NHS cancer testing service at ‘tipping point’
NHS cancer testing service at ‘tipping point’
A stark warning has been issued this week by Cancer Research UK (CRUK) that NHS cancer testing services are at tipping point, caused by increased demand and a lack of capacity.
Tackling this is essential, according to pathology expert Professor Manual Salto-Tellez, “We need to act now before this situation gets worse. It’s vital that patients are diagnosed at an early stage when treatment is more likely to be successful.”
CRUK says the UK’s cancer survival falls behind that of other European countries and is urging an improvement in early diagnosis through diagnostic services. The importance of this is emphasised by estimates from the charity that cancer diagnoses in the UK will rise from 352,000 (2013) to 500,000 (2035).
According to the report:
- One in two people will develop cancer at some point in their lifetime
- Well-resourced testing services are crucial to early diagnosis of cancer which in turn is vital to increase survival rates
- Up to 70% of clinical decisions are based on diagnostic testing
- Pathology numbers are not growing to meet rising demand for tests
Emma Greenwood, Cancer Research UK’s director of policy, said;
“Diagnostic services, including pathology, urgently need support and investment to ensure that diagnoses aren’t delayed and patients benefit from the latest treatment. The diagnostic bottleneck will only get worse without action now and this involves addressing staff shortages in imaging, endoscopy and pathology.”
A Department of Health spokesperson said, “Early and fast diagnosis is crucial in improving patient outcomes and experience. Getting pathology test results to patients quickly is a key part of this. That’s why we have invested over £2.5bn on efficient and robust pathology services across the NHS.”
Following the publication of the report Dr Martin Crockard, Head of Molecular R&D at Randox, said;
“As populations continue to age, illnesses like cancer, stroke, diabetes and cardiovascular disease will become more common. We know this is going to have a huge impact on healthcare systems but what is yet to be determined is how they will respond.
“Currently 70% of clinical decisions are using in-vitro diagnostics and that will likely increase – therefore it’s essential that pathology services are fully supported. Better diagnostics enables clinicians to make evidence-based decisions, which delivers improved patient outcomes.”
For more information regarding our preventive health philosophy please contact our PR team via email: randoxpr@randox.com
World Antibiotic Awareness Week at Randox
The global crisis of antimicrobial resistance is never far from the headlines. As part of World Amicrobial Awareness Week, we’ve been discussing the dangers and importantly the work being done to combat this growing threat.
There’s a very simple reason why we must all do what we can to tackle AMR. This year it’s thought 700,000 people died from drug resistant illnesses such as bacterial infections, malaria, HIV/Aids or tuberculosis. Experts warn that by 2050, this figure will rise to 10million.
Randox’s aim is to revolutionise global healthcare and we are committed to combating the threat of antibiotic resistance. We have a number of tests on the market that can help the fight against AMR, strengthen consumer confidence and ensure quality and safety for a number of different industries. So to round off this week, we spoke to two of our experts at Randox: Business Development Manager, Dr Mary Jo Kurth, and Molecular Diagnostics Manager, Dr Martin Crockard.
70% GP’s have been reported to prescribe antibiotics when they don’t know whether the infection is caused by the virus or bacteria.
At the frontline of the battle to curb AMR are the GPs but they’re not able to access the latest technology which can help them. Dr Mary Jo Kurth said, “In the current GP setting, diagnostic testing to determine whether a respiratory infection is bacterial or viral is unavailable, and therefore doctors often have to guess – or feel pressurised into prescribing antibiotics because patients demand it. However antibiotics only work to treat bacterial infections and are useless in treating infections that are caused by viruses.
“The consequences are severe. Medical procedures like organ transplantation and cancer chemotherapy need antibiotics to prevent and treat the bacterial infections that can be caused by the treatment. Without effective antibiotics, even routine operations could become high risk procedures if serious infections can’t be treated. The hard won victories against infectious diseases of the last fifty years will be jeopardized.”
Our Biosciences division have developed a test that can rapidly detect and identify the cause of 22 respiratory infections, in both the upper and lower respiratory tract, and therefore subsequently determine if an antibiotic is required as well as then identify the most effective antibiotic to take. Additionally our Confidante kit – the world’s first over-the-counter home sexual health test – can detect ten of the most common STIs with one patient sample and deliver accurate and reliable results securely and discreetly within one week. This takes the guesswork out of antibiotic prescription and could go a long way in fighting the antibiotic resistance crisis.
Dr Martin Crockard said, “Identifying the specific cause of illnesses provides opportunities to tailor treatment, reducing antibiotic misuse. Not all infections respond to antibiotics, however a multiplex approach which identifies bacterial, viral or fungal pathogens encourages improved clinical decision-making, refining treatment, leading to enhanced patient care.
“The molecular group here at Randox are developing a range of multiplex infection detection arrays to identify specific infection agents, allowing more appropriate use of antibiotics to improve patient care and reduce the onset of antibiotic resistance.”
In addition to tackling AMR via medical settings, there is work that can be done to deal with it in our food. Randox Food Diagnostics offer a comprehensive range of diagnostic solutions to allow for the detection and quantification of antibiotic residues within animal and food products. With validation across a range of matrices Randox Food allows producers to ensure their products are free from antibiotic residues.
As consumer awareness develops so does the need for antibiotic screening within agriculture and food production. Guaranteeing an antibiotic-free product strengthens consumer confidence and ensures food integrity on a global scale. Randox Food offers the Evidence Investigator matched with biochip array technology to provide the end user with fast, reliable results to ensure antibiotic free produce.
The UK Government recently commissioned a two year review into the crisis. Led by Lord Jim O’Neill, the final report outlined a new system of ‘market entry rewards’ worth $1.6 billion to the successful developer of a new antibiotic, which meets a prospectively-defined criteria of ‘unmet need’. Developers of alternative therapies aimed at tackling areas where there is unmet need due to rising AMR would also be eligible for these rewards. Such rewards would be paid after a successful product comes to market.
Chief Medical Officer, Dame Sally Davies said, “Antimicrobial resistance poses a catastrophic threat. If we don’t act now, any one of us could go into hospital in 20 years for minor surgery and die because of an ordinary infection that can’t be treated by antibiotics. That’s why governments and organisations across the world, including the World Health Organization and G8, need to take this seriously.
“This is not just about government action. We need to encourage more innovation in the development of antibiotics – over the past two decades there has been a discovery void around antibiotics, meaning diseases have evolved faster than the drugs to treat them.”
AMR will not go away on its own. It requires complex and comprehensive action across many sectors.
If you are interested in finding out more information, please visit randox.com
ISO 22870- Are you meeting expectations?
Quality control has recently become crucial in the Point-of-Care (POC) field due to the introduction of ISO 22870 regulations and increased focus in patient safety. Quality control is critical in reducing turnaround time and saving money.
There is now an international standard specifically for POC testing, ISO 22870. This standard is intended to be used in conjunction with the standard for medical laboratories, ISO 15189. This means that aspects relating to Point-of-Care such as training, competence and documentation should be carefully planned, implemented and governed by a quality management system and there is a requirement for QC and EQA to be performed, where available.
POCT is typically carried out by non-laboratory staff, therefore when selecting the appropriate IQC material for POCT there are a number of key characteristics you must consider;
- Format of the material – QC material employed should be liquid stable, requiring no preparation, reducing the likelihood of human error and increasing convenience.
- Value assignment – all values must be accurately assigned. Look out for suppliers who use a large number of independent labs to determine the target value.
- Third party controls – manufactured independently from any specific instrument or method third party controls are designed to deliver unbiased performance assessment.
- Storage – for convenience controls should be liquid stable, as these can be easily stored in a fridge at 2oC – 8oC and won’t need to be shipped on dry ice.
- Stability – a control with a good open vial stability will mean that it can be used for longer with less waste produced, meaning it is more convenient for the medical professional to use.
- Transportation– the liquid stable controls can be conveniently stored at 2oC – 8oC reducing the need to ship on dry ice
- Minimal training– easy to use with little training required, therefore suitable for use by non-laboratory personnel
In addition to IQC, External Quality Assessment (EQA) must also be employed to ensure a comprehensive review of test system performance. It is best to select a programme that offers frequent reporting with a large database of users. This will enable rapid error identification and ultimately accurate and reliable patient testing.
Our Acusera liquid ready-to-use controls include:
- Blood Gas Control– A liquid stable control provided in easy to open ampoules for added convenience and ease-of-use. Assayed, method specific target values are provided for the most common blood gas instruments.
- Liquid Cardiac Control– This is a highly convenient liquid stable cardiac control offering excellent consistency. Assayed, instrument specific target values are provided for 8 cardiac markers, enabling flexibility and consolidation.
- Liquid Urinalysis Control– Liquid control that is compatible for use with both manual and automated methods of dipstick analysis. Available in convenient 12ml vials or 25ml dropper bottles with assayed ranges provided for 13 parameters covering the chemical examination of urine specimens.
- Liquid HbA1c Control– This is another highly convenient liquid ready-to-use control. With an open vial stability of 30 days, keeping waste and costs to a minimum.
Complementary EQA programmes are also available to meet the needs of ISO 22870.
The UK Government is being urged to ban excessive use of antibiotics in farming
To coincide with the start of World Antibiotic Awareness Week the UK Government is being urged to ban excessive use of antibiotics in farming by a group of leading doctors, according to The Daily Telegraph.
Made up of 12 royal medical colleges, the British Medical Association and the Faculty of Public Health, the group say that the UK should “use the opportunity afforded by Brexit to lead the world in banning” preventative prescription of medicines on animals.
A decision made by the European Parliament earlier this year to ban mass agricultural medication has not yet been ratified by member states or the European Commission.
A Department of Environment, Food and Rural Affairs’ spokesman told the newspaper that dealing with AMR is a “top priority” though the paper notes it ‘stopped short of promising a ban.’
In 2015 McDonalds set itself a two year deadline to stop its US restaurants buying chicken raised with human antibiotics. It led to one of the US’s leading meat producers – Tyson Foods – promising to end the practice by September 2017 – which is, as The Guardian stated, “one of the most aggressive timelines yet set by an American poultry company.” The company’s CEO Donnie Smith told the newspaper: “We have found as we have reduced the level of antibiotics we use, whether it’s human use or vet-only, our cost has actually gone down. A lot of the ways we’ve been able to accomplish this is by working with our farmers on better husbandry practices. If this millennial mum wants a no-antibiotic ever..nugget we better supply that.”
Farmers Weekly reported this month on a Danish Crown initiative launched in 2015 whereby pig farmers attach an antibiotics-free tag to piglets at the neonatal stage. It’s removed at any point if antibiotic treatment is deemed necessary. It claims that although early farm trials suggest a production fall of up to 2.5 piglet per sow per year, the “premium covers additional costs if 35% or more piglets carry the tag to the slaughterhouse.”
Pig farmer Stine Mikkelsen carried out a major review of hygiene and health on her farm to reduce antimicrobial use to boost revenue by £11.25 per pig. She says that although production is down and labour costs did increase, it “feels good” to farm in this way. She told the newspaper, “I am very motivated to do something about it – it’s a hard route to take but I have a good feeling about this system.”
Randox Food Diagnostics is working with global leaders in the food industry to tackle antibiotic resistance and safeguard their use for both human and veterinary treatment.
Using a dedicated research and development team, Randox have the ability to respond rapidly to emerging new drugs of abuse and regulations in relation to food and animal safety, with sixty-five new residue drug targets are currently in development to keep up with the ever changing market of food safety. Randox Food Diagnostics are ensuring that all residue screening laboratories requirements are met by providing reliable food safety screening on a global scale.
On top of the food safety product range Randox Food also offer a range of analysers, reagents and test kits for use throughout the winemaking process to ensure quality is maintained in every bottle.
This product range includes the RX misano semi-automated wine analyser and the RX Monaco fully automated wine analyser.
For more information on what we do, please visit: www.randoxfood.com
The RX misano is currently unavailable to purchase in Germany
Dementia is now “our greatest medical challenge”
It has been announced today by the Office of National Statistics that dementia is the leading cause of death in the UK. Last year alone more than 61,000 people died of dementia and this figure is set to rise along with the ageing population. Currently, there are over 850,000 people with dementia in the UK- 40,000 of which are under the age of 65. This number is expected to reach over 1 million by 2025.
The majority of the dementia deaths were among women – 41,283 deaths in 2015 compared to 20,403 dementia deaths in men. For men it seems the leading cause of death is related to heart disease.
Hilary Evans, Chief Executive of Alzheimer’s Research UK, said, “These figures once again call attention to the uncomfortable reality that currently no-one survives a diagnosis of dementia.
“Dementia is not an inevitable part of ageing, it’s caused by diseases that can be fought through research, and we must bring all our efforts to bear on what is now our greatest medical challenge.”
Dementia describes the different brain disorders that trigger a loss of brain function. These conditions are all usually progressive and eventually severe. Alzheimer’s Disease is the most common type of dementia, affecting 62% of those diagnosed. Other types of dementia include; vascular dementia affecting 17% of those diagnosed and mixed dementia affecting 10%.
The most common symptoms of dementia include memory loss, confusion and problems with speech. However it is important to spot the early warning signs. These include finding it hard to follow conversations or programs on TV, forgetting names of friends or everyday objects and feeling confused even in a familiar environment.
Here at Randox we recognise the importance diagnosing dementia early and we worked with the Medical University of Vienna to develop the Randox ApoE4 Biochip Array which can identify the risk of developing Alzheimer’s within three hours. When we presented it earlier this year, it won the prestigious NACB/ AACC Distinguished Abstract Award.
The Biochip analyses Apolipoprotein E (ApoE), a gene which is recognised as one of the most significant genetic risk factors for dementia and other neurodegenerative diseases. There are three versions of the ApoE gene: E2, E3 and E4. The E4 version increases a person’s risk of developing late-onset Alzheimer’s disease, though it may also be associated with an earlier onset of memory loss. Everyone carries two copies of the ApoE gene but 25% of the population carry one copy of the ApoE4. Inheriting two copies of the E4 variant increases a person’s disease risk by 10 times or more.
The Biochip was developed at our state of the art site in Dungloe, ‘Teoranta’. R&D scientists Emma Harte said, “This type of testing is important in our quest to understand and diagnose Alzheimer’s, and empower patients to understand risks, consider medication and even make early lifestyle changes.
“Pairing this test with medical and family history for risk of Alzheimer’s disease has the real potential to advance personalised medicine. This fast, accurate testing will allow doctors and patients to make more informed choices earlier to potentially slow the possible progress of Alzheimer’s.”
If you would like to find out more information about our Alzheimer’s test contact us at randoxPR@randox.com
IQCP: Where Are We Now?
What is IQCP?
IQCP stands for Individualized Quality Control Plan, and it is an all-inclusive approach to creating a customized quality control plan for a laboratory.
IQCP focuses on assuring quality in the lab using more in-depth means than simply carrying out a certain number of QC tests at a specific frequency. Many different aspects of laboratory operations will be evaluated, such as the test system, reagents, environment, testing personnel etc.
Where are we now?
As of January 2016, many labs in and outside the USA have implemented their IQCP’s, but what impact has this had on day-to-day operations?
In order to gauge the overall effectiveness and user-experience of implementing IQCP, Westgard QC1 conducted a survey for all IQCP participants both in the USA and globally.
Opinions were mixed regarding the effectiveness of IQCP:
Positive Opinions of IQCP
- Some users found that IQCP decreased the number of QC materials required
- There is a greater emphasis on the pre and post-analytic phases of testing, thus improving process error identification
- Over half of global survey participants revealed that their IQCP identified unacceptable risk(s) in their test system, thereby creating a more robust process
- Of the labs whose IQCP’s were inspected in the USA, 96.3% were deemed adequate by the relevant regulatory bodyies
- Identification of errors can lead to additional personnel training, thereby increasing the knowledge and expertise of laboratory staff
Negative Opinions of IQCP
- Due to the length of time taken to create a single IQCP, coupled with the additional expense, several survey participants found that the benefits of IQCP did not justify using so many resources in its implementation
- Many labs raised concerns regarding the availability of guidance in developing an IQCP. Participants complained that useful guidelines were not provided quickly enough, and labs had to rush their IQCP implementation.
- Several survey participants felt as though there was widespread confusion over IQCP. Participants highlighted that the volume of questions from laboratory professionals proves that IQCP was not introduced by regulatory bodies in an organized or effective manner
- Some labs surveyed voiced the opinion that IQCP evaluation needs to be more standardized, and that inspections can either be too lenient or too stringent.
ISO 15189:2012 requirements
As with any new system, feedback is important for further refinement. IQCP appears to be a step in the right direction for the advancement of laboratory QC. According to Westgard’s survey1, only around 30% of US respondents were satisfied, showing that labs still feel improvements need to be made. Inspectoral standardization, or more concise, straightforward guidelines on IQCP implementation could be potential improvements for regulatory bodies to consider.
We would love to know your thoughts on the subject. Send us an email at acusera@randox.com.
References:
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Westgard QC. (2016).2016 IQCP Users Survey. Available: https://www.westgard.com/iqcp-user-survey-comments.htm. Last accessed 25-Oct-16.
Dealing with not being a dad yet – is IVF always the answer to infertility?
“Little things would set me off. I’d walk into work and a colleague’s car had a baby seat in the back. I’d question myself as a man. I question my masculinity.”
A new survey has been carried out by Infertility Network UK and Middlesex University London looking at the impact upon men of fertility problems. One in six couples in Northern Ireland experience difficulties conceiving a baby.
Two men spoke to the BBC about their own experiences.
Aaron, 42, said he and his wife have been trying to have a baby for eight years. “When people ask why we don’t have kids, it’s like are people that idiotic, that insensitive?” 40 year old James said he and his wife have been struggling to conceive for five years. “The silence is stifling. It’s like someone needs to say something.”
Fertility problems are as common in men as women. Male or female – your body’s fertility is a complex department that relies on total health and wellbeing. With Randox Health, you can find out exactly how your body is performing before trying for a baby.
Common causes of infertility for men
- low sperm count
- problems with the tubes carrying sperm
- problems getting an erection or ejaculating
- diabetes
- being overweight
Is IVF the only option?
Not according to one of the founding fathers of in-vitro fertilisation – Dr Robert Winston. In his book, The Essential Fertility Guide, he outlines fertility treatment options and suggests more than half of people referred to IVF clinics may be treated by alternatives. “There are numerous causes of infertility and the best treatment may be different in each circumstance. Unfortunately, the massive publicity given to IVF has led to most people believing that it is almost the only treatment and the most successful. This is utterly wrong. Couples rush into IVF far too frequently.”
He believes this happens when not enough time is spent investigating the underlying cause of infertility. “IVF is not the only treatment for infertility, and it’s often not the best treatment or the most successful. There are many treatments depending on the cause, and the cause should be established first.”
What you can do
If you’re thinking about trying for a baby, you might want to find out more about your current fertility levels and also whether or not there are any risk factors to consider in the future.
Randox has created one of the world’s most advanced reproductive health checks. Our personalised service involves physical and biological assessments, with 110 tests carried out in total, including DNA-based protein testing.
Dr Peter FitzGerald, founder and CEO of Randox said, “One in every six couples in Northern Ireland will experience difficulty conceiving. Through our research, we know it won’t always be down to a problem with the sperm, eggs and reproductive organs, but could also be a consequence of issues in other parts of the body such as hormone imbalance, obesity or stress.
“We use the very latest in diagnostic innovation to assess your whole body health, which gives clarity on how well you are now and crucially assesses your future health, which can help to boost your fertility levels.
“For many couples, we know that very sophisticated treatment, such as IVF is not always needed. Sometimes a deceptively simple change in lifestyle or diet will deliver positive results.”
Prepare for a stroke or take action to prevent one?
“If you experience any neurological symptom that comes on suddenly and is unfamiliar (eg not like your normal migraine) then you should seek urgent medical advice. And take an Aspirin (unless you’re allergic to it).” That’s the advice today from Dr Mark Porter, writing in The Times about what to do in the event you think you’re suffering a stroke.
It’s good advice to keep a packet in your medicine cabinet, but did you know that it’s thought 91% of strokes are avoidable?
What is a stroke?
For the brain to function properly, it needs the oxygen and nutrients provided by the blood. Stroke occurs when a blood vessel in the brain bursts or, more commonly, when a blockage develops which leaves the supply of the blood to the brain limited or completely obstructed and without treatment, cells in the brain quickly begin to die.
There are 3 different types of stroke:
- Ischaemic Stroke
- Haemorrhagic Stroke
- Transient Ischaemic Attack (TIA)
Avoidable risk factors
Research was carried out by McMaster University Canada – it compared the lifestyles of people who had a stroke with those who had not, involving nearly 27,000 participants from 32 countries. It found that 9 out of 10 strokes worldwide could be caused by risk factors – many of which can be avoided:
- Lowering blood pressure
- Exercising
- Eating healthily
- Maintaining a healthy weight
- Preventing diabetes
- Lowering cholesterol
- Cutting down on alcohol
- Stopping smoking
- Lowering stress
- Taking preventive medication for any heart arrhythmia
The most important modifiable risk is high blood pressure, increasing the risk by 47.9%, which is why it’s the key target across the world for reducing strokes.
Randox Health can help
Randox Health clinics offer you personalised preventive health programmes that provide a full profile of your entire body’s health, including diabetes health, lung health, liver health, heart health and many more areas. Upon receiving your results, you are given a programme to follow to help improve any areas of your health which are not ‘in the green’ on our scale. This helps you to prevent future illnesses and any unwanted surprises such as a stroke. We’ve helped over 3000 people in our clinics to date – book your test today.
The scary facts about cholesterol!
Cholesterol is a fatty substance also known as a lipid. It is made by the liver but can also be found in some foods. It is essential to let the body function normally. You will be sad to hear that high levels can increase your risk of serious health conditions. There are two main types; high-density lipoproteins (HDL) and low-density lipoproteins (LDL). HDL is known as good cholesterol. It carries cholesterol back to the liver, where it is broken down. LDL on the other hand carries cholesterol to the cells however if there is a surplus it can build up in the artery walls increasing the chances of a heart attack or stroke occurring.
Here are some scary facts about cholesterol…
- You can’t live without it – Cholesterol has been in your body since the day you were born. It is a building block for all cells. Not only that but all of our cells and hormones need it to function properly…unfortunately you are very unlikely to find good cholesterol in your typical trick-or-treat offerings.
- Not all patients on cholesterol-lowering medication respond optimally to it – In the recent past, aspirin (a drug used to reduce levels) was prescribed for people who had a perceived risk of a heart attack. However aspirin does not always work; up to 30% of patients could have a below optimum response to the drug and therefore be at a considerably increased risk of a recurrent cardiovascular event. This is may also be referred to as “aspirin resistance”.
- One third of adults have high cholesterol – Testing is advised every 5 years to monitor your levels to see any changes. To get the most accurate results tests should be carried out one week apart, however most testing facilities won’t follow this.
- High levels could be down to genetics – Diet you can change, genes you can’t! If your family has a history of high cholesterol then you are likely to have it as well. It has been suggested that 75% of cholesterol is due to genetics and the remaining 25% is down to diet and lifestyle choices.
- Women’s levels will fluctuate over their lifespan – Did you know that ladies? During the average woman’s lifespan, cholesterol levels will rise and fall due to pregnancy and menopause. During pregnancy levels will rise in order to help the baby develop. After birth the mother’s levels should return to normal however after menopause a woman’s LDL levels will rise to that higher of a man’s.
However it is not all doom and gloom this Halloween! Randox are here to treat you to a vast range of specialised blood tests to allow the most accurate diagnosis of cholesterol levels, allowing you to gauge how many sweets you can sneak in this Halloween! We offer a large array of routine and niche tests. The most popular and widely tested are HDL, LDL, total cholesterol and triglycerides. Some further risk assessment cholesterol tests which are not routinely run include sLDL, HDL3, Lp(a). These cholesterol biomarkers are also affected by the usual risk factors such as age, weight, smoking, etc.; however they can also be a result of one’s genes. As mentioned before aspirin resistance is a big problem affecting up to 30% of all patients on aspirin therapy. However Randox offer the TxBCardio™ test which is a unique test to diagnose and assess the effectiveness of aspirin therapy.
From all of us here at Randox we wish you a safe and happy Halloween!
For health professionals
Randox Laboratories manufacture a wide range of routine and niche biochemistry reagents suitable for both research and clinical use. These include a wide variety of automated routine and niche cardiac tests and our new HDL3-C assay. Please contact reagents@randox.com for further information.
Don’t Get Tricked This Halloween
Don’t Get Tricked This Halloween – Treat Your Lab to Randox True Third Party Controls Today!
Halloween – a celebration observed by many countries around the world on a yearly basis. Falling on October 31st this holiday is a chance for people to dress up, carve pumpkins, bob for apples, attend costume parties, trick-or-treat and tell scary stories.
It just so happens that we have a scary story for you – and what makes this story even scarier is that it’s a true story!
Our story starts off in a medical laboratory. This laboratory was running QC on their machine as they would do every day. Getting accurate results with no faults or problems arising from their machine, this laboratory was happy with how things were going – until one day when it all went wrong!
Having run their EQA/PT samples, the laboratory found themselves reviewing their report with shock –they noticed a large negative bias. To their horror the perceived ‘accuracy’ they had once achieved was now no longer the case. Right away the laboratory professional’s thoughts turned to the fact that approx. 70% of all clinical decisions are based on laboratory test results, meaning it is essential that the results provided are accurate and reliable in order to prevent potential misdiagnosis or inappropriate treatment. Had they sent incorrect patient results to the clinicians? Had a patient been misdiagnosed? Many thoughts fluttered around in their heads.
The laboratory repeated their QC and found that the results obtained were almost identical to the previous run. The laboratory knew there must be a problem with their QC or their instrument, so they began the troubleshooting process. Nothing. Nada. Zilch. “What was going on?” was the question on the lips of the laboratory professionals.
One of the laboratory professionals then stumbled across a case study that took place in the University of Verona and Academic Hospital of Parma, Italy. The study was related to a field recall of Intact PTH, the reagent was recalled after falsely elevated patient results were discovered. The alarming thing was that the same elevated performance was not identified by the instrument manufacturer’s control. The study reported that due to this issue there was potential for 40,000 inaccurate patient results from just 18 labs in the Lombardy region of Italy. The study also concluded that the issue could have been prevented if a third-party control, independent from calibrator materials had been used.
This PTH case study got the laboratory thinking that maybe they should source a true third party manufacturer… Having sampled a third party QC, the lab found their results now mirrored that of their EQA and patient samples and as such proceeded to make the switch from first party to third party.
The moral of this story is that first party controls can sometimes “trick” the lab into thinking their performance is acceptable. Quite often target values provided with first party quality controls are in the middle of the analytical range thus masking the issues at the low and high ends of the assay range. Laboratory professionals should “treat” their labs to the best QC material. ISO 15189 highlights that the “use of independent third party control materials should be considered, either instead of, or in addition to, any control materials supplied by the reagent or instrument manufacturer”. So this Halloween don’t randomly choose your QC supplier, treat your laboratory to the best, Randox QC.
All Randox controls are manufactured independently of any instrument or reagent, and designed for use with multiple instruments and methods ensuring, unbiased performance assessment.
