Mythbusting: Frequency of EQA Reports
Mythbusting: Frequency of EQA Reports
External Quality Assessment (EQA) is a vital aspect of laboratory testing and is often a regulatory requirement. The primary function of EQA is to provide the laboratory with an indication of test system accuracy through interlaboratory comparison. Ultimately participation in an EQA programme will give the laboratory greater confidence in the accuracy and reliability of the results they release.
When choosing an EQA scheme there are a variety of different options. It is important that laboratories weigh up the pros and cons of each option in order to choose the scheme that best suits their needs.
Many EQA schemes promote the distribution of multiple EQA samples per challenge or testing event as a benefit to the laboratory. By analysing multiple samples at each testing event, laboratories believe they are challenging their test system across a wider range of concentrations than would be possible if they were to analyse just one sample. However, this is not always the case as in many instances the levels can be very similar. Another consideration is the EQA report received by the laboratory. EQA reports are used to assess analytical performance and identify any test system failures, such reports can take more than one month to receive. In such instances it would be more beneficial if the laboratory tested just one sample at each bi-weekly/monthly challenge and received their report faster.
Report frequency should be priority for any laboratory when choosing an EQA scheme. A fast turnaround time will allow any test system errors to be identified sooner and necessary corrective actions to be taken immediately with minimum disruption to the lab. Perhaps the most important benefits of a rapid report turnaround is cost and time savings as it will significantly reduce the time and money spent re-running patient samples.
If the time between sending EQA results back to the organizer and receiving an EQA report is too long, it becomes more difficult to pin-point exactly when an error was encountered thus increasing the possibility of incorrect test results and possible misdiagnosis. While this would be considered the worst-case scenario, it is still a possibility.
Choosing an EQA provider that delivers both frequent analysis and a quick report turnaround will give the laboratories the confidence they need to report patient test results.
With the Randox International Quality Assessment Scheme (RIQAS), comprehensive reports are available within 72-hours of the submission deadline. Furthermore both bi-weekly and monthly analysis options are available.
To find out more on RIQAS and our extensive product portfolio, comprising 32 programmes, visit our page – http://www.randox.com/riqas-external-quality-assessment/ or alternatively contact us using the button provided.
The Importance of a Workplace Substance Misuse Policy
What is a workplace substance misuse policy?
Many organisations implement a policy that outlines the expectations they have concerning the misuse of drugs and/or alcohol and how this can affect performance and safety in the workplace. This can often be referred to as a substance misuse policy.
Employers hold the responsibility to ensure employees are fully aware of the company’s rules, regulations, testing and disciplinary procedures. Fundamentally, this is to guarantee complete workplace safety. The policy itself holds a vital importance providing employees with the knowledge of the standards expected of them in the workplace.
To ensure transparency of information, it is imperative that the policy is written in a clear, comprehensive manner. This should allow them to understand without confusion or misinterpretation the implications the organisation has in place for users who misuse substances.
Why is this policy so important for businesses to implement?
Alcohol and / or drug use increases the chances of problems occurring in the workplace. For example, studies have found that employees with alcohol problems are 2.7 times more likely to have an accident whilst at work.
Some of the main issues that associated with substance misuse in the workplace are:
- Absenteeism – It’s estimated that there are 17 million lost days of work per year due to substance misuse.
- Low productivity levels – Employees may lose focus in different tasks and become de-motivated.
- Inappropriate behaviour – Some cases of substance abuse may lead to inappropriate actions or in extreme cases crime
Evidence suggests that many people who suffer from alcohol and drug abuse are in employment. Studies show that 25% of registered drug addicts are in full-time employment and that 3.3% of all adults in England and Wales aged 16 – 59 classified as frequent users.
Significant issues such as these provide growing concerns for employers to put in place a workplace substance misuse policy to guarantee the welfare of all stakeholders. Under the Health & Safety Act 1974, employers have a duty to ensure the safety of their employees is met to all principles. Introducing an effective workplace policy is a key part in maintaining these standards.
The importance of a workplace policy for drugs and alcohol can benefit employers by:
- Building relationships with employees by showing them there is support available.
- Policies can raise awareness of issues in the business and can encourage staff members to take action if they feel they have a problem.
- Its importance can reduce the number of sick employees, it can also increase staff turnover & productivity levels.
- Employers who implement a workplace policy can also see a rise in efficiency, improved staff relationship, communication and improved corporate image and in some cases customer relations.
What we at Randox Testing Services can do:
Randox Testing Services is a market leader in the drug and alcohol testing industry. Our expertise is relied upon by safety-critical companies all over the world. We provide complete drug and alcohol testing solutions to a range of blue chip companies across multiple industries including aviation, transport, construction, maritime, retail and occupational health to name a few.
Our expert consultancy service allows employers to create an effective drug and alcohol misuse policy. We offer comprehensive advice, guidance and support in composing an effective policy and explaining best procedures and testing methods to use. We also provide assistance to employers with an existing substance misuse policy, helping to modify existing documents to ensure they are legally viable and can withstand challenge in court.
To ensure clear communication of any policy changes, our experts can come to your workplace and present the policy to your staff. By having a third party explain the policy employers can ensure all the benefits are communicated effectively. This way staff do not feel like they are being victimised or persecuted, but know their employer is looking after their workplace wellbeing.
Combining our consultancy service with our drug and alcohol testing service and / or point of care products, employers can find a complete testing solution from Randox Testing Services.
For more information on our products and services call +44 (0) 28 9445 1011, email, testingservices@randox.com or visit our website www.randoxtestingservices.com
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 Global Burden of Obesity
Obesity is a condition where a person has abnormal or excessive fat accumulation that presents a serious risk to health. This December, Randox are highlighting the health implications of this potentially deadly condition, especially throughout the midst of this festive season when it is all too easy to overindulge in fatty foods and sugary treats!
Worldwide obesity has almost tripled between 1975 and 2016, with over 650 million adults and 340 million children being recorded as obese in 2016 alone, highlighting that the prevalence of the condition is rapidly rising. Randox are dedicated to improving health and increasing the awareness and prevention of obesity and its consequences.
What are the causes and consequences of obesity?
With more people around the world adopting sedentary lifestyles and the increasing consumption of foods high in sugar and fat, there is a higher risk of an energy imbalance between calories consumed and calories expended, which is the fundamental cause of obesity. This increases the risk of a number of diseases such as cardiovascular disease, diabetes, musculoskeletal disease and some forms of cancer, with each condition having detrimental effects to your health.
One of the more serious consequences of obesity is type 2 diabetes mellitus (T2DM), where a resistance to insulin is developed causing blood sugar to rise higher than normal. This can lead to serious, long-term problems such as kidney damage, cardiovascular disease and blindness.
How are Randox supporting the battle against the world’s obesity crisis?
Through extensive investment in R&D, we are able to offer cutting-edge diagnostic tests to assess the risk of obesity-related diseases before they occur!
Randox offers the unique adiponectin test to assess the risk of developing T2DM. Low adiponectin levels have also been linked with the risk of developing other pathologies including metabolic syndrome and cardiovascular diseases. The adiponectin test is applicable to both patients with diagnosed clinical obesity, and those deemed to have a ‘healthy’ BMI through a condition known as ‘abdominal obesity’.
This is because while it is widely recognised that people who are overweight or obese are at higher risk of developing T2DM, you don’t have to be overweight to be at risk of developing diabetes. When abdominal visceral fat is stored further underneath the skin and accumulates around major organs, a condition known as abdominal obesity, it greatly increases the risk of developing T2DM. When abdominal visceral fat levels become increased, adipocytes which secrete the protein hormone adiponectin become reduced; this reduces the anti-inflammatory and insulin-sensitising properties of this powerful hormone.
The adiponectin test is available for use on hundreds of clinical biochemistry analysers, and can also be run on our world leading RX series range of clinical chemistry analysers. Find out more here: www.randox.com/obesity/
Our world-renowned quality control products help ensure the accuracy of obesity-related testing!
When diagnosing and monitoring obesity-related complications such as cardiovascular disease (CVD) and T2DM, it is vital that laboratories have a robust quality control system in place to ensure the accuracy and reliability of the results produced. This is especially true considering, 70% of medical decisions are based on a laboratory test result.
It is estimated that over 90% of T2DM is related to obesity. When monitoring diabetes, glycated haemoglobin (HbA1c) levels in the blood provide an indication of average blood glucose levels for the previous 3 months. It is therefore important that the chosen quality control will effectively challenge the test system across the patient reportable range, as an inaccurate result at the cut-off could mean a patient does not receive appropriate diabetes treatment. Our Acusera Liquid HbA1c control provides clinically relevant levels, not only helping to ensure accurate instrument performance but maximising laboratory efficiency. Find out more here: www.randox.com/obesity/
Obesity prevention
Thankfully, for those deemed to be at risk, obesity and related illnesses are largely preventable through engaging in regular physical activity (60 minutes daily recommended for adults), limiting energy intake from total fats and sugars and increasing the consumption of fruit and veg, whole grains and nuts. Knowing your risk allows you to stay in control of your health throughout this festive season!
Further to our clinical lab tests, our Randox Health clinics offer heart health, metabolic health and diabetes health testing as part of our Everyman, Everywoman and Signature packages to identify and assess risk of developing obesity-related diseases. Our clinics utilise the same cutting-edge tests and quality control that we have available to clinical laboratories globally, as well as our patented Biochip Array Technology (BAT).
For more information about our clinical diagnostic range of obesity-related products, visit www.randox.com/obesity/
Mythbusting: āUsing 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.
How can we help?
To learn how Randox can offer a complete solution for your laboratory, follow the links below or submit a question using the form above.
References
Westgard, S. (2011). Is QC Quality Compromised?. Available: https://www.westgard.com/qc-quality-compromised.htm. Last accessed 31st October 2017.
Got a question?
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.