Identifying and Reducing Pre-analytical Errors in the Medical Laboratory

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Identifying and Reducing Pre-analytical Errors in the Medical Laboratory

 

Medical laboratory professionals must comply with stringent and robust standards in all aspects of their daily activities. The set of standards to which a laboratory must comply will differ depending on the scientific discipline of the laboratory, however, ISO 15189:2022 – Medical Laboratories – Requirements for quality and competence, applies to all medical laboratories. This recent version of the standard introduces increased focus on risk stratification and mitigation for patients and laboratory stakeholders, placing more emphasis on quality control to improve the accuracy and validity of the results obtained.

In a clinical chemistry laboratory, as in others, internal quality control is of upmost importance. Internal quality control (IQC) is the process used to ensure that all results produced are accurate, reliable, and reproducible. To achieve this, a laboratory must carry out checks on the pre-analytical, analytical, and post-analytical phases of testing.

The pre-analytical phase of laboratory testing includes collection, handling, transportation, storage, and preparation of samples. Even when the highest level of care is taken to ensure that all aspects of the pre-analytical phase are suitable and correct, errors can occur, exhibiting the need for clear and efficient quality control processes.

As part of our Acusera quality control range, Randox has developed the Serum Indices quality control to aid in the detection of the common pre-analytical error’s haemolysis, icterus and lipemia, collectively known as HIL. HIL interference can have disastrous effects on the quantification of many analytes, and it is therefore vital to determine levels of interference to improve laboratory efficiency and reduce the frequency of erroneous results. Figure 1 shows a graph of wavelengths at which each of these interferents may affect assays and the table below describes these forms of interference:

 

Interference Description
Haemolysis The degradation of red blood cells causes interference between 340-440nm and 540-580nm. Red blood cells experience membrane disruption due to tangential stress which results in degradation of cellular integrity and the release of interfering cellular components such as haemoglobin, K+ ions  and aspartate aminotransferase. Haemolytic interference may be evident in assays such iron, lipase, albumin, and creatine kinase.
Icterus Interference as a result of high bilirubin concentrations, affecting assays measured between 400-550nm. The high bilirubin levels result in a yellowish pigmentation of the sample, caused by hepatic necrosis, sepsis, or several other conditions.  Most prevalent in neonatal departments, icteric interference can cause inaccuracies in assays for phosphate, creatinine, cholesterol, triglycerides, and uric acid.
Lipemia Interference caused by an aggregation of lipoproteins which affects the turbidity of samples. Lipemic interference can be cause by several mechanisms, the most common being the light scattering effect caused by aggregations of chylomicrons or other large forms of LDL. The larger the LDL molecule, the larger the lipemic effect.  Lipemic interference is evident in assays measured between 300-700nm, however, interference increases as wavelength decreases.

Classical determination of HIL interference took the form of a visual assessment. A sample was examined for tell-tale signs of one or more of these types of interference. However, these methods are subject to operator interpretation and lack harmonisation and uniformity across the industry.  These signs are detailed in the table below and illustrated in figure 2.

Interference Visual indicator
Haemolysis Red discoloration of serum samples which is directly proportional to the concentration of haemoglobin and other interfering erythrocyte components.
Icterus Yellow pigmentation of serum samples increases proportionally to the concentration of conjugated and unconjugated bilirubin.
Lipemia Increased sample turbidity proportional to lipid concentration.

Modern clinical chemistry analysers have onboard HIL detection capabilities which offer objective, semi-qualitative or qualitative analysis of these forms of interference in a more precise and consistent manner. Automation of HIL detection improves laboratory throughput along with test turnaround times and enhances the reportability of the results.

Errors at any stage of the analytical process will result in retesting of the sample. Errors in the pre-analytical phase can have repercussions such as increased cost of repeated sample collection and testing, poor test turnaround times, and more seriously, delayed or incorrect diagnosis causing an exacerbation in the condition of the patient. To add to the adverse outcomes on patients, repeated testing places additional stress on laboratory resources and staff which ultimately affects every aspect of a laboratory’s daily activities.

We hope that by using the Acusera Serum Indices quality control and EQA scheme we can help to improve the accuracy of laboratory testing around the world and remove some of the excessive strain placed on laboratories and the professionals who continually strive for the highest levels of quality in all their work.

How can Randox help?

Randox Sales Reps are experts in their fields and are available to discuss your specific requirements. 

Simply send us an email by clicking the link below and we will get in touch!


Medical Laboratory Professionals Week – Industry Insight

As part of our effort to raise awareness of the hard work and dedication displayed by laboratory professionals around the world, we have been talking to individuals from the industry to discover what it is like to work in a medical laboratory environment.

Here, we talk to Dean, a mobile laboratory manager for Randox, based in the UK, to find out what it is like to work in his role.

Q: Let’s start with your name and job title please.

A: I am Dean Gordon and I’m a laboratory manager.

Q: So, what does a normal workday look like for you?

A: A normal day consists of ensuring all our laboratories have everything they need to follow our standard operating procedures and ISO standards. This ranges from ensuring we have enough staff and stock on site to reviewing end of day reports and KPI’s.

Q: What encouraged you to pursue a career in clinical diagnostics?

A: I actually never considered a career in clinical diagnostics. Previously, I worked in marine biology all over the world. During the pandemic I found myself back in Northern Ireland in limbo and Randox were advertising scientific roles on the radio. I thought I would use my science degrees in this moment and work in the lab until the pandemic finished. Over 2 years later, I now find myself still working with Randox and managing ten clinic labs in London and still testing for covid!

Q: What is the most challenging part of your job?

A: The most challenging thing I find is keeping an open line of communication with so many different departments. As our operations have continued to grow over the past 2 years, the more departments you find yourself dealing with, from operations and different clinics to HR and recruitment. There are so many cogs in the wheel and you need to work well with them all to keep it turning!

Q: What is your favourite thing about your role?

A: I love how quickly things move. Since I have started managing labs with Randox, we have opened dozens of new labs and are constantly adding new tests to our portfolio. You always have to be prepared and ready to go when the next new thing is announced. It keeps things exciting. I never feel that I’m bored or standing still in this role.

Q: And finally, why should others consider a career in clinical diagnostics?

A: When you hear feedback from a customer that their test results have helped save or prolong their life and how grateful and happy they are, that they decided to pay for their test – you remember what you are doing can change lives for the better.

 

We also got the opportunity to speak to Meadhbh, the Randox Clinical Laboratory Services Laboratory Manager, to hear about her work activities and opinions on working in a medical laboratory.

Q: Can you tell us your name and job title please?

My Name is Meadhbh Sheerin, and I am the RCLS Laboratory manager for all of RCLS.

Q: What does a normal workday look like for you at RCLS?

A: Everyday can be slightly different depending on what needs done. But everyday includes morning checks to identify work yet to be completed and ensure target sample turnaround times are met, dealing with customer queries, updating the LIMS system, adding new and bespoke tests to our equipment, managing reagent and other consumables, maintaining up to date SOP and ensuring laboratory staff follow them, and  attending in management meetings scheduled. In addition to this I am responsible for hiring and training new staff, setting up new RCLS laboratories and managing the daily activities of other staff.

Q: What encouraged you to pursue a career in clinical diagnostics?

A: For me, it was that people’s health is a priority. Every day, we are saving lives and helping people with their diagnosis, prevent any health conditions, and help them get the right treatment if necessary.

Q: What is the most challenging part of your job?

A: Juggling everything in terms of staff, getting samples in and processed and reports out in time. There is an awful lot to do!

Q: What is your favourite thing about your role?

A: Every day is different and it’s challenging. It is rewarding to know that we are helping individuals to improve their health and that we are the future of diagnostics.

Q: And finally, why should others consider a career in clinical diagnostics?

A: I think everyone should consider a career in some sort of laboratory discipline because you are helping people improve their health and prevent further illness. Preventative care is better than a cure!

 

Like Dean and Meadhbh, there are millions of conscientious laboratory scientists and technicians which provide crucial testing services all over the world. Working in clinical diagnostics is an incredibly fulfilling career path, providing the opportunity to help people and save lives from a behind-the-scenes yet essential role. We would like to thank Dean and Meadhbh for taking the time out of their busy schedules to answer our questions. Finally, we would like to express our gratitude to all the Medical Laboratory Professionals who have worked tirelessly before, during, and after the pandemic and wish you all the greatest success in the future!

 

How can Randox help?

Randox Sales Reps are experts in their fields and are available to discuss your specific requirements. 

Simply send us an email by clicking the link below and we will get in touch!


Medical Laboratory Professionals Week 2023

 

Medical Laboratory Professionals week is taking place from 23rd – 29th April 2023. This is an annual celebration to highlight and acknowledge the contribution of medical laboratory professionals and pathologists to medicine and healthcare. Whether carrying out routine testing or performing vital analysis during states of emergency, patients around the world rely on the hard work and dedication of medical laboratory professionals.

Medical laboratory professionals’ and pathologists’ work often goes unnoticed due to the ‘behind the scenes’ nature of their activities, but today we would like to shine a light on their work and highlight the importance of these individuals to medicine and global health. The role laboratory professionals play in healthcare cannot be understated and Randox would like to give thanks to those around the world who undertake this responsibility every day.

For most people, the process after a sample is taken is largely enigmatic. Therefore, we at Randox would like to elucidate the processes involved and the considerable effort displayed by laboratory staff.

After a sample is taken, it is then transported to a laboratory. Even this supposedly simple process requires careful consideration to ensure the sample is suitable for testing upon reaching the laboratory.  Once received, laboratory staff carry out quality control checks to ensure the instrumentation to be used is functioning correctly and providing accurate results. The quality control procedure will differ depending on the scientific discipline but some form of validation of the test process is always required.

Once accurate and robust sample analysis has been carried out a pathologist examines these results or data and works to form a diagnosis. Using this diagnosis, a suitable therapeutic strategy can be determined and administered.

Test results are a major factor in a clinician’s decision for diagnosis and treatment, with 70% of all medical decisions being based on laboratory results. This demonstrates why diagnostics are so important and why Randox believes in celebrating those who make it happen.

As a major contributor to the diagnostics and healthcare industry, we are keenly aware of how important and hard-working medical laboratory professionals are, and the value they bring to the world. This week you’ll find articles featuring a short interview with a medical laboratory professional and a short educational piece on pre-analytical errors.

We hope everyone shares our enthusiasm for celebrating medical laboratory professionals and would like to thank all those who work tirelessly in medical laboratories around the world.

How can Randox help?

Randox Sales Reps are experts in their fields and are available to discuss your specific requirements. 

Simply send us an email by clicking the link below and we will get in touch!


MRSA – Emerging Therapeutic & Screening Approaches

Staphylococcus aureus is a gram positive, commensal bacteria found in normal human flora on the skin and mucous membranes. The commensal nature of this organism results in colonisation of around half of the general population, rising to around 80% in populations of healthcare workers, hospitalised patients and the immunocompromised1.  However, given the opportunity to colonise internal tissues or the bloodstream, S. aureus infection can cause serious disease. Skin conditions caused by S. aureus include impetigo, scalded skin syndrome, boils, and abscesses. Examples of more serious conditions include meningitis, pneumonia, endocarditis, bacteraemia, and sepsis2.

Antimicrobial resistance (AMR) has, and continues to be, one of the largest threats to global health. In 2019, it is estimated that 1.27 million deaths globally were directly attributed to AMR, based on the drug-susceptible counterfactual, with only ischaemic heart disease and stroke accounting for more deaths in that year1. Figure 1 shows a global distribution map of MRSA isolates from the data of this comprehensive study. Methicillin-resistant Staphylococcus aureus (MRSA) was first identified only one year after the introduction of the penicillin-like antibiotic, methicillin3. While methicillin is no longer used in clinical practice, the term MRSA is used to encompass resistance to commercially available antibiotics such as β-lactams3. For many years, much work has gone into seeking novel therapies to combat drug-resistant bacteria, however, the indiscriminate overuse of antibiotics seen around the world, along with other factors, continues to contribute to the rise in AMR.

Identification of drug-resistant strains of bacteria is crucial to allow for characterisation of the pathogen and correct treatment of the infection. Classical evaluation consists of a routine culture to verify a diagnosis based on presenting symptoms. However, this can be a time consuming and laborious process which may delay diagnosis and treatment of a potentially fatal infection1.

Methicillin-Resistant Staphylococcus aureus

Methicillin is of a class of antibiotics known as β-lactams which bind to the penicillin binding protein (PBP) of the bacteria. PBP is responsible for crosslinking between N-acetylmuramic acid and N-acetylglucosamine which forms the architecture of the bacterial cell wall. When β-lactams bind to the PBP, a build-up of peptidoglycan precursors triggers autolytic digestion of peptidoglycan, facilitated by hydrolase. This reduction in peptidoglycans results in the loss of the integrity of the bacterial cell wall and ultimately culminates in cell damage caused by high internal osmotic pressure.

While methicillin has lost its clinical utility due to the emergent resistance, MRSA is used to describe S. aureus which displays resistance to penicillin-like antibiotics such as amoxicillin and oxacillin, as well as other forms of commercially available antibiotics like macrolides, tetracyclines, and fluroquinolones4. A meta-analysis by Dadashi et al., showed that 43% of S. aureus isolates where methicillin-resistant, exhibiting the prevalence of MRSA5.

Transmission is possible from direct contact with an infected individual or through contact with fomites2. MRSA infections can be categorised as either community acquired infections (CA-MRSA), or hospital acquired infections (HA-MRSA). While rates of HA-MRSA have fallen over the last ten years, this decrease in infection rates has not translated to CA-MRSA6. This is evidence of the requirement for quicker, easier testing in community settings to identify those infected by MRSA and to trigger the initiation of isolation and treatment.

While the pathophysiology of MRSA will largely depend on the causative strain of bacteria, collectively, S. aureus is the most common bacterial infection in humans and may result in infections of varying severity including1:

  • Bacteraemia
  • Infective endocarditis
  • Skin and soft tissue infections
  • Osteomyelitis
  • Septic arthritis
  • Prosthetic device infections
  • Pulmonary infections
  • Gastroenteritis
  • Meningitis
  • Toxic shock syndrome
  • UTIs

Development of resistance and resistance mechanisms

Antimicrobial resistance arises from a combination of mechanisms. Genetic mutations are crucial in the development of resistance mechanisms. These genetic mutations must favour the survival of the mutated gene and the advantage of AMR mechanisms to the survival of bacteria cannot be understated. Regarding MRSA, S. aureus can gain resistance through horizontal gene transfer mediated by plasmids, mutations in chromosomal genes or mobile genetic elements4.  Methicillin-susceptible Staphylococcus aureus (MSSA) gains the staphylococcal cassette chromosome (SCCmec) gene, a gene containing mecA, which is responsible for some of the resistance mechanisms displayed by MRSA4. The collection of antibiotics the bacteria gains resistance to, will depend on the SCCmec gene type.

The first mechanism of resistance is the expression of β-lactamase which functions to degrade β-lactams, ultimately resulting in loss of function of the antibiotic. This enzyme hydrolyses β-lactam ions in the periplasmic space, denaturing the antibiotic before it can interact with bacteria3. The mecA gene encodes the protein penicillin-binding protein 2a (PBP-2a), a type of PBP which has lower affinity for β-lactams, as well as other penicillin-like antibiotics due its conformation, meaning that the presence of these antimicrobial agents does not confer a loss of structure in the bacterial cell wall1.

One study conducted by Hosseini et al., investigated resistance mechanisms in MRSA and showed that all multidrug resistance MRSA strains displayed biofilm formation as part of its resistance strategy7. Biofilms induce resistance to high concentrations and a large variety of antimicrobial agents and help regulate anti-bacterial immune responses. Biofilm formation is mediated by the protein, polysaccharide intercellular adhesin (PIA). Furthermore, MRSA strains which display biofilm formation are associated with more severe and more virulent infections7.

Current and Emerging Therapeutic Strategies

Other types of antibiotics have been used to treat MRSA infections over the years. Vancomycin has been used to combat infections resistant to penicillin-like antibiotics as they display a different mode of action. Vancomycin inhibits peptidoglycan synthesis by forming hydrogen bonds within the structure of peptidoglycan precursors2. While this strategy has proven effective for past 50 years, more and more strains are displaying vancomycin resistance in addition to resistance to penicillin-like antibiotics8. One study by Deyno et al., estimates the prevalence of vancomycin-resistant S. aureus in Ethiopia to be around 11% 4. Daptomycin is another antibiotic which has been shown to be effective in MRSA treatment. This cyclic lipopeptide binds to the bacterial membrane, resulting in cell death9.

Due to the decreasing number of available, effective antibiotics, novel therapeutic strategies are required to combat MRSA infection. One of the most promising approaches uses antimicrobial peptides (AMPs). AMPs are naturally occurring molecules of the innate immune system and have one of two mechanisms of action: membranolytic action and non-membranolytic action. AMPs normally consist of and amphipathic or cationic structure, between 5-50 amino acids long. Naturally occurring AMPs have been used as a model to develop synthetic AMPs, designed to neutralise the limitations of natural AMPs boasting an improved half-life and improved antimicrobial properties3. Membrane disruptive AMPs can be further categorised by mechanism of action. The first is the Toroidal-pore model in which AMPs form vertical pores in the bacterial membrane causing a change in conformation of the lipid head. Next is the Barrel-stave mode, in which AMPs bind to the bacterial membrane and aggregate before breaching the cell wall causing uncontrolled cell movement, resulting in cell death3. Finally, in the carpet model, the membrane is destroyed in a detergent-like action where the AMPS arrange on the cell membrane with their hydrophobic part facing the phospholipid bilayer, altering the surface tension of the membrane. This eventually results in the formation of micelles and the destruction of the bacterial membrane3.

Non-membrane disruptive AMPs require much more investigation; however, it is accepted that these AMPs enter the cell, reacting with important intracellular components inhibiting protein and nucleic acid synthesis, cell division and protease activity3.

Silver nanoparticles (AgNPs) exhibit broad spectrum antimicrobial properties through various mechanisms of action. These nanosized particles boast increased antimicrobial properties due to an increased surface area per volume ratio. The first mechanism of action to note is AgNPs direct adhesion to the bacterial membrane, which alters the structural integrity of the membrane, allowing the AgNPs to penetrate the cell, wreaking havoc on the intracellular components until it loses the ability to carry out essential cellular processes3.

Once the AgNPs aggregate on the bacterial surface, the difference in electrostatic charge, driven by the positive charge displayed by the AgNPs and negatively charged bacteria, pit formation occurs on the cell surface, inhibiting vital cellular movement, resulting in cell death3. AgNPs may also inhibit protein synthesis by denaturing ribosomes and directly interacting with DNA. This interaction can cause denaturing of the DNA helix and ultimately result in cell death3. Finally, AgNPs can induce the production of reactive oxygen species (ROS) and free radicals. The molecules cause irreversible cell damage to the bacteria3.

While AMPs and AgNPs each possess individual limitations such as toxicity and instability, studies show that a combination of these therapeutic strategies can overcome these issues, stabilising the antimicrobial agents to their respective target sites3.

Screening, Testing & Evaluation

Classical determination of MRSA and other bacterial infections consists of obtaining a patient sample and growing colonies from the patient sample in culture. These cultures can then be investigated under a microscope and characterised, allowing diagnosis and the initiation of treatment. Whilst effective, these methods are time consuming and laborious, taking up to three days for cultures to develop, somewhat limiting their utility for the diagnosis of potentially fatal infections.

New molecular rapid PCR microbiology techniques aid in the identification of bacterial strains through a three-step process involving extraction, amplification, and detection. These new methods allow for timely identification of infectious strains and AMR characterisation. Specific genes or sections of gene which are responsible for AMR can be detected, helping to achieve strain characterisation and aid physicians in prescribing the correct treatment plan. These methods improve test turnaround times to around one to two days and help to reduce the risk of costly human error and contamination.

Vivalytic MRSA/SA

Bosch Vivalytic MRSA/SA is an automated qualitative in vitro diagnostic test based on real-time PCR for the detection and differentiation of methicillin-resistant Staphylococcus aureus (MRSA) and Methicillin-sensitive Staphylococcus aureus (MSSA) DNA from human nasal- or oropharyngeal swabs to aid in the diagnosis of MRSA infection of symptomatic or asymptomatic individuals, providing results in less than 1 hour.

Without MRSA screening, many MRSA colonised patients remain unnoticed in hospitals and will not be isolated. Without Isolation many of these patients transfer the pathogen to at least one other patient during their hospital admission. PCR based screening is associated with high precision and fast time to results and is often used for early decisions on isolation and hygiene measures.

This POCT system provides fast, accurate characterisation of MRSA/SA strains while minimising the required user steps and reducing the need for expensive laboratory equipment helping physicians implement timely and effective treatments.

Detectable Pathogens:

  • Methicillin-resistant Staphylococcus aureus
  • Methicillin-sensitive Staphylococcus aureus

Specific Gene Targets:

  • SCCmec/orfX junction
  • MecA/MecC
  • SA422

Some of the other benefits of this test include:

  • Multiple sample types – Data shows that for approx. 13% of MRSA carriers, the pathogen is only located in the throat. Therefore, using throat swabs significantly increases the sensitivity of detection by approx. 26%.
  • Broad MRSA Range – mecA or mecC are the genes responsible for resistance to β-lactam antibiotics. mecA/meC is part of the mobile genetic element Staphylococcal cassette chromosome mec (SCCmec). Vivalytic MRSA/SA can detect mecA as well as mecC and a broad variety of SCCmec elements which help to reduce false negative results.
  • Fast time-to-result – Provides quick results in less than 1hr allowing quick decisions on therapies. Traditional culture time-to-result is 48-72hrs and laboratory PCR is 12-24hrs.
  • This highly automated system minimises the user steps required to achieve a result while limiting the requirement for expensive lab equipment and sample transportation. Vivalytic MRSA/SA POCT test allow the implementation of treatment as soon as 1hr after sample collection.

References

  1. Murray CJ, Ikuta KS, Sharara F, et al. Global Burden of Bacterial Antimicrobial Resistance in 2019: A Systematic Analysis. The Lancet. 2022;399(10325):629-655. doi:https://doi.org/10.1016/S0140-6736(21)02724-0
  2. Nandhini P, Kumar P, Mickymaray S, Alothaim AS, Somasundaram J, Rajan M. Recent Developments in Methicillin-Resistant Staphylococcus aureus (MRSA) Treatment: A Review. Antibiotics. 2022;11(5):606. doi:https://doi.org/10.3390/antibiotics11050606
  3. Masimen MAA, Harun NA, Maulidiani M, Ismail WIW. Overcoming Methicillin-Resistance Staphylococcus aureus (MRSA) Using Antimicrobial Peptides-Silver Nanoparticles. Antibiotics. 2022;11(7):951. doi:https://doi.org/10.3390/antibiotics11070951
  4. Liu WT, Chen EZ, Yang L, et al. Emerging resistance mechanisms for 4 types of common anti-MRSA antibiotics in Staphylococcus aureus: A comprehensive review. Microbial Pathogenesis. 2021;156:104915. doi:https://doi.org/10.1016/j.micpath.2021.104915
  5. Dadashi M, Nasiri MJ, Fallah F, et al. Methicillin-resistant Staphylococcus aureus (MRSA) in Iran: A systematic review and meta-analysis. Journal of Global Antimicrobial Resistance. 2018;12:96-103. doi:https://doi.org/10.1016/j.jgar.2017.09.006

 

  1. Kourtis AP, Hatfield K, Baggs J, et al. Vital Signs: Epidemiology and Recent Trends in Methicillin-Resistant and in Methicillin-Susceptible Staphylococcus aureus Bloodstream Infections — United States. MMWR Morbidity and Mortality Weekly Report. 2019;68(9):214-219. doi:https://doi.org/10.15585/mmwr.mm6809e1
  2. Hosseini M, Shapouri Moghaddam A, Derakhshan S, et al. Correlation Between Biofilm Formation and Antibiotic Resistance in MRSA and MSSA Isolated from Clinical Samples in Iran: A Systematic Review and Meta-Analysis. Microbial Drug Resistance. Published online March 10, 2020. doi:https://doi.org/10.1089/mdr.2020.0001
  3. Verma R, Verma SK, Rakesh KP, et al. Pyrazole-based analogs as potential antibacterial agents against methicillin-resistance staphylococcus aureus (MRSA) and its SAR elucidation. European Journal of Medicinal Chemistry. 2021;212:113134. doi:https://doi.org/10.1016/j.ejmech.2020.113134
  4. Deyno S, Fekadu S, Astatkie A. Resistance of Staphylococcus aureus to antimicrobial agents in Ethiopia: a meta-analysis. Antimicrobial Resistance & Infection Control. 2017;6(1). doi:https://doi.org/10.1186/s13756-017-0243-7

Lipoprotein (a) Awareness Day 2023

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.

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.

Benefits of the Randox Lp(a) assay

 

 WHO/IFCC Reference Material

 Dedicated Five-Point Calibrator Available

 Excellent Correlation

 Excellent Precision

 Liquid Ready-To-Use

 Available in nmol/L

Applications Available-
on Roche, Abbott, Beckman, and more.

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.

How can Randox help?

Randox Sales Reps are experts in their fields and are available to discuss your specific requirements. 

Simply send us an email by clicking the link below and we will get in touch!


THE 2023 RANDOX GRAND NATIONAL TROPHY IS REVEALED

THE 2023 RANDOX GRAND NATIONAL TROPHY IS REVEALED

Sunday 19th March

The Randox Grand National Trophy is one of the most iconic and prestigious sporting trophies in the world of horseracing. From the start of the Randox sponsorship of the Grand National in 2017, Randox CEO Dr Peter FitzGerald proposed a unique trophy would be designed and produced each year.  The winning owner receives the full size the trophy, with the winning trainer, jockey and groom all receiving a miniature version.

Each trophy is uniquely Randox and has a story to tell. The design of the trophy has evolved over the years and the 2023 trophy, which is revealed today, has a special significance as it incorporates several key elements that represent the company’s values and achievements – alongside a nod to a very special racehorse.

At the top of the trophy there is a beautifully crafted horse mid-jump, symbolising the 30 fences that the winner will navigate during the four-mile, two-and-a-half-furlong contest on Saturday 15th April. The horse is shown making its way over a horseshoe instead of a fence, representing protection and good luck.

In the centre of the trophy, a gold blood drop symbolises Randox’s diagnostic testing. This leads up to the DNA double helix, representing the company’s genomic testing capabilities. Randox offers seven different types of genetic testing, empowering people to find out more about their future health.

The base of the trophy features a molecular pattern, representing Randox’s molecular testing capabilities. The “o” in Randox is embellished with red enamel, symbolising accuracy and precision, which are integral to the Randox brand. The red enamel is also representative of a blood drop, used in much of Randox’s diagnostic testing.

Etched along the bottom of the trophy, is “Celebrating the 50th anniversary of Red Rum winning his first Grand National race” paying tribute to the legendary Red Rum’s first of his record three Grand National triumphs in 1972. The quartet of silver strands that connect the top and bottom of the trophy represent Randox’s support of racing and sponsorship of the Grand National.

 

Elizabeth Moran of Randox, who designed the trophy, said: “It was a wonderfully creative challenge to design this year’s trophy, reflecting both this national, iconic sporting event and Randox’s innovation within healthcare, and I think we got it just right.”

Silversmith Cara Murphy, who produced the trophy added: “I am delighted with what we have achieved.  This is a highly intricate trophy and was challenging to produce – the end result is a trophy to grace the podium and recognise the achievement of winning the world’s greatest steeplechase.”

The 2023 Randox Grand National Trophy is a beautiful and intricate work of art that embodies the company’s commitment to innovation, accuracy, and precision in the field of diagnostic testing. The horse, the horseshoe, and the nod to Red Rum all come together to create a stunning and symbolic celebration of horseracing.

During the Randox Grand National Festival (Thursday 13th April – Friday 15th April inclusive), the trophy as well as trophies from previous Randox Grand Nationals, can be viewed in trophy marquee next to the Red Rum Garden at Aintree Racecourse.

 


World Kidney Day 2023

World Kidney Day 2023

“Kidney health for all – Preparing for the unexpected, supporting the vulnerable”

Thursday 09th March 

Chronic Kidney Disease (CKD) is considered a leading cause of global mortality with an overall global prevalence rate of around 13%1. This figure rises to 15% in the US2 and the statistics show that these rates are likely to continue this upward trend3. CKD is defined as damage to the kidneys which affects its ability to correctly filter bodily fluids which ultimately results in renal replacement therapy in the form of dialysis or transplantation4. This sustained or chronic damage of the kidney encourages kidney fibrosis and loss of structure. The early stages of CKD are generally asymptomatic with symptoms beginning to manifest in stages 4 and 5. These symptoms include nausea & vomiting, fatigue & weakness, oliguria, chest pain, hypertension, to name a few4.

World Kidney Day is an annual, global campaign spearheaded by the International Society of Nephrology (ISN) and the International Federation of Kidney Foundations – World Kidney Alliance (IFKF – WKA) which intends to raise awareness of how critical our kidneys are and to limit the prevalence and impact of kidney disease5. This year’s focus is “Kidney health for all – preparing for the unexpected, supporting the vulnerable.”

It is no surprise that patients suffering from noncommunicable diseases (NCDs) such as CKD were subject to worse prognosis during the COVID-19 pandemic6 due to prioritising of ongoing complex care over acute patient care7. But a pandemic is only one circumstance, albeit a major one, which can affect the ability of hospitals and laboratories to uphold their normal testing capacity. For example, natural disasters can make it impossible for people to reach facilities for testing or treatment7. Similar situations could arise at a more local level such as road closures, power outages or public transport strikes which have the potential to delay diagnosis or treatment.

To this end, laboratories should look to introduce novel and effective methods for testing under adverse conditions. Rapid testing will be imperative to help achieve these goals and promote fast test turnaround times and accurate diagnosis. The Randox CKD Arrays, in conjunction with the Randox Evidence Investigator, allow for simultaneous and quantitative detection of multiple serum biomarkers of kidney damage-related analytes allowing diagnosis at a much earlier stage than traditional creatinine tests.

Utilising patented Biochip Technology, the Randox CKD arrays could improve patient risk stratification whilst monitoring the effectiveness of treatment. Diagnosis of CKD at early stages will allow earlier intervention for the treatment of kidney disease, and the prevention of further kidney damage. The utility of this test cannot be overstated. In adverse circumstances, the Randox Evidence Investigator could permit diagnosis of CKD and determination of CKD severity at the site of the patient, helping prepare for the unexpected and support the vulnerable.

More information of CKD and other kidney related conditions can be found at: Homepage – World Kidney Day

 

References
Bibliography
  1. Lv JC, Zhang LX. Prevalence and Disease Burden of Chronic Kidney Disease. Advances in Experimental Medicine and Biology. 2019;1165:3-15. doi:https://doi.org/10.1007/978-981-13-8871-2_1
  2. Centers for Disease Control and Prevention. Chronic Kidney Disease in the United States, 2021. US Department of Health and Human Services; 2021. https://www.cdc.gov/kidneydisease/pdf/Chronic-Kidney-Disease-in-the-US-2021-h.pdf
  3. Kovesdy CP. Epidemiology of chronic kidney disease: an update 2022. Kidney International Supplements. 2022;12(1):7-11. doi:https://doi.org/10.1016/j.kisu.2021.11.003
  4. Vaidya SR, Aeddula NR. Chronic renal failure. Nih.gov. Published 2019. https://www.ncbi.nlm.nih.gov/books/NBK535404/
  5. International Society of Nephrology. Homepage. World Kidney Day. Published 2023. https://www.worldkidneyday.org/
  6. Nikoloski Z, Alqunaibet AM, Alfawaz RA, et al. Covid-19 and non-communicable diseases: evidence from a systematic literature review. BMC Public Health. 2021;21(1). doi:https://doi.org/10.1186/s12889-021-11116-w
  7. Hsiao LL, Shah KM, Liew A, et al. Kidney health for all: preparedness for the unexpected in supporting the vulnerable. Kidney International. 2023;103(3):436-443. doi:https://doi.org/10.1016/j.kint.2022.12.013

 

For more information, please contact Market@randox.com

 


Randox announces ‘Race against Dementia’ as partner charity for Randox Grand National Festival 2023

RANDOX ANNOUNCES ‘RACE AGAINST DEMENTIA’

AS PARTNER CHARITY FOR RANDOX GRAND NATIONAL FESTIVAL 2023

Thursday 16th February

Randox today announces that Race Against Dementia, a global charity founded by three-times Formula 1 World Champion Sir Jackie Stewart, OBE, as its charity partner for the Randox Grand National Festival 2023.

Today, across the globe, more than 55 million people are living with dementia, with someone new being diagnosed with the disease every three seconds.  Unless a cure is found, it is estimated that one in three people born today will die with dementia.

Randox will support Race Against Dementia throughout the three-day Aintree festival, to highlight the impact of the disease and to raise funds for much needed research into its prevention and cure.

On Ladies Day (Friday 14th April), Randox’s sponsored race over the Grand National fences will be titled ‘The Randox Supports Race Against Dementia Topham Chase’, and there will be opportunities to reach out to both the racing public and, through the festival’s media coverage, to the nation.

The 2023 Festival will also enable a welcome return to Aintree for Sir Jackie, who raced at Aintree in the 1960s, at a time when Aintree was part of the Grand Prix circuit.

As a global diagnostics company, with over 40 years of experience and a focus on preventative healthcare, Randox and Race Against Dementia are natural partners.

In the pursuit of a cure for dementia, improved testing and diagnosis will both enhance patient management and greatly accelerate the race for treatment.

 

Dr Peter FitzGerald, Managing Director of Randox said:

“Randox is proud to partner with Race Against Dementia as our nominated charity for 2023.

“We understand the importance of taking action early regarding current and future health. As a global market leader within the clinical diagnostics field, it was an obvious choice for Randox to partner with a similarly ambitious organisation. Race Against Dementia is a cause very close to many of our hearts.”

 

Sir Jackie Stewart OBE, Founder of Race Against Dementia, said:

“Race Against Dementia is delighted to be supported by Randox Laboratories in our race to find a cure for dementia.

“It is a great privilege to partner with an organisation which is an active innovator and is supporting our mission to accelerate the progress of dementia research.

“We are confident that working together with Randox will help to raise funds that will allow us to break new ground in the search for a cure or prevention of dementia.

“On a personal front, I have raced at Aintree before – it is a pleasure to be back, with another ‘race’ in mind.”

 

Dickon White, Regional Director, The Jockey Club North West, said:

“We are proud to support Race Against Dementia at the Grand National Festival and extend our thanks to Randox for helping to bring this partnership to fruition.

“Being staged over the famous Grand National fences, the Randox Supports Race Against Dementia Topham Chase should prove a very suitable vehicle for helping to publicise the vital work of Race Against Dementia.”

 

About Randox Laboratories

With over 40 years of diagnostic experience, Randox is globally recognised as being at the forefront of diagnostic capability and understands the importance of comprehensive and reliable research.

Past research and development has identified key proteins associated with Alzheimer’s disease risk, stratifying at-risk populations, for early identification and assisting with clinical research.

Randox has recently made significant investment to deliver preventative, personalised testing packages across the nation and has opened over 20 new Randox Health clinics. Randox Health clinics focus on the provision of cost-effective, timely and accurate testing to identify risk to health, improve clinical diagnoses and promote preventative healthcare.

 

About Race Against Dementia

Race Against Dementia is a global charity, founded by Sir Jackie Stewart, OBE, to fund pioneering research into the prevention and cure of dementia.

RAD supports a number of Early Career Researchers in the UK, US, Australia, Europe and South Africa in order to accelerate dementia research.

RAD’s vision is a breakthrough in the prevention or treatment of dementia with the greatest of urgency.

 

www.raceagainstdementia.com

For more information, please contact Market@randox.com

 


Randox products go paperless in environmental friendliness initiative

News       About Us        IFUs

 

01 November 2019

Randox Kits Go Paperless

In the latest on a list of initiatives aimed at improving its environmental friendliness, Randox Laboratories has announced the removal of IFUs from its products, in a bid to go paperless.

As of 1st June 2019, all Randox Reagent, ELISA and QC kits no longer contain a copy of the product’s IFUs (Instructions For Use), to aid in reducing our carbon footprint.

Did you know, in the US, office copy paper alone still accounts for over 20% of total paper usage?

Randox is committed to reducing our environmental impact across all areas of the business, and going paperless will go a long way in contributing to the efforts the company already makes to be more environmentally-friendly.

We also have a dedicated Environmental team whose role it is to prevent pollution, reduce waste, recycle consistently, and in general, to control and reduce the risks to air, land and water.

Each year the team plants a new area of trees around Lough Neagh in Northern Ireland, where our headquarters are located, to make sure the area continues to develop and flourish, and to maintain the wildlife diversity.

And it’s not just the Environmental team who endeavour to reduce our atmosphere emissions and energy use. Whether a scientist or marketer, manufacturing operative or salesperson, each member of Team Randox makes an effort to reduce our waste where we can – for example by turning off our computers, heating and lighting when not in use, and maintaining our equipment properly in order to maximise their efficiency.

Our engineering and manufacturing team, in particular, take environmental factors into consideration daily – whether the material they have chosen is environmentally friendly, if their processes are efficient and if waste material can be recycled.

Our training department also went paperless recently. Rather than completing training documentation on paper, the team is now utilising a paperless data management system to reduce our impact on the environment even more.

And instead of IFUs being included within Randox product kits, they will all now be available for download on randox.com.

To access your Randox kit inserts please follow the steps below;

1. Under the “Support & Documentation” tab on Randox.com, you will be presented with a number of options. Under the ‘Product Inserts’ tab, you will be able to access:

-Kit inserts for Reagents (including RX series)

-Kit inserts for ELISAs

2. You will be required to login, or to create an account by clicking “Request Access.”

– Upon logging on, you will be able to select a general insert, RX series insert, ELISA insert and so on.

– Alternatively, you can search for a specific cat code using the search field on the right. You can also opt for the results to display in ascending or descending order and then simply search for the kit.

Please see below a breakdown of how to access Randox IFUs on Randox.com.

 

Also listed under the “Support & Documentation” tab on Randox.com are the following useful tabs:

• QC / Calibrator Documents
– IFUs and value sheets for QC material and calibrators
– No log-in required

• MSDS
– Material safety data sheets for all products
– No log-in required

Randox places great importance on looking after the environment and reducing our carbon footprint.

We are constantly trying to find more ways to reduce environmental impact, contribute to the reduction of global CO2 emissions, and make sure that the area of outstanding natural beauty in County Antrim in which we work is preserved for many generations to come.

Should you have any questions about how to access Randox Instructions For Use online, please contact applications@randox.com

For further information on what we do at Randox to protect the local environment, please contact the Randox PR Team: phone 028 9442 2413 or email randoxpr@randox.com

Want to know more about Randox?

Contact us or visit our homepage to view more.

Our Randox Products and Services

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Randox Horse Tales | Sir Anthony McCoy on Don’t Push It

There are few partnerships in sport that compare to that between the jockey and their horse.

To celebrate these incredible animals, Randox is launching a new series in which well-known equestrians share their memories of their favourite horses.

This week, we hear from the legendary Sir Anthony McCoy, 20-time Champion Jump jockey.

In 2010 he won the Grand National on Don’t Push it – a victory he credits with transforming the rest of his career.

For more information about Randox Horse Tales please contact Randox PR on 028 9445 1016 or email RandoxPR@randox.com


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