The RX series celebrate Medical Laboratory Professionals Week
The RX series celebrate Medical Laboratory Professionals Week
Medical Laboratory Professionals Week is taking place this year from 22nd– 28th April 2018. This is an annual celebration of professionals working in the laboratory, highlighting and recognising their contributions to medicine and healthcare.
To celebrate Medical Laboratory Professionals Week the RX series interviewed Aidan Murphy, one of our laboratory analysts at Randox to find out more about what his job in the lab entails day-to-day. Aidan works with the RX series of clinical chemistry analysers and Randox QC on a daily basis.
We asked Aidan a few questions about his life as a scientist. See what he gets up to in Randox on a daily basis …
1. What attracted you to a career in laboratory science?
Science has always interested me in both my academic and personal life, I always aspired to get a science based degree and after achieving this I now hope to improve my laboratory skills to increase my employability.
2. What were your stronger subjects at school?
My strongest subjects in school were biology, chemistry, music and politics. Some of which are more applicable to my current role than others.
3. What does your job in Randox entail?
My job entails a variety of roles ranging from testing Randox diagnostic kits before they’re released to customers as well as maintenance and precision checks of the machines in our lab.
4. What aspects of your job do you enjoy the most?
The independence in my job is great. Knowing what I have to do at the start of each week and the deadlines to do these jobs requires me to organise and prioritise my work accordingly.
5. What are some common preconceived ideas the public have about what laboratory staff do?
From my friends’ ideas of what I do in the lab I have found that a stereotypical image of a lab is one of a dark quiet lab full of strange equipment and even stranger people. However fortunately my lab is a lively one and thankfully with normal people.
6. In your opinion, what are the most important aspects of laboratory work?
Following correct protocols and procedures are imperative in an efficient laboratory. As well as this, good lab practice and good hygiene can have a massive effect on the accuracy of our results.
7. What’s in your lab coat pocket?
My lab coat pockets are quite boring. I have a pair of safety goggles, some post-its and some pens and markers.
8. In what ways does your work make a difference to people’s lives?
Randox is dedicated to improving the quality of diagnostics globally, so knowing that the kits that I have tested are then sent to customers to be used in patient diagnosis gives me a level of job satisfaction that I haven’t got from previous jobs.
Aidan is a fundamental member of the Randox team and plays an essential role in the diagnosis and prevention of disease through his work. Without our valuable laboratory team working extremely hard behind the scenes the lifesaving work we do here at Randox would not be possible.
To find out more about Randox products contact us at theRXseries@randox.com.
Check out our social media sites for more on Medical Laboratory Professionals Week.

Could there be 5 types of diabetes?
A peer-reviewed study, published in The Lancet Medical Journal suggests there are five types of diabetes. Could diabetes be more complex than we once thought? Could diabetes be segmented into five separate diseases?
What is diabetes?
Diabetes is an incurable disease which prohibits the body’s ability to produce and respond to insulin. Currently, diabetes is classified into two main forms, type 1 and type 2.
Type 1 diabetes is an autoimmune disease which manifests in childhood. In type 1 diabetes, the body’s white blood cells attack the insulin-producing cells in the pancreas. As a result, individuals with Type 1 diabetes rely on the injection of insulin for the remainder of their lives.
Type 1 diabetes affects 10 percent of individuals with diabetes. 96 percent of children diagnosed with diabetes have type 1. Type 1 diabetes in children is commonly diagnosed between the ages of 10 and 14. The prevalence of type 1 diabetes in children and young people (under the age of 19) is 1 in every 430-530 and the incidence of type 1 in children under 14 years of age is 24.5/100,000 (Diabetes UK, 2014).
Type 2 diabetes is the result of insulin resistance, meaning that the pancreas does not produce enough insulin or the body’s cells do not respond to the insulin produced. As type 2 diabetes is a mixed condition, with varying degrees of severity, there are a few methods to manage the disease, including dietary control, medication and insulin injections.
Type 2 diabetes is the most common form of diabetes, affecting 90 percent of individuals with diabetes, and has now become a global burden. The global prevalence of diabetes has almost doubled from 4.7 percent in 1980 to 8.5 percent in 2014, with a total of 422 million adults living with diabetes in 2014. It is expected to rise to 592 million by 2035. In 2012, diabetes accounted for 1.5 million deaths globally with hypertension causing a further 2.2 million deaths. 43 percent of these deaths occurred before 70 years of age. Previously type 2 diabetes was commonly seen in young adults but is now commonly seen in children as well. In 2017, 14% more children and teenagers in the UK were treated for diabetes compared to the year before (World Health Organization, 2016).
In both forms of diabetes, hyperglycemia can occur which can lead to number of associated complications including renal disease, cardiovascular disease, nerve damage and retinopathy.
The novel subgroups of adult-onset diabetes and their association with outcomes: a data-driven cluster analysis of six variables – peer-review study
This new research studied 13,270 individuals from different demographic cohorts with newly diagnosed diabetes, taking into consideration body weight, blood sugar control and the presence of antibodies, in Sweden and Finland.
This peer-reviewed study identified 5 disease clusters of diabetes, which have significantly different patient characteristics and risk of diabetic complications. The researchers also noted that the genetic associations in the clusters differed from those seen in traditional type 2 diabetes.
Cluster One – Severe autoimmune diabetes (SAID)
SAID is similar to type 1 diabetes. SAID manifests in childhood, in patients with a low BMI, have poor blood sugar and metabolic control due to insulin deficiency and GADA. 6% of individuals studied in the ANDIS study were identified with having SAID.
Cluster Two – Severe insulin-deficient diabetes (SIDD)
SIDD is similar to SAID, however, GADA is negative. This means that the characteristics of SIDD are the same as SAID, young, of a healthy weight and struggled to make insulin, however, SIDD is not the result of an autoimmune disorder as no autoantibodies are present. Patients have a higher risk of diabetic retinopathy. 18% of subjects in the ANDIS study were identified with having SIDD.
Cluster Three – Severe insulin-resistant diabetes (SIRD)
SIRD is similar to that of type 2 diabetes and is characterised by insulin-resistance and a high BMI. Patients with SIRD are the most insulin resistant and have a significantly higher risk of kidney disease, and microalbuminuria, and non-alcoholic fatty liver disease. 15% of subjects in the ANDIS study were identified as having SIRD.
Cluster Four – Mild obesity-related diabetes (MOD)
MOD is a mild form of diabetes which generally affects a younger age group. This is not characterised by insulin resistance but by obesity as their metabolic rates are close to normal. 22% of subjects in the ANDIS study were identified as having MOD.
Cluster Five – Mild age-related diabetes (MARD)
MARD is the most common form of diabetes manifesting later in life compared to the previous four clusters. Patients with MARD have mild problems with glucose regulation, similar to MOD. 39% of subjects in the ANDIS study were identified with having MARD.
This new sub-classification of diabetes could potentially enable doctors to effectively diagnose diabetes earlier, through the characterisation of each cluster, including: BMI measurements, age, presence of autoantibodies, measuring HbA1c levels, ketoacidosis, and measuring fasting blood glucose levels. This will enable a reduction in the incidence of diabetes complications and the early identification of associated complications, and so patient care can be tailored, thus improving healthcare (NHS, 2018) (The Week, 2018) (Ahlqvist, et al., 2018) (Collier, 2018) (Gallagher, 2018).
The Randox diabetes reagents cover the full spectrum of laboratory testing requirements from risk assessment, using our Adiponectin assay, to disease diagnosis and monitoring, using our HbA1c, glucose and fructosamine assays, to the monitoring of associated complications, using our albumin, beta-2 microglobulin, creatinine, cystatin c, d-3-hydroxybutyrate, microalbumin and NEFA assays.
Whilst this study is valuable, alone it is not sufficient for changes in the diabetes treatment guidelines to be implemented, as the study only represents a small proportion of those with diabetes. For this study to lead the way, the clusters and associated complications will need to be verified in ethnicities and geographical locations to determine whether this new sub-stratification is scientifically relevant.
References
Ahlqvist, E. et al., 2018. Novel subgroups of adult-onset diabetes and their association with outcomes: a data-driven cluster analysis of six variables. [Online]
Available at: http://www.thelancet.com/journals/landia/article/PIIS2213-8587(18)30051-2/fulltext?elsca1=tlpr
[Accessed 16 April 2018].
Collier, J., 2018. Diabetes: Study proposes five types, not two. [Online]
Available at: https://www.medicalnewstoday.com/articles/321097.php
[Accessed 16 April 2018].
Diabetes UK, 2014. Diabetes: Facts and Stats. [Online]
Available at: https://www.diabetes.org.uk/resources-s3/2017-11/diabetes-key-stats-guidelines-april2014.pdf
[Accessed 16 April 2018].
Gallagher, J., 2018. Diabetes is actually five seperate diseases, research suggests. [Online]
Available at: http://www.bbc.co.uk/news/health-43246261
[Accessed 16 April 2018].
NHS, 2018. Are there actually 5 types of diabetes?. [Online]
Available at: https://www.nhs.uk/news/diabetes/are-there-actually-5-types-diabetes/
[Accessed 16 April 2018].
The Week, 2018. What are the five types of diabetes?. [Online]
Available at: http://www.theweek.co.uk/health/92048/what-are-the-five-types-of-diabetes
[Accessed 16 April 2018].
World Health Organization, 2016. Global Report on Diabetes, Geneva: World Health Organization.

The Importance of Meeting ISO 15189 Requirements
Laboratory accreditation provides formal recognition to competent laboratories, providing a means for customers to identify and select reliable services (CALA, n.d.). Use of accreditation standards by clinical laboratories enables them to drive gains in quality, customer satisfaction, and financial performance. This is essential at a time when laboratory budgets are shrinking.
Some key benefits include:
- Recognition of testing competence – as mentioned above, customers can recognise the competence of a lab with an internationally recognised standard.
- Marketing advantage – accreditation can be an effective marketing tool as labs can demonstrate their quality and overall competence.
- Benchmark for performance – laboratories can determine whether they are performing to the appropriate standards and provides them with a benchmark to maintain that standard.
To maintain the global recognition gained from accreditation, labs are evaluated regularly by an accreditation body to ensure their continued compliance with requirements, and to check that standards are being maintained. (CALA, n.d.).
In a comprehensive study conducted by Rohr et al. (2016) it was found that, while accounting for as little as 2% of total healthcare expenditure, in vitro diagnostics (IVD) account for 66% (two thirds) of clinical decisions. Despite such a small percentage of budget dedicated to it, IVD plays a huge role in patient care so it is vital that there is guidance in place to ensure quality standards are met. Poor performance of tests at any stage of care and treatment can reduce the effectiveness of treatment and deny appropriate care to patients in need (Peter et al., 2010).
ISO 15189 is an international accreditation standard that specifies the quality management system requirements particular to medical laboratories and exists to encourage interlaboratory standardisation, it is recognised globally.
Meeting ISO Requirements
Scroll through below to learn how ISO 15189 regulates aspects of a clinical laboratory and how Randox can help you meet these suggestions.

Review of QC data
“The laboratory shall have a procedure to prevent the release of patient results in the event of quality control failure. When the QC rules are violated and indicate that examination results are likely to contain clinically significant errors, the results shall be rejected…QC data shall be reviewed at regular intervals to detect trends in examination performance”
– ISO 15189:2012
Acusera 24∙7 will automatically apply QC multi-rules, alert you to or reject any results that violate the QC multi-rules or performance limits, generate a variety of charts allowing visual identification of trends and provide access to real-time peer group data to assist with the troubleshooting process.
Calculation of MU
“The laboratory shall determine measurement uncertainty for each measurement procedure in the examination phases used to report measured quantity values on patients’ samples. The laboratory shall define the performance requirements for the measurement uncertainty of each measurement procedure and regularly review estimates of measurement uncertainty.”
– ISO 15189:2012
Acusera 24∙7 is the only QC data management platform that incorporates the automatic calculation of Measurement Uncertainty (MU) as well as other performance metrics, including Total Error.
More about Measurement Uncertainty and how Acusera 24∙7 can help
Commutability
“The laboratory shall use quality control materials that react to the examining system in a manner as close as possible to patient samples”
– ISO 15189:2012
Acusera True Third Party Controls are fully commutable, behaving like a real patient sample, reducing the need to re-assign QC target values when the reagent batch is changed, reducing labour and costs.
Medical decision levels
“The laboratory should choose concentrations of control materials, wherever possible, especially at or near clinical decision values, which ensure the validity of decisions made”
– ISO 15189:2012
Acusera True Third Party Controls are designed to challenge instruments across the entire clinical reporting range.
Comparison of results across instruments
“Laboratories with two or more analysers for examinations, should have a defined mechanism for comparison of results across analysers”
– ISO 15189:2012
Acusera 24∙7 is capable of combining multiple data sets on a single Levey-Jennings, Histogram of Performance Summary chart, enabling at-a-glance performance review and comparative performance assessment. A unique multi-instrument report is also available via our RIQAS EQA programme allowing performance of each instrument to be compared.
Third Party Control
“Use of independent third party control materials should be considered, either instead of, or in addition to, any control materials supplied by the reagent or instrument manufacturer”
– ISO 15189:2012
Acusera True Third Party Controls are manufactured completely independently of and calibrators and assigned values through a pool of instruments across the world, making them true third party controls.
At a conference in Belgium in 2016, data, which highlighted the most common areas of non-conformance in laboratories, showed that nonconformities were most prevalent in sections 5.5 and 5.6 of ISO 15189. This data is visualised in fig. A below. Furthermore, a study by Munene et al. (2017) has had similar findings, as visualised in fig. B. The greatest number of nonconformities occur in the sections that are concerned with insufficient assay validation and quality of examination procedures. These studies specifically identified the lack of independent controls, QC not at clinically relevant levels, commutability issues, and a lack of interlaboratory comparison as major issues.
Randox Quality Control products are designed to target these areas, making it easier to conform to ISO 15189 standards.
Acusera Third Party Controls
Interlaboratory Data Management
CALA. The Advantages of Being an Accredited Laboratory. Canadian Association for Laboratory Accreditation. Retrieved from http://www.cala.ca/ilac_the_advantages_of_being.pdf
Munene, S., Songok, J., Munene, D., & Carter, J. (2017). Implementing a regional integrated laboratory proficiency testing scheme for peripheral health facilities in East Africa. Biochemia Medica, 110-113. http://dx.doi.org/10.11613/bm.2017.014
Peter, T., Rotz, P., Blair, D., Khine, A., Freeman, R., & Murtagh, M. (2010). Impact of Laboratory Accreditation on Patient Care and the Health System. American Journal Of Clinical Pathology, 134(4), 550-555. http://dx.doi.org/10.1309/ajcph1skq1hnwghf
Rohr, U., Binder, C., Dieterle, T., Giusti, F., Messina, C., & Toerien, E. et al. (2016). The Value of In Vitro Diagnostic Testing in Medical Practice: A Status Report. PLOS ONE, 11(3), e0149856. http://dx.doi.org/10.1371/journal.pone.0149856
Randox Testing Services: The difference between CBD Oil, Cannabis Oil and Hemp Oil
CBD Oil, Cannabis Oil and Hemp Oil are naturally produced from the plant Cannabis Sativa. This article will aim to distinguish between the different variations, and highlights differences in their use, abuse and legal standing.
Cannabis is the name given to the common drug of abuse, made from various parts of the Cannabis Sativa plant that contain a high level of a chemical called THC (tetrahydrocannabinol). THC is the chemical responsible for most of cannabis’s psychological effects. It stimulates cells in the brain to release dopamine and interferes with how information is processed in the hippocampus, the part of the brain responsible for forming new memories. Strains of Cannabis Sativa are specifically bred for their high THC content in resinous glands on their flowers and some leaves.
Cannabis Oil contains a high level of THC and if administered can result in psychoactive effects. There is a growing movement to legalise THC in the form of oils or capsules for medicinal use (pain relief), however, like cannabis itself, it is currently illegal to possess, or supply cannabis oil in the UK.
CBD (or cannabidiol), like THC, is another chemical component extracted from the Cannabis Sativa plant. Unlike THC, CBD is not psychoactive and does not produce a ‘high’. CBD is derived from a specific hemp strain that is high in CBD and low in THC and is extracted from the whole plant (and not just the seed like hemp seed oil). The use of CBD oil is becoming widespread for its reported health-giving benefits. It is perfectly legal to use (because it contains negligible amounts of THC) and can be purchased from health food shops and on-line.
However, it is also sometimes (mistakenly) referred to as ‘cannabis oil’ which causes confusion.
Hemp is a fast-growing strain of Cannabis Sativa specifically bred for its fibre (for textile use), oils (including CBD oil) and nutritional benefits among its ever-expanding range of uses. However, hemp is bred to be low in THC. Hemp seed oil is acquired by pressing the hemp seeds only and contains neither THC nor CBD. Hemp oil is perfectly legal and you may find it in some health food products or even beauty products.
Effects of Cannabis
Cannabis is the most commonly abused drug in the UK and can produce a range of side-effects including an increased risk of developing a psychotic illness. For an extensive list of the side-effects of regular cannabis use download our free educational resource: http://www.randoxtestingservices.com/download/Effects-of-Cannabis-Poster.pdf
About Randox Testing Services
Randox Testing Services is a market leader in the drug and alcohol testing industry. Our expertise is relied upon by a range of leading safety-critical companies across the world.
We pride ourselves on helping our customers improve the health and safety of their working environment through helping them implement a comprehensive substance misuse policy. As experts in our field we ensure that we are aware of current drug trends and issues that are affecting society.
Contact us today at testingservices@randox.com or call 028 9445 1011 to speak with one of our experts.
The Importance of Equine Health
With the Grand National around the corner, Randox Reagents have investigated the importance of equine health, focusing on racehorses.
Maintaining good health in racehorses is vital as proper management can reduce the incidence of many disease conditions. Racehorses are bred, raised, and trained to perform as athletes. Therefore, it is vital that the performance health of racehorses is continually assessed to ensure that they are physically fit, happy and healthy.
Racehorse’s have a busy life. They are broken in from 18 months of age, usually using traditional methods such as long reining, followed by accepting a rider and training alongside other horses. At 2 years of age, the real training begins which focuses on fitness and speed rather than ‘schooling’ the horse in the conventional way. This training is undertaken alongside another horse to teach the trainee horse how to race but at the same time, it is taught to settle and listen to the jockey.
In peak season, the horse’s weekly exercise regime consists of: two days of fast gallop work with steady trotting or cantering the rest of the week, with a rest day on Sunday’s (depending on races scheduled for the horse).
The most important bodily systems for top athletic performance in racehorses include:
Skeletal system (including bone, tendons and ligaments) problems such as torn or stretched ligaments or tendons or a broken bone will be very painful, inducing lameness and prohibiting performance
Muscles enable the horse to perform. Fatigued or damaged muscles will result in poor performance as the horse cannot generate enough energy and strength to maintain its high performance
Respiratory system (nasal passages, throat and lungs) problems prohibits the normal flow of oxygen through the body, which prohibits the energy required for exercise
Cardiovascular system (heart, blood vessels, volume of blood and red blood cells) problems prohibits the movement of oxygen from the lungs to the muscles, again prohibiting the generation of energy required for exercise.
Central nervous system (CNS) problems can result in the loss of coordination and the fine control that accompanies minor problems to the CNS can significantly prohibit exercise performance
Due to the intense training that racehorses undergo, it is vitally important that their health is continually assessed to diagnose and treat injuries and the jockey allows the horse time to recover from the injury. The most common sites of injury include: forelegs, back and pelvis such as bowed tendon (tendonitis), strained suspensory ligaments, splints, osselets, sesamoid fractures, condylar fractures, knee fractures, bone chips, bucked skins and pin firing. It is vitally important that racehorses are allowed time to rest and heal after an injury. Training or racing a horse whilst injured can be detrimental.
Randox Equine Panel
Randox offer 10 scientifically proven assays for equine health which are made from the same high-quality material as our human assays, providing accurate and precise results. These assays have extensive measuring ranges for the accurate detection of disease or inflammation which are suitable for use with serum, plasma and whole blood. Instrument specific applications (ISA’s) are available for an extensive range of biochemistry analysers suitable for use with manual, semi-automated and fully automated analysers.
The Randox range of assays, suitable for equine use, cover a range of biomarkers:
Adiponectin is used to assess equine metabolic syndrome (EMS) which is characterised by obesity, regional adiposity, insulin resistance, and susceptibility to laminitis. Laminitis is one of the most common causes of lameness in horses. It is a painful and potentially crippling condition, which in severe cases usually results in the horse being humanely euthanised.
Aspartate Aminotransferase (AST) levels directly correlate with the severity of muscle inflammation or damage, or liver damage. The highest levels of AST will be seen around 24hours after muscle injury and persist for 2-3 weeks.
CK-NAC is a sensitive marker for the detection of musculoskeletal diseases; and is useful to assess the extent of severe muscle trauma, crush injuries, and burns and the likelihood of developing rhabdomyolysis.

Benefits of High-Sensitivity Troponin I (hs-TnI)
Benefits of High-Sensitivity Troponin I (hs-TnI)
Chest pain is a common symptom; 20% to 40% of the population will experience chest pain during their lifetime. There are many causes of chest pain, some of which are benign, while others are potentially life threatening. Importantly, in patients with chest pain caused by an acute coronary syndrome (ACS) or angina, there are effective treatments to improve symptoms and prolong life, emphasising the importance of early diagnosis in patients where chest pain may be of cardiac origin (Skinner et al, 2010). Chest pain is one of the most common reasons for emergency admission to hospital and is a heavy burden on health-care resources. A strategy to identify low-risk patients suitable for immediate discharge would have major benefits (Shah et al., 2015).
RIQAS Liquid Cardiac Programme
Interlaboratory data Management

Ford, C. (2017). Benefits of High Sensitivity Cardiac Troponin I at Admission. Clinical Laboratory Management Association, (July/August 2017), 22-24.
Shah, A., Anand, A., Sandoval, Y., Lee, K., Smith, S., & Adamson, P. et al. (2015). High-sensitivity cardiac troponin I at presentation in patients with suspected acute coronary syndrome: a cohort study. The Lancet, 386(10012), 2481-2488. http://dx.doi.org/10.1016/s0140-6736(15)00391-8
Skinner, J., Smeeth, L., Kendall, J., Adams, P., & Timmis, A. (2010). NICE guidance. Chest pain of recent onset: assessment and diagnosis of recent onset chest pain or discomfort of suspected cardiac origin. Heart, 96(12), 974-978. http://dx.doi.org/10.1136/hrt.2009.190066
Extreme Weather Results in High Risk of Mycotoxin Contamination
Mycotoxin contamination is a real and constant threat for feed and animal compound producers globally. Recently the University of Guelph, Guelph, Ontairo stated that the different geographical locations of cattle mean between 10 and 20 mycotoxins can be present at once. This is a result of extreme weather patterns across the US with excess moisture and drought in different areas causing an increase in the frequency of mycotoxins, creating challenges in protecting livestock from ingesting contaminated feed.
The most common mycotoxins found are Aflatoxin, Fusarium, Deoxynivalenol and Zearalenone. Aflatoxin is produced by Aspergillus flavus, a tropical fungus that thrives in high humidity and affects an animal’s liver, causing cancer in more extreme cases. Fusarium can develop in most temperate climates across the U.S and Canada. Fusarium poses a higher threat than other toxins as there are hundreds of different chemical structures to analyse to enable identification of the Fusarium.
Difficulties also arise in finding an analytical method sensitive enough to detect mycotoxins at low levels of contamination as small amounts can still lead to fatal results in horses, dogs and cats.
To prevent mycotoxin infection in feed, processors can implement a routine screening procedure with the help of Randox Food Diagnostics. Randox Food offer a multiplex screening system for the simultaneous detection of up to 10 of the world’s most prevalent mycotoxins including: Paxilline, Fumonisins (part of the Fusarium group), Ochratoxin A, Aflatoxin G1/G2, Aflatoxin B1/B2, Ergot Alkaloids, Diacetoxyscirpenol, Deoxynivalenol, T2 Toxin and Zearalenone. All compounds are screened at low limits of detection using Biochip Array Technology.
Biochip Array Technology is a patented technology created by Randox to facilitate the detection of contaminants and drug residues with over 20 evaluated matrices in feed (see full list below).
Animal Feed (Complete) | Millet | Sunflower |
Barley | Mustard Seed | Wheat |
Beet | Palm Kernel | Grass |
Buckwheat | Rapeseed | Whey |
Corn/Maize | Rice | Linseed |
Cotton Seed | Rye | Feed Pea |
Distillers Grain | Silage | Vetches (Vica) |
Hay | Soya | Oat |
To learn more about Mycotoxin testing with Randox Food Diagnostics email, info@randoxfooddiagnostics.com
Complement C4 – Biomarker for Systemic Lupus Erythematosus (SLE)
Systemic Lupus Erythematosus (SLE) is an autoimmune disorder associated with a deficiency in complement C4. Complement C4 is one of nine components of the complement system which is an integral part of the immune system that enhances (complements) the ability of antibodies and phagocytic cells to clear microbes and damaged cells from the host, promote inflammation, and attack the cell membrane of pathogens.
Complement C4 is a vital component of two immunology pathways: Classical pathway and Mannrose Binding Lectin (MBL) pathway.
The classical pathway is triggered by antibody-antigen complexes which induces a conformational change in the C1 complex. The activated C1 complex cleaves the C4 component, resulting in a reactive C4b which covalently binds to proteins or polysaccharides at the surface in close proximity of the C1 component. The bound C4b complexes binds to the C2 component rendering C2 for proteolysis by C1.
The MBL pathway is activated through the binding of MBL to mannose residues on the pathogen surface. This in turn activates the MBL-associated serine proteases, MASP-1 and MASP-2, which activates the C4 and C2 components, to form the C3 convertase, C4b2a. The C4b2a complex splits C3 into two fragments which causes the release of vasoactive mediators such as histamine.
Complement C4 deficiency is commonly associated with systemic lupus erythematosus (SLE).
According to lupus.org, 16,000 new cases of lupus are reported each year. Approximately 1 in 250 people may end up developing SLE at some point with 90% of SLE patients being female aged between 15-44 years. The causes of SLE are unknown, but are believed to be linked to environmental, genetic, and hormonal factors. 1.5 million Americans are living with diagnosed lupus.
There are four forms of lupus:
- Systemic – accounts for approximately 70% of all lupus cases. In half of these cases, a major organ or tissue in the body, such as the heart, lungs, kidneys, or brain will be affected.
- Cutaneous lupus – accounts for approximately 10% of all lupus cases and only affects the skin.
- Drug-induced lupus accounts for approximately 10% of all lupus cases and is caused by high doses of certain medications.
- Neonatal lupus is a rare condition in which the mother’s antibodies affect the fetus. At birth, the baby may have a skin rash, liver problems, or low blood cell counts, but these symptoms typically disappear completely after six months with no lasting effects.
The Randox Complement C4 assay
The Randox Complement C4 assay is used for the quantitative in vitro determination of complement C4 concentration in serum. The Randox Complement C4 assay can be used as a biomarker in the diagnosis and monitoring of SLE. It is the cell-bound levels of processed complement activation products, especially E-C4d (erythrocyte-bound C4) that makes the complement C4 assay a biomarker for SLE.
Key Features of the Randox Complement C4 assay
Liquid ready-to-use reagents – The Randox reagent comes in a convenient liquid format requiring minimal preparation thus reducing the risk of errors.
Exceptional correlation with standard methods – The Randox methodology was compared against other commercially available methods and the Randox Complement C4 assay showed a correlation coefficient of r=0.98.
Wide measuring range – The healthy range for Complement C4 is 7 -49 mg/dl. The Randox Complement C4 assay can comfortably detect levels outside of the healthy range measuring between 2.90 – 152 mg/dl.
Excellent stability – Stable until expiry date when stored at +2 to +8°C.

Looking after your kidney health during your pregnancy
With this year’s World Kidney Day theme focusing on women’s health and in particular, their kidney health, the campaign is drawing attention to the need for a higher awareness, timely diagnosis and proper follow-up of kidney issues amongst women.
One key area being highlighted by the campaign is the close links between pregnancy and kidney health problems. The two are intrinsically connected – with CKD considered a high-risk factor for problematic pregnancies and reduced fertility, and in turn, pregnancy-related complications, including preeclampsia, can increase the risk of kidney disease.
Although not commonly known, women who have Chronic Kidney Disease are at increased risk of hypertensive disorders and premature births – which can be devastating for all involved.
Women with Chronic Kidney Disease who become pregnant also usually have mild kidney dysfunction, the severity of which will depend on the stage the CKD is at.
It is clear therefore that there is a need for increased awareness of Chronic Kidney Disease in pregnancy, to timely identify its existence before conception, and to monitor its progress before, during and after birth.
With a comprehensive panel of kidney health tests, Randox are working to ensure timely diagnosis of kidney function problems, to ensure that necessary treatment is administered at the earliest possible stage, when it is most likely to be successful.
Pregnant women, or women hoping to get pregnant in the future, can therefore determine their kidney health and be empowered to embark upon the necessary lifestyle changes or treatment required to ensure a safe and healthy pregnancy.
For example, the Randox test for albumin, low concentrations of which are the earliest marker of kidney damage, can identify individuals with diabetic nephropathy (damage to the kidneys caused by diabetes) around 10 years earlier than standard protein tests. The Randox albumin test can therefore enable preventative measures to be taken to reduce your risk of developing kidney disease.
In addition to albumin, there are a number of other highly specific and sensitive tests for kidney health, which are available as part of a Randox Health Check at our Randox Health Clinics. These include;
- Estimated Glomerular Filtration Rate, which is an equation that considers age, gender, blood and protein levels to determine how well the kidneys are functioning.
- Creatinine, which is a waste product produced by muscle tissue, and removed by the kidneys. When kidney function is diminished, creatinine levels increase.
- Other proteins within the body which should be filtered by the kidneys, and are therefore measured to determine kidney function, include;
– Cystatin C
– Beta-2-Microglobulin
– Microalbumin, which is not usually found in urine, but can appear when normal kidney function is impaired.
- Minerals processed by the kidneys and analysed by Randox Health include;
– Magnesium
– Calcium
– Phosphate
– Potassium
– Sodium
Both World Kidney Day and Randox are working towards improving healthcare worldwide. With access to these high-performance kidney health tests, expectant mothers with kidney problems can be diagnosed early, before the condition develops into something more serious – keeping both you, and your baby healthy.
With early diagnosis we can improve patient treatment outcomes and reduce the number of people across the world suffering with kidney health problems.
If you are a clinician or lab interested in running renal function assays, download our Reagents Brochure or email reagents@randox.com
If you want to find out the status of your own Kidney Health, book a health check with Randox Health today. Speak to our team by phoning 0800 2545 130.
Rare inherited diseases of copper metabolism
This year, Randox Reagents are supporting Rare Disease Day on 28th February. Randox offer a test that aids in the diagnosis and monitoring of Wilson Disease and Menkes Disease which are rare inherited disorders of copper metabolism.
What is a rare disease?
According to the European Union, a rare disease is defined as a disease that affects less than 5 in 10,000 of the general population. 7% of the population will be affected by a rare disease at some point in their life. This equates to 30 million people in Europe.
Wilson Disease
Wilson Disease is a rare inherited autosomal recessive disorder of copper metabolism, characterised by excessive deposition of copper in various bodily tissues, particularly the liver, brain, and corneas of the eyes. This is due to mutations of the ATP7B gene which is responsible for encoding specific proteins that are responsible for the transportation of copper from the liver around the body, which is prohibited due to the mutations. If left untreated, Wilson Disease can cause hepatic disease, central nervous system dysfunction, or death. Approximately 1 in 30,000 people are affected by Wilson Disease worldwide (WDA, 2018). The first sign of Wilson Disease is liver dysfunction in more than half of patients, beginning at six years of age, however, it usually presents clinically in teenage years or early twenties manifesting as acute hepatitis. Some individuals with Wilson Disease have been thought to have infectious hepatitis or infectious mononucleosis and so it is vital that those with unexplained, abnormal liver tests are tested for Wilson Disease.
Menkes Disease
Menkes Disease is more likely to affect premature babies and is a rare inherited x-link recessive disorder of copper metabolism, characterised by sparse, kinky hair; failure to gain weight and grow at the expected rate (failure to thrive); and deterioration of the nervous system. This is due to mutations of the ATP7A gene which is responsible for the absorption of copper from food in the small intestines and supplying copper to certain enzymes that are critical for the structure of bone, skin, hair, blood vessels, and the nervous system. Approximately 1 in 100,000 people are affected by Menkes disease worldwide (USA National Library of Medicine, 2018). The first sign of Menkes Disease develops at 2-3 months of age and includes curly, sparse, coarse, dull, and discoloured haired.
As there are no cures for Wilson Disease or Menkes Disease, treatment aids to reduce/replace copper within the body. The Randox Copper assay can comfortably detect copper levels outside of the healthy range to aid in the diagnosis and monitoring of treatment of Wilson Disease and Menkes Disease.
Randox Copper Assay
The Randox Copper assay is used to measure the amount of copper in the blood; to help with the diagnosis and monitoring of rare inherited diseases related to copper toxicity (Wilson Disease) and copper deficiency (Menkes Disease). Copper deficiency is less likely because a normal diet contains plenty of copper including organ meats, beans, and wholegrains, however, copper deficiency is more likely to occur in those who are malnourished, more likely children.
For more information visit: https://www.randox.com/copper
To request an application for your specific analyser, contact reagents@randox.com
