Product Spotlight: Liquid Assayed Chemistry Premium Plus

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Product Spotlight: Liquid Assayed Chemistry Premium Plus

product spotlight - Liquid Assayed Chemistry Premium Plus - Chemistry Control

Routine clinical chemistry is the basis of a laboratory’s daily testing, it is, therefore, important to choose a chemistry control which offers the greatest consolidation, accuracy, and stability.

Acusera Liquid Assayed Chemistry Premium Plus Control

The Acusera Liquid Assayed Chemistry Premium Plus control is one of the most comprehensive chemistry controls on the market, with instrument specific values provided for 99 analytes. A unique combination of proteins, lipids, cardiac markers, therapeutic drugs, immunoassay, and routine chemistry parameters enables effective consolidation, as well as time and cost savings. As a true third party control, it is manufactured independently from any analyser, with values assigned using our unique value assignment process, target values are available for several common analyser platforms. Containing an impressive array of lipids and Immunoassay parameters, this Acusera Chemistry control offers unrivaled consolidation.

Key Features & Benefits

  • Liquid for ease of use
  • Human based serum
  • Assayed instrument specific target values and ranges
  • High levels of CRP and other proteins eliminate the need for multiple controls
  • Stable to expiry when stored at -20°C to -70°C
  • Open vial stability of up to 7 days at 2°C – 8°C
  • Analytes (click to expand)

    Albumin (Electrophoresis)
    Alpha-1-Globulin (Electrophoresis)
    Alpha-2-Globulin (Electrophoresis)
    Beta-Globulin (Electrophoresis)
    Gamma-Globulin (Electrophoresis)
    Alpha-HBDH
    α-1- Acid Glycoprotein
    α-1-Antitrypsin
    Β-2-Microglobulin
    Acid Phosphatase (Total)
    AFP
    Albumin
    Alkaline Phosphatase
    Amikacin
    ALT
    Amylase
    Amylase (Pancreatic)
    Apo A-1
    Apo B
    AST
    Bicarbonate
    Bile Acids
    Bilirubin Direct
    Bilirubin Total
    C-Reactive Protein
    Caffeine
    Calcium
    Carbamazepine
    CEA
    Ceruloplasmin
    Chloride
    Cholesterol
    Cholinesterase

    CK Total
    Complement C3
    Complement C4
    Copper
    Cortisol
    Creatinine
    D-3-Hydroxybutyrate
    DHEA Sulphate
    Digoxin
    Ethanol
    Ferritin
    Folate
    FSH
    Free T3
    Free T4
    Gamma GT
    Gentamicin
    GLDH
    Glucose
    Haptoglobin
    hCG
    HDL Cholesterol
    IgA
    IgE
    IgG
    IgM
    Iron
    Lactate
    LAP
    LDH
    LDL Cholesterol
    Leutinising Hormone
    Lipase

    LP(a)
    Lithium
    Magnesium
    Myoglobin
    Osmolality
    Paracetamol
    Phenobarbital
    Phenytoin
    Phosphate Inorganic
    Potassium
    Prealbumin
    Progesterone
    Prolactin
    Protein Total
    PSA Total
    Salicylate
    Sodium
    Testosterone
    Theophylline
    Total T3
    Total T4
    TSH
    TIBC
    Transferrin
    Triglycerides
    Troponin T
    T Uptake
    Urea
    Uric Acid
    Valproic Acid
    Vancomycin
    Vitamin B12
    Zinc

Featured Analytes

C-Reactive Protein (CRP)

CRP is a protein made by the liver and released into the blood within a few hours after tissue injury, the start of an infection, or other cause of inflammation. It is tested to detect the presence of inflammation and can be used to monitor the response to treatment for inflammatory disorders. CRP is included in the Liquid Assayed Chemistry Premium Plus control, ensuring accurate instrument performance at key decision levels and further reduces the number of individual controls required. CRP is available at elevated levels in the level three control.

Troponin T (TnT)

A troponin test measures the levels of troponin proteins in blood and is used when a patient is suspected to have suffered a heart attack. These proteins are released when the heart muscle has been damaged, such as with a heart attack. More damage to the heart would result in a higher level of Troponin T. As a highly consolidated contorol, the Liquid Assayed Chemistry Premium Plus includes Troponin T, meaning a separate control is not required.

Related Products

Interlaboratory Data Management

RIQAS Chemistry EQA

Continue Reading

Download some of our related brochures below and broaden your understanding.

Product Spotlight Archive

Don’t forget to visit our Product Spotlight Archive and see spotlights from past months


Metabolism: how Randox is helping to diagnose metabolic conditions

Many people talk about their metabolism as if it is a muscle or organ they can somehow control. In reality, your metabolism refers to a series of chemical processes in each cell that turn the calories you eat into fuel to keep you alive.

Metabolism is the biochemical process of combining nutrients with oxygen to release the energy our bodies need to function. Your resting metabolic rate (RMR) is the number of calories your body burns to maintain vital body functions such as heart rate, brain function and breathing. RMR accounts for up to 75 percent of the calories you burn each day. Knowledge of your individual RMR is a critical piece of information to appropriately establish daily calorie needs.

The body’s major organs — the brain, liver, kidneys, and heart — account for about half of the energy burned at rest, while fat, the digestive system, and especially the body’s muscles account for the rest.

Did you know?

Approximately 20-25% of the world’s adult population have metabolic syndrome?

A common misconception surrounding metabolic health is that it refers solely to your weight, and if you are overweight you are considered to be unhealthy. But in actual fact this may not be entirely true. Good metabolism means that your body is in good overall health, which doesn’t account for just your weight! Common metabolic disorders include genetic metabolic disorders, diabetes and metabolic syndrome. Understanding and testing to see how well your metabolism is functioning is key to ensuring long lasting health.

Genetics

There are a number of genetic metabolic disorders caused by mutations of single genes. Examples of common disordersinclude Gaucher’s disease, hemochromatosis and cystic fibrosis. Gaucher’s disease is a genetic disorder that affects the body’s ability to break down fat that can accumulate in the liver/spleen and bone marrow. Hemochromatosis is a condition that is caused by the over-absorption and build-up of iron while cystic fibrosis is a metabolic disorder that appears as a result of a build-up of mucus in lungs/liver and intestines. Each of these metabolic disorders affect certain organs from functioning properly and therefore your overall healthiness.

Diabetes

Type 2 diabetes is one of the most common types of  metabolic disorders in the world that is expected to affect 592 million people by 2035. It is characterised by high blood sugar, insulin resistance or a lack of insulin being produced by the pancreas. Insulin resistance occurs when the body isn’t able to use insulin the right way which increases blood glucose levels. Insulin is needed for cells to take in glucose (sugar) from the bloodstream and convert it into energy. Over time this lack of insulin can damage the organs in your body.

Metabolic Syndrome

Metabolic syndrome (also known as syndrome X, Reaven’s syndrome, and CHAOS) is not a disease but a collection of risk factors that affect your health; these include high blood pressure, high blood sugar/cholesterol and abdominal fat. Left untreated, these risk factors, together, can lead to long term serious problems including an increased risk of heart disease, stroke and developing type 2 diabetes.

Can you improve your metabolic health?

Yes! The good news is that if you discover that your metabolic health is not up to scratch you can improve it through a combination of diet, exercise and lifestyle adjustments such as:

  • 30 minutes of moderate to intense exercise 5-7 times a week
  • Low-dose aspirin to reduce your risk of stroke or heart attack
  • Quit smoking
  • Medication for blood pressure/cholesterol/ blood sugar
  • Limit alcohol intake
  • Eat a healthy balanced diet

Related Products 

Randox has developed the RX series of clinical chemistry analysers for superior semi-automated and fully automated testing. The RX series extensive dedicated test menu goes beyond routine testing and has many unique and high-performance tests available. Our range of tests covers several parameters to assess your overall metabolic health.

Metabolic Health Profile

Albumin Chloride Potassium
Alkaline Phosphatase  C0Total Sodium
ALT Creatinine Total Bilirubin
AST (GOT) Glucose Total Protein
Direct Bilirubin Lactate Urea
Calcium

The RX series clinical chemistry analysers provide laboratories with a robust and smart solution ensuring you maintain a consistent workflow and can provide accurate results first time, every time. Offering excellent customer support services, our trained engineers are on hand to work with you in preserving the continuity of your operations while maximising the potential of your RX series instrument.Our world-famous test menu of high quality reagents ensures excellence in patient care, guaranteeing unrivalled precision and accuracy reducing costly test re-runs or misdiagnosis and offering complete confidence in results.

For more information visit: https://www.randox.com/clinical-chemistry-analysers/

 

 

 


How Randox is helping to diagnose metabolic conditions

Metabolic health is a term used to describe a collection of required chemical reactions that take place in all living organisms. A metabolic disorder develops when an abnormal chemical reaction occurs which alters the normal metabolic process.

A common misconception surrounding metabolic health is that it refers solely to your weight, and if you are overweight you are considered to be unhealthy. But in actual fact this may not be entirely true. Good metabolism means that your body is in good overall health, which doesn’t account for just your weight! Common metabolic disorders include genetic metabolic disorders, diabetes and metabolic syndrome. Understanding and testing to see how well your metabolism is functioning is key to ensuring long lasting health.

Genetics

There are a number of genetic metabolic disorders caused by mutations of single genes. Examples of common disorders include Gaucher’s disease, hemochromatosis and cystic fibrosis. Gaucher’s disease is a genetic disorder that affects the body’s ability to break down fat that can accumulate in the liver/spleen and bone marrow. Hemochromatosis is a condition that is caused by the over-absorption and build-up of iron while cystic fibrosis is a metabolic disorder that appears as a result of a build-up of mucus in lungs/liver and intestines. Each of these metabolic disorders affect certain organs from functioning properly and therefore your overall healthiness.

Diabetes

Type 2 diabetes is one of the most common types of  metabolic disorders in the world that is expected to affect 592 million people by 2035. It is characterised by high blood sugar, insulin resistance or a lack of insulin being produced by the pancreas. Insulin resistance occurs when the body isn’t able to use insulin the right way which increases blood glucose levels. Insulin is needed for cells to take in glucose (sugar) from the bloodstream and convert it into energy. Over time this lack of insulin can damage the organs in your body.

Metabolic Syndrome

Metabolic syndrome (also known as syndrome X, Reaven’s syndrome, and CHAOS) is not a disease but a collection of risk factors that affect your health; these include high blood pressure, high blood sugar/cholesterol and abdominal fat. Left untreated, these risk factors, together, can lead to long term serious problems including an increased risk of heart disease, stroke and developing type 2 diabetes.

Can you improve your metabolic health?

Yes! The good news is that if you discover that your metabolic health is not up to scratch you can improve it through a combination of diet, exercise and lifestyle adjustments such as:

  • 30 minutes of moderate to intense exercise 5-7 times a week
  • Low-dose aspirin to reduce your risk of stroke or heart attack
  • Quit smoking
  • Medication for blood pressure/cholesterol/ blood sugar
  • Limit alcohol intake
  • Eat a healthy balanced diet

Related Products 

Randox has developed the RX series of clinical chemistry analysers for superior semi-automated and fully automated testing. The RX series extensive dedicated test menu goes beyond routine testing and has many unique and high-performance tests available. Our range of tests covers several parameters to assess your overall metabolic health.

Metabolic Health Profile

Albumin Chloride Potassium
Alkaline Phosphatase  C0Total Sodium
ALT Creatinine Total Bilirubin
AST (GOT) Glucose Total Protein
Direct Bilirubin Lactate Urea
Calcium

The RX series clinical chemistry analysers provide laboratories with a robust and smart solution ensuring you maintain a consistent workflow and can provide accurate results first time, every time. Offering excellent customer support services, our trained engineers are on hand to work with you in preserving the continuity of your operations while maximising the potential of your RX series instrument. Our world-famous test menu of high quality reagents ensures excellence in patient care, guaranteeing unrivalled precision and accuracy reducing costly test re-runs or misdiagnosis and offering complete confidence in results.

For more information visit: https://www.randox.com/clinical-chemistry-analysers/

 

 

 


Product Spotlight: Liquid Lipid Control

product spotlight - liquid lipid control

Cardiovascular disease (CVD) is a general term for conditions affecting the heart or blood vessels. It is usually associated with a build-up of fatty deposits inside the arteries and increased risk of blood clots. It can be associated with damage to arteries in organs such as the brain, heart, kidney and eyes. Some types of CVD include coronary heart disease, strokes and aortic disease. Some of the main causes of CVD are smoking, high cholesterol, diabetes and high blood pressure (NHS, 2016).

These diseases can be extremely dangerous and lead to permanent damage or even death, therefore, it is vitally important for laboratories to be confident in their analyser’s ability to accurately diagnose and monitor the risk of these diseases.

Randox Liquid Lipid Control

The Randox Acusera Liquid Lipid quality control includes assayed target values and ranges for 8 analytes covering the complete lipid profile. With a 30 day open vial stability the Acusera Liquid Lipid control will reduce waste, whilst remaining easy and convenient to use. Three distinct levels are available covering low risk, borderline risk, and high risk concentrations of HDL and LDL cholesterol, ensuring the clinically relevant decision levels are tested, eliminating the need to purchase additional high and low level controls. Containing no Sodium Azide, which can interfere with direct clearance methods for  detecting HDL and LDL cholesterol, ensuring ultimate accuracy and confidence in results.

Key Features & Benefits

  • Liquid for ease of use
  • 100% human serum
  • Assayed target values provided
  • True third party control
  • Stable to expiry date at -20°C to -80°
  • Open vial stability of 30 days at 2°C to 8°C

Analytes

Apolipoprotein A  |  Apolipoprotein B  |  Cholesterol (HDL)  |  Cholesterol (LDL)
Cholesterol (Total)  |  C-Reactive Protein (CRP)  |  Lipoprotein (a)  |  Triglycerides

Featured Analytes

HDL Cholesterol

High-Density Lipoproteins (HDL) are one of the major classes of plasma lipoproteins. HDL is often referred to as ‘good cholesterol’ because it transports cholesterol from the tissues of the liver for removal from the body. High levels of HDL can indicate a lower risk of developing heart disease.

Apolipoprotein A-1

Apolipoprotein A-1 is one of the main protein forms found in High Density Lipoproteins (HDL). The chief role of Apolipoprotein A-1 is in the activation of lecithin cholesterol acyltransferase (LCAT) and the capture and removal of free cholesterol from extra hepatic tissue. Studies have shown that there is an inverse relationship between Apolipoprotein A-1 and coronary artery disease (CAD).

Related Products

Acusera Lipid Control

RIQAS Lipid EQA

Continue Reading

Download some of our related brochures below and broaden your understanding.

Product Spotlight Archive

Don’t forget to visit our Product Spotlight Archive and see spotlights from past months

References

NHS. (2016). Heart attack. nhs.uk. Retrieved 15 February 2018, from https://www.nhs.uk/conditions/heart-attack/

National Institute for Health and Care Excellence. (2014). Myocardial infarction (acute) Early rule out using high-sensitivity troponin testsNice.org.uk. Retrieved 15 February 2018, from https://www.nice.org.uk/guidance/dg15/chapter/3-clinical-need-and-practice


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


Product Spotlight: RIQAS CO-Oximetry EQA

Product Spotlight - RIQAS CO-Oximetry EQA Programme

RIQAS CO-Oximetry EQA

The RIQAS CO-Oximetry EQA Programme is a comprehensive programme suitable for monitoring the performance of 7 CO-Oximetry parameters. All samples are supplied in a liquid ready-to-use format ideal for both clinical and point-of-care testing (POCT).

Background

CO-Oximetry is a methodology that measures the levels of the oxygen-carrying protein haemoglobin, which is the chief component of red blood cells. CO-Oximetry is a useful tool in that it helps determine the levels of various forms of haemoglobin.

Key Benefits & Features

  • Liquid ready-to-use
  • Monthly reporting
  • Submit results and view reports online via RIQAS.Net
  • Suitable for POCT

Liquid ready-to-use

The liquid stable formulation requires no preparation making the samples extremely easy and convenient to use.

Consolidation

Covering 7 CO-Oximetry parameters, the RIQAS CO-Oximetry programme offers a streamlined approach to your EQA, allowing you to test your whole CO-Oximetry menu.

RIQAS

RIQAS is the largest international External Quality Assessment (EQA)/ Proficiency Testing (PT) scheme, there are currently more than 45,000 participants in 133 countries. World renowned for reducing the number of individual programmes required by even the most demanding laboratories.

Analytes

  • Carboxyhaemoglobin (COHb / HbCO)
  • Methaemoglobin (MetHb)
  • Oxygen Content (O₂CT)
  • Oxygen Saturation (sO / Vol O)
  • Oxyhaemoglobin (OHb / HbO)
  • Total Haemoglobin (tHb)
  • Reduced / Deoxyhaemoglobin (RHb / HHb)

Related Products

RIQAS Blood Gas EQA

Suitable for monitoring the performance of 10 blood gas parameters.

  • Accredited to ISO/IEC 17043
  • Liquid ready-to-use
  • Aqueous material
  • Monthly reporting
  • Submit results and view reports online via RIQAS.Net
  • Suitable for POCT

Download some of our related brochures below and broaden your understanding.

Product Spotlight Archive

Don’t forget to visit our Product Spotlight Archive and see spotlights from past months


References

Chatburn, R. (2014). To co-ox or not to co-oxAcutecaretesting.org. Retrieved 19 February 2018, from https://acutecaretesting.org/en/articles/to-coox-or-not-to-coox


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.

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

cardiac

 


Reconstituting Lyophilised Controls

What is Lyophilisation?

Lyophilisation or ‘freeze drying’ is the process by which water is removed from a product after it is frozen and placed under a vacuum, allowing the ice to change directly from solid to vapor without passing through a liquid phase. The process consists of three separate processes:

  1. Freezing
  2. Primary Drying (Sublimation)
  3. Secondary Drying (Desorption)

There are many benefits to using a lyophilised control including; improved product shelf-life and enhanced stability of volatile analytes. For example, many lyophilised controls have a shelf life of up to four years from the date of manufacture resulting in a reduction of costly new lot validation studies. Furthermore, lyophilised controls can be aliquoted and refrozen to extend the working stability of the product.

Reconstituting Lyophilised QC Material

The process of reconstitution involves adding a specified volume of distilled water to lyophilised QC material. The water should completely dissolve the lyophilised contents, giving a liquid solution, which is ready for analysis.

Reconstitution is a straightforward process, but requires a high level of precision. Small errors can have serious implications to the reconstituted material:

  • If too much water is pipetted during reconstitution, the material will be heavily diluted and results will be lower than expected
  • If too little water is pipetted during reconstitution, the material will not be sufficiently diluted, and results will be higher than expected
  • If the correct volume of water is pipetted, but a small amount of water gets stuck in the pipette tip due to poor pipetting technique, results will be higher than expected

If a lyophilised control has been reconstituted incorrectly the contents of the vial will be wasted. It is therefore vitally important that controls are reconstituted with care.

Materials and Methods Required

The list of requirements for an accurate and consistent reconstitution technique is not extensive, but each requirement is vital. Labs should have:

  • Calibrated volumetric pipettes
  • Sterile, appropriately sized pipette tips
  • Distilled water, or other reconstitution fluid as specified
  • Technician with good pipetting technique
  • Lyophilised QC stored according to manufacturer’s specifications

How to Reconstitute Lyophilised QC Material

Each different lyophilised control may require slightly different preparation, always refer to the instructions for use before reconstituting control material. The below guide provides a general overview of the reconstitution process, using the Randox Human Assayed Chemistry Premium Plus control (HN1530) as an example

  1. Place the vial of lyophilised QC on a flat surface, carefully remove the lid and the rubber stopper making sure not to spill any material
  2. Using a calibrated pipette and sterilised pipette tip, add exactly 5ml of distilled water directly into the QC vial, ensuring no water is left in the pipette tip, or on the rim/side of the vial
  3. Place the rubber stopper and lid firmly back onto the QC vial, and leave to stand for 30 minutes
  4. After 30 minutes, gently invert the QC vial 10-15 times to ensure the contents is completely dissolved, making sure to avoid the formation of foam. It is important that you DO NOT SHAKE the vial. Alternatively place the vial on a roller for 30 minutes to ensure the contents is thoroughly mixed
  5. Once satisfied all material has been completely dissolved, proceed to use the QC product in accordance with the ‘Control’ section of the individual analyser application
  6. Once finished, refrigerate any unused material. It is good practice to label the vial with the date of reconstitution to prevent the use of material outside of the recommended stability period
  7. Prior to reusing lyophilised material, mix the contents thoroughly by gentle inversion, as highlighted in Step 4

Additional Considerations

It is important to remember that there may be slightly different reconstitution requirements for different QC material. For this reason, it is vital that the instructions provided on the QC Kit Inserts are closely followed.

Reconstituting lyophilised QC can be time-consuming. Therefore, Randox Acusera offer convenient 5ml distilled water serum diluent to assist laboratories with reconstitution of lyophilised controls. These user-friendly pour over vials streamline the reconstitution process and eliminate the risk of pipetting errors.

If you have any further questions regarding lyophilised controls or would like to contact us, please do so by emailing us at acusera@randox.com or use the contact us button provided.


The Benefits of True Third Party Controls

The Benefits of third party controls

In the clinical laboratory, Quality Control (QC) refers to the process of detecting analytical errors to ensure both the reliability and accuracy of patient test results. Poor performance can result in misdiagnosis, delayed/inappropriate treatment, increased costs and may even be potentially life threatening for the patient. Third party controls offer a better solution to ensure optimum performance and accuracy, read on to learn how.

  • 1. Dependent / First Party Controls

    Dependent controls refer to any control material that has been produced by the instrument or reagent manufacturer for use on a specific test system. Such controls are often manufactured from the same raw materials as the calibrator, making them less sensitive to subtle changes in performance.

    As dependent controls are generally optimised for use with the manufacturer’s test system, these controls can mask weaknesses, and therefore, are increasingly considered less effective than independent controls.

  • 2. Semi-Dependent Controls

    Semi-dependent control material, although produced independently of the instrument or reagent, is often supplied or recommended by the instrument/reagent manufacturer. It is this manufacturing relationship between the two that requires close scrutiny when considering if these controls are fit-for-purpose.

    Although the control material is not produced by the instrument manufacturer, it is produced according to their exact specifications and therefore, optimised to work with a specific platform.

  • 3. Independent / Third Party Controls

    Independent or third party quality control material has not been designed or optimised for use with any instrument, kit or method. This complete independence enables the quality control material to closely mirror the performance of patient samples, and in doing so, provide an unbiased, independent assessment of analytical performance across multiple platforms.

Benefits of using third party controls

Third party controls have been designed to deliver an independent, unbiased assessment of performance with any instrument or method helping you gain accreditation. Below are some of the key benefits of third party controls:

  • Values assigned using a large number of independent laboratories ensuring statistically valid targets.
  • Highly consolidated controls allow for space, time, and ultimately, cost savings.
  • Boosted shelf life ensures continuity of supply and reduced costs
  • Reduced preparation times by removing the need for multiple instrument controls

Regulatory Requirements

Third party controls are growing in popularity across the globe. More and more laboratories are beginning to use third party controls as part of their daily QC strategy. The benefits of such controls are widely accepted and recommended by both key opinion leaders and regulatory bodies in the field of Quality Control.

“Use of independent third party control materials should be
considered, either instead of, or in addition to, any control
materials supplied by the reagent or instrument manufacturer”

ISO 15189:2012 Section 5.6.2.2
ISO 15189:2012 Medical Laboratories – Requirements for Quality and Competence

Case Studies

The benefit of running third party controls in your laboratory cannot be underestimated. The following case studies highlight their many benefits and how they have helped laboratories across the world to provide more accurate and reliable test results.

Case Study One: Identifying Lot-to-Lot Variability with Third Party Controls

A laboratory in the UK contacted Randox Technical Services, reporting higher than expected QC results for
Thyroglobulin. When using a third party control (Acusera Immunoassay Premium Plus) the results were four
times higher on their main analyser compared to other systems. However, when they ran the instrument
manufacturer’s control alongside the third party control it did not show the same problem.

After reviewing EQA data, the Technical Services team confirmed there was a significant difference in results
compared to other instruments, and set about helping the laboratory troubleshoot. After an exhaustive
review of procedures and processes, the customer contacted the instrument manufacturer, who advised of a
positive bias with several batches of reagent, including the batch the laboratory was using.

Conclusion: By using a third party control the laboratory was able to detect a shift in results after changing
reagent batch that the instrument manufacturer’s control did not.

Case Study Two: Overcoming Instrument Errors with Third Party Controls

A laboratory using the Acusera Assayed Chemistry Premium Plus control contacted Randox Technical Services
after observing a consistent negative bias for ALT which was not replicated by the instrument control. They
had previously contacted their instrument manufacturer who advised that the problem was with the control
and not the reagent or instrument.

Randox investigated the problem and demonstrated that patient results were also wrongly reported low. This
later led the instrument manufacturer to recommend a wash stage to eliminate any interference.

Conclusion: The use of a third party control in this instance enabled the identification of a procedural error
with the instrument that the recommended control did not.

Benefits of Acusera True Third Party Controls

Explore the benefits of Randox Acusera third party controls below.

  • Value Assignment
  • Material
  • Stability
  • Consolidation
  • Concentrations & Levels
  • Third Party Controls
  • Traceability
  • Flexibility

Our extensive range of assayed quality controls are supplied with highly accurate target values for a wide range of instruments and methods. Our unique value assignment process utilises thousands of independent laboratories globally ensuring target values won’t change throughout the shelf life of the control and eliminates the need to spend time and money performing value assignment in-house.

Accuracy coupled with unrivalled traceability to International Reference Laboratories, provides a product of unsurpassed accuracy and reliability.

We take quality seriously, that’s why all QC products are manufactured to the highest possible standard delivering control products of unrivalled quality. Our superior manufacturing processes ensure stability claims and analyte levels won’t differ significantly from lot to lot. You can therefore be sure of receiving the same standard of product time and time again.

Regular shifts in QC results when a reagent batch is changed can be both costly and frustrating for many labs, resulting in a frequent need to reassign target values. Designed to be commutable, the Acusera range of Internal Quality Controls will react to the test system in a manner as close as possible to the patient sample helping you to meet ISO 15189:2012 requirements while ultimately ensuring accurate & reliable instrument performance. Furthermore our lyophilized controls contain no added preservatives or stabilisers ensuring a sample matrix that closely matches the patient sample.

ISO 15189:2012 states, “The laboratory shall use quality control materials that react to the examining system in a manner as close as possible to patient samples”.

All controls for use with immunoassay/immunology based methods are manufactured using only 100% human components demonstrating our commitment to quality and eliminating costly QC shifts when reagent batch is changed.

Working stability and product shelf life are important considerations for any lab when choosing which internal quality control material is best suited to their needs. Labs often spend up to one month validating new material, a process which can be minimised by opting for a control with an extended shelf life. At Randox our lyophilised controls have a shelf life of up to four years and our liquid controls a shelf life of up to two years from the date of manufacture ensuring continuity of lot supply and ultimately reducing the need for expensive new lot validation studies.

Each of our third party controls will have its own reconstituted or open vial stability, some of the analytes will have limitations, however we pride ourselves on not misleading customers with false claims. The extended open vial and reconstituted stabilities will help laboratories to minimise waste and reduce costs.

Randox is a leading provider of multi-analyte, third party controls designed to allow any lab to carry out highly accurate QC using fewer controls. In  an industry where budgets and resources are increasingly under pressure, highly consolidated controls will ensure high levels of throughput without compromising on accuracy. Uniquely comprising up to 100 analytes in a single control product, costs, preparation time and storage space are dramatically reduced without sacrificing on quality.

The presence of analytes at key decision levels in all Acusera controls will not only ensure accurate test system performance across the clinical range, but will further aid consolidation and maximise laboratory efficiency by eliminating the need to purchase additional high or low level controls, which are often expensive.

Available in multiple levels, the Acusera range of third party controls are designed to challenge laboratory instruments throughout the patient reportable range.  The presence of analytes  at clinically relevant decision levels not only helps to ensure accurate instrument performance but maximizes laboratory efficiency by eliminating the need to purchase additional low/high concentration controls at extra expense.

Randox also employs easy to use colour-coded packaging to help distinguish between different levels and reduce costly mix-ups.

ISO 15189:2012 states, “The laboratory should choose concentrations of control materials wherever possible, especially at or near clinical decision values, which ensure the validity of decisions made”.

Randox Acusera is a world leading manufacturer of true third party controls providing a cost effective, high quality solution for any lab – regardless of their size or budget. Designed to provide an unbiased, independent assessment of performance, our internal quality controls have not been manufactured in line with, or optimised for use with any particular reagent, method or instrument helping you to easily meet ISO 15189:2012 recommendations.

ISO 15189:2012 states that the “use of independent third party control material should be considered, either instead of, or in addition to, any control materials supplied by the reagent or instrument manufacturer.”

Read more about the benefits of third party controls here.

Traceability refers to the property of a measured result or calibrator value to be related or traced back to a reference measurement procedure or reference material through a series of measurements with known uncertainties.

The European parliament and council directive 98/79 EC require values assigned to both calibrators and control materials on in vitro diagnostic medical devices to be traceable to a recognised reference material or reference measurement procedure of higher order, e.g. SI units.

Guidelines have been set for diagnostic manufacturers to follow when assigning calibrator values and establishing traceability. These guidelines were set by the European standards EN/ISO 17511 and also EN/ISO 18153. The Randox traceability pathway has been established with reference to standards ISO 17511 and ISO 18153. The pathway has been followed to establish traceability for Randox calibrators allowing all patient results to be traced right back to the source.

With an extensive range of assayed/unassayed, liquid/lyophilised and single/multi-analyte controls, the Acusera portfolio has a solution to suit all laboratory preferences.

Custom Controls
Randox is a market leader in the manufacture of customised quality controls designed to meet the individual and unique requirements of even the most specialised laboratories.

Find out more about custom controls

Continue Reading

Acusera Third Party Controls

Download Third Party Benefits Brochure

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