Identifying and Reducing Pre-analytical Errors in the Medical Laboratory
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.
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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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
WHO/IFCC Reference Material
Dedicated Five-Point Calibrator Available
Dedicated Five-Point Calibrator Available
Excellent Correlation
Excellent Correlation
Excellent Precision
Excellent Precision
Liquid Ready-To-Use
Liquid Ready-To-Use
Available in nmol/L
Available in nmol/L
Applications Available-on Roche, Abbott, Beckman, and more.
Applications Available-
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!
International Day of Women and Girls in Science!
International Day of Women and Girls in Science!
On Saturday 11th February, we are celebrating International day of Women and girls in Science! This day is an opportunity to celebrate and promote equal access to science for women and girls.
Why this Day is Important
The purpose of International Day of Women and Girls in Science (IDGWS) is to bring everyone forward for sustainable and fair development in society. The international day allows us to celebrate women’s achievements in science and places the necessary focus on ensuring girls are equally equipped with the skills necessary to enter a career in STEM.
This year commences the 8th year of International Day of Women and Girls in Science and aims to particularly focus on the role of women and girls in science in relation to the Sustainable Development Goals (SDGs). As Gender equality has always been a fundamental issue for the United Nations, the empowerment of women and girls will make a vital contribution, not only to economic development, but also across all the Goals of the 2030 Agenda for Sustainable Development. In doing so the IDWGS aims to connect women and girls in science to the international community, strengthening connections to science, society and the development of strategies aimed towards the future.
*Click the individual photographs for their full interview*
International Day of Women and Girls in Science!
International Day of Women and Girls in Science!
On Saturday 11th February, we are celebrating International day of Women and girls in Science! This day is an opportunity to celebrate and promote equal access to science for women and girls.
Ahead of the 11th, we have interviewed five influential Women who fulfil STEM based roles across Randox Laboratories. They have shared their experiences and thoughts on Women and girls in the science industry.
Our fifth interview is with Marketing Manager, Lynsey Adams.
Why did you pursue a career in STEM?
I have always been interested in biology and what makes us unique. For that reason, I chose to study Genetics at Queens University Belfast. I have been lucky enough to work in the life sciences industry ever since.
What is your role in Randox and how long have you worked in the company for?
When I first came to Randox 15 years ago, I started off in Technical Support. I then progressed into the Marketing department and worked my way up to where I am today, to be the Head of Marketing. My role predominantly involves Marketing our scientific product ranges as well as B2C product offerings and sponsorships. Having a background in science has helped me to excel in my Marketing role and I am fortunate to be able to have the opportunity to do both the things that I enjoy and am passionate about.
What change have you seen for women in science over the years?
There has been an increase of women in STEM in general, whether that be more females studying STEM related subjects at university or exploring a career in STEM. Throughout the years, I have been privileged to work with so many females in managerial and authoritative roles within Randox.
Have you found it harder or any different going into your career in science as a woman?
Throughout the years I have been fortunate enough to have female teachers and lecturers provide crucial STEM related education who encourage females to pursue a career in STEM. During my working career I have experienced the same opportunities as other colleagues and seen an increase in women exceling in science.
How do you think we can encourage more women to go into the science industry?
Awareness of the varied career paths available within STEM related industries would be beneficial. The availability of work experience, placement, apprenticeship and graduate programmes like those offered at Randox helps to expose both males and females to the many exciting opportunities in the field.
If you have one piece of advice as a woman starting out the STEM industry, what would it be?
STEM is an equal playing field, so have confidence in your own ability and intelligence to get to where you want to be.
For more information, please contact Market@randox.com
International Day of Women and Girls in Science!
International Day of Women and Girls in Science!
On Saturday 11th February, we are celebrating International day of Women and girls in Science! This day is an opportunity to celebrate and promote equal access to science for women and girls.
Ahead of the 11th, we have interviewed five influential Women who fulfil STEM based roles across Randox Laboratories. They have shared their experiences and thoughts on Women and girls in the science industry.
Our fourth interview is with Head of RCLS Quality, Emma McGoldrick.
Why did you pursue a career in STEM?
I have always been interested in how things work. I enjoyed Maths and Science at school and chose to study Biomedical Science at university because it gave an overview of different areas of science and had a lot of practical modules.
What is your role in Randox and how long have you worked in the company for?
I started in Randox in 2018 working in the RTS laboratory doing routine analysis. During the pandemic I moved across to RCLS and was involved in the Covid-19 testing as a PCR shift lead and eventually a Deputy Lab Manager. In 2022, when the testing demands were decreasing, I moved into the RCLS Quality Department and became the Head of Department.
The Quality Department are responsible for ensuring the validity of results that are sent out to our customers, allowing them to have confidence in our service. The Quality Department are also responsible for maintaining our accreditation status and applying for any new accreditations for new testing.
What change have you seen for women in science over the years?
Over the years I have seen an increase in the number of women, not only in science, but in positions of responsibility or authority.
Have you found it harder or any different going into your career in science as a woman?
I wouldn’t say I have found it more difficult as such but at times you can be very conscious of the fact that it can be a very male dominated field and as a result of that feel that you have to work harder or do more to be taken seriously.
Fortunately, in the course of my career I have had a lot of female managers and colleagues. In fact, out of pure circumstance my team is predominantly women which is quite nice to work in a very supportive environment.
How do you think we can encourage more women to go into the science industry?
I think it is important to showcase careers in Science and STEM to give young girls the insight into what they can achieve. It is important to support young girls in school and allow them to feel heard and encouraged that they can do whatever they choose without any undue pressure in adhering to societal gender roles. Outreach to primary school age girls as well as high school age girls and showing them the variety of careers available to them in STEM is an important step in encouraging more women to go into STEM.
If you have one piece of advice as a woman starting out the STEM industry, what would it be?
I would say to any women starting out in STEM to keep going and pursue their career path and not to be put off. There is plenty of room for women in STEM and they shouldn’t be afraid to take up space in the field.
For more information, please contact Market@randox.com
International Day of Women and Girls in Science!
International Day of Women and Girls in Science!
On Saturday 11th February, we are celebrating International day of Women and girls in Science! This day is an opportunity to celebrate and promote equal access to science for women and girls.
Ahead of the 11th, we have interviewed five influential Women who fulfil STEM based roles across Randox Laboratories. They have shared their experiences and thoughts on Women and girls in the science industry.
Our third interview is with Business Development Manager, Remy Patton.
Why did you pursue a career in STEM?
I was always interested in Biology and studied Biomedical Science at University in Edinburgh. During my degree I spent a lot of time in the lab, but after 4 years of studying I knew working in a lab environment full time wasn’t for me. I wanted a sales role, staying within the medical industry. After taking a gap year I applied for the Graduate Scheme at Randox. I have been given the opportunity to progress quickly in this role and now get the best of both worlds – engaging with customers, while also using my Scientific background.
What is your role in Randox and how long have you worked in the company for?
I am a Sales Manager, overseeing some of our European markets. I have been working at Randox for just over 3 years and am lucky enough to get the opportunity to travel internationally every month. While on work trips I visit current customers, build relationships with potential new customers, all while promoting our Randox Quality Control portfolio. Being in the field also allows me to see Randox products being used in real-life scenarios. Ultimately, the products we sell ensures accurate patient results, which is our number one priority.
What change have you seen for women in science over the years?
Women are gradually infiltrating into this industry, due to STEM subjects being encouraged at school from a young age. We now have successful role models, inspiring future generations of female STEM workers. In Randox, we have career focused women working in many different departments, such as Manufacturing, Engineering and Logistics – which were once male dominated sectors.
Have you found it harder or any different going into your career in science as a woman?
In this role, I have never felt disadvantaged to be female and have actively been encouraged to progress in the company and further my career. I’ve had the same opportunities as my male colleagues and feel that I can provide the same quality of service to the company.
How do you think we can encourage more women to go into the science industry?
We can promote equal opportunities for both male and female candidates and make it clear that females are as successful in the science industry as males. We can also team up with local schools and universities to hold workshops, to show women exactly how many different opportunities there are to explore within science.
If you have one piece of advice as a woman starting out the STEM industry, what would it be?
My advice would be for women to believe in their abilities to succeed!
For more information, please contact Market@randox.com
International Day of Women and Girls in Science!
International Day of Women and Girls in Science!
On Saturday 11th February, we are celebrating International day of Women and girls in Science! This day is an opportunity to celebrate and promote equal access to science for women and girls.
Ahead of the 11th, we have interviewed five influential Women who fulfil STEM based roles across Randox Laboratories. They have shared their experiences and thoughts on Women and girls in the science industry.
Our second interview is with Lead Biomedical Engineer- Sarah Hamilton.
Why did you pursue a career in STEM?
At A-Level I studied Technology & Design, Biology & Chemistry. I always enjoyed the process of facing a problem scenario and working through design processes to form a solution. The problems I identified were always centred around healthcare issues. During A-Levels, I also had the opportunity to take part in the Sentinus Golden Crest Award, an initiative promoting STEM in schools. I went on to pursue a career in Engineering largely down to the great exposure I had to the industry during my time at school. Biomedical Engineering appealed to me most as it had the added aspects of applying biological/biochemical principles to technology in ways that improve healthcare provision and create products that directly impact quality of life. As part of my degree, I had an Industrial placement year, this experience was within Medical Device R&D where I had some amazing mentors who helped me see that Engineering R&D was definitely the correct career path for me.
What is your role in Randox and how long have you worked in the company for?
My role within Randox is Lead Biomedical Engineer within the Engineering R&D department. I started in 2017 having graduated from Ulster University as a Biomedical Engineer. During the last 6 years I have progressed to a Team Leader role. In this role I co-ordinate a team of 7 people from Senior to Placement Biomedical Engineers.
Within this team we work across multiple projects which are all in different stages of development. My main role is to plan and facilitate the completion of testing ranging from early prototype development through to Verification & Validation. The Biomedical Engineering role involves working within a multidisciplinary team of Mechanical, Electrical & Embedded Design Engineers, Software Developers & Testers and Scientists (Chemists & Physicists). In Engineering, we also work alongside Assay Development Scientists and Lab Scientists. In doing so we ensure our product requirements are in line with user needs and performance is as expected.
What change have you seen for women in science over the years?
Comparing my time at school & university to now, there has been a noticeable change in the emphasis put on STEM careers. It is great to see employers from a variety of industries participating in more outreach programmes aimed at both primary, secondary and tertiary education levels, similar to the Sentinus Award which first got me interested in a STEM career. Many of my colleagues, and I, have participated in different events aimed at promoting careers in STEM. And I know many companies have diversity and inclusion programmes with aims of attracting more females into STEM roles at both junior and more senior levels. I feel that this has helped change attitudes of both woman and men from what was previously considered normal within STEM.
Have you found it harder or any different going into your career in science as a woman?
When I started as a graduate engineer, I was the only female in a team of 15 men, so, while I have found the industry still quite predominately male, I don’t believe this poses any setbacks for starting out in a STEM career or for career progression. Currently, within my own team of Biomedical Engineers, we have an even split of woman to men which is a positive step in the right direction, and I look forward to seeing that equality normalised in future. Overall, getting to work within a group of likeminded people who work together to solve multiple complex problems is extremely rewarding.
How do you think we can encourage more women to go into the science industry?
I think improving and promoting initiatives that provide exposure/insight into the STEM industry in schools is one of the best ways to inspire the next generation. It allows more girls to see the many different roles in the STEM industry which they might not otherwise have been aware of or considered pursuing.
If you have one piece of advice as a woman starting out the STEM industry, what would it be?
Have confidence to make sure you are heard.
For more information, please contact Market@randox.com
