Randox QC unveils brand new multi-analyte commutable Acusera Infectious Disease Controls
Randox QC unveils brand new multi-analyte commutable Acusera Infectious Disease Controls
Randox Quality Control is set to introduce its brand new Acusera Infectious Disease (Serology) Controls at the American Association for Clinical Chemistry 2019, designed to deliver a cost-effective, high quality solution for the analysis of infectious diseases whilst producing trustworthy results.
The Infectious Disease Serology Internal Quality Controls will include quality control material for Lyme Disease, ToRCH, Epstein-Barr virus, HIV, Hepatitis A virus, Human T-lymphotropic virus, Cytomegalovirus, and Varicella zoster virus (Chickenpox or Shingles).
Manufactured from human plasma, each control is designed to react to the test system in the same manner as the patient sample, helping to meet ISO 15189:2012 requirements while also reducing inconvenient shifts in QC results when reagent batches are changed.
Lynsey Adams, Randox Quality Control Manager, commented;
“These controls are the first of their kind on the market to be used on a wide range of immunoassay analysers. Unlike the current practice of analyser-specific tests, these controls can be used across a wide range of laboratory technologies and, with a working stability of 60 days at 2°c to 8°c, waste and costs are kept to a minimum.”
Acusera Infectious Disease (Serology) Controls are also multi-analyte and therefore, testing can be consolidated to just a small number of vials, saving laboratories valuable space and time. A single control can be used to assess performance across a range of analytes.
Key benefits of the Acusera Infectious Disease Controls;
- All samples are provided in a user-friendly, liquid, ready-to-use format
- Manufactured from human plasma, each control reacts to the test system in the same manner as a patient sample
- Designed to deliver an independent, unbiased assessment of performance with any immunoassay instrument
- Working stability of 60 days ensures waste and costs are kept to a minimum
- Multi-marker controls help reduce the number of individual controls required
- Designed to challenge clinically-relevant levels, samples will ensure accurate and reliable instrument performance
Ideal for microbiology and virology laboratories, blood banks, public health laboratories or clinical laboratories performing serology testing, Randox QC’s Acusera Infectious Disease (Serology) Controls are set to revolutionise serology testing and provide reliable, accurate results time and time again.
For further information please email acusera@randox.com, visit www.randoxqc.com or tel: +44 (0) 28 9442 2413 / fax: +44 (0) 28 9445 2912
Randox launches whole pathogen Blood Borne Virus Controls at AACC
Whole pathogen Blood Borne Virus (BBV) controls have been brought to market by global diagnostics company Randox Laboratories.
The molecular controls, available under the brand name Qnostics, are versatile in monitoring the presence of BBVs, including HIV, Hepatitis B and Hepatitis C.
For use with molecular methods, the controls are manufactured using whole pathogens and therefore mimic the patient sample, providing the best sample matrix for laboratories.
Lynsey Adams, Randox Quality Control Manager, explained;
“We’re delighted to be able to bring to market these whole pathogen Blood Borne Virus Controls, which are designed to help molecular laboratories effectively manage assay performance.
“Using whole pathogens in the development of the controls ensures we meet the demands of today’s molecular diagnostics laboratories by monitoring the entire testing process.”
The Molecular BBV controls from Randox, which are liquid frozen for user convenience and ease of use, will aid microbiology and virology laboratories to monitor assay drift and ultimately will help to ensure accurate test system performance. Each control is designed to be medium positive and are suitable for use with a variety of molecular workflows.
Lynsey added;
“These versatile Blood Borne Virus controls can be used in the daily monitoring of assay performance, but are equally applicable for use in the validation/verification of new assays, and may also be used for troubleshooting after poor EQA performance.”
Randox Blood Borne Virus Molecular Controls are manufactured to ISO 13485 standards and calibrated against an independent Internal Reference Material. Also included within the Qnostics BBV range are Molecular Q panels. Each molecular Q panel includes a negative, low, medium and high positive sample designed to cover more of the assays measuring range.
Key Features and Benefits of Randox Blood Borne Virus Qnostics Controls:
- Third party controls as recommended by ISO 15189:2012
- Specifically designed to meet the demands of today’s molecular diagnostics laboratory and laboratories carrying out Nucleic Acid Testing (NAT)
- Suitable for use across a wide range of molecular assays to monitor the entire molecular workflow from extraction to amplification and detection
- Flexible and suitable for use with the majority of commercial and in-house molecular methods
- Traceable to the current relevant WHO International Standards and characterised by digital PCR
- Liquid frozen for user convenience and ease of use, with no additional preparation required
- Calibrated against an independent Internal Reference Material (IRM)
- Quality products manufactured to ISO 13485: 2016 standards
- Manufactured using whole pathogens and therefore mimic the patient sample providing the best possible sample matrix for laboratories
- New controls available include Hepatitis B (HBV) Medium Q Control, Hepatitis C (HCV) Medium Q Control and HIV Medium Q Control
- US-IVD labelled for clinical use
For further information please visit https://www.randox.com/molecular-infectious-disease-controls/blood-borne-virus-testing/, visit us at stand 1101 at this year’s AACC or email market@randox.com
Randox launches new Acusera Verify linearity sets for Roche Cobas and Beckman systems
Randox Quality Control is set to launch new Acusera Verify linearity sets at the American Association for Clinical Chemistry 2019.
Randox Linearity sets are designed to challenge a larger segment of an instrument’s reportable range, and test validity of system calibration. The Acusera Verify materials will cover testing of C-reactive Protein, Rheumatoid Factor, Lipids, Therapeutic Drugs, and Esoterics, amongst others and are compatible for use with Roche Cobas and Beckman systems.
Materials also include a unique combination of analytes, meaning laboratories do not need multiple products for testing, which reduces both costs and need for storage space.
Lynsey Adams, Randox Quality Control Manager, commented;
“Acusera Verify’s range of instrument-dedicated calibration verifiers are designed to challenge the entire Analytical Measuring Range, whilst remaining convenient to use and helping to meet Clinical Laboratory Improvement Amendments (CLIA) requirements.”
According to CLIA, a laboratory should perform and document calibration verification procedures at least once every 6 months and/or whenever one of the following occur;
- A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range.
- There is a major preventive maintenance or replacement of critical parts that may influence test performance.
- Control material reflects an unusual trend or shift, or are outside of the laboratory’s acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem.
- Laboratory’s established schedule for verifying the reportable range for patient test results requires more frequent calibration verification.
- New instrument validation.
CLIA also recommends that a minimum of 3 levels are tested covering the low end, mid-point and high end of the reportable range. The Clinical and Laboratory Standards Institute (CLSI) however, recommend at least 5 levels are tested. It is also considered best practice that laboratories run at least 3 replicates of each level in the same way they would a patient or control sample.
Acusera Verify from Randox QC will ensure that laboratories meet the recommended CLIA and CLSI guidelines in both a timely and costly manner.
Randox Linearity sets available:
- C-Reactive Protein (CRP) Linearity Verifiers
- High Sensitivity C-Reactive Protein (hsCRP) Linearity Verifier
- Esoterics Linearity Verifier
- Rheumatoid Factor (RF) Linearity Verifier
- Lipids Linearity Verifier
- Apolipoprotein A1 (Apo A1) & Apolipoprotein B (Apo B) Linearity Verifier
- Therapeutic Drug Monitoring (TDM) Linearity Verifier
- CO2 and Electrolytes Linearity Verifier
Acusera Verify also allows users to access real-time peer group data and automatically-generated statistics through a cloud-based data reduction software package which is supplied with all linearity sets. This provides laboratories with comprehensive graphs of results and at-a-glance performance assessment.
For further information please email acusera@randox.com, visit www.randoxqc.com or tel: +44 (0) 28 9442 2413 / fax: +44 (0) 28 9445 2912
Tackling Worldwide Drugs of Abuse
Throughout November, we’ve been highlighting how the Randox clinical teams – Randox Rx series, Randox Reagents and Randox QC – are aiding the fight against drugs of abuse.
Drugs of Abuse are a growing problem worldwide and represent a significant burden to healthcare systems as well as creating problems in an individual’s lifestyle. It has been estimated by the WHO (World Health Organisation) that 31 million people globally suffer from drug use disorders and 3.3 million deaths each year are linked to the abuse of both drugs and alcohol.
The abuse of drugs is one of the most pressing issues in the United States of America. Drug abuse not only affects the individual, but also can have far-reaching consequences that affect family, employment, personal health, health care systems, local communities, and society as a whole.
- Misuse of illicit drugs affects society through secondary costs incurred such as crime, reduced productivity at work, and health care expenses.
- Substance abuse costs the US health care system about $11 billion, with overall costs reaching $193 billion.
- Substance abuse and addiction also affects other areas of life and can cause broken families, destroyed careers, death due to negligence or accident, domestic violence, physical abuse and child abuse.
- Drug abuse and addiction changes the chemistry of your brain. The longer you use your drug of choice, the more damage is caused and it becomes more difficult to return to ‘normal’ during drug rehabilitation.
- In 2013, 22.7 million Americans needed treatment for a substance use disorder – almost 9% of the population over the age of 12. Only about 2.5 million received treatment as a specialist facility with 20% of admissions for opiate addication treatment and 17% for the treatment of marijuana abuse.
To find out more about how Randox is helping in the fight against Drugs of Abuse, please visit https://www.randox.com/drugs-of-abuse/ or for more information about Randox RX, Randox Reagents or Randox QC, please email marketing@randox.com.
November focus: Drugs of Abuse
Throughout November, the Randox clinical teams – Randox Reagents, Randox Rx series and Randox QC – will be highlighting how the Randox product range can be utilised to allow for the most accurate analysis of Drugs of Abuse, with a particular focus placed with the Evidence MultiSTAT. The Evidence MultiSTAT is a fast, fully automated and versatile immunoanalyser that enables on-site detection of up to 21 Drugs of Abuse from a single sample of oral fluid, urine or blood.
Drugs of Abuse are a growing problem worldwide and represent a significant burden to healthcare systems as well as creating problems in an individual’s lifestyle. It has been estimated by the WHO (World Health Organisation) that 31 million people globally suffer from drug use disorders and 3.3 million deaths each year are linked to the abuse of both drugs and alcohol.
Randox have reacted to this growing concern and are now a world leader in the Drugs of Abuse testing field. Our product range currently comprises classical, prescription and synthetic drugs.
The Evidence MultiSTAT offers a simple drug screening solution to those who have little or no knowledge of laboratory procedures. As an extremely versatile desktop analyser, it is ideally suited to a variety of settings including both the clinical laboratory and the emergency room.
Randox Reagents – Drugs of Abuse Assays
In order to assist in dealing with the ongoing burden of substance abuse, Randox Reagents offer a comprehensive range of ten assays to test for some of the top most commonly-abused substances including alcohol, methamphetamines, cocaine, methadone, cannabis, benzodiazepines, barbiturates, EDDP and ecstasy and opiates. The Randox Drugs of Abuse assays are liquid, ready-to-use for increased efficiency and applications are available for over 30 different analysers.
RX Series – Toxicology testing
Renowned for quality and reliability, the RX series range of clinical chemistry analysers boasts a world-leading test menu comprising of both therapeutic drugs and Drugs of Abuse. Our toxicology range comprises amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine metabolite, ecstasy, EDDP, ethanol, methadone and opiates. The RX series range of clinical chemistry analysers ensures a high degree of accuracy with a wide range of testing throughputs to suit all laboratories, big or small.
RIQAS Urine Toxicology Programme
Designed to monitor the performance of 20 Drugs of Abuse tests in urine, our RIQAS urine toxicology EQA program is suitable for both qualitative and quantitative methods of analysis. As the largest EQA scheme in the world, access to large peer groups is guaranteed. Additional benefits include; monthly analysis, user-friendly reports allowing at-a-glance performance assessment, ability to register up to five instruments per programme and cost savings via our unrivalled consolidation.
For more information about Randox RX, Randox Reagents or Randox QC, please email marketing@randox.com.
Nutritional status: copper deficiency
Did you know that copper is an essential trace mineral present in all tissues? It works with iron to help the body form red blood cells. It also helps keep the blood vessels, nerves, immune system and bones healthy while also aiding in iron absorption. In rare situations, copper deficiency can occur and lead to anaemia and osteoporosis.
Symptoms of copper deficiency include:
- Fatigue & weakness as cells use copper to generate ATP, the body’s main source of energy. This means that copper deficiency could affect your energy levels.
- Frequent sickness as copper plays an important role in maintaining a healthy immune system.
- Weak and brittle bones as copper is involved in the processes that create cross-links inside your bones. These cross-links ensure bones are healthy and strong.
- Problems with memory and learning as copper plays an important role in brain function and development.
Sensitivity to cold as copper, along with minerals like zinc, help maintain optimal thyroid gland function. Low thyroid levels can make you feel colder more easily.
There are many foods that are high in copper. These include leafy greens, including turnip, greens, spinach, kale and mustard greens. Asparagus and summer squash are two other excellent sources of copper while legumes, whole grains, nuts and seeds are also good sources of the substance.
Randox Reagents, RX and QC are helping to diagnose copper deficiency at the earliest possible stage. The Randox copper assay is used to measure the levels of copper in the blood in order to determine copper toxicity. Combining this with the Randox zinc assay can aid in identifying the cause of liver damage in a patient, leading to correct treatment and recovery.
Find out more about how Randox is helping to diagnose nutritional status and deficiencies here: https://www.randox.com/nutritional-status/
How Randox is helping to diagnose nutritional status
At Randox, we’re dedicated to improving health worldwide and are consistently trying to break our own innovative records. Throughout the month of July, we’ll be introducing you to how we’re helping to diagnose nutritional deficiencies and define individual nutritional status among patients.
Zinc
Randox Reagents
Randox Reagents have the highest quality reagents on the market and a test menu comprising of over 113 assays. Unique to Randox is the zinc assay which is important in the diagnosis of kidney and liver damage.
Our zinc assay can be used to measure the levels of zinc in a patient’s urine providing insight into the levels of zinc in the body. This, combined with our copper assay, can aid in identifying the cause of liver damage in a patient, leading to correct treatment and recovery.
The RX series
The RX series offers the most comprehensive testing profile for assessing nutritional status to identify any nutritional deficiencies or any other nutritional issues within an individual.
The RX series zinc test can identify a zinc deficiency in an individual which is often a result of a low dietary intake and can lead to many problems including impaired immune and cognitive functions, kidney disease and diabetes.
Randox Quality Control
World-leading diagnostics would be nothing without world-leading quality control materials to ensure consistency and accuracy across all results. The Randox Acusera Liquid Chemistry Premium Plus control is the most comprehensive chemistry control available.
Stay tuned over the course of the month as we highlight how we’re helping in the fight against nutrient deficiencies.
£50m Randox Centres of Excellence launched in Northern Ireland
A record £50 million investment which will deliver cutting-edge technologies to diagnose conditions like cancer, heart conditions and infectious diseases has been announced by Northern Ireland diagnostics company Randox Laboratories and Invest Northern Ireland.
This major project involves the establishment of three Centres of Excellence, enabling Randox R&D scientists to work collaboratively with colleagues from Queen’s University Belfast and Ulster University. The centres are being officially launched today at the Randox Science Park. The ceremony will include a keynote address from Sir John Bell, who chaired the UK Government’s Life Sciences Industrial Strategy Board.
Advanced diagnostics have been identified as key to delivering sustainable improvement to healthcare systems struggling to cope with increasing levels of chronic and preventable conditions. Having been focused in this field for over 36 years, Randox has a successful track record of developing new and innovative tests – examples include assessing those at risk of Alzheimer’s disease and genetic cardiac conditions, to promote and enable preventive treatment, and a new clinically-approved test to diagnose prediabetes.
Managing Director of Randox Laboratories, Dr Peter FitzGerald, who today launched the three Centres of Excellence, said;
“When almost a quarter of the deaths of people under 75 in the UK are considered preventable, we need to ask ourselves what can be done to improve healthcare outcomes. There is an undeniable case for radical change in the way healthcare is delivered, and sophisticated diagnostics will be at the fore of this revolution.
“Enabling earlier and more accurate diagnosis, to identify those at the earliest stages of illness, ideally before the onset of any symptoms, is a game-changer. Through early intervention we can restrict the development of chronic conditions and improve people’s lives. Our view of the future is one where people are empowered through earlier diagnosis to stay healthier for longer, and where healthcare systems are freed to deliver quality services to patients. Our announcement today demonstrates our continuing commitment in this field.
“We are grateful for the support offered by Invest NI and look forward to addressing these pressing healthcare needs.”
The Centres of Excellence will focus respectively on clinical diagnostics, engineering for biosciences and quality control. The project, which will strengthen collaborative partnerships between Randox, Queen’s University Belfast and Ulster University, will accelerate the development of new technologies and drive healthcare improvements regionally, nationally and across the globe.
Of the £23m of support offered by Invest NI, £5m will go toward research projects at Ulster University and Queen’s University Belfast.
Welcoming the investment, Alastair Hamilton, Chief Executive of Invest NI said;
“Randox has a long history of investing heavily in innovation and R&D which has enabled it to create a globally competitive export driven business, capable of developing world leading research. This major investment will enable Randox to perform cutting-edge R&D which has the potential to revolutionise the global healthcare industry. This is excellent news for Northern Ireland’s life and health sciences sector. Northern Ireland is enjoying a growing international reputation as a region of expertise and knowledge in key areas such as Diagnostics, Precision Medicine and Advanced Manufacturing. The three new Centres of Excellence will help build on this and enhance Northern Ireland’s credibility, provide supply chain opportunities, and encourage knowledge transfer with our universities.”
Sir John Bell, commenting on the potential for the UK Life Sciences sector said;
“The life sciences industry represents one of the dominant economic sectors in the UK, and one with considerable potential for growth. However, whilst we have many natural strengths we cannot afford to be complacent. We must strive to optimise our science base, to encourage collaboration across academia, industry and the NHS, and grow our industrial capabilities. To do so we need to use our extensive data sets to best effect, and have in place a strong skills strategy. Success requires vision and drive. To that end I would like to congratulate Dr FitzGerald and Randox in the establishment of these three R&D collaborative Centres of Excellence – these are assets of national standing and will have a meaningful impact in enabling earlier and more accurate diagnosis, driving improvements in patient care, regionally, nationally and globally. They are leaders in this field, committed to innovation, and I wish them every success.”
Professor Jim McLaughlin, Director of Ulster University’s Nanotechnology and Integrated Bioengineering Centre, added;
“This very welcome investment enables pioneering Randox-inspired engineering capacity at Ulster University and reflects our research commitment to the life sciences industry. From nanotechnology to the development of systems that will enable large scale laboratory capability to be produced in the palm of your hand, the partnership brings shared industry and academic research excellence from the lab into the marketplace. Life sciences is a vital economic sector locally and this collaboration will advance diagnostics and ultimately enhance patient health outcomes.”
Dr David Jess, Senior Lecturer at Queen’s University Belfast School of Mathematics and Physics, added;
“The Randox Centres of Excellence will allow Queen’s University Belfast to continue to deliver cutting-edge and world leading research. We look forward to collaborating further with industry to develop pioneering research, focused on the needs of society.”
Invest NI’s R&D support is part funded by ERDF under the EU Investment for Growth and Jobs Programme 2014 – 2020.
For further information please contact the Randox PR Team: phone 028 9442 2413 or email randoxpr@randox.com
Take control of your heart health with Randox
Your heart is amazing. Not only is it your most critical organ but also one of the most hard-working. The average adult heart beats around 100,000 times a day, acting as a giant pump for all the blood in your body. Indeed, every day your heart pumps over nine litres of blood through a system of blood vessels over 60,000 miles long – it’s little wonder, then, the importance placed on looking after such a vital muscle.
The heart works 24/7, only taking a rest when you sleep with the natural drop of heart rate and blood pressure. Over time, and influenced by lifestyle choices, the heart grows weaker, needing to work harder to fulfil its function. Crucial lifestyle changes now could limit your risk of developing serious cardiac conditions, such as Cardiovascular Disease (CVD) in the future. Factors which can contribute to your CVD risk include genes inherited from parents or grandparents, smoking, an unhealthy diet, excessive alcohol consumption and low physical activity levels.
You can’t change your DNA, but you can find out what it means to you and your family. One of our advanced tests can identify people living with a common but often hidden disorder – Familial Hypercholesterolemia (FH). Fewer than 12% of people in the UK know they have this potentially fatal condition. It is characterised by dangerously high levels of cholesterol which can lead to early onset cardiovascular disease.
While lifestyle changes may help to limit your risk of CVD, and related heart condition, it is impossible to eradicate it completely for everyone. Accounting for 31% of deaths worldwide, CVD is the number one cause of death globally but early screening could lower this figure significantly. That’s why it’s vitally important to detect CVD early before a coronary event like a heart attack occurs.
Today in the UK, 530 people will go to the hospital with a suspected heart attack. Only a fifth of these people will actually be having a heart attack. 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), 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, making sure those at high-risk are given medical intervention earlier.
Early screening in the form of a comprehensive health check is essential to detect cardiac irregularities before they become serious problems. Heart damage builds up over time, meaning that when detected early enough, lifestyle changes can help to reduce cardiac risk and potentially even prevent a cardiac event occurring.
Therefore, it is vitally important that individuals are tested for CVD to detect them in the earliest stages to reduce damage, prevent further damage, or even death. Furthermore, many people suffer from inherited cardiac risk factors, which stresses the need for accurate testing.
Randox offer the complete laboratory solution to cardiac risk assessment information to doctors and hospitals, and also directly to the public at Randox Health. Our range of both traditional and novel cardiac risk biomarkers, along with our technologically-advanced range of analysers, serves to allow us to offer the most advanced, most accurate health check available on the planet.
As well as your cardiovascular risk score, a Randox Health check will also assess your cholesterol levels, FH risk, triglycerides, creative kinase, myoglobin, troponin levels and many more heart health indicators. In total, a Randox Health check can assess up to 350 different markers of irregularity or disease in the whole body, from heart to hormone health and skin to stomach.
Many serious future health issues are preventable now with action. Find out more about our health check programmes here.
About Randox Health
Randox Health is a global leader in healthcare diagnostics; today more than 5% of the world’s population – in excess of 370 million people across 145 countries – receives medical diagnosis using Randox products each year.
After investing over £220 million in the invention and production of revolutionary blood-science technology, a single Randox Health check will deliver a complete picture of your health – as it is now and, crucially, how it is likely to develop in the future.
Randox Health has proven that signs of disease or irregularity can be caught at their earliest stage. This means that, with early action, some cases of illness can even be prevented altogether. Our health checks include, but are not limited to, cancer surveillance, fertility monitoring, heart health, nutrition, digestive and diabetes health.
In other words, from one health check, you’ll receive up to 350 results and afterwards avail of expert advice from the Randox scientists or a Randox Health GP. Not only that, but a complete 12-month programme and repeat testing come as standard so you can have full confidence that you are really taking care of yourself.
Find out more information about Randox Health checks here: https://www.randoxhealth.com/our-packages/
RX Series
Randox has developed the RX series range of clinical chemistry analysers for high-quality semi-automated and fully automated testing. Choose between the RX misano, RX monaco, RX daytona+, RX imola, and the RX modena depending on the throughput of your laboratory. The RX series offers a suitable analyser for your laboratory’s needs. For more information on the Randox RX series, please click here or email therxseries@randox.com
Reagents
Randox offers an extensive range of third party diagnostic reagents which are internationally recognised as being of the highest quality; producing accurate and precise results. We have the largest test menu of 118 assays, covering over 100 disease markers including specific proteins, lipids, therapeutic drug monitoring, drugs of abuse, antioxidants, coagulation, diabetes and veterinary testing. A wide range of formats and methods are available providing greater flexibility and choice for any laboratory size. In addition to flexible pack sizes and a comprehensive list of analyser applications, we can also provide dedicated reagent packs (Randox Easy Read and Easy Fit regents) for a wide range of chemistry analysers providing you with freedom of choice from an independent manufacturer.
For more information on Randox Reagents, please click here or email reagents@randox.com
Acusera – Internal Quality Control
The Acusera cardiac controls have been designed to cover a wide range of cardiac markers at clinical decision levels, eliminating the extra expense of an additional low level control. The controls are available in a both liquid ready-to-use and lyophilized formats making them ideal for all situations and manufactured from 100% human serum a matrix similar to that of the patient is guaranteed. For more information on the Randox Acusera internal quality control, please click here or email acusera@randox.com
RIQAS – External Quality Control
The RIQAS Liquid Cardiac EQA programme is designed to monitor the performance of up to 9clinically significant cardiac markers including: CK-MB mass, D-dimer, Digoxin, homocysteine, hsCRP, myoglobin, NT proBNP, troponin I, and troponin T. RIQAS is ISO/IEC 17043 accredited and allows the registration of up to five instruments at no extra cost. All samples are 100% human serum and provided in a liquid ready-to-use format for enhanced convenience. Submit your results bi-weekly and view reports online via RIQAS.Net. For more information on RIQAS, the world’s largest international EQA scheme, please click here or email acusera@randox.com
For further information, please contact the Randox PR team via email: randoxpr@randox.com or phone 028 9442 2413
The Complete Solution to Cardiac Risk Assessment
“CVDs are the number 1 cause of death globally: more people die annually from CVDs than from any other cause”. In 2015, roughly 17.7 million people died from CVD, representing 31% of all global deaths: 7.4 million were due to coronary heart disease and 6.7 million were due to stroke. (WHO, 2017)
Cardiac health and regular cardiovascular screening is important to enable risk factors to be detected in their earliest stages. There are a few factors which contribute to CVD. These include: smoking, unhealthy diet, excessive alcohol consumption, low physical activity levels. Whilst there are only a few factors contributing to CVD, these can be maintained by the patient through living a healthy lifestyle including: quitting smoking, consuming no more than the recommended allowance of alcohol, cutting out junk food, and exercising for 30 minutes a day, 3 – 5 days a week. In a perfect world, this would be easy and CVD would not be a global problem. However, due to busy lifestyles, cravings, reduced willpower, and convenience, not all individuals in today’s world will be able to avoid CVDs. Therefore, it is vitally important that individuals are tested for CVDs to detect them in the earliest stages to reduce damage, prevent further damage, or even death. Furthermore, many individuals suffer from inherited cardiac risk factors, which stresses the need for accurate testing of both traditional and novel cardiac risk biomarkers.
Randox offer the complete solution to cardiac risk assessment including: RX analysers, traditional and novel reagents, internal quality control (Acusera), and external quality control (RIQAS).
RX Series
Randox has developed the RX series range of clinical chemistry analysers for high-quality semi-automated and fully automated testing. Choose between the RX misano, RX monaco, RX daytona+, RX imola, and the RX modena depending on the throughput of your laboratory. The RX series offers a suitable analyser for your laboratory’s needs. For more information on the Randox RX series, please click here or email therxseries@randox.com
Reagents
As previously mentioned, early assessment of cardiac risk is vital. Randox offer a range of novel risk biomarkers for both very early and the genetic assessment of cardiac risk.
The niche Adiponectin assay allows for the early assessment of CVD. Adiponectin levels are inversely correlated with abdominal visceral fat which has proven to be a strong predictor of T2DM. Body-Mass Index (BMI) is a common method for determining which patients are classified as underweight, healthy, overweight or obese, however, BMI does not take into account gender, ethnicity or activity levels. For example, measuring the BMI of athletes who have a high BMI due to muscle weighing heavier than fat would classify them as obese which is inaccurate. Measuring adiponectin levels is therefore a much more reliable indicator of at-risk patients compared to BMI.
LDL cholesterol is often referred to as the ‘bad cholesterol’. High concentrations of LDL-cholesterol is considered to be the most important clinical predictor, of all single parameters, with respect to coronary atherosclerosis. However, sLDL is a smaller, more dense subfraction of LDL-cholesterol. sLDL particles more readily permeate the inner arterial wall and are more susceptible to oxidation. Individuals with a predominance of sLDL have a 3-fold increased risk of myocardial infarction. Measurement of sLDL allows the clinician to get a more comprehensive picture of lipid risk factors and tailor treatment accordingly.
Elevated levels of Lp(a) are considered to be both a casual risk factor and independent genetic marker of atherosclerotic disorders. The major challenge associated with Lp(a) measurement is the size variation of apo(a) within Lp(a). Dependent upon the size of apo(a) in the assay calibrator, many assays under or overestimate apo(a) size in the patient sample. Numerous commercially available products suffer apo(a) size related bias, resulting in an over estimation of Lp(a) in samples with large apo(a)molecules and an under estimation in samples with small apo(a) molecules. The antibody used in the Randox method detects the complete Lp(a) molecule providing accurate and consistent results. This was proven by the IFCC who developed a gold standard ELISA reference assay and compared 22 commercially available tests. The Randox Lp(a) method displayed the least (minimal) amount of apo(a) size related bias, proving it be a superior offering.
HDL3 Cholesterol is a smaller and more dense subfraction of the HDL particle. HDL is the scavenger of cholesterol within arterial walls and the levels of HDL3 is too low, the ability to remove this cholesterol is reduced. Therefore, it is widely accepted that there is an inverse correlation between HDL3 and CVD risk.
Instrument Specific Applications (ISA’s) are available for a wide range of biochemistry analysers. Contact us to enquire about your specific analyser.
For more information on Randox Reagents, please click here or email reagents@randox.com
Acusera – Internal Quality Control
The Acusera cardiac controls have been designed to cover a wide range of cardiac markers at clinical decision levels, eliminating the extra expense of an additional low level control. The controls are available in a both liquid ready-to-use and lyophilized formats making them ideal for all situations and manufactured from 100% human serum a matrix similar to that of the patient is guaranteed. For more information on the Randox Acusera internal quality control, please click here or email acusera@randox.com
RIQAS – External Quality Control
The RIQAS Liquid Cardiac EQA programme is designed to monitor the performance of up to 9clinically significant cardiac markers including: CK-MB mass, D-dimer, Digoxin, homocysteine, hsCRP, myoglobin, NT proBNP, troponin I, and troponin T. RIQAS is ISO/IEC 17043 accredited and allows the registration of up to five instruments at no extra cost. All samples are 100% human serum and provided in a liquid ready-to-use format for enhanced convenience. Submit your results bi-weekly and view reports online via RIQAS.Net. For more information on RIQAS, the world’s largest international EQA scheme, please click here or email acusera@randox.com
For further information, please contact the Randox PR team via email: randoxpr@randox.com or phone 028 9442 2413
