The Importance of Meeting ISO 15189 Requirements
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.
Fig. A
Fig. B
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.
For health professionals
If you are a veterinarian or laboratory who are interested in running equine assays, Randox offer a wide range of high-quality routine and niche assays including: albumin, alkaline phosphatase, bilirubin, calcium, GLDH, glucose and urea. These can be run on most automated biochemistry analysers.
Instrument Specific Applications (ISA’s) are available for a wide range of biochemistry analysers. Contact us to enquire about your specific analyser.
For more information, email reagents@randox.com
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.
For health professionals
If you are a clinician or laboratory who are interested in running specific protein assays, Randox offer a wide range of high-quality routine and niche assays including: Cystatin C, Complement C3, CRP, Lipoprotein (a), Apolipoprotein C-II, Apolipoprotein C-III and Apolipoprotein E. These can be run on most automated biochemistry analysers.
Instrument Specific Application (ISA’s) are available for a wide range of biochemistry analysers. Contact us to enquire about your specific analyser.
For more information, download our Specific Proteins Brochure email reagents@randox.com
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
Alprazolam and Prescription Drug Abuse
Alprazolam, also known as the trade name Xanax, is a widely prescribed anxiety drug in the US. Alprazolam is a minor tranquilliser which can cause sedation, short term memory loss and depress the nervous system, slowing down the brain and body. Recommended for short term use, the drug can be highly addictive and only be obtained on private prescription in the UK.
People have been known to crush or melt the dangerous tranquilliser that comes in a tablet form, to inject the substance. Extremely dangerous and fatal, the chalk in the tablets can cause collapsed veins and lead to an abscess and infection.
A recent article by BBC News uncovered that Alprazolam is being purchased online and abused by children as young as 13. The news comes after reports of social media sites being used to buy dangerous substances and locate drug dealers. In 2017, up to 20 teenagers from Wiltshire needed treatment after using Alprazolam. This year in Sussex alone, several young people have been admitted to hospital after taking the prescription drug.
A spokesperson from Pfizer, a Xanax manufacturer, expressed concerns over the alarming rise of counterfeit Xanax drugs and the growing availability on the dark web. Discussing the issue, they mentioned that ingredients such as boric acid, heavy metals and floor polish have been found in counterfeit Xanax medications. Defined as “part of our youth culture” Nick Hickmott from Addaction states, it is currently debatable how many people are currently using Alprazolam. London’s MP Bambos Charalambous has called for awareness campaigns and further research to be conducted in order to support services.
Alprazolam is not the only widely abused prescription drug, as criminal gangs were reported smuggling tens of millions of prescription drugs out of the UK’s protected supply chain. Northern Ireland have also expressed concerns over the rise of pregabalin, with BBC spotlight revealing a 46% rise from a data base of 20 million prescription records written by GPs across the country in the past four years. However, the biggest killer in Northern Ireland is tramadol, a prescription painkiller taken by thousands daily.
Randox Toxicology offer the most comprehensive drugs of abuse test menu across multiple forensic matrices. Our level of expertise in toxicology has enabled us to provide the DoA ULTRA panel, which can screen for a wide range of prescription drugs of abuse, including Alprazolam and Tramadol. Using our revolutionary Biochip Array Technology, Randox Toxicology provide a complete immunoassay profile in the initial screening phase.
For more information about our DoA ULTRA panel and how Randox Toxicology are fighting drugs of abuse, email us at info@randoxtoxicology.com
For further information, please contact the Randox PR team via email: randoxpr@randox.com or phone 028 9442 2413
Acetaminophen-Induced Acute Kidney Failure
Acetaminophen is a commonly used medicine for pain-relief. During cold and flu season, it is common to resort to pain-relief medicines to relieve headaches, and ache and pain symptoms associated with a cold or flu as there is no cure. However, the therapeutic range for acetaminophen is 10-30 mg/l, which is small and very easy to go over. During cold and flu season, it is important to monitor the amount of paracetamol entering your body as acetaminophen is more dangerous than suspected. At therapeutic levels, acetaminophen does not produce any adverse effects, however, long-term treatment, prolonged use, and taking a few more than the recommended dose can be severely damaging and fatal. Accidental acetaminophen overdose took the lives of 1,500 people in the U.S between 2001 and 2010. The Randox Acetaminophen assay is used to determine the concentration levels of acetaminophen in the blood to determine if an overdose has taken place.
It is commonly recognised that acetaminophen overdose causes hepatotoxicity, but it is less commonly recognised that it can also cause nephrotoxicity in less than 2% of patients. Nephrotoxicity is toxicity of the kidneys and is often associated with a reduced amount of glutathione which is important for normal cellular metabolism in the kidneys. The Randox Glutathione Reductase assay is required for the regeneration of reduced glutathione. Glutathione is often discussed in association with the Randox Glutathione Peroxidase, which requires reduced glutathione for activation. Both Glutathione reagents are unique to Randox.
Acute renal failure due to acetaminophen manifests as acute tubular necrosis, which can occur alone or in combination with hepatic necrosis. Nephrotoxicity can also occur when the therapeutic levels of acetaminophen are not exceeded. This most commonly occurs when acetaminophen is taken in combination with alcohol. Upon testing acetaminophen levels and the results fall within the therapeutic range, the Randox Ethanol assay can test alcohol levels to determine if a combination of alcohol and acetaminophen caused nephrotoxicity. Renal impairment may be more common than previously suspected as acute renal failure occurs in 10-40% of patients with severe hepatic necrosis. Upon testing acetaminophen to determine toxicity, Randox also offer the following renal tests to test for nephrotoxicity:
- Creatinine (Enzymatic and JAFFE)
- Cystatin C
- IgG
For more information visit: https://www.randox.com/acetaminophen
To request an application for your specific analyser, contact reagents@randox.com
