Identification and Differentiation of Viral and Bacterial Respiratory Infection to Guide Antibiotic Stewardship

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Identification and Differentiation of Viral and Bacterial Respiratory Infection to Guide Antibiotic Stewardship

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Identification and Differentiation of Viral and Bacterial Respiratory Infection to Guide Antibiotic Stewardship

 

The development of point-of-care testing is critical in the identification and differentiation between bacterial and viral respiratory infections. Defining the indications of infection to improve antibiotic stewardship, ensures that patients are protected from unnecessary antibiotic use and antibiotic resistance. It has been shown that particular protein biomarkers, such as myxovirus resistance protein (MxA) and C-reactive protein (CRP), differentiate infections between bacterial and viral. Using point-of-care platforms, such as Randox’s VeraSTAT, for detection of these protein biomarkers may provide more rapid and cost-effective discriminating tools.

The treatment of bacterial and viral infections can differ significantly, however people are often treated with empirical antibiotics due to a lack of paid and accurate testing. Although early intervention of infection is urgent, current diagnostic methods are either time intensive or inaccurate. The challenges clinicians are faced with in the differentiation of viral or bacterial respiratory infection can lead to delayed diagnosis, misappropriation of antibiotics and increased healthcare costs.

MxA protein has the potential to greatly enhance the rapid detection of viral respiratory infections as it increases significantly when there is actuate viral infection. CRP is the dominant acute phase protein often used to guide treatment of a bacterial infection or inflammation associated with tissue injury, inflammatory disorders, and associated diseases.

CRP & MxA together, allow clinicians to make appropriate decisions in supporting antimicrobial stewardship and guide the appropriate use of antibiotics, saving time performing unnecessary tests, providing unnecessary treatment which missing the opportunity to provide the right treatment in a timely manner.

The Randox VeraSTAT is a simple, accurate, portable point of care device which delivers rapid results via the use of patented cathodic electrochemiluminescence technology (C-ECL). Designed with the aim of offering users the next generation of rapid diagnosis, the VeraSTAT eliminates the requirement to send samples to a laboratory and instead returns results in as little as 6 minutes.

 

  • Eliminates delays in sending samples to the lab and facilitate immediate decision making at the point of care.
  • Lightweight, portable and convenient, the Randox VeraSTAT can be used in a variety of locations to deliver results as required, such as a GP surgery or Emergency Department.
  • Intuitive user interface guides the operator through the entire testing process.
  • All necessary reagents are conveniently included in each single use, sealed cassette with no preparation required. All necessary consumables are supplied with the kit.
  • The Randox VeraSTAT allows for results to be exported via Bluetooth connectivity.
  • Flexible test menu comprising of a range of immunoassay, protein, inflammatory, diabetes & infectious disease markers.

 

Novel testing approaches identifying the type of infection at the point of care are essential in accurately guiding appropriate antibiotic treatment. Although these tests can’t determine what type of viral or bacterial infection a patient has, it will determine whether the infection is viral or bacterial, further testing is then carried out to determine what type of pathogen the patient has via PCR – the gold standard. The ability to distinguish between viral and bacterial infections is the most effective guide for clinical decision making and is an innovative tool for antibiotic stewardship.

 

References

1 – Fleming-Dutra K.E., Hersh A.L., Shapiro D.J. Prevalence of inappropriate antibiotic prescriptions among US ambulatory care visits, 2010–2011. JAMA. 2016;315:1864–1873. doi: 10.1001/jama.2016.4151.

2 – Cals JW, Hopstaken RM, Butler CC, Hood K, Severens JL, Dinant GJ. Improving management of patients with acute cough by C-reactive protein point of care testing and communication training (IMPAC3T): study protocol of a cluster randomised controlled trial. BMC Fam Pract. 2007;8:15.

3- New report calls for urgent action to avert antimicrobial resistance crisis [Internet]. World Health Organization. World Health Organization; 2019

4 – Hutchings MI, Truman AW, Wilkinson B. Antibiotics: past, present and future. Curr Opin Microbiol. (2019) 51:72–80. doi: 10.1016/j.mib.2019.10.008

 

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Celebrating World Hepatitis Day 2022!

Hepatitis is a condition that affects the liver and can be caused by an infection with a virus. With five different types of Hepatitis from A to E, the most common types of viral Hepatitis are A, B and C. These three viruses affect millions of people worldwide, causing both short-term illnesses and long-term liver disease.

World Hepatitis Day highlights the need to accelerate the fight against viral hepatitis and the importance of testing and treatment for those in need. The “I can’t wait” campaign brought to us by World Hepatitis Alliance, amplifies the voices of those affected demanding immediate action and the end of the stigma and discrimination attached.

Currently there are 325 million people who live with hepatitis globally with more than 1.1 million lives lost to hepatitis B and hepatitis C.

It is important to note that the use of appropriate quality control measures is vital in ensuring the appropriate daily performance of the assay used in the laboratory independent of the technology.

Features & Benefits of Randox Molecular Blood Borne Virus (BBV) Controls

  • Traceable to International Standard (where available) or to Internal Reference Material
  • Liquid frozen for user convenience and ease of use
  • The panels are suitable for use with the majority of commercial and in-house molecular methods
  • Manufactured to ISO: 13485 quality standards

Download brochure here

In addition to this, we have our third party Infectious Disease (Serology) Controls which are designed to deliver a cost-effective, high-quality solution for the analysis of infectious disease. Our controls are compatible for use on wide range of immunoassay platforms.

Features and Benefits

  • Liquid ready to use – All samples are provided in a user-friendly, liquid ready-to-use format significantly reducing preparation time and the risk of pipetting errors.
  • Commutability- Manufactured from human plasma each control is designed to react to the test system in the same manner as the patient sample, helping to meet ISO 15189:2012 requirements.
  • True third-party controls – Designed to deliver an independent, unbiased assessment of performance with any instrument or method the Acusera range will help to meet ISO 15189:2012 requirements and eliminate the need for multiple instrument specific controls.
  • Reduced waste – With a working stability of 60 days art 2oc to 8oC waste and costs are kept to a minimum.
  • Consolidation – The availability of multi-marker controls will reduce the number of individual controls required ultimately reducing costs, time, and storage space.
  • Clinically relevant – Designed to challenge clinically relevant ranges our low reactive samples will ensure accurate and reliable instrument performance.
  • Acusera 24.7 – Our Acusera Infectious Disease (Serology) Controls are compatible for use with our interlaboratory data management software Acusera 24.7.

For more information about Third party Infectious Disease (Serology) Controls:

Visit our website: Serology Quality Controls

Or email: qualitycontrol@randox.com

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Randox Equine Awards NI 2022

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Randox Congratulates Manor Equine Vets on winning Best Vet Practice Equine Award 2022

Randox would like to congratulate Manor Equine Vets on winning the Best Vet Practise award at the Randox Equine Awards NI 2022. The Best Veterinary Practise category also included a highly commended award for Oldstone Veterinary Clinic.

Quirine Tettelaar, owner of Manor Equine Vets said “I was very happy to win the award and it was a big surprise! I would like to thank all my lovely clients, friends, and family for their support over the last couple years since starting my business. Hard work and dedication really pays off. It was lovely to read all the comments people left to vote, that was the best part of the awards! I feel really appreciated.”

This event was hosted by Raymond Bready and held at the Titanic Hotel Belfast on Saturday 25th June 2022.

With over 400 guests attending, Randox highlighted the new VeraSTAT-V test which detects the earliest signs of inflammation in horse blood. This stable side test is easy to use and provides quantitative results in six minutes.

Randox testing allows for a healthy horse and healthy rider.

Manor Equine Vets, Quirine Tettelaar and Randox’s Connor Gallagher Celebrate Best Vet Award at The Randox Equine Awards NI 2022

For press enquiries please contact Ellen Watson in the Randox PR team:  randoxpr@randox.com

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Biomedical Science Day 2022

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Biomedical Science Day 2022

Biomedical Science Day is taking place this year on Thursday 9th June 2022. This is an annual celebration to increase the awareness of Biomedical Science and to promote to the public the importance of it.

Biomedical scientists play a key role in diagnosis, quality development and assurance, treatment, research, and development in the modern medical sciences. To celebrate and give recognition we have interviewed one of our RCLS clinical deputy managers, Jayme Hamilton.

 

This is what Jayme has to say about his role in Biomedical Science:

 

 

1. What attracted you to pursue a career in biomedical science?

My degree was in Biological Sciences with Professional Studies. Through it, I was able to design my degree based in my own interests and curiosities, which drew me to exploring the molecular and chemical pathways that elicit biological pathways and also how biotechnology is opening up a future to personalised health and therapies. What I find interesting it how a complete complement of biomarkers needs to be assessed to offer a full illustration of what’s going on under the skin.

2. How many different labs have you worked in?

I have been fortunate to work within several Laboratories to some capacity early in my career. I had a very fulfilling placement within a Method Development and Validation lab at a pharmaceutical company, as well as completing a challenging honours project in population genetics in my final year of university.  Since joining Randox, I have had opportunities to work across several Clinical and Molecular Laboratories with talented colleagues from all sorts of backgrounds; within Liverpool and London in England, Holywood and Antrim in N. Ireland and Los Angeles in California.

 

3. Do you enjoy the practical or theoretical aspect of biomedical science?

Theoretical- I have a drive to learn and understand and thankfully in science that is a continuous journey, as new forms of diagnostics and analysis are born and our understanding can grow or even change.  With a good understanding of the science and a multidisciplinary team of talented individuals to collaborate with, it makes executing the practical work all the more rewarding.

 

4. What is your favourite part of your day in work?

The end of the day -but not why you might think. I have been trying to be more reflective and as the start of the day can be very busy and hands on, I have found it helpful to review my workload and responsibilities, as well as that of those I help lead, at the end of the day; to better look ahead to tomorrow and acknowledge the efforts of the team.

 

5. What’s in your lab coat pocket?

Pens, markers, and more pens. My favourite being my engineering pen, with a torch and stylus included.  Thankfully we push for a more paperless world, but a busy lab can need some quick notes to be made. I’m also a very visual person and find it easiest to communicate to colleagues with notes or even a quick sketch.

 

6. In your opinion, what are the most important aspects of laboratory work?

The results we release. Fundamentally the data we release it for the benefit to the individual they deprived from. By stringently monitoring our quality checks and adhering to the procedures and processes we implement, we can have confidence that the results we release have a high level qualitative and interpretive value.

 

7. In what ways does your work make a difference to people’s lives?

At a personal level, as a clinical deputy manager I aim to optimise and evolve the duties of the colleagues I work with to make their jobs easier and more fulfilling and by extension the functionality of the lab more efficient.

In doing so, I broadly think the work we are doing as a collective, is bringing personalised testing to the masses and in doing so, add to improving the public’s understanding of science, in such that they can begin to take their health into their own hands in a measurable and meaningful way.

 

8. What is your dream career within biomedical science?

Living the dream. So far in my career I have been able to learn and develop within a profession that aligns with my interests, whilst simultaneously contributing to expanding and exciting industry. Throughout which I have had the opportunity to collaborate with many fantastic, talented, intelligent and hardworking people, from an array of disciplines, during the growth of a impressive clinical testing service as well as a nationwide covid testing service.

 

 

 

 

Jayme is a fundamental member of Randox and plays an essential role in the team, as do all our employees. Without our valuable laboratory team working extremely hard behind the scenes the lifesaving work we do here at Randox would not be possible. We thank each one of you for your hard work every day.

To find out more about our Biomedical Science, contact us at market@randox.com

 

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Celebrating Lp(a) Awareness Day 2022 today!

Randox are raising awareness for Lipoprotein(a), we want to drive awareness on tests that are available to you to decrease the risk of stroke, heart attack or other heart diseases.

Lp(a) is a risk factor for atherosclerosis and related diseases including CHD and stroke. It is increasingly recognised as the strongest known genetic risk factor for premature coronary artery disease. The biggest challenge that exists surrounding Lp(a) measurement is the heterogeneity of the apolipoprotein(a) isoforms, resulting in the underestimation or overestimation of Lp(a) concentrations.

Benefits of the Randox Lp(a) assay

WHO/IFCC reference material – The Randox Lp(a) assay is calibrated in nmol/l and traceable to the WHO/IFCC reference material (IFCC SRM 2B) and provides an acceptable bias compared with the Northwest Lipid Metabolism Diabetes Research Laboratory (NLMDRKL) gold standard method.

Dedicated calibrator & control available – Five point calibrator with accuracy-based assigned target values (in nmol/l) is available, accurately reflecting the heterogeneity of the apo(a) isoforms. Dedicated Lp(a) control is available offering a complete testing package.

Excellent correlation – A correlation coefficient of r=0.995 was displayed when the Randox method was compared against other commercially available methods.

Excellent precision – The Randox Lp(a) assay displayed a within run precision of <2.54%.

Liquid ready-to-use – The Randox Lp(a) assay is available in a liquid ready-to-use format for convenience and ease-of-use.

Applications available – Instrument-specific settings can be provided for a wide range of clinical chemistry analysers.

 

The biggest challenge that exists surrounding Lp(a) measurement is the heterogeneity of the apo(a) isoforms, resulting in the underestimation or overestimation of Lp(a) concentrations. In immunoassays, the variable numbers of repeated KIV-2 units in Lp(a) act as multiple epitopes. This is where standardisation across calibrators is vital. Unless the calibrants do have the same range of isoforms as test samples, those with higher numbers of the KIV-2 repeat, will represent with an overestimation in Lp(a) concentrations and those with smaller numbers of the KIV-2 repeat, will represent with an underestimation. The smaller isoforms are strongly associated with higher Lp(a) concentrations. Lack of standardisation of the calibrant would result in an underestimation of Lp(a) associated CVD risk. It is important to note that an Lp(a) immunoassay employing isoform insensitive antibodies does not exist.

 

DID YOU KNOW?

Lp(a) has been identified to be a key risk factor for cardiovascular complications in individuals with COVID-19!

It is well documented that pre-existing comorbidities such as diabetes and CVD are associated with greater severity and higher fatality rates in those with COVID-19.  Those with either baseline elevated Lp(a) or those whose Lp(a) levels increased following infection from COVID-19, or both, maybe at a significantly increased risk of developing thromboses. Elevated Lp(a) levels may cause acute destabilisation of pre-existing but quiescent, atherosclerotic plaques, which could induce an acute myocardial infarction or stroke.

Identifying any possible health conditions that would relate to early signs of stroke, heart attack or other heart diseases will allow you to make any decisions on an appropriate diet, lifestyle changes and early treatment to reduce your risk of further problems.

For more information about Lp(a):

Visit our website: Lipoprotein(a) [Lp(a)] | Reagents | Randox Laboratories

Or email: marketing@randox.com

 

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SARS-CoV-2 Vascular & Multi-System Dysfunction Whitepaper

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30 June 2021

SARS-CoV-2 Vascular & Multi-System Dysfunction Whitepaper Download

COVID-19, the disease caused by SARS-CoV-2, is an infectious disease caused by a newly discovered coronavirus. While many of whom become infected by the disease will experience mild to moderate cold or flu-like symptoms, those with health complications – such as autoimmune diseases, asthma, heart disease and diabetes – are at risk of developing serious illness and adverse outcomes.

As of September 2021, over 228 million COVID-19 cases have been confirmed worldwide, with an estimated one in six patients experiencing complications which could be life threatening, with over £116 billion spent by the UK government alone on measures to combat the disease. This drastic spending has been mirrored across the globe, with the significant economic burden expected to be suffered for generations to come.

The whitepaper provides a brief overview of the COVID-19 pandemic, before discussing vascular abnormalities and associated complications brought on by the virus, such as multi-system disfunction, acute respiratory disease syndrome (ARDS) and hepatic, renal & cardiovascular function.

 

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World Health Day 2021

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7th April 2021

Building a fairer, healthier world

World Health Day is a global health awareness day celebrated every year on 7th April, under the sponsorship of the World Health Organisation (WHO) who sees it as an opportunity to draw worldwide attention to a subject of major importance to global health. Each year is related to a particular theme and this year’s focus is “building a fairer, healthier world”.

In view of the ongoing global COVID-19 pandemic where restrictions remain in place across most parts of the world, this time has highlighted that some people are able to live healthier lives and have better access to health services than others. COVID-19 has hit all countries hard, but its impact has been harshest on those communities which were already vulnerable, who are more exposed to the disease, less likely to have access to quality health care services and more likely to experience adverse consequences as a result of measures implemented to contain the pandemic, placing additional stress on healthcare systems across the world.

The COVID-19 pandemic has disrupted and even halted particular health services with most countries (90%) reporting that many routine and elective services have been suspended, while critical care – such as cancer screening and treatment and HIV therapy has seen high-risk interruptions (WHO, 2020).

the enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social condition.” (WHO, 2021).

Randox has adapted to the emergence of the COVID-19 pandemic by developing pioneering tests to diagnose COVID-19, offering a range of COVID-19 testing solutions using Randox’s patented Biochip Technology capable of conducting multiple tests simultaneously on a range of molecular testing platforms, with results available from the Vivalytic, Evidence Investigator and Randox Discovery.

With a game-changing global partnership formed between Randox Laboratories and Bosch Healthcare Solutions combining science and technology, successfully launching the Vivalytic – the all in one solution for molecular diagnostics, the Vivalytic has been designed against the challenges posed by climate change and to contribute towards sustainability. The Vivalytic cartridges are CO2 neutral – this means that emissions that are in our direct sphere of influence are neutralised – making a further contribution to climate protection.

Furthermore, Randox’s vision is to improve healthcare worldwide and to ensure physicians and the public have access to the latest advancements in clinical diagnostics to aid diagnosis, treatment, and management of patients. Randox offer a comprehensive biochip test menu to support and combat challenges facing global health on an everyday basis from testing for Chronic Lung Disease (CLD) to predicting Alzheimers Disease. View Randox’s full Biochip Technology Immunoassay test menu here.

Please contact marketing@randox.com for further information on any of the mentioned above.

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Approaching the Fundamental Impact of STIs Worldwide

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02 March 2021

The Global Economic Burden of STIs & The Impact of the COVID-19 Pandemic on Sexual Health Whitepaper Download 

Sexual Health encompasses; genito-urinary medicine, sexually transmitted infections (STIs), HIV, contraception, psychosexual medicine, abortion services, teenage pregnancy and sexual and reproductive health. It is delivered in various settings, providing care across specialised services as well as through primary and third sector organisations.

Sexual and reproductive health is a fundamental public health issue and is clearly recognised by the World Health Organisation (WHO). This whitepaper focuses on the profound impact of sexually transmitted infections (STIs) worldwide with WHO reporting that more than 1 million STIs are acquired every day (WHO, 2020).

The whitepaper discusses issues such as antimicrobial resistance, in particular gonorrhoea, and the challenges faced in a social and public concept due to the COVID-19 pandemic.

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Dr Peter FitzGerald: “Nothing will ever be the same again.”

Dr Peter FitzGerald: Nothing will ever be the same again.

An Interview with Ulster Business Editor John Mulgrew in The Belfast Telegraph, in which Dr FitzGerald speaks to John about developing and helping roll out millions of tests for Covid-19, a forever changed society, the high likelihood of a similar pandemic returning and when a vaccine for the virus could be found.

Dr Peter FitzGerald’s expertise and opinion has probably never been taken as seriously as it has in the last few months.

“Nothing will be the same again,” he tells Ulster Business. And, of course, he’s right.

His firm Randox – based in Antrim – has been on the front line of testing for Covid-19 right across the UK and beyond. And as a result, he’s hired hundreds of new staff and built a £30m testing lab to deal with additional deluge of work resulting from a global pandemic unlike anyone here has ever seen.

“I think there is a reasonable chance there will be more pandemics, with globalisation and increased population,” he told Ulster Business. “I have no idea how much it will come back again in second wave.

“We know we have the capacity as a company to respond, and respond well. I suspect the country is going to be better prepared… it’s hard to predict.”

The medical testing giant’s first involvement with the current coronavirus strain began back in January, before it became an increasingly concerning dinner conversation in homes across Northern Ireland.

“In late January, research called and were looking at doing a test,” Peter said. “We downloaded the genetic sequence of the virus and spent the next two weeks developing a test. We can do it very quickly, as we already had coronaviruses on chip.

“It was sent to Public Health England, which took a while to prove it. We then got a contract to test for the NHS… we were doing what we thought was for the national good.”

The initial deal didn’t include all of the UK, but Randox is now also testing Northern Ireland.

“We do the testing and we have different analysers that do the testing as well, which we sell to labs across the world.”

The virus has led to a new complete lab being built (in which Peter is pictured in) to deal with the additional testing. “We decided to accelerate the manufacturing in our Randox Science Park in Antrim,” he says.

As a result, it has hired around 200 staff in the space of six to eight weeks to deal with the surge.

“Because we had closely related strains of the virus, it was wasn’t so difficult to modify our tests to allow for slightly different variations… once we got the contract we soon realised that we didn’t have enough lab space to deal with the ramp up.

“We then decided to be 33,000 sq ft of new lab space, and it was needed in three weeks. We got that done – work was 24 hours a day, and seven days a week. It’s now operating well. That has been very important in the process.”

Randox had a workforce of around 1,450 worldwide before the coronavirus crisis began, but has since taken on around 280 additional staff for a range of roles, partly in ramping up demand for the additional testing.

“A lot were being taken on a temporary basis but many will be permanent. We are not sure of the final numbers, but well over 100.” Those roles include scientists, manufacturers, and engineers.

“Nothing will be the same again,” Peter says. “What it has done is heightened the importance of testing. People sometimes don’t know what we do here at Randox… but people now realise.

“In the end, it’s a good thing. We are advocates of testing. It identities disease before symptoms occur and can save lives in many occasions. It saves lives and saves costs. It fits in with what we have been trying to do for years… as far as we are concerned, it’s the silver lining.

“We have customers worldwide and other products kept going. We moved around 100 scientists into Covid-related things and then they have gone back to normal jobs as we bring in new people.

“Some of our R&D projects have changed, new systems and new analysers allow for efficient and accurate testing.”

Peter says that just a small element of the business has seen a decrease amid the crisis, while other areas around Covid-19 have grown. “Only a small element of core business decreased. But our Covid and other genetic products have increased… overall sales will be up and by end of year normal business up as well.”

As a result of the latest expansion and growth across the business, generally speaking, Peter says the workforce looks set to climb to 1,650, with around 500-600 based at its main headquarters, just outside Antrim.

Peter’s also keen to reiterate the importance of Northern Ireland and its people to Randox. “This is our home base. It’s where we do our primary R&D and manufacturing. We also have a facility in Donegal.”

And, could all of this happen again soon, with a further outbreak or a similarly devastating strain or pandemic?

“(We are) more prepared and our technology is getting more accepted through bio chips. Early detection is a very important next stage. You don’t want people who have a cough or fever to think they have Covid all the time. That is where testing comes in and that differentiates.”

Peter says the next stop forward in a bid to address similar future incidents it also understanding how our immune systems work – better.
“The other major step forward in many ways is understanding the immune system better. How to better respond to infection. This will be very important.

“Some people are susceptible, and this could be genetic. (It’s about) working on certain genes in those who may have a bad attack. It will prepare humans better, the body’s defence, dealing with it as well.

“I have a deficiency in a particular gene which means I’m more susceptible to respiratory (conditions) but the spin-off of the gene means I’m less susceptible to certain cancers. This is the issue – it is so complex. One could be a strength and one moment, a weakness.”

And as for the formulation of a proven vaccine, Peter says: “I would say it would be well into next year.”

    For further information please email randoxpr@randox.com

    Photo Credit Elaine Hill

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    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.

    Respondent Map - Westgard QC Survey

    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.


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