National Cholesterol Month
National Cholesterol Month
National Cholesterol Month
Foe or Friend? Your Health is your Wealth.
It’s National Cholesterol Month, time to raise awareness on the dangers high cholesterol can have on your body and the strain it can have on your precious heart, the centre piece and vital organ that keeps you alive and pumps blood to every corner of your body.
Cardiovascular disease is the leading killer, claiming 17.9 million lives globally each year. 80% of these are due to strokes and heart attacks. Its not too late to get checked out and to alter your lifestyle habits.
Randox Laboratories provides a comprehensive range of reagents for Cardiovascular disease with sdLDL providing detailed testing of cholesterol levels and overall Cardiovascular Health, see more in the blog below.
Cholesterol can be a friend, but it can also be a foe. Maybe you associate bad cholesterol with the result of being overweight, this is not always the case, without a balanced diet, essential exercise, you are at risk of being in the cholesterol danger zone.
Small dense Low-Density Lipoprotein (sdLDL) carries cholesterol to and from cells in the body, it is one of two proteins. However, it is more atherogenic than LDL cholesterol meaning it has a higher tendency to leave fatty deposits in the blood and has a greater ability to block arteries.
Low-density lipoprotein (LDL) is key for progression and development of cardiovascular disease and plague build up (atherosclerosis). LDL has a couple of subclasses sdLDL being one, making it a more reliable marker for the discovery and testing of cardiovascular issues.
sdLDL has a significantly greater atherogenic potential than LDL sub-group. This makes the portion of sdLDL a better marker to predict cardiovascular disease and issues than LDL. It provides a greater understanding of lipoprotein risk within patients; it is more comprehensive in detecting cardiovascular risk in comparison to the original LDL-C test. It is a valuable screening tool in allowing to detect for diseases and abnormalities in the cardiovascular system. As sdLDL-C is particularly atherogenic, a person with elevated sdLDL-C levels has a 3-fold increased risk of myocardial infarction.
Randox provides the “only direct automated sdLDL-C kit on the market, The Randox sdLDL-C ‘Ex-Seiken’ test is a direct method for the quantitative determination of sdLDL-C using automated chemistry analysers, capable of accommodating two-reagent assays. The assay consists of two steps and is based on the use of well-characterised surfactants and enzymes that selectively react with certain groups of lipoproteins.”
Benefits include,
- Direct, automated test for convenience and efficiency
- Rapid analysis results can be produced in as little as ten minutes, facilitating faster patient diagnosis and treatment plan implementation.
- Good correlation to the gold standard ultracentrifugation method
- Liquid ready-to-use reagents for convenience and ease of use
- Applications available detailing instrument specific settings for a wide range of analysers
- Clearance method sdLDL-C controls and calibrator available.
Foe or Friend? Your Health is your Wealth.
References
Fernandez-Alvarez R, Gonzalez-Rodriguez AP, Gonzalez E, Rubio-Castro A, Dominguez-Iglesias F, et al. Serum Ferritin as Prognostic Marker in Classical Hodgkin Lymphoma Treated With ABVD-based Therapy. Leukemia & Lymphoma . 2015;56(11):3096-3102.
Randox (2023) Ferritin: Reagents, Randox Laboratories. Available at: https://www.randox.com/ferritin/ (Accessed: 20 September 2023).
Rosário C, Zandman-Goddard G, Meyron-Holtz EG, D’Cruz DP, Shoenfeld Y. The hyperferritinemic syndrome: macrophage activation syndrome, Still’s disease, septic shock and catastrophic antiphospholipid syndrome. BMC Medicine . 2013;11(185).
Sharma J, Sharma R. A prognostic marker in patients with sepsis in pediatric age group: A prospective cohort study. International Journal of Medical and Health Research . 2018;4(3):86-89.
The Royal College of Pathologists. Guidance on the Use and Interpretation of Clinical Biochemistry Tests in Patients with COVID-19 Infection.; 2020. Accessed September 18, 2023. https://www.rcpath.org/uploads/assets/3f1048e5-22ea-4bda-953af20671771524/G217-RCPath-guidance-on-use-and-interpretation-of-clinical-biochemistry-tests-in-patients-with-COVID-19-infection.pdf
World Health Organisation. WHO Guideline on Use of Ferritin Concentrations to Assess Iron Status in Individuals and Populations.; 2020. Accessed September 18, 2023. https://www.who.int/publications/i/item/9789240000124
World Heart Day
World Heart Day!
The powerhouse of the body, beating 100,00 times every day, pumping eight pints of blood, through an intertwining network of blood vessels. Delivering oxygen and nutrients to muscles and the vital organs of the body. The centrepiece, what keeps us alive, the heart!
Why put strain on the very thing that keeps us alive? The heart is the most important muscle working constantly, embracing a healthy lifestyle can lower the risk of developing a stroke or heart attack, and can prevent cardiovascular disease. No matter your age young or old, you can begin to take care of your heart. Making healthier choices, watching what you eat, exercising regularly are all good habits to start or continue to look after your precious heart.
Randox Laboratories offer a wide selection of Reagents specifically for Lipid testing. Lipid tests are the most important cardiac risk tests. They assess an individual’s risk of a stroke or heart attack and can provide an indication if someone is going to have a cardiac episode, caused by blockages of arteries and blood vessels. Lipid tests screen for abnormalities of cholesterol and triglyceride levels in the blood, allowing for preventative measures to take place to reduce the chances of cardiovascular diseases.
Complete lipid profiles consist of HDL Cholesterol, LDL Cholesterol, Total Cholesterol and Triglycerides. These profiles measure the current cholesterol and triglycerides levels also, measuring potential emerging risk factors of cardiovascular disease.
‘Benefits of Randox’s Lipid testing includes;
Enhanced convenience with liquid ready-to-use reagents (Triglycerides kits also come in lyophilised form)
Excellent correlation to reference methods for security of accurate results
Applications for a wide range of clinical chemistry analysers
Wide measuring ranges able to comfortably detect abnormal lipid levels.
Cost effectiveness for even small throughput labs – all lipid assays are stable to expiry when stored at 2-8⁰C (except for Triglyceride kits, stable for 21 days)’
Randox provides the “only direct automated sdLDL-C kit on the market, The Randox sdLDL-C test, is a direct method for the quantitative determination of sdLDL-C using automated chemistry analysers, capable of accommodating two-reagent assays. The assay consists of two steps, and is based on the use of well-characterised surfactants and enzymes, that selectively react with certain groups of lipoproteins.
Benefits include,
Direct, automated test for convenience and efficiency
Rapid analysis results can be produced in as little as ten minutes, facilitating faster patient diagnosis and treatment plan implementation.
Good correlation to the gold standard ultracentrifugation method
Liquid ready-to-use reagents for convenience and ease of use
Applications available detailing instrument specific settings for a wide range of analysers
Clearance method sdLDL-C controls and calibrator available.
One of Randox’s Reagents offered is the Lipoprotein (a) assay known as Lp(a). It is similar to LDL cholesterol but a lot more viscous.
High levels of lipoprotein can clog arteries very easily, leading to the potential of a stroke or cardiovascular disease at any age. Lp(a) is made in the liver containing fat and protein, their main role is to carry lipids around the body. Lp(a) remains relatively stable over a lifespan and is determined predominantly through genetics. Just a single Lp(a) test is believed to be enough to improve accuracy of a cardiovascular risk assessment. Repeat testing can also be initiated if a secondary cause is suspected, or therapeutic measures to lower Lp(a) levels have been investigated.
Benefits of the Lp(a) assay;
WHO/IFCC Reference Material
Dedicated Five-Point Calibrator Available
Excellent Correlation
Excellent Precision
Liquid Ready-To-Use
Applications Available
References
BHF (2023) How your heart works, British Heart Foundation. Available at: https://www.bhf.org.uk/informationsupport/how-a-healthy-heart-works (Accessed: 19 September 2023).
Family Doctor (2023) Keeping Your Heart Healthy, familydoctor.org. Available at: https://familydoctor.org/keeping-heart-healthy/ (Accessed: 19 September 2023).
Heart UK (2023) High lipoprotein(a), What Is High lipoprotein(a)? | Cholesterol Conditions | HEART UK. Available at: https://www.heartuk.org.uk/genetic-conditions/high-lipoproteina (Accessed: 20 September 2023).
Randox (2023b) Lipid: Reagents, Randox Laboratories. Available at: https://www.randox.com/lipid-reagent (Accessed: 19 September 2023).
Ferritin-Blog
Ferritin Assay
Ferritin, a protein but also an indicator of the body’s iron levels and stores is valuable when tested alongside other proteins and lipids to identify the function of muscle metabolism, transporting oxygen and DNA synthesis.
Anaemia is the cause of iron deficiency, a shortage of red blood cells resulting in the stores being inadequate in meeting the necessary needs for metabolism. Literature has identified that this could be the result of haemolysis and excessive bleeding. Testing regarding Ferritin, renal function and glucose are used to determine the sole cause of anaemia. Some symptoms of this deficiency include extreme fatigue, decreased productivity, diminished physical performance and significantly reduced immunity. However, in stark contrast having an over accumulation of iron in the body can be the result of hereditary disorders of haemochromatosis and thalassaemia.
Iron seeks to bind with a protein as it’s very reactive as a biomarker, so while being stored in cells iron binds to Ferritin, this in turn makes Ferritin an ideal predictor of iron reserves. Toxicity from elemental iron causes tissue damage and collates free radicals. Excess iron collated in the body over time causes serious damage to the liver and vital organs, causing liver failure, cirrhosis, skin pigmentation, heart failure and arrythmia. There is no way to eliminate excess iron from the body, so regulation of iron stores is vital to check of changes in iron absorption. As Ferritin is the primary iron storage, without it iron levels cannot be regulated and can cause serious damage.
Ferritin itself is produced on a very small level before being released in the bloodstream. During inflammation episodes, due to infections, rare conditions or even obesity, Ferritin levels can become significantly elevated. It poses as a challenge to accurately diagnose iron deficiency and can unfortunately lead to a misled evaluation regarding the possible overload of iron. This issue is being worked on to resolve and be able to accurately measure iron levels while inflammation is present. CRP may also be used as an aid to help rule out the elevated Ferritin levels from the cause of inflammation.
Ferritin is described as ‘an intracellular hollow protein’, comprised of around 4500 iron atoms within the iron core, surrounding the core are 24 subunits. In contrast, a reduced Ferritin level in serum indicates a deficiency and or depletion of iron stores, however it may not determine advanced depletion.
Randox Laboratories offer an accurate Ferritin Assay, used to detect iron levels and aid in the diagnosis and treatment of conditions such as anaemia.
‘Benefits of the Ferritin Assay include’.
Wide measuring range of 5.08 – 443 mg/dl for the accurate detection of clinically important results
Automated immunoturbidimetric assay eliminating the need for any dedicated equipment.
Liquid ready-to-use reagents for convenience and ease-of-use
Stable to expiry when stored at +2 to +8°C.
Applications available detailing instrument-specific settings for the convenient use of the Randox Ferritin assay on a wide range of biochemistry analysers
Complementary controls and calibrators offering a complete testing package.
Some clinical points to note include. Ferritin has been observed in 89% of patients with Adult-Onset Stills Disease, there have been elevated Ferritin levels of five times the normal range in over half of patients with this disease. COVID-19 critically ill patients experienced elevated concentrations, along with Sepsis patients that are not recovering also experience a stark increase in their Ferritin levels.
Click the link below to find out more on our Ferritin Assay!
References
Fernandez-Alvarez R, Gonzalez-Rodriguez AP, Gonzalez E, Rubio-Castro A, Dominguez-Iglesias F, et al. Serum Ferritin as Prognostic Marker in Classical Hodgkin Lymphoma Treated With ABVD-based Therapy. Leukemia & Lymphoma . 2015;56(11):3096-3102.
Randox (2023) Ferritin: Reagents, Randox Laboratories. Available at: https://www.randox.com/ferritin/ (Accessed: 20 September 2023).
Rosário C, Zandman-Goddard G, Meyron-Holtz EG, D’Cruz DP, Shoenfeld Y. The hyperferritinemic syndrome: macrophage activation syndrome, Still’s disease, septic shock and catastrophic antiphospholipid syndrome. BMC Medicine . 2013;11(185).
Sharma J, Sharma R. A prognostic marker in patients with sepsis in pediatric age group: A prospective cohort study. International Journal of Medical and Health Research . 2018;4(3):86-89.
The Royal College of Pathologists. Guidance on the Use and Interpretation of Clinical Biochemistry Tests in Patients with COVID-19 Infection.; 2020. Accessed September 18, 2023. https://www.rcpath.org/uploads/assets/3f1048e5-22ea-4bda-953af20671771524/G217-RCPath-guidance-on-use-and-interpretation-of-clinical-biochemistry-tests-in-patients-with-COVID-19-infection.pdf
World Health Organisation. WHO Guideline on Use of Ferritin Concentrations to Assess Iron Status in Individuals and Populations.; 2020. Accessed September 18, 2023. https://www.who.int/publications/i/item/9789240000124
Sexually Transmitted Infections ā Rapid Testing at the Point of Care
Urgency, Challenges and Advances in STI Testing
Sexually transmitted infections (STIs) are a major global health issue, with over 30 pathogens causing an estimated one million infections daily, a number that is rising. Surveillance programs in countries like the United States and Canada have reported an increase in STIs such as syphilis, gonorrhoea, and chlamydia. STIs can have serious consequences for sexual health, including infertility and chronic pelvic pain, particularly affecting women. The World Health Organization (WHO) has recognised the urgency of addressing this problem and has recommended measures to end the STI healthcare issue by 2030. Integrated testing, including multiplex and point-of-care testing, is considered essential. However, implementation of these recommendations at regional and national levels is lacking. Rapid point-of-care PCR tests that can detect multiple pathogens simultaneously would greatly improve STI diagnosis and containment. Currently, Randox, in collaboration with Bosch offers two STI test panels on the Vivalytic POC system: Vivalytic STI and Vivalytic MG, MH, UP/UU panels, capable of detecting multiple pathogens in a single test run, with results available within hours.
The Global Burden
- The WHO estimates 374 million new infections of chlamydia, gonorrhoea, syphilis, and trichomoniasis annually.
- Chlamydia is the most frequently reported STI in Europe, followed by gonorrhoea and syphilis.
- Countries with comprehensive STI screening programs, like Denmark, have higher prevalence rates than the European average.
- The UK has a comprehensive screening program for chlamydia targeting 15-24-year-olds, with cases accounting for 60% of total cases in the European Region.
- The actual infection rate in countries without systematic screening is likely higher than official figures suggest.
- Reported cases of gonorrhoea and syphilis in the European Region have increased, particularly among certain age groups and higher numbers in men than women.
Gaps in Current STI Testing Strategies
The European Centre for Disease Prevention (ECDC) acknowledges the growing concern of STIs in Europe and emphasises the importance of testing in their recent report. While various European countries have screening programs for chlamydia, testing options for other STI pathogens are usually limited. The lack of accessible testing, combined with the prevalence of asymptomatic infections, increases the risk of STI transmission and hampers containment efforts. Prevention campaigns and low-threshold testing opportunities are crucial to address the spread of STIs. The UK’s chlamydia screening program, implemented in 2008, demonstrated the benefits of community-based testing services and led to a significant increase in diagnosed cases, reducing the number of unreported cases.
Infections and Co-Infections
- Co-infections, where multiple sexually transmitted pathogens are present simultaneously, are common but often go undetected due to limited testing.
- Symptoms of co-infections can be difficult to differentiate since different pathogens can cause similar or overlapping symptoms.
- However, most STIs, even in high-risk groups, are caused by a single sexually transmitted pathogen.
- In cases where co-infections need to be detected, a rapid and comprehensive differential diagnosis of sexually transmitted pathogens is crucial for initiating appropriate therapy promptly.
The Importance of Rapid Results at the Point of Care
- Rapid detection and treatment of STIs are crucial to prevent further spread.
- Traditional STI diagnostics in specialized laboratories can result in delays of several days or up to 1-2 weeks until test results are available to the physician.
- Delays occur due to transportation of samples, laboratory workflow, result transfer, and scheduling additional appointments.
- The delay in treatment initiation can lead to decreased patient compliance and missed appointments.
The Vivalytic STI test provides results directly at the point of care (POC) in less than two and a half hours. It eliminates the need for sample transportation to a central laboratory. In addition, patients can receive their test results on the same day of the visit, allowing for immediate initiation of appropriate treatment.
In a Nutshell
Sexually transmitted infections (STIs) spread due to various factors. Many STIs do not show symptoms, resulting in numerous unreported and untreated cases that can have fatal consequences depending on the specific pathogen. Increasing awareness and implementing a decentralised low-threshold testing strategy can significantly reduce infections, particularly among high-risk groups. Speed and comprehensive testing of relevant pathogens are crucial for targeted therapy and containing STIs. Rapid PCR tests used at the point of care (POC) are emerging as important technologies due to their advantages. Patients receive same-day results and immediate treatment, providing clarity in just one visit. Clinicians can provide up-to-date diagnoses and treatments, even in decentralised or hospital settings, benefiting high-risk patients with limited access to healthcare.
Vivalytic
The Bosch Vivalytic, is an advanced and automated platform for molecular diagnostics that utilises PCR to detect pathogens. It offers applications for various medical disciplines and requires only a few steps from sample collection to obtaining results. The patient sample is processed automatically within the Vivalytic analyser, and the test result is displayed on its integrated screen. The time it takes to get results depends on the specific Vivalytic application. For the STI Panel, which simultaneously detects 10 common sexually transmitted pathogens, the time to result is 2.5 hours. On the other hand, the Vivalytic MG, MH, UP/UU panel, used to detect mycoplasmas and/or ureaplasmas, provides results in approximately one hour.
By conducting fully automated analyses at the point of care, Vivalytic saves valuable time for hospitals, labs, genitourinary clinics and doctor’s offices during their routine processes.
| STI Panel | MG, MH, UP, UU Panel |
|---|---|
| Chlamydia trachomatis | Mycoplasma genitalium |
| Neisseria gonorrhoeae | Mycoplasma hominis |
| Trichomonas vaginalis | Ureaplasma parvum/Ureaplasma |
| Mycoplasma genitalium | |
| Treponema pallidum | |
| Mycoplasma hominis | |
| Ureaplasma urealyticum | |
| Haemophilus ducreyi | |
| Herpes simplex virus I | |
| Herpes simplex virus II |
At a Glance
- The Vivalytic system allows fully automated sample analysis with minimal manual steps.
- It eliminates the need for expensive and complex laboratory equipment.
- Vivalytic supports both single and multiplex tests.
- The Vivalytic does not require peripheral equipment such as a laptop, keyboard, barcode scanner, or charging station.
- The cartridge used in the system ensures hygienic and safe operation as a closed system.
- Cartridges can be stored and used at room temperature.
- Vivasuite, a cloud-based solution, facilitates convenient device management.
- The Vivalytic can be seamlessly integrated into existing IT structures using HL7, Ethernet, USB, or WLAN.
For more information please contact us at: marketing@randox.com
World Health Day 2023
Randox is celebrating WORLD HEALTH DAY!
We are dedicated to improving healthcare using innovative diagnostic technologies, for a range of health conditions including heart disease, diabetes, Alzheimer’s disease, cancer, and stroke.
Whilst the science is complex, the applications are not. Diagnostic testing takes place every day behind the scenes of GP surgeries, laboratories, and hospitals.
To celebrate and raise awareness of the health industry, we have written the article below which focuses on the challenges in cancer screening, diagnosis, improving risk stratification, and patient management.
Give it a read and let us know your thoughts!
Overcoming the challenges in cancer screening, diagnosis, improving risk stratification & patient management
The problem
Cancer diagnosis is an art, in many cases requiring complex equipment and time-consuming protocols to achieve only relatively specific and sensitive tests. There are several approaches used to screen for and diagnose different forms of cancer including the identification of biomarkers, quantification of metabolic analytes and genomic sequencing, each displaying their own advantages and limitations.
The identification and quantification of analytes is an effective screening method for some cancers. The Glasgow Prognostic Score (GPS) utilises serum CRP and albumin quantification to provide invaluable prognostic information for pancreatic, colorectal, hepatocellular and other forms of malignant tumours1. While this, and other similar methods can provide reliable, prognostic data they are rarely considered diagnostic. Furthermore, tests such as these often require multiple samples or large sample volumes, repeated hospital visits, and manually dominated test protocols, increasing the risk of human error.
Next generation sequencing (NGS) is an innovative form of genomic sequencing used in cancer diagnosis to identify genes, parts of genes, and genetic mutations known to be related to either cancer in general, or specific forms of cancer. Whilst accurate, NGS screening requires expensive, complex equipment and prolonged protocols, somewhat limiting their utility in providing patients with a timely diagnosis.
Finally, a variety of imaging techniques can be used to visualise tumour growth in the body. These methods are well established, however, are normally not independently diagnostic and can only detect large groups of cancer cells, or tumours, which are evident only in the later, more fatal stages of cancer.
Due to limited resources and other contributing factors, an estimated 1 million cancer diagnosis have been missed in Europe since the beginning of the COVID-19 pandemic2, providing evidence for the need for fast, simple, and accurate screening and diagnostic techniques.
The solution
In 2002, Randox invested £180 million to develop the patented Biochip Array Technology (BAT) in response to the known limitations in diagnostics. This ground-breaking assay technology utilises multiplex testing methodology to provide a rapid, accurate and user-friendly methods for the diagnosis and screening of a wide variety of biomarkers. For use in molecular and protein-based immunoassays, BAT works by combining a panel of related biomarkers in a single biochip with one set of reagents, controls, and calibrators. Unlike other forms of testing which require a sample for each individual test, BAT can provide simultaneous qualitative and quantitative detection of a wide range of biomarkers from a single sample.
The biochip detection system is based on a chemiluminescent reaction. This is the emission of light, without heat, as a result of a chemical reaction. An enzyme is used to catalyse the chemical reaction on the biochip which generates the chemiluminescent signal. The light emitted from the chemiluminescent reaction that takes place in each Discrete Test Regions (DTR) is simultaneously detected and quantified using a Charge-Coupled Device (CCD) Camera.
Each biochip has up to 49 Discrete Test Regions meaning up to 44 tests can be carried out simultaneously. The additional DTRs are reserved for internal quality control and visual reference, a unique Biochip Array Technology feature.
Advantages of Biochip Array Technology
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Reduced times spent on individual tests as a result of multiplex testing, helping reduce required time and expense .
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The vast biochip test menu allows clinicians to detect routine and novel markers for advanced diagnostic analysis.
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Multiple sample types can be used on a single analyser including serum, plasma, whole blood, urine, oral fluid and alternative matrices.
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Testing for multiple markers helps to simultaneously increase the amount of returned patient information allowing for more informed patient diagnosis.
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BAT has a proven high standard of accurate test results with CV’s of less than 10%.
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Barcoded biochips and patient samples ensure complete traceability of results.
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Biochips are manufactured free from Biotin-streptavidin to reduce cross-reactivity.
Randox BAT has been used to develop several arrays for the detection of routine and novel biomarkers related to various forms of cancer, allowing for improved risk stratification and improve patient management reducing current invasive diagnosis methods.
Randox Pancreatic GlycoMarker Array
Pancreatic cancer is an aggressive form of cancer, one associated with very poor prognosis, often not diagnosed until it has reached the late stages. The 5-year survival rate of 9% attributed to pancreatic cancer indicates a requirement for fast, effective screening and diagnosis. The only FDA approved biomarker for use in pancreatic cancer diagnosis is CA 19-9. However, this biomarker has been shown to display inadequate sensitivity and high levels of false results when used independently and is known to be indicative of various forms of cancer1.
To this end, Randox has developed the Pancreatic GlycoMarker Array, which utilises three distinct biomarkers in a glycosylation-based multiplex detection system. The simultaneous detection of CA 19-9, Carcinoembryonic antigen (CEA) and Alpha-1-Acid Glycoprotein (A1AG) from a single patient sample provides increased sensitivity and specificity for pancreatic cancer when compared with traditional CA 19-9 analysis alone1. Capable of providing results in under 2 hours, this array provides impressive test turnaround times enabling effective intervention and treatment.
| Biomarker | Description |
| CA 19-9 | Cancer antigen 19-9 is a sialyl-Lewis A tetrasaccharide which around 10% of the population cannot express. It is associated with various forms of cancer most importantly, pancreatic, colorectal, and hepatic cancers. Levels of CA 19-9 are also known to be elevated in non-malignant diseases such as chronic pancreatitis1. |
| CEA | Carcinoembryonic antigen is a widely utilised biomarker for different tumours. In pancreatic cancer, increased CEA levels were shown to be evident in 60% of patients3 |
| A1AG | Alpha-1-Acid Glycoprotein is primarily produced by the liver; however, expression has been shown by various cancer cells. Altered glycosylation of A1AG is indicative of malignancy and metastasis4. |
The table below has been taken from an analysis carried out by Randox to determine the Area under curve (AUC), sensitivity, and specificity of these biomarkers, both as a full panel, and individually:
Table 1. Results of an investigation to determine the Area under curve (AUC), sensitivity and specificity of Randox GlycoMarker Array targets both individually and as a panel.
Colorectal Cancer
KRAS, BRAF, PIK3CA Array
Colorectal cancers (CRCs) are the third most common form of cancer, accounting for an estimated 1.93 million cases in 20205. There are three major genes which, when mutations occur, are associated with CRC: KRAS, BRAF and PIK3CA.
Kirsten rat sarcoma (KRAS) is an oncogene frequently mutated in CRC. Around 40% of CRC patients display missense mutations in KRAS most of which occur in codons 12, 13 and 616. The protein encoded by this gene acts as a molecular switch, alternating between a GDP-bound inactive state and a GTP-bound active state. The binding of GTP to the KRAS protein is key in the binding of effectors and the initiation of several downstream pathways which promote cell growth and proliferation. Mutations in the KRAS gene will result in a disruption in hydrolysis of GTP and/or an increase in nucleotide exchange, resulting in an accumulation of the KRAS protein in its active state, the subsequent, continuous activation of downstream signalling pathways and ultimately the proliferation of cancer cells6. Approximately 85% of KRAS mutations occur in codons 12, 13, and 61, with codon 12 being host to 65% of these. Mutations in these codons are associated with extremely poor prognosis compared with wild-type (WT) KRAS cases6.
Mutations in the BRAF gene are evident in an average of 12% of CRC patients, the majority of which are attributed to a BRAF V600E (valine 600 to glutamate) substitution7. CRC patients which display this mutation have a median overall survival (OS) of 11 months and are associated with high levels of epigenetic expression through DNA methylation when compared with WT BRAF patients. V600E mutations are known to inhibit the expression of caudal-type homeobox 2 (CDX2), a tumour suppressor and transcriptional factor crucial in the regulation of intestinal epithelial cell differentiation, cell adhesion, and polarity. The loss of CDX2 activity is associated with high levels of metastasis and poor prognosis in CRC patients7.
PIK3CA mutations are common in various forms of cancer, promoting carcinogenesis through the dysregulation of important cancer signalling pathways. PIK3CA encodes the alpha catalytic subunit of PIK3 (phosphatidylinositol-4,5-bisphosphate 3-kinase), which is responsible for the phosphorylation of phosphatidylinositol-4,5-bisphosphate to phosphatidylinositol-4,5-triphosphate. This newly phosphorylated molecule simultaneously binds kinase PDK1, mTORC2 and serine/threonine kinase, AKT. The phosphorylation of AKT results in the downstream activation of pro-carcinogenic factors and inhibition of tumour suppressor activity, including inhibition of the transcription factor, FOXO1. FOXO1 has several important functions relating to cell apoptosis and proliferation and acts as a context-dependant tumour suppressor8.
The Randox KRAS, BRAF, PIK3CA Array is based on a combination of multiplex PCR and biochip array hybridization for high discrimination between multiple wild‑type and mutant DNA regions in the KRAS, BRAF, and PIK3CA genes. Providing there are enough copies of DNA present, approximately 1% of mutants can be readily detected in a background of wild‑type genomic DNA. A unique primer set is designed for each mutation target and control, which will hybridize to a complementary DTR on the biochip array. Each DTR corresponds to a particular mutation target. With the ability to simultaneously detect 20 mutation points within the KRAS, BRAF and PIK3CA genes, this array can aid clinicians in diagnosis and screening of CRC and help provide insightful information regarding treatment options and prognosis.
Female Bladder Cancer Array
Bladder cancer is considered the most significant cause of haematuria. Bladder cancer is very common, estimated to be the 6th most common in men and 17th most common form of cancer in women9. However, this disparity means bladder cancer in women is often overlooked and the associated haematuria is often attributed to other diagnosis. Those who are correctly diagnosed often experience delayed diagnosis and treatment resulting in worse survival probability10. Cystoscopy, an invasive endoscopy procedure of the urethra and bladder, is the gold standard for the diagnosis. This procedure carries high risk of infection, bleeding and is extremely uncomfortable for the patient. Furthermore, bladder cancer is associated with a high recurrence rate, meaning patients require monitoring for the remainder of their lives, displaying the urgent need for less invasive, fast, effective, and gender-specific screening methods for bladder cancer detection.
The urgent need for evidence-based risk stratification models for screening, diagnosis and subsequent management of patients presenting with haematuria prompted Randox to develop the Female Bladder Cancer Array. Utilising a combination of biomarkers known to provide high sensitivity and specificity, this array is designed to assist clinicians to differentiate patients presenting with haematuria from those with other causes, while removing the need for invasive imaging techniques. This array detects IL-12p70, IL-13, Midkine and Clusterin to provide a comprehensive panel of targets aiding clinicians in risk-stratification, diagnosis, and ongoing monitoring of female bladder cancer patients.
Biomarker |
Description |
IL-12p70 |
Interleukin 12p70 is a disulphide linked heterodimeric cytokine which regulates inflammation by linking innate and adaptive immune responses and potent inducer of antitumor immunity. |
IL-13 |
Interleukin-13 is an immunoregulatory cytokine which plays an important role in carcinogenesis through affecting tumour immunosurveillance. IL-13 in the bladder cancer patients suggests that this cytokine is involved in progression in bladder cancer patients. |
Midkine |
Midkine is a member of a family of heparin-binding growth factors, which has been reported to have an important role in angiogenesis and is associated with bladder cancer progression. |
Clusterin |
Clusterin is conserved glycoprotein that has been distinguished from human fluids and tissues which plays a key role in cellular stress response and survival. It is evident in cancer metastasis, which is particularly important to design the strategies for treating metastatic patients. |
The Evidence Investigator
The Evidence Investigator is a compact semi-automated benchtop analyser. It is a perfect fit for medium throughput laboratories seeking maximum use of bench space without compromising on the volume of samples processed.
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Estimated turnaround time: Less than 5 hours
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Detection from nucleic acid
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Batch testing
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Suitable for laboratory setting
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Comprehensive test menu
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Medium to high throughput – 54 samples and reporting 540 results in less than 5 hours
For references related to this article- References
For more information on this, please contact us at: market@randox.com
WHD References
References
Bibliography
- Khomiak A, Brunner M, Kordes M, et al. Recent Discoveries of Diagnostic, Prognostic and Predictive Biomarkers for Pancreatic Cancer. Cancers. 2020;12(11):3234. doi:https://doi.org/10.3390/cancers12113234
- Lawler M, Davies L, Oberst S, et al. European Groundshot—addressing Europe’s cancer research challenges: a Lancet Oncology Commission. The Lancet Oncology. Published online November 2022. doi:https://doi.org/10.1016/s1470-2045(22)00540-x
- Mancera-Arteu M, Giménez E, Balmaña M, et al. Multivariate data analysis for the detection of human alpha-acid glycoprotein aberrant glycosylation in pancreatic ductal adenocarcinoma. Journal of Proteomics. 2019;195:76-87. doi:https://doi.org/10.1016/j.jprot.2019.01.006
- Virág D, Kremmer T, Lőrincz K, et al. Altered Glycosylation of Human Alpha-1-Acid Glycoprotein as a Biomarker for Malignant Melanoma. Molecules. 2021;26(19):6003. doi:https://doi.org/10.3390/molecules26196003
- World Health Organization. Cancer. World Health Organization. Published February 3, 2022. https://www.who.int/news-room/fact-sheets/detail/cancer
- Zhu G, Pei L, Xia H, Tang Q, Bi F. Role of oncogenic KRAS in the prognosis, diagnosis and treatment of colorectal cancer. Molecular Cancer. 2021;20(1). doi:https://doi.org/10.1186/s12943-021-01441-4
- Grothey A, Fakih M, Tabernero J. Management of BRAF-mutant metastatic colorectal cancer: a review of treatment options and evidence-based guidelines. Annals of Oncology. Published online April 2021. doi:https://doi.org/10.1016/j.annonc.2021.03.206
- Voutsadakis IA. The Landscape of PIK3CA Mutations in Colorectal Cancer. Clinical Colorectal Cancer. Published online February 2021. doi:https://doi.org/10.1016/j.clcc.2021.02.003
- Ferlay J, Colombet M, Soerjomataram I, et al. Cancer statistics for the year 2020: an overview. International Journal of Cancer. 2021;149(4). doi:https://doi.org/10.1002/ijc.33588
- Duggan B, O’Rourke D, Anderson N, et al. Biomarkers to assess the risk of bladder cancer in patients presenting with haematuria are gender-specific. Frontiers in Oncology. 2022;12:1009014. doi:https://doi.org/10.3389/fonc.2022.1009014
Lipoprotein (a) Awareness Day 2023
Randox are raising awareness for Lipoprotein(a), we want to drive awareness on tests that are available to you to decrease the risk of stroke, heart attack or other heart diseases!
Lp(a) is a risk factor for atherosclerosis and related diseases including CHD and stroke. It is increasingly recognised as the strongest known genetic risk factor for premature coronary artery disease.
Identifying any possible health conditions that would relate to early signs of stroke, heart attack or other heart diseases will allow you to make any decisions on an appropriate diet, lifestyle changes and early treatment to reduce your risk of further problems.
Benefits of the Randox Lp(a) assay
WHO/IFCC Reference Material
Dedicated Five-Point Calibrator Available
Excellent Correlation
Excellent Precision
Liquid Ready-To-Use
Available in nmol/L
Applications Available-on Roche, Abbott, Beckman, and more.
The biggest challenge that exists surrounding Lp(a) measurement is the heterogeneity of the apo(a) isoforms, resulting in the underestimation or overestimation of Lp(a) concentrations. In immunoassays, the variable numbers of repeated KIV-2 units in Lp(a) act as multiple epitopes. This is where standardisation across calibrators is vital. Unless the calibrants do have the same range of isoforms as test samples, those with higher numbers of the KIV-2 repeat, will represent with an overestimation in Lp(a) concentrations and those with smaller numbers of the KIV-2 repeat, will represent with an underestimation. The smaller isoforms are strongly associated with higher Lp(a) concentrations. Lack of standardisation of the calibrant would result in an underestimation of Lp(a) associated CVD risk. It is important to note that an Lp(a) immunoassay employing isoform insensitive antibodies does not exist.
How can Randox help?
Randox Sales Reps are experts in their fields and are available to discuss your specific requirements.
Simply send us an email by clicking the link below and we will get in touch!
THE 2023 RANDOX GRAND NATIONAL TROPHY IS REVEALED
THE 2023 RANDOX GRAND NATIONAL TROPHY IS REVEALED
Sunday 19th March
Elizabeth Moran of Randox, who designed the trophy, said: “It was a wonderfully creative challenge to design this year’s trophy, reflecting both this national, iconic sporting event and Randox’s innovation within healthcare, and I think we got it just right.”
During the Randox Grand National Festival (Thursday 13th April – Friday 15th April inclusive), the trophy as well as trophies from previous Randox Grand Nationals, can be viewed in trophy marquee next to the Red Rum Garden at Aintree Racecourse.
World Kidney Day 2023
World Kidney Day 2023
“Kidney health for all – Preparing for the unexpected, supporting the vulnerable”
Thursday 09th March
Chronic Kidney Disease (CKD) is considered a leading cause of global mortality with an overall global prevalence rate of around 13%1. This figure rises to 15% in the US2 and the statistics show that these rates are likely to continue this upward trend3. CKD is defined as damage to the kidneys which affects its ability to correctly filter bodily fluids which ultimately results in renal replacement therapy in the form of dialysis or transplantation4. This sustained or chronic damage of the kidney encourages kidney fibrosis and loss of structure. The early stages of CKD are generally asymptomatic with symptoms beginning to manifest in stages 4 and 5. These symptoms include nausea & vomiting, fatigue & weakness, oliguria, chest pain, hypertension, to name a few4.
World Kidney Day is an annual, global campaign spearheaded by the International Society of Nephrology (ISN) and the International Federation of Kidney Foundations – World Kidney Alliance (IFKF – WKA) which intends to raise awareness of how critical our kidneys are and to limit the prevalence and impact of kidney disease5. This year’s focus is “Kidney health for all – preparing for the unexpected, supporting the vulnerable.”
It is no surprise that patients suffering from noncommunicable diseases (NCDs) such as CKD were subject to worse prognosis during the COVID-19 pandemic6 due to prioritising of ongoing complex care over acute patient care7. But a pandemic is only one circumstance, albeit a major one, which can affect the ability of hospitals and laboratories to uphold their normal testing capacity. For example, natural disasters can make it impossible for people to reach facilities for testing or treatment7. Similar situations could arise at a more local level such as road closures, power outages or public transport strikes which have the potential to delay diagnosis or treatment.
To this end, laboratories should look to introduce novel and effective methods for testing under adverse conditions. Rapid testing will be imperative to help achieve these goals and promote fast test turnaround times and accurate diagnosis. The Randox CKD Arrays, in conjunction with the Randox Evidence Investigator, allow for simultaneous and quantitative detection of multiple serum biomarkers of kidney damage-related analytes allowing diagnosis at a much earlier stage than traditional creatinine tests.
Utilising patented Biochip Technology, the Randox CKD arrays could improve patient risk stratification whilst monitoring the effectiveness of treatment. Diagnosis of CKD at early stages will allow earlier intervention for the treatment of kidney disease, and the prevention of further kidney damage. The utility of this test cannot be overstated. In adverse circumstances, the Randox Evidence Investigator could permit diagnosis of CKD and determination of CKD severity at the site of the patient, helping prepare for the unexpected and support the vulnerable.
More information of CKD and other kidney related conditions can be found at: Homepage – World Kidney Day
References
Bibliography
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Lv JC, Zhang LX. Prevalence and Disease Burden of Chronic Kidney Disease. Advances in Experimental Medicine and Biology. 2019;1165:3-15. doi:https://doi.org/10.1007/978-981-13-8871-2_1
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Centers for Disease Control and Prevention. Chronic Kidney Disease in the United States, 2021. US Department of Health and Human Services; 2021. https://www.cdc.gov/kidneydisease/pdf/Chronic-Kidney-Disease-in-the-US-2021-h.pdf
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Kovesdy CP. Epidemiology of chronic kidney disease: an update 2022. Kidney International Supplements. 2022;12(1):7-11. doi:https://doi.org/10.1016/j.kisu.2021.11.003
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Vaidya SR, Aeddula NR. Chronic renal failure. Nih.gov. Published 2019. https://www.ncbi.nlm.nih.gov/books/NBK535404/
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International Society of Nephrology. Homepage. World Kidney Day. Published 2023. https://www.worldkidneyday.org/
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Nikoloski Z, Alqunaibet AM, Alfawaz RA, et al. Covid-19 and non-communicable diseases: evidence from a systematic literature review. BMC Public Health. 2021;21(1). doi:https://doi.org/10.1186/s12889-021-11116-w
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Hsiao LL, Shah KM, Liew A, et al. Kidney health for all: preparedness for the unexpected in supporting the vulnerable. Kidney International. 2023;103(3):436-443. doi:https://doi.org/10.1016/j.kint.2022.12.013
For more information, please contact Market@randox.com