Tackling Worldwide Drugs of Abuse
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
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:
- Freezing
- Primary Drying (Sublimation)
- 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
- 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
- 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
- Place the rubber stopper and lid firmly back onto the QC vial, and leave to stand for 30 minutes
- 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
- 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
- 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
- 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.
This Christmas, treat your laboratory to the “gift” of Randox Quality Control
At Christmas time all around the globe, people search for the best gift for their loved ones, something they will really like. At Randox Quality Control, we understand you care for your patients, and your laboratory. This year, show how much you care by treating your lab to a Randox Quality Control.
With over 35 years’ experience in the market, Quality Control is our passion and streamlining QC practice is our forte! Our extensive product offering comprises true third party controls, interlaboratory data management, external quality assessment and calibration verification.
Last year we looked in depth at Acusera – our range of true third party controls. This year, lets add another product to the Christmas wish list in the form of RIQAS, the world’s largest EQA scheme. Don’t wait until Christmas to wake up to a RIQAS programme under your tree – enrol in one of our comprehensive programmes today.
With over 45,000 laboratory participants across 133 countries, our RIQAS portfolio spans 32 comprehensive programmes ranging from Chemistry to Immunoassay, Lipids to Cardiac, Drugs to Serology and much more!
User-friendly, one page per parameter reports are available within 72 hours of the submission deadline. These reports enable at-a-glance performance assessment, ultimately allowing your laboratory to save valuable time. You will also gain access to complimentary multi-instrument and inter-laboratory reports as well as an end-of-cycle report summarising laboratory performance for each cycle and helping to identify progress over time.
Consolidation is key – and with an extensive parameter index available (up to 360 parameters) RIQAS will help you to significantly reduce costs, time and the number of individual programmes required to cover your test menu.
All RIQAS samples are free from interfering preservatives ensuring a commutable matrix that reacts to the test system in the same manner as a patient sample.
Additionally, enrolling in RIQAS isn’t just enrolling in an EQA scheme. Our programmes are accepted by National and International accreditation bodies worldwide and at the end of each cycle, participation in the scheme results in a certificate that can be used to decorate your laboratory all year around – not just at Christmas!
So this Christmas don’t give your laboratory second best, choose RIQAS, and reap the rewards.
To find out more on any of our RIQAS programmes visit our website – https://www.randox.com/riqas-external-quality-assessment/ or email us at acusera@randox.com
Randox Quality Control wish you all Season’s Greetings & a Prosperous New Year!
Mythbusting: ‘Using IQC and EQA From the Same Provider Leads to QC Bias’
Some laboratory professionals believe that using Internal Quality Control (IQC) and External Quality Assurance (EQA, also known as Proficiency Testing) material from the same provider can lead to increased levels of qc bias, or that their test system will not be appropriately challenged. It is important to address these concerns, because some labs may in fact be hindering their own performance by using IQC and EQA material from different sources.
It is important to first understand how IQC and EQA work together to help form a complete Laboratory Quality Management System.
IQC and EQA in Laboratory Quality Management
IQC is a means of monitoring test system precision on a daily basis. IQC effectively evaluates test system performance over time, so that any sudden or gradual shifts in performance can be detected. However, while IQC is an effective performance monitor, it cannot detect more intricate problems like calibration errors or wide acceptable limits provided by some QC manufacturers.
EQA is essential for challenging test system accuracy, and is carried out less frequently than IQC testing. EQA samples are tested ‘blind’ and the results are returned to the scheme organiser. As EQA testing compares an individual lab’s performance to other labs using the same method and instrument, it is a very effective tool for identification of potential issues.
Is there any disadvantage to using IQC and EQA material from the same provider?
The answer to this question depends primarily on the source material of the IQC and EQA. If an IQC provider manufactures their material using artificial additives or components of animal origin, then it will not be suitable to use EQA material from the same provider. Westgard (2011) maintains that using non-commutable IQC or EQA material can lead to results becoming compromised due to matrix effects – something which would not happen using commutable controls.
For example, with Immunoassay testing, non-human components of IQC material interact with antibodies in the reagent in a different way to fully human patient samples – ultimately giving unpredictable shifts, and not adhering to the ISO 15189 requirement to: “use quality control materials that react to the examining system in a manner as close as possible to patient samples”.
However, if the IQC and EQA material is manufactured using a source material which is similar in composition to patient samples (100% human), this commutable control will adequately mimic patient sample performance; meaning labs can use EQA and IQC material from the same provider with confidence that the integrity of their results is maintained.
Conclusion
ISO 15189 also states: “Use of independent third party control materials should be considered…”. In this instance, ‘Independent’ does not mean from a separate provider. It means that the QC material should not be optimized for use on one specific instrument (i.e. not dependent on a single instrument/method type).
No regulatory body states a requirement to use different providers for IQC and EQA material. Indeed, using IQC from one provider and EQA from another provider could increase the risk of labs using non-commutable material.
Labs should use commutable IQC and EQA material for a true assessment of their test system. Randox QC and RIQAS EQA are specifically designed with commutability in mind, giving labs a control which reflects patient sample performance and ensures excellent performance.
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References
Westgard, S. (2011). Is QC Quality Compromised?. Available: https://www.westgard.com/qc-quality-compromised.htm. Last accessed 31st October 2017.
