Welcome to the Evidence Series

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Welcome to the Evidence Series


For over 30 years, we have been researching and manufacturing market-leading diagnostics products globally. With a mission statement of ‘dedicated to improving health worldwide’ the patient needs are a central focus of everything we do. It is this experience and commitment to improving healthcare that has allowed us to continually improve our product offering and make advancements globally to reach as many people as possible and provide greater diagnostic facilities.

From this experience and commitment to research, we believe we have developed a technology that has changed diagnostic testing forever.

Biochip Array Technology

In 2002, we invented a world first, which changed the landscape of diagnostic testing forever. Biochip Array Technology is a precision multiplex testing platform allowing for the simultaneous quantitative or qualitative detection of a wide range of analytes from a single sample.

Biochip Array Technology uniquely offers immunoassay diagnostic testing for simultaneous multi-analyte biomarker detection. After addition of a single patient sample to the biochip, analytes present in the sample bind to the specific biochip bound ligands. The degree of binding is determined using a chemiluminescent light source and quantified using a Charge Coupled Device (CCD) camera and imaging system.

An individual biochip has up to 49 Discrete Test Regions with each detecting a different biomarker. That means up to 44 tests can be carried out simultaneously, with the additional DTRs being reserved for visual quality control and visual reference; a feature unique to Biochip Array Technology.

The Evidence Series

Having developed this patented technology following £250 million investment in research and development, we needed a platform that allowed Biochip Array Technology capabilities to be showcased. Step forward the Evidence Series. The series includes the Evidence, the Evidence Evolution, the Evidence Investigator and the Evidence MultiSTAT. Each analyser has been designed and built with boundary pushing engineering, to ensure financial, labour and time savings for the end user.

Have a read below of the brief overview of each analyser in the Evidence Series

Evidence Evolution

The world’s first fully automated random-access biochip testing platform, the Evidence Evolution is the world’s most advanced immunoanalyser. With the capability to process up to 2,640 tests per hour, the Evidence Evolution offers complete system integration, as well as the most comprehensive test menu on the market.


As the world’s first Biochip Array Technology system, the Evidence immunoanalyser has revolutionised laboratory screening worldwide. With the capability to process 3,960 tests per hour and a sample capacity of 360, the Evidence is ideal for use in a high throughput laboratory.

Evidence Investigator

The Evidence Investigator is a compact, semi-automated benchtop immunoanalyser that offers efficient and comprehensive testing across a range of applications including clinical diagnostics, molecular, toxicology and food diagnostics. The Evidence Investigator boasts a throughput of up to 2,376 tests per hour, offering efficiency without compromising on accuracy.

Evidence MultiSTAT

The Evidence MultiSTAT is a fully automated immunoanalyser that enables on-site simultaneous detection of up to 44 analytes from a single sample of oral fluid, urine or blood. With a three-step process and results generated in less than 20 minutes, the Evidence MultiSTAT is an ideal solution for those with no knowledge of laboratory procedures and offers a throughput of up to 132 tests per hour.


About the Randox Evidence Series

The Evidence Series is set to revolutionise diagnostic testing forever. Offering unrivalled capabilities across all analysers, we truly believe that the Evidence Series range of immunoassay analysers can meet your diagnostic testing capabilities. For more information on any of the Evidence Series analysers, please visit http://www.randox.com/evidence-series/ or contact us evidenceseries@randox.com.

World Heart Day 2017 – Randox Reagents

Join us as we celebrate World Heart Day on the 29th of September 2017. Randox Reagents aim to make a difference around the world and inspire millions to be heart healthy through offering a wide range of cutting edge cardiology and lipid reagents.

Cardiovascular disease (CVD) is responsible for 17.5million deaths per year worldwide, making it the leading cause of death (WHO, 2015). This figure is predicted to rise to 23.6million by 2030, emphasising the need for further risk assessment biomarkers to be taken into account in the assessment of CVD.

Some of our most unique cardiac assessment reagents include:


HDL3 is our most recent addition to our cardiology testing panel. HDL3 is a sub-fraction of the HDL molecule, and enhances risk profiling of CVD due to its strong correlation with MI; elevated levels of HDL3 particles reflect abnormally increased triglyceride content of the HDL particle. This means that whilst a patient may have high levels of HDL, they may also have elevated levels of HDL3 which essentially renders the potentially potent protection factor of HDL as a cholesterol scavenger as almost useless.

Randox offers an automated HDL3 assay for the quantitative determination of HDL3 cholesterol in human serum or plasma. For more information, click here.


sLDL is a subtype of LDL Cholesterol. It is more atherogenic due to its small size which makes it more susceptible to oxidation, and enables it to more readily permeate the inner arterial walls, causing damage and destruction. As such, the measurement of sLDL is extremely valuable as a vital risk marker of MI; in fact, elevated levels of sLDL are associated with a three-fold increased risk of MI.

Randox offers an automated sLDL assay with a wide measuring range of 0.189-22.2 mmol/l; therefore it will comfortably detect levels outside of the healthy limit of 4.90 mmol/l, ensuring a worthy addition for true assessment of CVD risk. For more information, click here.


Lp(a) offers an excellent addition to the lipids profile, and should be considered due to its role in the assessment of genetically inherited risks of CVD. As genetically determined, Lp(a) remains fairly constant and is unaffected by lifestyle changes and some treatments. Elevated levels are associated with premature development of atherosclerosis and CVD, and are independent of other lipids. Testing for elevated levels is recommended for patients with a family history of premature CVD or elevated Lp(a), and for patients who have developed CVD at a young age.

Randox Lp(a) offers superior methodology, as it contains a very high density of isoform-insensitive antibodies and detection reagent. There is a five point calibrator available which takes into account the heterogeneity of the Lp(a) molecule for each of the levels, which results in excellent commutability of the calibrator with patient samples. For more information, click here.


You can download our cardiology & lipid testing brochure for a full list of our specialised reagents!

For more information, please contact us at reagents@randox.com

Heart attack test H-FABP 12 times faster than current methods

As the supplier of a pioneering diagnostic able to assist with differentiating between coronary pain and non-cardiac chest pain, Randox Laboratories has this week welcomed news about the importance of introducing new innovations which can significantly improve patient outcomes.

Prioritising people presenting with a heart attack over those with non-cardiac chest pain is one of the biggest challenges A&E doctors face – there are around 200,000 heart attacks each year in the UK, but around 1 million people come to A&E with chest pains.  According to a team from King’s College London, as reported by the BBC, a faster, more accurate diagnosis of whether chest pain is caused by a heart attack would save the health service millions of pounds each year by sending well patients home and freeing up beds. Yet current testing methods do not efficiently differentiate between high-risk patients and the estimated 80% of patients who are not having a heart attack.

Randox’s revolutionary test for Heart-Type Fatty Acid-Binding Protein (H-FABP) however, when combined with current testing, is able to rule out a heart attack for patients who present at A&E with chest pain which is caused by other conditions such as respiratory issues, meaning they may not need emergency admission.

When measured at the time a patient presents to A&E with chest pain, H-FABP enables doctors to triage patients suffering with a heart attack more efficiently than before.

Dr. Gary Smyth, Medical Director at Randox Laboratories, hopes that more efficient testing will become widely available so that doctors can identify and prioritise patients at risk;

“Despite the best efforts of our NHS colleagues, EDs across the UK are under tremendous pressure.  In many cases people are presenting with chest pain but aren’t suffering from a heart attack, and given that current cardiac tests are not as sensitive as clinicians would like, these patients are being admitted unnecessarily, taking up beds and valuable resources.

 “It is imperative that newer, faster tests are adopted because fundamentally this means saving lives.”

H-FABP is released into the bloodstream within 30 minutes of a heart attack, whereas people who are currently admitted to hospital with chest pains may have to wait several hours for test results.  Even the latest heart attack test to be adopted by the NHS, troponin, can take up to six hours to provide confirmation.

H-FABP, conversely, is released from the heart during the early stages of a heart attack and because it is so small, it can be detected when the heart cells are being damaged, rather than at the stage when troponin would usually be detected – when cell death has already occurred.  The test can also be used to identify people who are at high risk of heart attack in the near future.

Dr. Peter FitzGerald, Founder and Managing Director of Randox Laboratories, commented;

“Research shows that patients who were troponin negative and therefore sent home from hospital, but who were positive for H-FABP, were at high risk of death – as high as a 20% chance of death that same year.

 “If the H-FABP test was added to existing tests upon arrival at hospital, doctors could quickly and accurately rule out the 80% of chest pain patients who are not having a heart attack, allowing resources to be focused on those who are actually at high risk.”

For further information on H-FABP, please visit http://www.randox.com/h-fabp/, or contact the Randox PR team by phoning (0) 28 9442 2413 or emailing randoxpr@randox.com

World Heart Day – 29th September 2017

World Heart Day – 29th September – Introduction

This year (29th September 2017) join us as we help to raise awareness for World Heart Day! The theme for this year’s World Heart Day is to share the power – and you know what they say… “Knowledge is Power” so throughout this blog we will be providing vital knowledge as well as tips to having a healthy heart!

The heart is a muscular organ that pumps blood around the body and is indeed central to your circulatory system. The system consists of a network of blood vessels, including, veins, arteries and capillaries. These vessels transport blood – as well as carrying oxygen and other important nutrients – to every part of the body. Ensuring a healthy heart is therefore vital.

What is CVD?

When too much pressure is put on our hearts we start to run into some issues – the general term for conditions affecting the heart is Cardiovascular Disease – better known as CVD. The exact cause of CVD is far from clear, with many factors increasing your chances of developing CVD. These risk factors can include, but are not limited to, high blood pressure, smoking, high cholesterol, being overweight or in many cases, can be hereditary.

It is important to note that Cardiovascular Disease is accountable for nearly half of all non-communicable disease (NCD) deaths, therefore making it the number one killer across the globe! Scary thought considering there are a whopping 17.3 million CVD related deaths per year – including stroke and heart disease. Understanding CVD in today’s society is more important than ever before, we need to know the truth about CVD and be able to decipher the facts from the fiction. Below you can see a few examples of common misconceptions regarding CVD and also some that are indeed true.

Only older men can get heart disease/CVD


Cardiovascular Disease can develop before birth


Exercising won’t help if you’re genetically predisposed to CVD


Low and middle-income countries are the most susceptible to CVD


It is estimated that by 2030 the number of deaths, due to CVD, will rise to an enormous 23 million globally! However, by raising awareness of the critical numbers and facts we can all help prevent CVD by making small, simple lifestyle changes.

Tips for a Healthy Heart

Using our “art into heart” graphic below, we decided to outline some of our Randox QC top tips for staying healthy! Why not try some of them and feel the effects of having a happy, healthy heart!

This World Heart Day, join us and many more around the world, to raise awareness for this great cause and unite together to “Share the Power”.

Why choose Randox Adiponectin?

During the second week of our adiponectin educational month, we begin to focus on the key features and benefits of Randox Adiponectin. Check back here every day to read about a different feature of our automated biochemistry reagent.

Read on to find out more!

A – Automated Biochemistry Assay

One of the most important features of Randox Adiponectin is that it is an automated biochemistry assay, removing the inconvenience and time consumption associated with traditional ELISA based testing. Moving from ELISA to automated methods also allows laboratories to expand their test offerings to patients and clinicians.

D – Decreased Serum Adiponectin Levels

Adiponectin is the most abundant protein secreted by adipose tissue and exhibits insulin-sensitising and anti-inflammatory properties, therefore decreased levels of serum adiponectin is an independent risk factor for progression to type 2 diabetes as well as being linked with other pathologies such as metabolic syndrome, cancer and cardiovascular disease.

I –  Increase in Adiponectin Levels

An increase in adiponectin levels is inversely associated with progression to type 2 diabetes mellitus (T2DM) and subsequently, a reduced risk of cardiovascular events and several obesity-associated cancers. Adiponectin levels can be increased through diet, physical activity and the reduction of abdominal visceral fat.

P – Preventing and Treating Obesity Related Diseases

Studies have highlighted that adiponectin exhibits anti-inflammatory, anti-atherogenic and anti-diabetic properties, with various functions possibly serving to prevent and treat obesity-related diseases and cardiovascular disease.

O – You Don’t Have to be Overweight to be at Risk

It is widely recognised that people who are overweight are a higher risk of developing T2DM, metabolic syndrome, cardiovascular disease and cancer. This is commonly assessed through measuring Body Mass Index (BMI), however it has limitations and varies in reliability based on age, sex and race. Risk is more accurately identified through abdominal visceral fat (AVF) levels.  Adiponectin levels have been shown to have a direct inverse correlation with AVF levels making adiponectin levels a much more reliable indicator of at-risk patients.

N – Niche Product from Randox

Randox automated Adiponectin is a niche product, meaning that we are one of the only manufacturers to supply this reagent in an automated biochemistry format. This is superior to traditional T2DM risk assessment methods.

E – Extensive Measuring Range

Randox Adiponectin has an extensive measuring range of 0.5-40µg/mL, which is vital for clinically accurate results. This ensures that low and high levels of adiponectin are detected within a sample, giving a more accurate assessment of T2DM risk.

C – Complementary Controls and Calibrators

Alongside our adiponectin reagent, we also have complementary controls and calibrators available, offering a complete testing package. Below are the details for our adiponectin controls and calibrators:

Adiponectin Control Level 2AO28013x1ml
Adiponectin Control Level 3AO28023x1ml
Adiponectin CalibratorAO28004x1ml

T – Time Consumption

Randox Adiponectin is an automated assay format, meaning that you save time in the laboratory and removes the inconvenience compared to traditional ELISA methods. In addition, when running ELISA methods, the risk of error and contamination is higher than automated methods, which can compromise clinical results.

I – Immunoturbidimetric (Latex Enhanced) method

Randox Adiponectin adopts a Latex Enhanced Immunoturbidimetric method which delivers high performance. This method works through measuring the absorbance of light, whereby inert microscopic particles enlarge the immune complexes, amplifying the reaction and significantly increasing the sensitivity of the reaction.

N – Normal weight

A normal body weight doesn’t mean you are not at risk of developing T2DM. Abdominal Visceral Fat (AVF) is stored deeper than subcutaneous fat and can be wrapped around the body’s major organs such as the liver. With higher levels of AVF inversely correlated with adiponectin levels, this makes adiponectin a strong predictor of T2DM risk and other pathologies such as metabolic syndrome, cancer and CVD.

Please contact us at reagents@randox.com for more information.

Measuring T2DM Risk with Randox Automated Adiponectin

During the first week of our adiponectin educational month, we focused on different aspects of our free white paper “Early Risk Assessment of Type 2 Diabetes Mellitus Through the use of the Biomarker Adiponectin”, which details the features and benefits of Randox automated Adiponectin, clinical significance and a comparison to traditional methods for diabetes risk assessment.

Randox Adiponectin is an automated biochemistry reagent, used as a biomarker which can powerfully predict the development of pathologies such as Type 2 Diabetes Mellitus (T2DM) and cardiovascular disease (CVD). With the global prevalence of diabetes continually rising in adults over 18 years of age, from 4.7% in 1980 to 8.5% in 2014, adiponectin should be an integral part of every laboratory’s testing panel. Offering an improved method for assessing risk, with a convenient format for routine clinical use, Randox Adiponectin will enable physicians to accurately evaluate more individuals.

Read on to find out more!

Monday 11th September

Traditional Methods for Diabetes Risk Assessment

Randox adiponectin offers a more improved, automated method for assessing Type 2 Diabetes Mellitus (T2DM) risk compared to traditional methods of diabetes risk assessment. Such methods include:

  • Fasting Plasma Glucose (FPG) – This is the most commonly used biochemical method of assessing T2DM, however, the specificity of this test is poor. Although many individuals are identified as having impaired fasting glucose (IFG), their absolute risk of conversion to diabetes is only 5-10% per year.
  • Oral Glucose Tolerance Test (OGTT) – This method is more accurate for risk assessment than other traditional methods, however, it is rarely used in practice as it is takes two hours to perform and is uncomfortable for patients.

Non-biochemical methods for assessing a patient’s risk of developing T2DM take into consideration gender, age, family history of T2DM, BMI, waist size and high blood pressure to give a risk score. Two of the most popular, traditional indicators include:

  • Waist circumference – measures abdominal fat reliably, but its association with visceral fat varies by gender and ethnicity.
  • Body Mass Index (BMI) – is another common method, however it has limitations in measuring athletes and varies depending on age, sex and race.

Given the limitations of OGTT and FPG, an improved method for assessing T2DM risk, with a convenient format for routine clinical use, would enable physicians to accurately evaluate more individuals. Randox adiponectin is an automated biochemistry test utilising a latex enhanced immunoturbidimetric method which removes the inconvenience and time consumption associated with traditional methods of testing, making it a superior method of testing T2DM.


Tuesday 12th September

Clinical Significance

Recent studies have advocated the testing of adiponectin in clinical settings. It has applications in assessing risk in several diabetes-related conditions including prediabetes, T2DM and GDM. These studies include:

BMJ (2016): Adiponectin levels predict prediabetes risk: the Pathobiology of Prediabetes in A Biracial Cohort

This study found that among health white and black adults with parental history of T2DM, adiponectin level is a powerful risk marker of incident prediabetes. Thus, the association of adiponectin with diabetes risk is evident at a much earlier stage in pathogenesis, during transition from normoglycemia to prediabetes.

Diabetes Care (2013): Low Pre-pregnancy Adiponectin Concentrations Are Associated With a Marked Increase in Risk for Development of Gestational Diabetes mellitus

This was a study carried out on 4098 women who had children within 6 years of initial blood sample and none of whom were pre-diabetic or diabetic. It was found that lower adiponectin concentration measured on average 6 years before pregnancy were associated with a 5-fold increased risk of developing GDM.


Implications for Clinicians

Adiponectin measurement is not yet a routinely run test in many laboratories worldwide and it is therefore not available for many clinicians to request. Yet the implications of this becoming widely available could be extremely valuable as it can help to assess:

  • Type 2 Diabetes Mellitus and Incident prediabetes
  • Cardiovascular events
  • Gestational Diabetes

When risk is identified via adiponectin measurement, it is essential for individuals to carry out lifestyle modification to reduce visceral fat levels and lowering T2DM risk. This will also help to prevent the development of cardiovascular diseases and metabolic syndrome through the improvement of adiponectin production. This indicates that Randox automated adiponectin should be a routinely run test across the world.

13th September 2017

Methods of Measuring Adiponectin

Randox adiponectin automated method has many benefits for the laboratory, as the only method of adiponectin measurement available beforehand was through the ELISA assay. The benefits of switching from ELISA to an automated method include efficiencies and expansion.


The main drawback of using ELISAs for clinical testing within a laboratory is that it is time consuming and personnel consuming as it uses heavy resources with manual interaction. Switching from ELISA to an automated method for the detection of adiponectin increases time and personnel efficiency considerably which leads to cost effectiveness. This benefits laboratories through:

  • Ensuring quality in testing practices and confidence in clinical results
  • Lowering the risk of error and contamination avoiding compromising clinical results



Laboratories can expand their test offerings to patients and clinicians by transitioning analytes which were historically only available on ELISA methods. Adiponectin being available in an automated biochemistry format allows laboratories to expand their test menu with ease and enables the inclusion of adiponectin into routine testing panels. It also allows for detailed patient testing profiles through increased testing range and without the manual restrictions placed by running ELISA techniques.

Randox is presently the only diagnostic manufacturer who has a globally available automated biochemistry test for adiponectin measurement.

14th September 2017

Randox Automated Adiponectin Assay

The Randox adiponectin assay principle:

  • The sample is reacted with a buffer and anti-adiponectin coated latex
  • The formation of the antibody-antigen complex during the reaction results in an increase in turbidity – this is measured as the amount of light absorbed at 570nm.
  • A sample with higher adiponectin levels will contain more adiponectin and so more antibody-antigen complexes will be formed and the increase in turbidimetry
  • By constructing a standard curve from the absorbance of the standards, the adiponectin concentration of the sample can be determined.

Benefits of Randox adiponectin:

  • A niche product meaning we are one of the only manufacturers to provide the adiponectin test in an automated biochemistry format
  • Automated assay removing inconvenience and time consumption associated with traditional ELISA testing
  • Applications available for a wide range of automated biochemistry analysers ensuring ease of programming and confidence in results
  • Latex Enhanced Immunoturbidimetric method delivering high performance
  • Extensive measuring range for measurement of clinically important results
  • Complementary controls and calibrators available offering a complete testing package

The Randox automated immunoturbidimetric adiponectin test offers an improved method for assessing T2DM risk, with a convenient format for routine clinical use, to enable physicians to accurately evaluate at-risk individuals.

Please contact us at reagents@randox.com for more information!

Download our white paper from the resource hub.

Committed to meeting customers’ needs

At Randox Quality Control, we strive to meet and exceed customer expectations ensuring high quality products and superior customer service are at the top of our priority list.

How can Randox Quality Control help you?

High Quality QC

The Acusera range of true third party controls boasts an impressive range of benefits ultimately designed to help laboratories reduce costs and time while also ensuring an accurate and reliable test system.

The extended shelf life of our controls allows the same lot of control to be used for a period of up to 2 years keeping costly new lot validation studies to a minimum.  We may also be able to sequester lots on your behalf.

The availability of commutable controls designed to react to the test system in the same manner as a patient sample and controls targeted at clinical decision levels will not only help you to meet ISO 15189:2012 requirements but will effectively challenge instrument performance.

Click here to find out more about our QC range.

Customer support

The Randox global support network are on hand with expert advice to ensure timely, accurate and helpful resolution of any issues or queries you may have. The added benefit of quick delivery of product orders further highlights how we work with and for our customers to provide the best service available.

Customer Reviews

Don’t believe us? Read a few of the reviews we have received from laboratories around the world;

“I would like to thank the Randox team for the excellent service when helping to reserve and manage our IQC orders, lot numbers and stock.” – Chief Biomedical Scientist, London, 2017.

Request your free QC consultation by contacting us today! Get in touch and we can arrange for your laboratory to have a consultation with one of our Randox QC specialists. Alternatively, if you would like to leave us a review you can do so by emailing acusera@randox.com.

Centralised QC Data Management Platform

Busy laboratories are not uncommon, in fact, many laboratories are expanding and their workload is increasing as a result. In labs like this, time is limited therefore ease of use and accessibility are valuable traits when it comes to the technology used to monitor daily QC activities.

With this in mind, Randox Quality Control are pleased to announce the launch of a new centralised platform for the management of both daily QC activities and calibration verification.

Convenience is key and that is what we have aimed for with the launch of this new platform. With laboratory professionals at the front of our minds, the platform delivers access to QC data at the click of a button ensuring the review process is as simple as possible.

What is available on the new QC platform?

With the new QC platform users have access to both;

By encompassing these two programs onto one easy to use platform, laboratories can save precious time allowing them to focus on other important tasks with the reassurance that their data is easily accessible.

Further information on Acusera 24.7 Live Online and Acusera Verify can be seen below;

Keep your instrument in check with Acusera Verify

Designed with convenience in mind the Acusera Verify range of linearity sets will help you to easily meet CLIA requirements for calibration verification. The availability of instrument dedicated, liquid ready-to-use materials covering a wide range of cardiac markers, specific proteins and therapeutic drugs enables specific instrument requirements to be met, while challenging the complete reportable range. Complimentary data reduction software is provided with all linearity sets delivering access to:

  • Easy-to-interpret charts for at-a-glance performance assessment
  • Unique traffic light system indicating pass or fail
  • Automatically generated statistics
  • Peer group data updated live in real-time

Stress free QC analysis with Acusera 24.7

Acusera 24.7 Live Online is an interlaboratory data management package complementing our Acusera range of true third party controls. With the recent launch of version 2.0, the software is smarter, faster and more powerful than ever before.

Designed to help laboratories efficiently review QC data from all of their laboratory instruments, the software generates a wide range of charts and reports enabling quick & easy identification of QC failures and emerging trends.  Unique access to peer group data updated instantly in real-time facilitates comparative performance assessment and helps speed up the troubleshooting process, easily identifying if a problem is unique to your lab or a widespread issue.

Contact us today and register your interest in Acusera Verify & Acusera 24.7 Live Online.

Lipoprotein(a) Foundation commend celebrity personal trainer, Bob Harper, as he speaks out about the risk of Lp(a)

The Lipoprotein(a) Foundation have commended health and fitness expert Bob Harper for speaking out after recently suffering a heart attack. The celebrity personal trainer and host of the US television series ‘The Biggest Loser’, has revealed that high levels of Lp(a) were responsible for the heart attack he suffered at the age of 51 at the beginning of this year.1

Harper had been completing a normal workout at his gym when he suffered full cardiac arrest. Luckily, two doctors were in the vicinity who saved his life by performing CPR and using an Automated External Defibrillator (AED). In an interview following his heart attack, Harper has said,

“I’ve learned a lot about the fact genetics does play a part in this, it is so important to know your health… I’m a guy that lives a very healthy lifestyle, very regimented, I work out all the time, but there were things going on inside of my body that I needed to be more aware of and I strongly encourage anyone that’s listening right now to go to their doctor, get their cholesterol checked, see what’s going on on the inside”.

Scroll down to watch the interview in full.

What is Lp(a)?

Lp(a) is a particle which is produced in the liver and found in the blood which carries cholesterol, fats and proteins. Levels of Lp(a) in individuals are genetically determined, and are not affected by diet, exercise or lifestyle changes.2

So how does a seemingly fit and healthy person have a heart attack at the age of 51?

Lp(a) is currently the strongest inherited risk factor for heart attack and stroke, with one in five people globally inheriting high Lp(a).1 Levels of Lp(a) are not routinely tested in standard cardiovascular assessments, and despite the particle itself being an altered form of LDL cholesterol, standard cholesterol tests do not reveal inherited Lp(a) levels as it is independent from total cholesterol and LDL levels.3

High Lp(a) can also be unrelated to other common risks factors of cardiovascular diseases for example, smoking, diet, diabetes, high blood pressure and lack of exercise. This is why seemingly healthy individuals can have high Lp(a) in their genes and still be at high risk of cardiovascular diseases.

Why is Lp(a) not routinely measured if high levels pose such a risk?

The widespread use of Lp(a) as an independent risk factor for cardiovascular disease risk has, until recently, been hindered by the lack of internationally accepted standardisation and the fact that many commercial Lp(a) methods suffer from apo(a) size related bias, potentially leading to patient misclassification.

The size of the apo(a) protein is genetically determined and varies widely hence, levels of Lp(a) can vary up to 1000-fold between individuals.4 To find out more about the clinical significance of Lp(a), please refer to the section below entitled ‘For Health Professionals’.

What can you do if you have high Lp(a)?

Research has shown that lowering Lp(a) could significantly reduce the impact of cardiovascular diseases. A recent study published in the American Heart Association journal, Arteriosclerosis, Thrombosis and Vascular Biology, found that reducing high Lp(a) could potentially prevent up to 1 in 14 cases of myocardial infarction (heart attack) and 1 in 7 cases of aortic valve stenosis.5 Of those studied, nearly one third of heart attacks and half of all cases of aortic stenosis were attributed to high Lp(a).6 This study demonstrates the clinical significance of measuring Lp(a), making it a major independent genetic risk factor for cardiovascular diseases.

Why test Lp(a)?

Lp(a) will be tested as part of a lipid profile if: there is a strong family history of CVD, a patient has existing heart or vascular diseases, a patient has an inherited predisposition for high cholesterol or if a person has had a stroke or heart attack but has normal lipid levels.7

Dr Christie Ballantyne, Chief of Cardiology at Baylor College of Medicine, has said “the most important part of knowing your Lp(a) level is understanding your overall risk and finding the right lifestyle modifications or medications to target all the other traditional risk factors. Those risk factors become even more important to monitor when your Lp(a) levels are high”.8

For patients

If you are concerned that you may be at risk of having elevated levels of Lp(a) due to your family history, ask your doctor or medical provider to test lipoprotein (a), along with other lipid tests, to clinically evaluate your risk of developing cardiovascular diseases.

For health professionals

Click below for information regarding the challenges associated with the measurement of Lp(a) and the clinical significance it holds.

The widespread use of Lp(a) as an independent risk factor for cardiovascular disease risk has, until recently, been impeded by the lack of internationally accepted standardisation and the fact that many commercial Lp(a) methods suffer from apo(a) size related bias, potentially leading to patient misclassification. The size of the apo(a) protein is genetically determined and varies widely hence, levels of Lp(a) can vary up to 1000-fold between individuals.4 

As a result, international criteria has been set to overcome these challenges. The International Federation of Clinical Chemistry (IFCC) Working Group on Lp(a) recommends that laboratories use assays which do not suffer from apo(a) size-related bias, in order to minimise the potential risk of misclassification of patients for coronary heart disease. The Lipoprotein(a) Foundation has referenced Marcovina and Albers (2016) as their recommendation for the best Lp(a) test.9 This recommendation is a result of the following conclusions:

  • Robust assays based on the Denka method are available, which are reported in nanomoles per litre (nmol/L) and are traceable to WHO/IFCC reference material
  • Five point calibrators with accuracy assigned target values will minimise the sensitivity to apo(a) size

A number of guidelines are in place for the testing of Lp(a) in patients.

-The European Guidelines for Management of Dyslipidaemia state that Lp(a) should be measured in individuals considered at high risk of CVD or with a strong family history of premature CVD.

-The European Atherosclerotic Society suggest that Lp(a) should be measured once in all subjects at intermediate or high risk of CVD/CHD who present with10 :

1. Premature CVD
2. Family hypercholesterolaemia
3. A family history of premature CVD and/or elevated Lp(a)
4. Recurrent CVD despite statin treatment
≥3% 10-year risk of fatal CVD according to the European guidelines
6.  ≥10% 10-year risk of fatal and/or non-fatal CHD according to the US guidelines

-EAS Consensus Panel states the evidence clearly supports Lp(a) as a priority for reducing cardiovascular risk, beyond that associated with LDL cholesterol.  Clinicians should consider screening statin-treated patients with recurrent heart disease, in addition to those considered at moderate to high risk of heart disease.

  • The Randox Lp(a) assay is one of the only methodologies on the market that detects the non-variable part of the Lp(a) molecule and therefore suffers minimal size related bias – providing more accurate and consistent results. The Randox Lp(a) kit is standardised to the WHO/ IFCC reference material SRM 2B and is closest in terms of agreement to the ELISA reference method.
  • Five calibrators with accuracy-based assigned target values are provided – which accurately reflect the heterogeneity of isoforms present in the general population
  • Measuring units available in nmol/L upon request
  • Highly sensitive and specific – method for Lp(a) detection in serum and plasma
  • Applications are available for a wide range of biochemistry analysers – which detail instrument-specific settings for the convenient use of Randox Lp(a) on a variety of systems
  • Liquid ready-to-use reagents – for convenience and ease-of-use

For further information on Lp(a), click here or email: reagents@randox.com

Watch the interview with Bob Harper here:

1. Lipoprotein(a) Foundation, Lipoprotein(a) Foundation Thanks Bob Harper for Revealing High Lp(a) Levels Led to His Recent Heart Attack on The Dr Oz Show, 2017 Available from: http://www.businesswire.com/news/home/20170425006724/en/ [Accessed: 16 March 2017]

2. Lipoprotein Foundation, Understand Inherited Lipoprotein (a), Available from: https://goo.gl/bH5A8R [Accessed: 16 March 2017]

3. Kumar, V., Abbas, A. K. and Aster, J. C., Robbins and Cotran Pathologic Basic of Disease, (Philadelphia: Elsevier Saunders, 2015), p. 494 in Google books, https://goo.gl/VEnVX9 [Accessed 27th April 2017]

4. Kamstrup P.R., Tybjaerg-Hansen A., Steffensen R., Nordestgaard B.G. Genetically elevated lipoprotein (a) and increased risk of myocardial infarction. JAMA. Vol. 301, p. 2331-2339 (2009).

5. Afshar, M. Kamstrup, P.R., Williams, K., Snidermann, A. D., Nordestgaard, B.G., Thanassoulis, G., Estimating the Population Impact of Lp(a) Lowering on the Incidence of Myocardial Infarction and Aortic Stenosis – Brief Report., Ateriosclerosis, Thrombosis, and Vascular Biology, 2016;36:2421-2423, Available from: http://doi.org/10.1161/ATVBAHA.116.308271

6. The Lipoprotein(a) Foundation, Lipoprotein(a) Foundation Supports National Heart Valve Disease Month, Highlights Genetic Link between Lp(a) and Aortic Valve Disease, Business Wire. (2017), Available from: https://goo.gl/LhQFGj [Accessed: 16 March 2017]

7. Lab Tests Online, Lp(a), 2014, Available from: https://goo.gl/W2PWSN [Accessed: 16 March 2017]

8.Gutierrez, G., The heart attack risk factor you haven’t heard of, Baylor College of Medicine, 2017, Available from: https://goo.gl/9X4Xko [Accessed: 16 March 2017]

9. Marcovina, S.M. and Albers, J.J. Lipoprotein (a) measurements for clinical application. Lipid Res. Vol. 57, p. 526-37 (2016).

10. Nordestgaard, B. G., Chapman, M. J., Ray, K., Bore´n, J., Andreotti, F., Watts, G. F., Ginsberg, H., Amarenco, P., Catapano, A., Descamps, O. S., Fisher, E., Kovanen, P. T., Kuivenhoven, J. A., Lesnik, P., Masana, L., Reiner, Z., Taskinen, M. R., Tokgozoglu, L., and Tybjærg-Hansen, A., for the European Atherosclerosis Society Consensus Panel. Lipoprotein(a) as a cardiovascular risk factor: current status. European Heart Journal. Vol. 23, p. 2844-2853 (2010).


A week dedicated to unsung heroes! – Medical Laboratory Professionals Week 2017

From April 23rd to April 29th we are celebrating Medical Laboratory Professionals Week! This is a week dedicated to raising awareness for those who work in a laboratory & the hard work that goes unnoticed every day in laboratories around the world.

Have you ever wondered what happens between submitting your patient sample and receiving your results? Have you ever wondered who conducts the detailed laboratory testing for your annual check-up such as cholesterol and glucose levels? Or who analyses these results? The answer, a Medical Laboratory Professional (MLP). MLP’s provide up to 70% of the medical laboratory results for physicians and others to make informed decisions about a patient’s diagnosis and aftercare treatment plan. The work that laboratory professionals do each and every day is integral to providing excellent patient care.  They perform and interpret billions of laboratory tests every year.

Providing accurate and reliable test results is of the utmost importance for laboratory professionals and also for us at Randox. With a passion for Quality Control, and with more than 30 years’ experience developing Laboratory QC for the in vitro diagnostics market, we believe in producing high quality material designed to streamline procedures, whilst reducing costs in laboratories of all sizes and budgets. These qualities have been reflected in our Acusera true third party quality controls, Acusera 24.7 interlaboratory data management software, Acusera Verify Calibration Verification material and RIQAS, the largest international EQA scheme.

Randox Quality Control would like to take this opportunity to thank all the laboratory professionals around the world and especially our own laboratory staff – you truly are the “Unsung Heroes of Healthcare”.

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