Give the Gift of Health this Christmas with Randox Health
Give the Gift of Health this Christmas with Randox Health
Showing you care comes in many different packages.
This year, you can give the ‘gift of health’ to someone you love, through a Randox Health Gift Card.
Randox Health has the most comprehensive health screening programmes in the world, as well as a wide range of specialised tests. The Everyman, Everywoman and Signature programmes carry out up to 350 tests. That means your results deliver a complete understanding of your health: your heart, kidneys, thyroid, fertility, bones and more. And it doesn’t just tell you how you are now, but helps you to manage your health for the future.
Each one of our programmes lasts for twelve months and include personalised health plans, a private consultation with an expert and repeat testing. This unique aspect enables you to see exactly what impact you’re making on your health as you follow our recommendations.
Specialised testing is also available on areas including cardiac health, coeliac autoimmune disease, hormonal health and genetic testing.
The programmes are available at our clinics in London, Holywood and Crumlin, and also through our innovative mobile health clinic. Gift cards can be purchased from as little as £20.
To find out more and purchase the most thoughtful of Christmas presents – a gift card for the ‘gift of health’ – click here.
To book a health screening at a Randox Health clinic in Crumlin, Holywood or London, please call 0800 2545 130.
For further information please contact the Randox PR Team by emailing randoxpr@randox.com or phoning 028 9442 2413
The Importance of External Quality Assessment in HIV Enzyme Immunoassay Testing
Introduction
Quality Control (QC) is vital for the clinical laboratory in order to ensure the accuracy and precision of patient test results. Without a robust QC strategy, test system errors could go undetected, potentially resulting in misdiagnosis and inappropriate/delayed patient treatment.
QC can be divided into two main components; Internal Quality Control (IQC) and External Quality Assessment (EQA).
What are IQC and EQA?
IQC is used in the daily monitoring of test system precision and reproducibility. IQC essentially compares the internal laboratory’s performance over time, highlighting any deviations from ‘normal’ performance. While IQC is a good method of testing performance, it is not always robust enough to detect calibration errors or issues associated with ‘wide’ acceptable limits.
In an External Quality Assessment (also known as Proficiency Testing, or PT) program the EQA provider will deliver ‘blind’ samples to all EQA participants. The use of such ‘blind’ samples ensures EQA can be used to measure a laboratory’s bias and accuracy. These samples are analysed by the lab and results are returned to the EQA provider for analysis. The data are examined, means and SDs are calculated, and any outliers are highlighted. Reports are then generated and delivered to each participant, giving a summary of performance in comparison to the rest of the participant group.
Why Should Laboratories Carry out EQA Testing?
The World Health Organisation (WHO) recommends that a robust QA program should be implemented in any lab which carries out HIV testing, and Internal and External quality control should be carried out on an ongoing basis1.
Participating in a rigorous and robust EQA scheme is a requirement of ISO 15189. All labs seeking ISO 15189 accreditation need to be part of an EQA scheme which appropriately challenges their test system.
The Cost of Poor Quality EQA
The most common method of HIV detection is to utilise Enzyme Immunoassay (EIA) antibody testing2. EIA tests are highly sensitive and can be optimised for automation, facilitating high-volume testing. However, with higher volumes of testing comes a higher probability of error. With EIA assays, the most common error encountered is false positive results2.
False positive results have a number of implications. Any screen-positive results must be verified using a confirmatory test; usually a Western Blot assay. The Western Blot is much more labour intensive and expensive than EIA tests, and is not efficient enough for high volume testing2. Therefore, if a laboratory is producing a higher than average number of false positive results due to poor quality assurance practices, they will ultimately spend significantly more time and money on confirmatory tests.
How can EQA Improve HIV Testing Accuracy?
The main use of EQA is to verify the accuracy of laboratory testing. Accuracy refers to the closeness of the obtained result to the ‘true’ value. As EQA is tested using ‘blind’ samples, operator bias is eliminated and the test system can be appropriately challenged.
EQA can also be used as a means of detecting deficiencies with IQC. For example, some IQC providers supply assayed IQC material with very wide acceptable limits, with 2SD often +/- 20% from target value. For this reason, labs may believe their performance is good, but when scrutinized by EQA with narrow acceptable limits, performance will be identified as substandard.
What to Look for in a Good EQA Scheme
Laboratories can join either Local, National or International EQA schemes. An International EQA scheme would provide the best return on investment due to the higher peer group size and more diverse demographic of participants. Some key factors which typify a good quality EQA scheme include:
- Accreditation to ISO 17043 – Being accredited to this standard ensures the EQA scheme is fit for purpose
- Frequent Distribution – Regular EQA analysis allows for rapid identification of errors and any necessary corrective actions can be taken as soon as possible
- Large Number of Participants – Ensures an extensive database of results for a range of analytical methods and instruments. In addition, larger participant groups increase statistical validity of results
- Clinically Relevant Ranges – Analytes should be present at both normal and abnormal ranges, as to ensure medical decision limits are adequately tested
- Comprehensive Reports – Much of the value of participating in an EQA scheme lies in the report generated by the provider. Reports should be comprehensive, providing a range of statistical metrics and charts
How can Randox Help?
The Randox International Quality Assessment Scheme (RIQAS) incorporates all the above features, as well as many others, into the world’s most comprehensive EQA scheme. With more than 45,000 participants worldwide, RIQAS offers unrivalled peer group comparison, and has earned its place as the most popular EQA scheme in the world.
Conclusion
An EQA scheme operates like an early warning system; it can alert the lab and document the need for, stimulate and monitor improvement. However, the improvements themselves must be implemented and maintained by the lab.
Investment in a good EQA scheme can save labs a substantial amount of time and money, so it is worthwhile to invest wisely.
To sign up for RIQAS or to learn more, sign up using the form below!
References
- World Health Organisation, Laboratory Methods For Diagnosis Of HIV Infection In Infants And Children. Geneva: World Health Organisation. 2010;5.
- Fearon M. The laboratory diagnosis of HIV infections. The Canadian Journal of Infectious Diseases & Medical Microbiology. 2005;16(1):26-30.
Drink and Drug Drive Limits UK and Ireland
As part of Randox Testing Services‘ ongoing efforts to raise awareness around issues related to drugs and alcohol we will be running a drink and drug drive campaign in the first two weeks of December. This campaign will detail the different drink and drug drive limits across the UK and Ireland and highlight how these limits differ from border to border.
Drink Drive Limits UK & Ireland
As can be seen in the table below, the drink drive limits across England, Wales and Northern Ireland are the same whereas Scotland has a lower limit. In December 2014 the limit was reduced in order to bring Scotland in line with most other European countries. The drink drive limit in the Republic of Ireland is the same as Scotland.
| General Public | |||
| Breath | Blood | Urine | |
| Ireland | 22µg | 50mg | 67mg |
| Scotland | 22µg | 50mg | 67mg |
| Rest of UK | 35µg | 80mg | 107mg |
*Value is volume of Alcohol per 100ml of Sample
The limits above apply to the general public, however across Ireland lower limits have been set for professional drivers:
| Professional Drivers | |||
| Breath | Blood | Urine | |
| Ireland | 9µg | 20mg | 27mg |
*Value is volume of Alcohol per 100ml of Sample
In the UK the Railways Transportation Safety Bill was passed introducing these lower limits for HGV drivers, pilots, train drivers etc. This bill is active in England, Wales and Northern Ireland. Ireland replicated the UK by introducing this in Ireland’s Road Traffic Act 2010. Scotland currently don’t have regulations in place so the drink drive limits are the same regardless of occupation.
Drug Drive Limits UK & Ireland
Section 5A Road Traffic Act was passed in the UK on 2nd March 2015 which requires only the presence of drugs above a specified limit can provoke criminal proceedings against a driver. Roadside swab tests are currently being utilised across England, Wales and the Republic of Ireland.
Roadside tests are used to detect the presence of four different types of drugs, the main two being cannabis and cocaine. The roadside tests only show a positive or negative reading that identifies traces of these drugs in the users system. If traces are shown, a blood sample is taken to identify the limit of the substance in a person.
If a roadside test doesn’t pick up traces of a substance an arrest can still be made if police have strong concerns that a driver may be under the influence of a substance they cannot detect at roadside. A blood sample is then taken for a more in-depth analysis to see if there are any drugs in the drivers system. The Scottish Government won’t have roadside testing put in place until 2019. It is still illegal to drive under the influence of drugs in Scotland and arrests can still be made.
Unlike alcohol, there are no separate drug drive limits for the general public and professional drivers:
| Drug Driving Limits | |||
| Cannabis | Cocaine | Heroin | |
| Ireland | 1µg | 10µg | 5µg |
| England and Wales | 2µg | 10µg | 5µg |
*Values are amount of substance per 1 litre of blood
The Scottish Government confirmed drug-driving limits and roadside testing will be introduced in Scotland in 2019. Currently in Scotland and Northern Ireland it is illegal to drive if impaired by drugs and when police suspect a motorist of drug-driving, they carry out a field impairment test.
This method is still used in the UK and Ireland for drivers under the influence of other drugs not picked up in a swab test. If the individual fails this they can be arrested and taken for a doctor’s examination to see if the person is impaired to the extent that they are unfit to drive. Then a blood sample is taken to prove if these drugs are in their system.
For more information on these limits follow us on Twitter @RandoxTesting to avail of the information and resources we will be sharing over the first 2 weeks in December.
You can also access our download wall which includes a range of educational posters, brochures and resources by visiting http://www.randoxtestingservices.com/downloads/
About Randox Testing Services
At Randox Testing Services we offer complete drug and alcohol testing solutions to a wide range of industries across the globe. We work with companies to help create and implement effective workplace testing policies that suit their needs and budget.
To support our customers our additional services include training and education courses as well as policy reviews and consultancy. Our experts are at hand to discuss any testing requirements you may have. To get in touch email testingservices@randox.com today.
The Evidence Evolution: The world’s most advanced immunoassay analyser
What sets the Evidence Series apart from its competitors is its flexibility across the range of immunoassay analysers. No other range of analysers has the capability in terms of throughput in comparison to the Evidence Series. With this established, we are delighted to introduce the latest in the Evidence Series range, the Evidence Evolution.
Join the Evolution
We believe that the Evidence Evolution is the world’s most advanced immunoassay analyser. The Evidence Evolution is the most versatile analyser Randox has ever produced. By utilising the same multiplex technology as the other Evidence Series analysers, the Evidence Evolution can process up to 44 results from a single sample, with a maximum throughput of up to 2640 tests per hour. With such a high volume of potential throughput, you may think that reporting time will be compromised, that is simply not the case. The Evidence Evolution can produce the first set of results in less than 36 minutes, with one sample of up to 44 results reported every minute after. The speed of reporting time distinguishes the Evidence Evolution from its competitors, and allows the analyser to further display its capabilities.
Innovation
By utilising patented Biochip Array Technology, the Evidence Evolution offers batch analysis, true random access and STAT testing capabilities. These, combined with retrospective testing, allows the user to build a more in-depth patient profile.
With such swift reporting times, the Evidence Evolution can boast of a true walkaway time of 2 hours, in a laboratory setting, this can be vital. With multiple daily tasks to be completed, time is of the essence, and the Evidence Evolution has been designed to lessen the workload of laboratory staff. By being able to offer a combination of continuous sample and reagent loading, plus automated on-board sample dilution, the Evidence Evolution will have a positive impact in busy laboratories.
Complete Picture
A fast reporting time and high throughput capabilities is just the tip of what the Evidence Evolution can offer. The analyser has the capability to test across multiple matrices, allowing for more flexibility in sampling. It also comes equipped with state of the art intuitive software and advanced precision bio-drive robotics, meaning the Evidence Evolution is an analyser that has been designed and developed to meet the needs of a modern, high throughput laboratory, by a company that has a deep understanding of laboratory needs.
About the Randox Evidence Series
The Evidence Series is set to revolutionise diagnostic testing forever. Offering unrivalled capabilities across all analysers, we truly believe that the Evidence Series range of immunoassay analysers can meet your diagnostic testing capabilities.
For more information on the Evidence Evolution, or any of the Evidence Series analysers, please visit http://www.randox.com/evidence-series/ or contact us evidenceseries@randox.com.
Diagnosing diabetes with the RX series
Diabetes is a lifelong condition that causes a person’s blood sugar level to become too high.
If you have diabetes, your body is unable to break down glucose into energy. This is because there’s either not enough insulin to move the glucose, or the insulin produced doesn’t work properly [1] which can lead to serious health complications.
The RX series range of analysers have one of the largest test menus available on the market which includes an extensive diabetes testing panel. Tests within the RX series diabetes panel allow for Diagnosis, Monitoring and Risk Assessment of Diabetes.
Adiponectin
An adiponectin test system is a device intended for the quantitative in vitro determination of adiponectin concentration in human serum or plasma.
Adiponectin is a protein hormone, produced and secreted by fat cells (adipocytes), which is normally found in reasonably high concentrations within the blood. Adiponectin regulates the metabolism of lipids and glucose and influences the body’s response to insulin and inflammation.
Adiponectin levels are inversely correlated with abdominal visceral fat (AVF) levels, which have proven to be a strong predictor of several pathologies including metabolic syndrome, type 2 diabetes mellitus (T2DM), cancers and cardiovascular disease (CVD). It is widely recognised that people who are overweight are at a higher risk of developing T2DM, however measure waist circumference and Body Mass Index (BMI) are not enough. As such adiponectin levels are a much more reliable indicator of at-risk patients.
A number of key publications have advocated the testing of adiponectin in clinical settings and concluded that higher adiponectin levels are associated with a lower risk of T2DM across diverse populations.[2]
Fructosamine
A fructosamine test system is a device intended for the quantitative in vitro determination of glycated protein (fructosamine) concentration in human serum or plasma.
Fructosamine is a mid-term indicator of diabetic control as it can provide information on a person’s averge blood glucose levels over the preceding 14-21 days.
Due to the shorter time span of fructosamine, it is often used to evaluate the effectiveness of medication changes and to monitor the treatment of gestational diabetes.
HbA1c
A Haemoglobin A1c test system is a device intended for the quantitative in vitro determination of Haemoglobin A1c concentration in whole blood.
In a diabetic patient, where blood glucose levels are abnormally elevated, the level of HbA1c also increases proportionally to the level of glucose in the blood and has been widely accepted as an indicator of the mean daily blood glucose concentration over the preceding 6-8 weeks. It is therefore, a long term indicator of diabetic control.
Diagnosing diabetes with the RX series
The RX series range of clinical chemistry analysers have many benefits when testing patients for diabetes. With analysers ranging from the RX misano semi-automated analyser to the RX modena which can perform up to 1200 tests per hour the RX series analysers offer a suitable platform for your laboratory, ensuring results are received in a time efficient manner. Windows based software and easily recognisable icons ensure that the RX series analysers are easy to use and allows for an enhanced laboratory productivity. Laboratory cost savings can also be achieved with a low water consumption available on each RX series analyser.
Other RX series analyser features include:
Diabetes Test Menu:
Consolidate your testing with a comprehensive diabetes testing panel available on the RX series analysers. A large number of tests can be carried out on one platform, including direct HbA1c testing, providing consolidation opportunities and real cost savings.
Accurate Testing:
High quality results are achieved first time, every time. This saves operator time and avoids unnecessary additional costs of repeat testing and reduces the possibility of patient misdiagnosis.
Unrivalled performance:
Built in inventory management system automatically calculates remaining reagent volume and the number of tests available. Superior performance means minimal downtime and swift reporting of results.
If you would like more information in relation to the RX series testing capabilities please contact us by emailing: theRXseries@randox.com
Westgard’s Great Global QC Survey 2017
In a QC survey conducted this year, Sten Westgard reached out to more than 45,000 laboratory professionals to gain a comprehensive view of the world’s Quality Control practices. It was one of the largest surveys that have been conducted and shared publicly.
Read on as we take a summarised look at our favourite bits.
Setting control Limits
Most labs are using their actual performance to set their mean and SD, however, a large percentage of labs still use manufacturer’s ranges, peer group ranges, and other non-individual sources for SD. These ranges can typically be set wider than they would if the ranges were based on their actual mean and SD. This can result in labs releasing incorrect patient results.
Laboratories were asked if they used 2 SD control limits on all tests and it was found that a majority use 2 SD. The strict use of 2 SD can generate a high level of false rejections (9% for two controls and higher for three). This causes a high level of out-of-control events; the use of QC multi-rules is recommended.
The types of Controls used by labs
More than 60% of labs were found to be using manufacturer controls, the drawbacks of which are well known. The latest ISO standards strongly encourage the use of independent / third-party controls. Westgard speculates that this will become a mandatory requirement in the next version of ISO 15189.
Frequency of QC
The first question about frequency asked how often labs ran QC during a run. Respondents reported how often they schedule QC in their labs. Around half only run QC at the beginning of a run with labs running it throughout the day coming in close second. A small proportion of labs reported running QC at both the beginning and the end of a run.
The final, least popular option involves spacing out QC based on test volume, the most scientific method determining how many patient samples can be run between controls without raising the risk of unacceptable results.
The next question asked about the overall frequency of QC. Most labs are meeting the once-a-day minimum standard for CLIA regulations.
“QC frequency remains primarily based on the rotational speed of the earth, not driven by needs of the clinician and patient.” – Sten Westgard
QC Frequency Influences
Regulator and accreditation requirements lead the way in influencing the frequency of QC with manufacturer recommendations, and professional judgement following close behind. Only a quarter of labs use the volume of testing to guide their QC frequency and one in six look to EP23 or IQCP for guidance.
Managing QC
Most labs are using on-board instrument informatics to support their QC charting, followed by LIS charting programs, and peer group software.
Of significance is the number of labs using Excel spreadsheets as their primary QC tool as well as standalone QC programs or even manual graph paper. This could be due to varying technological capabilities where some locations may not have access to, or the funds to afford, informatics.
A combined third of labs are out-of-control every day. In some labs this could be the result of running such a high volume of controls that false rejections are inevitable. However, rationalising in this way can lead to ‘alert fatigue’, where users begin to ignore alert flags and stop troubleshooting.
More than a quarter of labs have an out-of-control flag every few days while another roughly one in six have just one per week. A small number of labs report having few QC flags.
Managing QC Costs
Finally, laboratories were asked about the steps they take to manage QC costs. 60% claimed that they take no steps to manage costs. One in six reduced QC frequency, one in eight switched to cheaper controls, while, worryingly, almost one in ten changed their QC rules or widened limits.
Conclusion
Westgard’s Global QC Survey suggests there exists many inefficient implementations of Quality Control, with plenty of room for improvement. The current state of QC is, like many aspects of healthcare, unsustainable. Labs must adopt better approaches or risk their continuing feasibility, or worse, their patient’s results.
How Randox Can Help
Westgard highlights particular issues with labs mismanaging costs, still using manufacturer controls, and setting control limits – this is where Randox comes in.
Acusera Third Party Controls offer the highest quality solution for any lab – regardless of 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 recommendations. Unrivaled consolidation allows for significant cost savings.
Acusera 24•7 Live Online allows you to automatically apply multi-rules and generate charts to help with setting accurate control limits, helping you get your quality control under control.
Reference: Westgard, S (2017), The 2017 Great Global QC Survey Results
To learn more about how Randox Quality Control can help you improve your QC visit the pages below or fill out the contact form and someone will be in touch.
The Risk of Gestational Diabetes to Women ā World Diabetes Day
Every year, Randox Reagents support World Diabetes Day on the 14th November. This year, the theme is ‘Women and diabetes – our right to a healthy future’ with the International Diabetes Federation running a campaign aiming to provide all women with diabetes with affordable and equitable access to care and education to better manage their diabetes and improve their health outcomes. A type of diabetes that affects women is gestational diabetes.
Gestational diabetes – what is it?
Gestational Diabetes Mellitus (GDM) is a form of diabetes which appears in pregnancy, characterised by high blood sugar due to the hormones produced in pregnancy, usually developing in the second or third trimester and disappearing after giving birth. This is a serious condition which can lead to the baby growing larger than usual and can coincide with premature birth, stillbirth and pre-eclampsia, which are detrimental to a mother’s health.
According to the International Diabetes Federation, 1 in 7 births is affected by gestational diabetes. In addition, approximately half of women with a history of GDM go on to develop type 2 diabetes within five to ten years after delivery.
Diagnosis and Monitoring of Gestational Diabetes
Due to the severe complications that can occur with gestational diabetes, it is extremely important to accurately diagnose and monitor the condition. Tests which are commonly used to diagnose diabetes include HbA1c and glucose, including fructosamine, which due to the shorter time span, is particularly useful to evaluate the effectiveness of medication changes and to monitor the treatment of gestational diabetes.
Complications associated with gestational diabetes include diabetic ketoacidosis, a serious complication of diabetes which occurs when blood sugar levels are consistently high and insulin levels are severely low, making it essential to measure D-3-Hydroxybutyrate levels. This is a niche test which is available from Randox Reagents – find out more here.
Preventing Gestational Diabetes
As well as diagnosing and monitoring gestational diabetes, it is important that women get tested early in order to put in place measures to help avoid developing diabetes, improving quality of life for themselves and their baby. Ways in which they can do this is through adopting a healthier lifestyle in terms of monitoring diet and getting regular exercise.
Randox offer an automated adiponectin test which predicts the risk of patients developing both gestational and Type 2 Diabetes Mellitus (T2DM). Therefore, it is important to measure adiponectin before pregnancy as low concentrations are associated with reduced glucose tolerance during pregnancy and can identify women at high risk for gestational diabetes.1
Innovations in diabetes testing has led to the ability to more accurately detect risk, diagnose and manage the complications of diabetes. Randox offer a wide range of diabetes reagents in an automated biochemistry format, allowing rapid and accurate assessment for both laboratory professionals and clinicians.
Join Randox Reagents on World Diabetes Day 2017 to help spread awareness and prevent gestational diabetes in women by providing them with access to education and improve their health outcomes!
Randox are dedicated to providing the highest quality tests for diabetes diagnosis, complications monitoring and risk assessment – download our diabetes brochure to find out more about what we have to offer!
For more information, please contact us at reagents@randox.com
Sharing our preventive health message this World Diabetes Day
One of the fastest growing health threats of our times is diabetes. Type-2 diabetes is now among the most common long-term health conditions affecting people right across the globe. On World Diabetes Day we want to raise awareness of this particular condition – because it’s possible to spot warning signs and take steps to prevent it.
THE BACKGROUND
Since 1996, the number of people living with diabetes has more than doubled and type-2 diabetes is by far its most prevalent form. Though it is potentially reversible, using more advanced diagnostics, clinicians can diagnose pre-diabetes and enable patients to make lifestyle changes to avoid the condition from developing in the first place.
THE FUTURE
Adiponectin is a biomarker which can powerfully predict the development of pathologies such as Type 2 Diabetes Mellitus (T2DM) and cardiovascular disease (CVD). This biomarker can be tested as an automated biochemistry reagent from Randox.
With the global prevalence of diabetes continually rising in adults over 18 years of age, from 4.7% in 1980 to 8.5% in 2014, adiponectin should be an integral part of every laboratory’s testing panel. Randox Adiponectin will enable physicians and clinicians to accurately evaluate more individuals, with a convenient format for routine clinical use.
When risk is identified via adiponectin measurement, it is essential for individuals to carry out lifestyle modification to lower T2DM risk. This will also help to prevent the development of cardiovascular diseases and metabolic syndrome. This indicates that Randox automated adiponectin should be a routinely run test across the world.
OUR CASE STUDY – SIR AP MCCOY
Earlier this year Sir AP McCoy came to Randox Health. After a career dedicated to becoming the world’s most successful jockey, he was never going to leave the next stage of his life to chance. It was lucky he did: our advanced test for adiponectin was within the panel of tests run and was able to identify that AP was pre-diabetic.
Don’t leave your health to chance. 70% of cases of type-2 diabetes are preventable by adopting a number of lifestyle changes, so take action today.
For further information phone the Randox PR Team on 028 9442 2413, or email randoxpr@randox.com
From Columbia to the UK: The trail that’s fuelling the worldwide cocaine epidemic
With the demand for cocaine in the UK rocketing, Top British Chef Gordon Ramsay has recently travelled to Columbia to the source of the problem, to learn more about this growing epidemic.
Having spent time with local farmers who own cocaine plants that resemble vineyards, and visiting Honduras, one of the most dangerous countries and known as the world’s warehouse of cocaine, he emphasized the urgent need to combat the drugs industry that is consuming this country.
Highlighted throughout the two-part series was the amount of cocaine that is being trafficked to the shores of the UK each year. Speaking with the metropolitan police who tackle up to 200 drug gangs in London alone, it was estimated that up to 300 tons of cocaine, with a street value of £10 billion, is being brought in to the country through a web of secretive routes used by drug traffickers.
Gordon commented that not only is cocaine a growing global problem, but it is one that is prevalent within the culinary world, including his own restaurants where he has been asked to dust the drug on top of soufflés as icing sugar, and found traces of this deadly drug in both his staff and customer toilets.
With the cocaine problem showing no signs of slowing down, Randox Toxicology are constantly working to develop the newest drug tests to meet the demands of the ever-growing drug market. The Evidence MultiSTAT was developed for use in non-laboratory settings such as workplaces, police stations and low throughput laboratories and to provide highly accurate qualitative as quickly as possible.
This revolutionary analyser enables on-site simultaneous detection of up to 21 classical, prescription and synthetic drugs from a single patient sample, reducing the burden on current systems, the risk of adulteration and helping the fight against the cartels who control the cocaine trade in South America.
For more information on our Evidence Analysers or any of our drug panels email info@randoxtoxicology.com
Diabetes ā World Diabetes Day (14th Nov 2017)
World Diabetes Day
With World Diabetes Day on Tuesday 14th November 2017, we take a look at what diabetes is and why quality control is so important.
What is Diabetes?
Diabetes is a life-long condition which occurs when the glucose level in the blood is too high because it can’t enter the body’s cells to be used as fuel. There are two types of diabetes: type 1 and type 2. They are distinct conditions and must be treated and managed differently.
Type 1 Diabetes
Type one diabetes is an autoimmune condition in which the body attacks insulin-producing cells, this causes a lack of insulin, leading to an increased blood glucose level. Around 10% of people with diabetes has type 1.
Type 2 Diabetes
A mixture of genetic and environmental factors causes type 2 diabetes. The body doesn’t make enough insulin or the insulin it does create does not work correctly, leading to a glucose build up in the blood. It’s thought that up to 58% of type 2 diabetes can be prevented or delayed through healthy lifestyle choices.
Role of Quality Control
Quality control plays a crucial role in ensuring accurate and reliable diabetes monitoring. 70% of medical decisions are based on a laboratory test result and QC is vital in ensuring the results the laboratory report are both accurate and reliable.
Want to know what makes a good HbA1c control? Read on to find out.
Clinically Relevant Levels
In the diagnosis of diabetes, glycated haemoglobin (HbA1c) in blood provides an indication of average blood glucose levels in the previous three months. HbA1c is the recommended standard of care for type 2 diabetes monitoring. HbA1c is measured using the range below:
HbA1c – Clinically Relevant Levels
| HbA1c | mmol/mol | % |
|---|---|---|
| Normal | Below 42 mmol/mol | Below 6.0% |
| Prediabetes | 42 to 47 mmol/mol | 6.0% to 6.4% |
| Diabetes | 48 mmol/mol or over | 6.5% or over |
It is important to assess the full clinical range of an assay, i.e. the range between the lowest and highest results which can be reliably reported. 48 mmol/mol is the cut-off for diabetes diagnosis, it is crucial that this can be measured accurately because any inaccuracy could mean the difference between being diagnosed and treated and not.
In terms of accreditation, 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’.
Benefits of Third Party Controls
The importance of third party controls is evident. Third party controls can help identify instrument, reagent, and procedural errors. Unchecked these errors could lead to incorrect patient results, further leading to misdiagnosis.
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.
Again, in terms of accreditation, ISO 15189 states – “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.”
Many laboratories perform HbA1c testing on a dedicated machine and as a result, are not always using a third party control.
Controlling Waste
Wastage is a common issue when running HbA1c due to the pre-treatment step required for many HbA1c controls and poor stability of some controls on the market. Look out for controls with an extended open vial stability to help reduce waste and keep costs low.
How can Randox help?
To help you get your QC in check for World Diabetes Day, Randox Acusera HbA1c control contains both HbA1c and Total Haemoglobin, with a reconstituted stability of 4 weeks to reduce waste and reduce costs. To find out more about our HbA1c control visit the page using the button below or fill out the form above.
References
Diabetes: The basics. (2017). Diabetes UK. Retrieved 3 November 2017, from https://www.diabetes.org.uk/diabetes-the-basics
Khan, H et al. (2016). Significance of HbA1c Test in Diagnosis and Prognosis of Diabetic Patients. Biomarker Insights, 95. http://dx.doi.org/10.4137/bmi.s38440