of H-FABP Measurement Against Traditional Acute Kidney Disease Measurement Tools

For years, no standard method for definition or diagnosis  was in place for AKI. The RIFLE classification was introduced in 2004, which defined and staged renal failure over seven days into five classes of increasing severity including; risk, injury, failure, loss and end-stage kidney disease.

The RIFLE criteria were then revised by the Acute Kidney Injury Network (AKIN) and introduced four main changes including replacing the period of seven days for serum creatinine (SCr) with forty eight  hours and implementing SCr changes as low as 0.3 mg/dL as the lowest measure considered as AKI. However, despite these changes the Kidney Disease Improving Global Outcome (KDIGO) proposed that AKI is defined when any of the three criteria are met including increase in SCr by 50% in seven days, increase in SCr > 0.3 mg/dL or oliguria.7

However, despite these advances, identification and management of AKI is still difficult for two main reasons. The change of SCr does not occur until two to three days after the initial insult. Also, serum creatinine can rise for a variety of reasons such as tubular injury, hemodynamic alterations or cardio-renal interactions.

The utility of SCr as biomarker for CSA- AKI is questionable as changes occur 48 hours to seven days after the original insult.5 The delays in diagnosis of CSA-AKI may have detrimental effects as prolonging the diagnosis period may result in the disease already being well established.12

Also, a main issue concerning the AKI criteria established is its relevance to the perioperative period. Many surgical patients arrive in hospital without preoperative SCr concentrations being measured, potentially leading to over-diagnosis of AKI. However, when patients do arrive with a preoperative SCr concentration, the opposite can occur and immediate postoperative period SCr concentrations can be lower than baseline as a result of haemodilution.  A comparison of the postoperative and preoperative values can lead to under-diagnosis of AKI and consequently delayed treatment.12

The research conducted has illustrated that SCr is not the most appropriate biomarker for diagnosis of AKI. Studies have demonstrated that H-FABP has more clinical utility and is released less than thirty minutes after myocardial injury and renally excreted within 24 hours, showing that as a biomarker it responds faster than creatinine.12

How Randox can Help

The Randox H-FABP test tests utilises an immunoturbidimetric method, offers a wide measuring range and is available liquid ready-to-use for convenience and ease of use.

Want to know more?

Contact us or visit the Randox H-FABP Site

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  • References

    1. National Kidney Foundation. Acute Kidney Injury (AKI). National Kidney Foundation. [Online] National Kidney Foundation. [Cited: February 3, 2019.] https://www.kidney.org/atoz/content/AcuteKidneyInjury.
    2. Biomarkers for the prediction of acute kidney injury: a narrative review on current status and future challenges. Geus, de, MG, Betjes and J , Bakker. 2, s.l. : NCBI, 2012, Vol. 5.
    3. Kidney Care UK. A range of useful facts and stats about kidneys. Kidney Care UK. [Online] Kidney Care UK. [Cited: February 15, 2019.] https://www.kidneycareuk.org/news-and-campaigns/facts-and-stats/.
    4. Centers for Disease Control and Prevention. Trends in Hospitalizations for Acute Kidney Injury — United States, 2000–2014. Centers for Disease Control and Prevention. [Online] Centers for Disease Control and Prevention, March 16, 2018. [Cited: February 22, 2019.] https://www.cdc.gov/mmwr/volumes/67/wr/mm6710a2.htm.
    5. Cardiac Surgery-Associated Acute Kidney Injury. Mao, h, et al. s.l. : Karger, 2013, Vol. 3.
    6. Acute Kidney Injury Associated with Cardiac Surgery. Rosner, Mitchell and Okusa, Mark. 1, s.l. : Clinical Journal of American Society of Nephrology, 2016, Vol. 1.
    7. Cardiac surgery-associated acute kidney injury. Loubon, Christian, et al. 4, s.l. : NCBI, 2016, Vol. 19.
    8. Acute kidney injury following cardiac surgery: current understanding and future directions. O’Neal, Jason, Shaw, Andrew and Billings, Frederic. s.l. : NCBI, 2016, Vol. 20.
    9. Heart-type fatty acid-binding protein predicts long-term mortality after acute coronary syndrome and identifieshigh-risk patients across the range of troponin values. Kilcullen, N, et al. 20, s.l. : Epub, 2012, Vol. 50.
    10. Preoperative serum h-FABP concentration is associated with postoperative incidence of acute kidney injury in patients undergoing cardiac surgery. Oezkur, Mehmet, et al. 117, s.l. : BMC Cardiovascular Disorders, 2014, Vol. 14.
    11. The serum heart-type fatty acid-binding protein (HFABP) levels can be used to detect the presence of acute kidney injury on admission in patients admitted to the non-surgical intensive care unit. Shirakabe, A, et al. 1, s.l. : NCBI, 2016, Vol. 16.
    12. Perioperative acute kidney injury. Goren, O and Matot, I. 2, s.l. : British Journal of Anaesthesia, 2015, Vol. 115.

Rare Disease Day: 28th February 2019

28th February 2019

Rare Disease Day: 28th February 2019

Rare Disease Day raises awareness of rare diseases and how patients’ lives are affected. Many rare diseases remain incurable and many go undiagnosed. 1 in 20 people will live with a rare disease at some point in their life and this is why it is so important to raise awareness.1

What is a rare disease?

There is no single definition for a rare disease, as many countries identify them differently. In the United States, the Rare Diseases Act of 2002 defines a rare disease by its prevalence: “any disease or condition that affects fewer than 200,000 people in the United States”. However, the EU defines a rare disease as a condition that affects less than 5 in 10,000 of the population. There are approximately 7000 rare diseases and disorders and 50% of people affected by rare diseases are children.2,3

Hyperlipoproteinemia type III

This rare disease day, Randox will be raising awareness of hyperlipoproteinemia type III.  Hyperlipoproteinemia type III, also known as dysbetalipoproteinemia or broad beta disease, is a rare genetic disorder characterised by improper breakdown of lipids, specifically cholesterol and triglycerides.  The condition is caused by mutations in the Apo-E gene, however the inheritance of this condition is complicated due to the development of symptoms having to be triggered by a secondary factor to raise lipid levels. These factors include diabetes, obesity or hypothyroidism.

It is unknown exactly what the prevalence of the condition is, but it is estimated to affect approximately 1 in 5,000 – 10,000 of the general population and it has been found that it affects males more often than females, with women rarely being affected until after menopause.4,5

Figure A. Example of cholesterol and lipid build-up [6] 

Symptoms

Symptoms for hyperlipoproteinemia type III will vary for each individual and some people may even be asymptomatic. The most common symptom is the development of xanthomas which are deposits of fatty material, the lipids, in the skin and underlying tissue. Xanthomas may appear on the palms of the hands, eyelids, soles of the feet or on the tendons of the knees and elbows.

> Chest pain or other signs of coronary artery disease

> Cramps in the calves when walking

> Sores on toes

> Stroke-like symptoms such as trouble speaking, dropping on one side of the face, weakness in an arm or a leg and a loss of balance6

Complications can arise if the condition is left untreated and these can include: myocardial infarction, ischemic stroke, peripheral vascular disease, intermittent claudication and gangrene of the lower extremities.7

Diagnosis

Although there is no specific diagnostic test for hyperlipoproteinemia type III, diagnosis is based on clinical evaluation and identification of symptoms. Research has indicated that an algorithm comprising a number of dysbetalipoproteinemia indices may be helpful in the diagnosis of the disease.  These include:

> Low apolipoprotein B to total cholesterol ratio

> Elevated levels of triglycerides

> Elevated levels of total cholesterol8

Managing the condition

The condition cannot be cured but treatment is to control conditions such as obesity, hypothyroidism and diabetes. Most patients will go through dietary therapy to control their intake of cholesterol and saturated fat. This prevents xanthomas, high levels of lipids in the blood, exercise will also help to lower lipid levels. However, dietary changes may not be effective for some individuals and this is where drugs may be used to lower lipid levels instead.

How Randox can Help

Randox offer a range of routine and niche assays within the lipid testing panel to monitor lipid levels and to identify associated complications.  Some of these tests include:

Apolipoprotein B

The Randox Apolipoprotein B tests utilises an immunoturbidimetric method, offers a wide measuring range and is available liquid ready-to-use for convenience and ease of use.

Learn more about the Randox Apolipoprotein B Test

Total Cholesterol

The Randox Total Cholesterol test utilises the CHOD-PAP method and offers an extensive measuring range with a wide range of kits available to suit a wide range of laboratory sizes.

Learn more about the Randox Total Cholesterol test

Triglycerides

The Randox Triglycerides test utilises the GPO-PAP method while offering an extensive measuring range with both liquid and lyophilised formats available offering choice and flexibility.

Want to know more?

Contact us or download our Cardiology and Lipid Testing brochure to learn more.




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  • References

    [1] Rare Disease Day. What is Rare Disease Day? Rare Disease Day. [Online] 2019. [Cited: February 21, 2019.] https://www.rarediseaseday.org/article/what-is-rare-disease-day

    [2] Genetic Alliance UK. What is a Rare Disease? Rare Disease UK. [Online] 2018. [Cited: February 21, 2019.] https://www.raredisease.org.uk/what-is-a-rare-disease/

    [3] NZORD. Rare Disease Facts and Figures. NZORD. [Online] 2019. [Cited: February 21, 2019.] https://www.nzord.org.nz/helpful-information/rare-disease-facts-and-figures.

    [4] NORD. Hyperlipoproteinemia Type III. NORD. [Online] 2019. [Cited: February 21, 2019.] https://rarediseases.org/rare-diseases/hyperlipoproteinemia-type-iii/

    [5] GARD. Hyperlipidemia Type 3. National Centre for Advanciing Translational Sciences. [Online] December 29, 2016. [Cited: February 21, 2019.] https://rarediseases.info.nih.gov/diseases/6703/hyperlipidemia-type-3

    [6] Falck, Suzanne. Everything you need to know about hyperlipidemia. Medical News Today. [Online] December 21, 2017. [Cited: February 21, 2019.] https://www.medicalnewstoday.com/articles/295385.php

    [7] Medline Plus. Familial Dysbetalipoproteinemia. Medline Plus. [Online] May 16, 2018. [Cited: February 21, 2019.] https://medlineplus.gov/ency/article/000402.htm.

    [8] Dysbetalipoproteinemia: Two cases report and a diagnostic algorithm. Kei, Anastazia, et al. 4, s.l. : World Journal of Clinical Cases, 2015, Vol. 3.


Overcoming the burden of Diabetes and Cardiovascular Disease

The Prevalence 

Cardiovascular disease (CVD) is the number one cause of death globally with more people dying annually from CVD than any other disease state. In 2018, according to the American Heart Association, CVD accounted for nearly 836,546 deaths in the USA (1) with over 17 million known deaths recorded worldwide. It is also proclaimed that around 1.5 million people globally die each year because of diabetes and diabetes related complications. (2) Is there a common link? Can this issue be controlled?

Studies have suggested that diabetes is one of the leading related conditions associated with increased risk of CVD death. A recent study undertaken in 2018 examined the association of many risk factors associated with CVD, the study was broken down by disease state with over 17,000 participants involved. The findings highlighted that 17.9% of these patients suffered from diabetes mellitus and death from a cardiovascular event. (3) Many other pilot and research studies discovered similar findings considering further risk factors such as high blood pressure, abnormal cholesterol and high triglycerides, obesity, lack of exercise and lifestyle choices such as smoking, alcohol and drug abuse. All of which are common with patients who suffer from diabetes, placing them at an increased risk of CVD.

Findings highlighted that over 68% of people aged over 65 living with diabetes die from some form of heart disease with 16% of individuals dying from an ischemic stroke. (4)   The ability to tackle the prevalence of increased death from CVD and diagnosis of diabetes has become a global burden with the international diabetes federation projecting that 592 million people worldwide will have diabetes by 2035. (5)

Worldwide, the increase of diabetes is becoming an economic burden on the patient and healthcare systems mainly due to the direct costs of medical care and the indirect costs of moderated productivity, tied to diabetes and CVD related morbidity and mortality. Many scholars have highlighted economic burden as a primary attribute to both macrovascular and microvascular complications such as coronary artery disease, myocardial infarction, hypertension, peripheral vascular disease, retinopathy, end-stage renal disease and neuropathy. (6)

DID YOU KNOW?

The RX Series offers the worlds largest clinical chemistry test menu

Overcoming the Burden

As CVD is the most prevalent cause of mortality and morbidity in patients with diabetes, effective treatment and analysis is required to control and decrease the number of CVD deaths across the globe. Tackling this issue head on, the Randox RX series introduce Direct HbA1c which refers to glycated haemoglobin which is a product of haemoglobin (a protein which can be found in red blood cells) and glucose from the blood making it glycated.

Testing for HbA1c provides an indication of what an individual’s average blood sugar level has been over recent weeks/months and is generally considered as an indicator of how well the patient is managing and controlling their diabetes. This is significant for those who suffer from diabetes because the higher the levels of HbA1c, the higher the chance of an individual suffering from further diabetes related issues, therefore testing for HbA1c improves the predictions of a CVD event occurring.

The Randox RX series have Direct HbA1c testing capabilities on the RX Daytona +, RX imola and RX modena. Our latex enhanced immunoturbidimetric method which the RX series utilises makes the test simple and quick to perform. The removal of the pre-dilution step removes the risk of human error compromising your results without the need for a separate HbA1c analyser.

Offering the world’s largest test menu, the RX series has an extensive range of cardiac, diabetes and lipid tests with excellent correlation to gold standard methodologies designed to allow laboratories to expand their testing capabilities onto one single platform, providing cost savings through consolidation.

References:

  1. American Heart Association. (2018). Heart Disease and Stroke Statistics 2018 At-a-Glance.Available: https://www.heart.org/-/media/data-import/downloadables/heart-disease-and-stroke-statistics-2018—at-a-glance-ucm_498848.pdf. Last accessed 7th Feb 2019.
  2. World Heart Federation. (2017). Cardiovascular diseases (CVDs) – Global facts and figures.Available: https://www.world-heart-federation.org/resources/cardiovascular-diseases-cvds-global-facts-figures/. Last accessed 7th Feb 2019.
  3. Gomadam, P et al, (2018). Blood pressure indices and cardiovascular disease mortality in persons with or without diabetes mellitus. Journal of Hypertension. 36 (1), 1-5.
  4. Heart attack and stroke symptoms. (2018). Cardiovascular Disease and Diabetes.Available: https://www.heart.org/en/health-topics/diabetes/why-diabetes-matters/cardiovascular-disease–diabetes. Last accessed 7th Feb 2019.
  5. Aguiree F, Brown A, Cho NH, Dahlquist G, Dodd S, Dunning T, Hirst M, Hwang C, Magliano D, Patterson C. (2013) IDF Diabetes Atlas.
  6. Bahia LR, Araujo DV, Schaan BD, Dib SA, Negrato CA, Leão MP, Ramos AJ, Forti AC, Gomes MB, Foss MC, Monteiro RA, Sartorelli D, Franco LJ, Value Health. (2011), 137-40.

Why Choose the Randox RX series?

Why Choose the RX series?

Notorious for quality and reliability, the Randox RX series delivers on precision, reliability and accuracy, revolutionising patient testing in a variety of laboratory types including Clinical Laboratories, University & Research Institutes and Veterinary Laboratories.

The RX series is world renowned for delivering superior performance, our comprehensive test menu comprises over 113 clinical chemistry assays – 22 more than our nearest competitor.  In addition to this we offer superior methodology for many assays with excellent correlation to gold standard methods. Our test menu is constanty expanding and currently covers routine chemistry, specific proteins, lipids, cardiac markers, therapeutic drugs, drugs of abuse, antioxidants and diabetes testing including direct HbA1c testing capabilities.  Designed to meet the needs of your laboratory, our range of novel tests allow laboratories to expand their test menu without expanding their lab ultimately reducing costs, labour and the risk of error without the need for additional / specialised equipment.

With a versatile range of semi-automated and automated analysers, the RX series offers flexibility to suit the needs of all laboratory requirements. Built on the foundations of robust hardware and intuitive software, the RX series will reduce costly test re-runs and potential misdiagnosis.  With minimal analyser downtime significant cost and time savings are a reality.

Our prominent reputation of providing laboratories with unrivalled customer and technical support across the globe surpasses that of any of our competitors complementing our extensive and world leading test menu. We pride ourselves in both the delivery and functionality of high quality clinical chemistry analysers, dedicated reagents and support ensuring accuracy and reliability in reporting patient results.

DID YOU KNOW?

The RX Series offers the worlds largest clinical chemistry test menu

Offering the World’s Largest Clinical Chemistry Test Menu

Most recently the RX series welcomed the addition of Direct HbA1c to our testing panel, available to be run on the RX Daytona +, RX imola and RX modena. If you are interested in running your assays on a routine biochemistry analyser, Randox offers a large range of high quality routine and niche protein assays that can be run on most automated analysers.

Click to discover more about our world leading RX series Testing menu or contact us today @theRXseries to find out how we can improve your laboratories testing capabilities.

Choose from the RX misano, RX monacoRX daytona+, RX imola and RX modena to start your journey with the RX series today.


Obesity and Kidney Disease: What is the Connection?

30th January 2019

Obesity and Kidney Disease: What is the Connection?

The month of January has forever been the month of resolutions with many choosing to ditch the sweets and join the gym. However, for many these efforts are limited to January and bad habits are quick to remerge. Obesity has been a burden on the health service for many years with the problem, like many people’s waist lines, only continuing to expand.

Recent findings have shown that this problem is no longer just increasing in developed countries but also in developing countries. In fact, worldwide obesity has tripled since 1975. In 2016, more than 1.9 million adults were classed as overweight, of which over 650 million were obese.1 These are shocking statistics for a condition that is preventable. As a global concern, it is important to assess all the potential risks of this problem.

The most common diseases associated with obesity are cardiovascular disease (CVD) and diabetes. However, the associated risks are much greater than this. Being overweight may also increase the risk of certain types of cancer, sleep apnea, osteoarthritis, fatty liver disease and kidney disease.2

Obesity is now recognised as a potent risk factor for the development of renal disease.3 Excess weight has a direct impact on the development and progression of chronic kidney disease (CKD). Globally, the prevalence of diabetic kidney disease rose by 39.5% between 2005 and 2015, coinciding with the increased CKD prevalence.4 In obese individuals, the kidneys have to work harder, filtering more blood than normal to meet the metabolic demands of increased body weight, increasing the risk of kidney disease.

The traditional diagnostic test for renal impairment is creatinine. This test is carried out through the measurement of creatinine levels in the blood to assess the kidneys ability to clear creatinine from the body. This is called the creatinine clearance rate which helps to estimate the glomerular filtration rate (GFR), which is the rate of blood flow through the kidneys.5

Problems arise when using creatinine for CKD testing as a number of factors need to be taken into consideration including age, gender, ethnicity and muscle mass. For this reason, black men and women exhibit higher creatinine levels than white men and women, raising concern over the accuracy of this test for certain patient groups.6 In addition, serum creatinine is not an adequate screening test for renal impairment in the elderly due to their decreased muscle mass.7

The main disadvantage of using creatinine to screen for renal impairment is that up to 50% of renal function can be lost before significant creatinine levels become detectable as creatinine is insensitive to small changes in GFR. Consequently, treatment is not provided at the appropriate time which can be fatal, therefore, an earlier and more sensitive marker for renal function is vital.8

These disadvantages have not only been highlighted in research but also by the national institute for health and care excellence (NICE).  NICE updated the classification of CKD in 2004 to include the albumin: creatinine ratio (ACR). They split chronic kidney disease patients into categories based on GFR and ACR. Figure 1 highlights the different categories and risk of adverse outcomes. NICE recommend using eGFR Cystatin C for people in the CKD G3aA1 and higher.9

Figure 1 Classification of Chronic Kidney Disease using GFR and ACR categories.9

Despite these suggestions, Creatinine is still being used for G3a1 and increasing risk levels.

The utility of cystatin C as a diagnostic biomarker for kidney disease has been documented to show superiority of traditional CKD tests. There is no ‘blind area’ making it very sensitive to small changes in GFR and capable of detecting early reductions.  Furthermore, this marker is less influenced by diet or muscle mass and has proven to be a beneficial test in patients who are overweight.8

A number of studies support the statement: ‘Cystatin C levels are higher in overweight and obese patients’. This is important because when cystatin c levels are too high, it may suggest that the kidneys are not functioning properly. One study conducted, using a nationally representative sample of participants, found that overweight and obesity maintained a strong association with elevated serum cystatin C. This suggests that weight can affect the levels of cystatin C and therefore the likelihood of developing kidney disease.10

How Randox can Help

The Randox automated Latex Enhanced Immunoturbidimetric Cystatin C tests offers an improved method for assessing CKD risk, combined with a convenient format for routine clinical use, for the early assessment of at risk patients. Randox is currently one of the only diagnostic manufacturers who offer an automated biochemistry test for Cystatin C measurement, worldwide.

Want to know more?

Contact us or visit our featured reagent page to learn more.




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The move from Nephelometry to Immunoturbidimetric Testing

Background

In clinical diagnostics, proteins are part of a wide range of biochemical markers used to identify health and disease in patient samples. Proteins play a key role in the human body, as they are involved in almost every process and can be associated to functions and regulatory pathways that are either signature for disease onset or a target for therapeutic intervention.

There are two main methods used to detect proteins in patient samples; nephelometry and immunoturbidimetry.  Nephelometry although traditionally thought to be more sensitive can be expensive due to higher consumable costs.  In addition to this nephelometers can be inefficient and are limited by their test menu.  Immunoturbidimetric tests are an increasingly accepted alternative to nephelometry for specific protein assays, and studies have shown a close correlation between Randox immunoturbidimetric tests and nephelometry. This particularly lies with the latex enhanced immunoturbidimetry methodology utilised by Randox.

Why the RX series?

Renowned for quality and reliability, the RX series excels in clinical testing combining robust hardware, intuitive software and a world leading test menu featuring routine and novel high performing reagents.

Running specific protein tests on the RX series provides laboratories with a wide range of advantages. The move from nephelometric testing to immunoturbidimetric lowers laboratory costs as nephelometry requires the use of dedicated instruments which are much slower, have higher consumable costs and require highly trained personnel, with the disadvantage of not being able to perform any other type of assay on a single platform.

The RX series improves laboratory efficiencies not just saving costs but also time. Our range of routine clinical chemistry analysers provide users with flexibility and versatility through consolidation of testing onto one single platform.

DID YOU KNOW?

The RX Series of analysers now welcomes the addition of Direct HbA1c Testing on the RX daytona +, RX imola & RX modena

High Performing and Unique Testing Menu

The RX series of specific protein assays assist in the diagnosis and evaluation of various conditions each with excellent sensitivity and limited inference levels. Randox manufacture immunoturbidimetric kits for the study of a wide range of specific proteins including unique products such as Apolipoprotein C-II, Apolipoprotein C-III, Apolipoprotein E, Cystatin C and Microalbumin.

Most recently the RX series welcomed the addition of Direct HbA1c to our testing panel, available to be run on the RX Daytona +, RX imola and RX modena. If you are interested in running your protein assays on a routine biochemistry analyser, Randox offers a large range of high quality routine and niche protein assays that can be run on most automated analysers.

Click to discover more about our world leading RX series Testing menu or contact us today @theRXseries to find out how we can improve your laboratories testing capabilities.


World Diabetes Day: The Biggest Burden on the NHS

14 November 2018

World Diabetes Day

Diabetes

Approximately 400,000 people in the UK are living with type 1 diabetes, with over 29,000 being children and young people [1]. Type 1 diabetes affects 96% of all children with diabetes in England and Wales, with incidences increasing by approximately 4% each year.

Globally, the UK has the fifth highest rate of type 1 diabetes diagnosis in children (aged up to 14) with 85% of these children having no family history of the condition. Whilst the condition isn’t fatal and can be managed, it cannot be cured. Type 1 diabetes increases the risk of developing other health problems such as heart disease, stroke, foot and circulation problems, sight problems including blindness, nerve damage and kidney problems. However, many of these related conditions are preventable and it is recommended to stabilise blood sugar levels, attend diabetes appointments regularly and complete a diabetes course to educate patients and family members and prevent the risk of further help complications[2].

Diabetes in children

Children under five are at the highest risk of developing diabetic ketoacidosis due to a late diagnosis and it is also thought to be due to of lack of public knowledge of the signs and symptoms attributed to type 1 diabetes. Such symptoms include:

  • Frequent urination as the kidneys are trying to expel excess sugar in the blood, resulting in dehydration which leads to extreme thirst.
  • Increased hunger or unexpected weight loss because the body is unable to attain enough energy from food
  • Slow healing cuts as high blood sugar levels can affect blood flow which can cause nerve damage.
  • Fatigue as the body is unable to convert sugar into energy
  • Irritable behaviour combined with other symptoms can be a means of concern

Diabetes and the NHS

Diabetes costs the NHS approximately £9.8 billion per year, an estimate of 10% of total expenditures. Hospital admissions of children and young people with diabetes presents a considerable burden on themselves, their families and the NHS. It is estimated that approximately 80% of these cases are potentially avoidable.

A report produced by the National Paediatric Diabetes Audit found that although the numbers of admissions didn’t significantly differ year to year, it highlighted differences in terms of socio-economic risk factors:

  • Living in a deprived area increases the risk of hospital admissions which can be attributed to lack of education in the community about diabetic symptoms and the management of diabetes.
  • Children below 5 years of age have a 35% increased risk of hospitalisation compared to those aged 5-9
  • Females have a 33% increased risk of developing type 1 diabetes compared to males.
  • Children with poor diabetes control have a twelve-fold increased risk of hospital admission
  • Insulin pump users have a 27% increased risk of hospital admission compared to those who use insulin injections.
Figure A. Number of preventable paediatric diabetes admissions  [3] 

Prevention

There are campaigns in place to aid in the early diagnosis of type 1 diabetes which mainly focus on raising awareness of the signs and symptoms of diabetes. On this World Diabetes Day, it is important to know that it is not just simply the responsibility of the diabetic patient to prevent admission but the main responsibility lies with the diabetic teams that inform the families with children who are diagnosed with type 1 diabetes.

Paediatric diabetes teams should ensure that the families and the children receive structured education for self-management when diagnosed and throughout the illness. In doing so, the diabetic teams should implement blood ketone testing from diagnosis and utilise the nationally agreed hypoglycaemia management guidelines. It is also important that diabetic teams are fully aware of the patient characteristics associated with a greater risk of admission and that they use this knowledge to develop anti-admission strategies specifically tailored to the needs of each individual group.

Primary care practitioners should seek access to a specialist diabetic team who they can refer to when deciding if a patient requires admission to hospital. Furthermore, they should access blood glucose and ketone testing to identify patients at risk of diabetic ketoacidosis that require hospital admission.

How Randox can Help

Randox offer a range of assays to diagnosis and monitor diabetes and to monitor associated complications.  Some of these tests are unique to Randox, including:

Fructosamine

The Randox fructosamine assay employs 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.

Learn more about the Randox Fructosamine test

D-3-Hydroxybutyrate (Ranbut)

The Randox D-3-Hydroxybutyrate (Ranbut) assay detects the most abundant and sensitive ketone in the body, D-3-Hydroxybutyrate. The Randox Ranbut assay is used for the diagnosis of ketosis, more specifically diabetic ketoacidosis. Other commercially available tests, such as the nitroprusside method, are less sensitive as they only detect acetone and acetoacetate, not D-3-Hydroxybutyrate.

Learn more about the Randox D-3-Hydroxybutyrate test

Adiponectin

The Randox adiponectin assay is a biomarker in diabetes testing as adiponectin is a protein hormone responsible for regulating the metabolism of lipids and glucose and influences the body’s response to insulin. Adiponectin levels inversely correlates with abdominal visceral fat levels.

Want to know more?

Contact us or visit our Diabetes panel page to learn more.




Related Products

Randox Reagents

Resource Hub

  • References

    [1] National Paediatric Diabetes Audit and Royal College of Paediatrics and Child Health, National Paediatric Diabetes Audit Report 2012-15: Part 2, 2017

    [2] NHS, “Avoiding Complications” – Type 1 Diabetes, Available at: https://www.nhs.uk/conditions/type-1-diabetes/avoiding-complications/ [Accessed on 24th October 2018].

    [3] “Potentially Preventable Pediatric Hospital Inpatient Stays for Asthma and Diabetes, 2003-2012”, www.hcup-us.ahrq.gov, 2015. [Online] Available: https://www.hcup-us.ahrq.gov/reports/statbriefs/sb192-Pediatric-Preventable-Hospitalizations-Asthma-Diabetes.jsp [Accessed 08-Nov-18]


Automation vs. ELISA

Background

The technological developments and scientific innovations in the field of clinical chemistry from the early 1950’s to date have been vast, enhancing laboratory capabilities and providing the necessary support to clinicians and laboratories to improve patient diagnosis and treatment. (1) Laboratory automation today is a complex integration of robotics, computers, liquid handling and numerous other technologies with a fundamental purpose of saving time and improving performance through the elimination of human error.

Complementing this, in the early 1950’s ready-to-use assay reagent kits, with instructions for use introduced a very significant innovation to the field of automation eliminating the process of manually preparing reagent. (2)

Despite the many advancements in automation many clinical laboratories continue to use manual methods such as ELISA for some specialised tests. (3)

Inefficiencies with ELISA based methods

Manual ELISA based techniques are notoriously inefficient and are particularly draining on time and personnel due to the manual intervention required. The manual nature of the method also means there is greater potential for human error ultimately resulting in lack of sensitivity and potential for cross-reactivity. (4,5)

For many laboratories, the transition from traditional ELISA techniques to an automated method for the detection of the same analyte will significantly improve both costs and time.

Renowned for quality and reliability the RX series range of clinical chemistry analysers ensures confidence in patient testing.

DID YOU KNOW?

The RX Series of analysers allows for automation of specialised tests that previously would have only been possible via traditional ELISA methods e.g. Adiponectin, G-6PDH and Cystatin C.

 

Expanding Capabilities and Performance

With patient care holding a primary focus on clinical chemistry testing, the RX series range of semi-automated and automated analysers offer versatility to suit all laboratory requirements. Expanding your laboratory’s capabilities with our world leading extensive dedicated test menu offers cost savings through consolidation of both routine and specialised tests. By transitioning analytes historically only available as an ELISA based test, laboratories can expand their offering with ease to both patients and clinicians.

Our open system approach to clinical testing offers unique opportunities for consolidation, most of our unique and high-performance assays may be run on any clinical chemistry instrument without the need for specialised equipment.

Outperforming ELISA methodology, the RX series delivers a testing platform that requires limited or no manual preparation. With ELISA, the test is run on a 96 well plate using only a single assay with recommendations to duplicate or triplicate samples to evacuate the extent of errors, therefore increasing time and costs. The RX series of analysers each have different levels of throughput to adapt to the requirements of all laboratories.  Utilising robust hardware and intuitive software the RX series guarantees accurate and precise patient testing.

References:

  1. Olsen K. The first 110 years of laboratory automation: technologies, applications, and the creative scientist. J Lab Autom. 2012; 17:469-80.
  2. Rosenfeld L. A golden age of clinical chemistry: 1948-1960. Clin Chem. 2000; 46:1705.14.
  3. Kricja LJ, Savory J. International year of chemistry 2011. A guide to the history of clinical chemistry. Clin Chem. 2011; 57:1118-26.
  4. Wild D, Sheehan C, Binder S. Introduction to immunoassay product technology in clinical diagnostic testing. In: Wild D, editor. Immunoassay Handbook: Theory and Applications of Ligand Binding, ELISA and Related Techniques. 4th Oxford, UK: Elsevier; 2013.
  5. Hawker CDED. Laboratory automation: total and subtotal. Clin Lab Med. 2007; 27:749-70.

Flu Season – Molecular Infectious Disease Testing

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Spotlight Home        IQC        EQA        Infectious Diseases

28 September 2018

Flu Season

Influenza (Flu)

Flu is a contagious respiratory illness cause by influenza viruses that infect the throat, nose, and sometimes lungs. It can cause illness and sometimes death. Getting vaccinated is the best way to prevent catching flu [1].

There are four types of seasonal flu, A, B, C, and D. Types A and B cause seasonal epidemics of disease. Illnesses range from severe to mild and can even result in death in high risk groups. High risk groups include, pregnant women, children under 5 years of age, the elderly, and people with chronic or immunosuppressive medical conditions [2].

Symptoms of Flu [3]

• Sudden fever (temperature above 38C)
• Feeling tired
• Headache
• Sore throat
• Loss of appetite
• Aching
• Chesty cough

Diagnosing Flu

A test to detect Influenza viruses can be used to determine whether a patient has the flu. A swab is taken from either the nose or back of the throat and sent for testing. Molecular assays can be used to detect genetic material of the virus [4]. Molecular methods play an important role in the diagnosis and surveillance of influenza viruses. Molecular diagnostics allow timely and accurate detection of influenza and are already implemented in many laboratories. The combination of automated purification of nucleic acids with real-time PCR should enable even more rapid identification of viral pathogens such as influenza viruses in clinical material [5].

The spread of Flu

Flu season begins as early as October, reaches its peak in February, and ends in March. In the southern hemisphere, flu season falls between June and September. Wherever it’s cold, it’s flu season. This can be seen in Figure A below, which shows google searches for the term ‘flu’ for the last five years for USA (northern hemisphere) and Australia (southern hemisphere). It is obvious that flu is prevalent at different times in the northern and southern hemisphere.

However, it’s a common misconception that flu is caused by the cold. There are many theories as to why the flu season comes in winter [7]:

1. People spend more time indoors, with windows closed, not getting fresh air.
2. A lack of Vitamin D and melatonin from reduced sunlight, weakening the immune system.
3. Influenza virus thrives in the cold, dry air of winter

Of course, there have been attempts to test these theories, but animals do not contract the virus like humans, so testing is difficult. A researcher named Peter Palese decided to test theory 3 after finding an old medical journal article that reported guinea pigs are infected and spread the flu like humans.

Google Searches for 'Flu' in USA and Australia for the last 5 years
Figure A. Google Searches for ‘Flu’ in USA and Australia for the last 5 years [6]

Having set up cages with varying temperatures and relative humidity, he observed how they affected the spread of the flu virus. He found Influenza spread more effectively in cold, dry air [8].

A theory about why this is the case is associated with how the virus moves through the air. When someone breaths out, they release little virus-containing droplets in to the air. The droplet then begins to evaporate. A lower relative humidity means there is less water in the air, meaning there is more room in the air for additional moisture, allowing the droplets to evaporate. A higher humidity means the droplet can’t evaporate because there isn’t as much room for more moisture, and the virus is not suspended into the air [9].

Whatever the case, the fact remains: when winter comes around, the flu will follow.

Prevention

You can avoid catching the flu by getting the flu shot, investing in a humidifier, keeping your hands clean, and limiting contact with those who are already ill. Immunity gained from vaccination decreases over time, so annual vaccination is recommended. Vaccines are most effective when they closely match viruses in circulation. The constantly evolving nature of Influenza viruses requires the WHO Global Surveillance and Response System to monitor influenza viruses around the world and update vaccinations accordingly.

Personal protective measures can be taken in addition to vaccination [2]:

• Properly washing and drying the hands
• Covering the mouth and nose when coughing and sneezing
• Self-isolation when showing symptoms of influenza
• Avoiding contact with sick people
• Avoiding touching the eyes, nose, and mouth

How Randox can Help

Randox offers molecular controls, calibrators, and EQA programmes for respiratory infection testing, which includes Influenza A and B, Adenovirus, Rhinovirus, and others.

Want to know more?

Contact us or visit our Qnostics page to learn more.

Related Products

Molecular EQA

Acusera Controls

RIQAS EQA

Resource Hub

  • References

    [1] “Key Facts About Influenza (Flu) | Seasonal Influenza (Flu) | CDC”, Cdc.gov, 2018. [Online]. Available: https://www.cdc.gov/flu/keyfacts.htm. [Accessed: 25- Sep- 2018].

    [2] “Influenza (Seasonal)”, World Health Organization, 2018. [Online]. Available: http://www.who.int/en/news-room/fact-sheets/detail/influenza-(seasonal). [Accessed: 27- Sep- 2018].

    [3] “Flu”, nhs.uk, 2018. [Online]. Available: https://www.nhs.uk/conditions/flu/. [Accessed: 25- Sep- 2018].

    [4] “Diagnosing Flu | Seasonal Influenza (Flu) | CDC”, Cdc.gov, 2018. [Online]. Available: https://www.cdc.gov/flu/about/qa/testing.htm. [Accessed: 25- Sep- 2018].

    [5] J. Ellis and M. Zambon, “Molecular diagnosis of influenza”, Reviews in Medical Virology, vol. 12, no. 6, pp. 375-389, 2002.

    [6] “Google Trends”, Google.com, 2018. [Online]. Available: https://trends.google.com/trends/. [Accessed: 26- Sep- 2018].

    [7] “The Reason for the Season: why flu strikes in winter – Science in the News”, Science in the News, 2014. [Online]. Available: http://sitn.hms.harvard.edu/flash/2014/the-reason-for-the-season-why-flu-strikes-in-winter/. [Accessed: 26- Sep- 2018].

    [8] A. Lowen, S. Mubareka, J. Steel and P. Palese, “Influenza Virus Transmission Is Dependent on Relative Humidity and Temperature”, PLoS Pathogens, vol. 3, no. 10, p. e151, 2007.

    [9] “Why Is There a Winter Flu Season?”, Popsci.com, 2013. [Online]. Available: https://www.popsci.com/science/article/2013-01/fyi-why-winter-flu-season#page-5. [Accessed: 26- Sep- 2018].


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