Sexually Transmitted Infections – Rapid Testing at the Point of Care
Sexually Transmitted Infections – 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.
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|
|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.
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
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.
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
Reduced times spent on individual tests as a result of multiplex testing, helping reduce required time and expense .
The vast biochip test menu allows clinicians to detect routine and novel markers for advanced diagnostic analysis.
Multiple sample types can be used on a single analyser including serum, plasma, whole blood, urine, oral fluid and alternative matrices.
Testing for multiple markers helps to simultaneously increase the amount of returned patient information allowing for more informed patient diagnosis.
BAT has a proven high standard of accurate test results with CV’s of less than 10%.
Barcoded biochips and patient samples ensure complete traceability of results.
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.
|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.
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.
Interleukin 12p70 is a disulphide linked heterodimeric cytokine which regulates inflammation by linking innate and adaptive immune responses and potent inducer of antitumor immunity.
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 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 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.
Estimated turnaround time: Less than 5 hours
Detection from nucleic acid
Suitable for laboratory setting
Comprehensive test menu
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: firstname.lastname@example.org
- 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
Available in nmol/L
Applications Available-on Roche, Abbott, Beckman, and more.
The biggest challenge that exists surrounding Lp(a) measurement is the heterogeneity of the apo(a) isoforms, resulting in the underestimation or overestimation of Lp(a) concentrations. In immunoassays, the variable numbers of repeated KIV-2 units in Lp(a) act as multiple epitopes. This is where standardisation across calibrators is vital. Unless the calibrants do have the same range of isoforms as test samples, those with higher numbers of the KIV-2 repeat, will represent with an overestimation in Lp(a) concentrations and those with smaller numbers of the KIV-2 repeat, will represent with an underestimation. The smaller isoforms are strongly associated with higher Lp(a) concentrations. Lack of standardisation of the calibrant would result in an underestimation of Lp(a) associated CVD risk. It is important to note that an Lp(a) immunoassay employing isoform insensitive antibodies does not exist.
How can Randox help?
Randox Sales Reps are experts in their fields and are available to discuss your specific requirements.
Simply send us an email by clicking the link below and we will get in touch!
THE 2023 RANDOX GRAND NATIONAL TROPHY IS REVEALED
THE 2023 RANDOX GRAND NATIONAL TROPHY IS REVEALED
Sunday 19th March
The Randox Grand National Trophy is one of the most iconic and prestigious sporting trophies in the world of horseracing. From the start of the Randox sponsorship of the Grand National in 2017, Randox CEO Dr Peter FitzGerald proposed a unique trophy would be designed and produced each year. The winning owner receives the full size the trophy, with the winning trainer, jockey and groom all receiving a miniature version.
Each trophy is uniquely Randox and has a story to tell. The design of the trophy has evolved over the years and the 2023 trophy, which is revealed today, has a special significance as it incorporates several key elements that represent the company’s values and achievements – alongside a nod to a very special racehorse.
At the top of the trophy there is a beautifully crafted horse mid-jump, symbolising the 30 fences that the winner will navigate during the four-mile, two-and-a-half-furlong contest on Saturday 15th April. The horse is shown making its way over a horseshoe instead of a fence, representing protection and good luck.
In the centre of the trophy, a gold blood drop symbolises Randox’s diagnostic testing. This leads up to the DNA double helix, representing the company’s genomic testing capabilities. Randox offers seven different types of genetic testing, empowering people to find out more about their future health.
The base of the trophy features a molecular pattern, representing Randox’s molecular testing capabilities. The “o” in Randox is embellished with red enamel, symbolising accuracy and precision, which are integral to the Randox brand. The red enamel is also representative of a blood drop, used in much of Randox’s diagnostic testing.
Etched along the bottom of the trophy, is “Celebrating the 50th anniversary of Red Rum winning his first Grand National race” paying tribute to the legendary Red Rum’s first of his record three Grand National triumphs in 1972. The quartet of silver strands that connect the top and bottom of the trophy represent Randox’s support of racing and sponsorship of the Grand National.
Elizabeth Moran of Randox, who designed the trophy, said: “It was a wonderfully creative challenge to design this year’s trophy, reflecting both this national, iconic sporting event and Randox’s innovation within healthcare, and I think we got it just right.”
Silversmith Cara Murphy, who produced the trophy added: “I am delighted with what we have achieved. This is a highly intricate trophy and was challenging to produce – the end result is a trophy to grace the podium and recognise the achievement of winning the world’s greatest steeplechase.”
The 2023 Randox Grand National Trophy is a beautiful and intricate work of art that embodies the company’s commitment to innovation, accuracy, and precision in the field of diagnostic testing. The horse, the horseshoe, and the nod to Red Rum all come together to create a stunning and symbolic celebration of horseracing.
During the Randox Grand National Festival (Thursday 13th April – Friday 15th April inclusive), the trophy as well as trophies from previous Randox Grand Nationals, can be viewed in trophy marquee next to the Red Rum Garden at Aintree Racecourse.
World Kidney Day 2023
World Kidney Day 2023
“Kidney health for all – Preparing for the unexpected, supporting the vulnerable”
Thursday 09th March
Chronic Kidney Disease (CKD) is considered a leading cause of global mortality with an overall global prevalence rate of around 13%1. This figure rises to 15% in the US2 and the statistics show that these rates are likely to continue this upward trend3. CKD is defined as damage to the kidneys which affects its ability to correctly filter bodily fluids which ultimately results in renal replacement therapy in the form of dialysis or transplantation4. This sustained or chronic damage of the kidney encourages kidney fibrosis and loss of structure. The early stages of CKD are generally asymptomatic with symptoms beginning to manifest in stages 4 and 5. These symptoms include nausea & vomiting, fatigue & weakness, oliguria, chest pain, hypertension, to name a few4.
World Kidney Day is an annual, global campaign spearheaded by the International Society of Nephrology (ISN) and the International Federation of Kidney Foundations – World Kidney Alliance (IFKF – WKA) which intends to raise awareness of how critical our kidneys are and to limit the prevalence and impact of kidney disease5. This year’s focus is “Kidney health for all – preparing for the unexpected, supporting the vulnerable.”
It is no surprise that patients suffering from noncommunicable diseases (NCDs) such as CKD were subject to worse prognosis during the COVID-19 pandemic6 due to prioritising of ongoing complex care over acute patient care7. But a pandemic is only one circumstance, albeit a major one, which can affect the ability of hospitals and laboratories to uphold their normal testing capacity. For example, natural disasters can make it impossible for people to reach facilities for testing or treatment7. Similar situations could arise at a more local level such as road closures, power outages or public transport strikes which have the potential to delay diagnosis or treatment.
To this end, laboratories should look to introduce novel and effective methods for testing under adverse conditions. Rapid testing will be imperative to help achieve these goals and promote fast test turnaround times and accurate diagnosis. The Randox CKD Arrays, in conjunction with the Randox Evidence Investigator, allow for simultaneous and quantitative detection of multiple serum biomarkers of kidney damage-related analytes allowing diagnosis at a much earlier stage than traditional creatinine tests.
Utilising patented Biochip Technology, the Randox CKD arrays could improve patient risk stratification whilst monitoring the effectiveness of treatment. Diagnosis of CKD at early stages will allow earlier intervention for the treatment of kidney disease, and the prevention of further kidney damage. The utility of this test cannot be overstated. In adverse circumstances, the Randox Evidence Investigator could permit diagnosis of CKD and determination of CKD severity at the site of the patient, helping prepare for the unexpected and support the vulnerable.
More information of CKD and other kidney related conditions can be found at: Homepage – World Kidney Day
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
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
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
Vaidya SR, Aeddula NR. Chronic renal failure. Nih.gov. Published 2019. https://www.ncbi.nlm.nih.gov/books/NBK535404/
International Society of Nephrology. Homepage. World Kidney Day. Published 2023. https://www.worldkidneyday.org/
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
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
RIQAS Microbiology FLYER MAR23
Free Health Testing For Sandwell Residents As Council Partner With Randox Health To Detect Early Warning Signs of Serious Illness
Sandwell Council partners with Randox Health to launch free health checks service
Sandwell Council initiative places prevention at the centre of healthcare
Thousands of eligible Sandwell residents are being offered diagnostic NHS Health Checks to detect any early signs of diabetes, heart and kidney disease and hypertension.
The early identification of individuals with the potential to develop these conditions will enable the NHS to intervene and, in many cases, prevent the onset of potentially life-changing and life-threatening illnesses.
In a pioneering initiative, the Sandwell tests and online self-assessment provision will be provided by a partnership comprising the council’s Healthy Sandwell team, the NHS and diagnostics company Randox Health – whose tests and clinics will be used to facilitate the innovative testing. Tests and clinics will be available for Sandwell residents in both Sandwell and, if convenient, in Birmingham.
The awarding of the contract to Randox Health to provide the tests follows an open tender process by Sandwell Council. The company has demonstrated success in providing 17 million PCR tests to NHS Test and Trace during the Covid-19 pandemic, helping prevent thousands of hospitalisations and deaths in the UK.
Free tests will be offered to Sandwell residents aged between 40 and 74 who have not previously suffered coronary heart disease, strokes, diabetes or kidney disease. Each will, in the next few weeks, begin receiving letters inviting them to the 20-minute NHS check, with branding from Randox, Healthy Sandwell and the NHS. The letter will include a link to the Randox website through which the tests can be booked.
Sandwell residents who have not yet received a GP letter and believe they are eligible can visit the Randox website https://nhshealthcheck.randox.com, take an eligibility check and then book their own appointment.
Tests will be carried out by specially trained staff at a number of community pop-up clinics in locations in Sandwell such as leisure centres and community spaces, aiming to reach those most at risk of having an undiagnosed serious illness.
Tests for Sandwell residents will also be available at Randox Health’s Birmingham Clinic (39-40 High Street, B4 7SL).
Test results will be made available to GPs for inclusion on patient medical records through Health Diagnostics Ltd, a third-party provider. Randox will hold none of the data from the test results.
Not only will the testing programme enable prevention and mitigation through the early identification of serious illness, it will also allow lifestyle modification on issues including smoking, alcohol and weight management.
Councillor Suzanne Hartwell, Sandwell Council’s Cabinet Member for Adults, Social Care & Health, said:
David Ferguson, Chief Operating Officer for Randox Health said:
1. Sandwell Council
Sandwell Council will participate in the partnership through Healthy Sandwell, which is part of the council’s Public Health team. Healthy Sandwell provides a range of services to support local people to make positive lifestyle changes, such as quitting smoking or losing weight. Further information: https://www.healthysandwell.co.uk/
2. Randox Health
Established in 1982, Randox is the largest healthcare diagnostics company from the UK and Ireland.
Undertaking research, development, manufacture and distribution of innovative laboratory tests and analysers, Randox provides 15% of all worldwide cholesterol tests and 10% of all clinical chemistry tests. More than 5% of the world’s population (over 370 million people) receive medical diagnosis using Randox products each year.
Randox Health focuses on the provision of timely and accurate testing to identify risk to health, improve clinical diagnoses and promote preventative healthcare; aiming to achieve better healthcare outcomes whilst reducing the burden on clinical services.
In early 2020 Randox recognised the threat from COVID-19 and quickly developed a test to accurately identify the virus. Testing at scale commenced within weeks to support the UK’s National Testing Programme and private clients. Randox has processed more than 25 million gold-standard PCR tests for the National Testing Programme and private COVID testing for travel.
Randox Health is clear that better diagnostics are unquestionably critical to future improvements within healthcare and is committed to remaining at the forefront of that field.
Its growing network of High Street clinics now operate in 20 locations around the UK and Ireland, including Birmingham.
Randox Laboratories and Roquefort Therapeutics Collaborate to Develop Midkine Cancer Antibodies
Randox and Roquefort Therapeutics collaborate to develop midkine cancer antibodies
Randox Laboratories collaborate with Roquefort Therapeutics, an LSE market listed biotech company, dedicated to developing first in class medicines in the high value, high growth oncology market. The partnership is focused on the field of medical diagnostics only, in relation to Roquefort’s Midkine antibody portfolio.
The collaboration Randox will allow to utilise Roquefort’s Midkine antibodies in the field of medical diagnostics. Randox will therefore engage with Roquefort in research programmes to identify new cancer diagnostics that will be treatable with the companies Midkine products.
Why this partnership is important?
Midkine is a herapin binding protein, known for being important in embryonic development. While normally undetected in healthy adults, it is often highly expressed in cancer, inflammatory conditions and autoimmune disorders. Extensive research has revealed that blocking Midkine with antibodies can help slow tumour growth, reduce metastasis and overcome treatment resistance.
Within the partnership, Randox focuses on medical diagnostics to detect cancers expressing Midkine, produce the diagnostics essential for clinical trials and help Roquefort Therapeutics remain focused on developing first in class oncology medicines.
Randox are highly committed to preventative healthcare through early and more accurate diagnostics therefore this partnership with Roquefort Therapeutics is vitally important. Early diagnosis significantly increases a patient’s chance of survival thus using medical diagnostics to identify patients with cancer expressing Midkine is essential to the development of first-in-class cancer medicines and the future of cancer treatments.
When talking about the partnership, Dr Peter Fitzgerald, Managing Director of Randox said
About Roquefort Therapeutics
Roquefort Therapeutics is a cancer focused biotech company developing first in class drugs in the high value and high growth oncology segment prior to partnering or selling to big pharma. Since listing in March 2021, Roquefort successfully acquired Lyramid Pty Ltd, a leader in the development of medicines for a new therapeutic target, Midkine and has since developed a leadership position in Midkine intellectual property.
Roquefort Therapeutics’ focused portfolio consists of four fully funded, novel patent protected, pre-clinical, anti-cancer medicines that include:
- Midkine antibodies with significant in vivo efficacy and toxicology studies
- Midkine RNA therapeutics with novel anti-cancer gene editing action
- MK cell therapy with direct NK-mediate anti-cancer action and
- SiRNA targeting novel STAT-6 target in solid tumour showing significant in VIVO efficacy.
For more information, please contact email@example.com
Randox announces ‘Race against Dementia’ as partner charity for Randox Grand National Festival 2023
RANDOX ANNOUNCES ‘RACE AGAINST DEMENTIA’
AS PARTNER CHARITY FOR RANDOX GRAND NATIONAL FESTIVAL 2023
Thursday 16th February
Randox today announces that Race Against Dementia, a global charity founded by three-times Formula 1 World Champion Sir Jackie Stewart, OBE, as its charity partner for the Randox Grand National Festival 2023.
Today, across the globe, more than 55 million people are living with dementia, with someone new being diagnosed with the disease every three seconds. Unless a cure is found, it is estimated that one in three people born today will die with dementia.
Randox will support Race Against Dementia throughout the three-day Aintree festival, to highlight the impact of the disease and to raise funds for much needed research into its prevention and cure.
On Ladies Day (Friday 14th April), Randox’s sponsored race over the Grand National fences will be titled ‘The Randox Supports Race Against Dementia Topham Chase’, and there will be opportunities to reach out to both the racing public and, through the festival’s media coverage, to the nation.
The 2023 Festival will also enable a welcome return to Aintree for Sir Jackie, who raced at Aintree in the 1960s, at a time when Aintree was part of the Grand Prix circuit.
As a global diagnostics company, with over 40 years of experience and a focus on preventative healthcare, Randox and Race Against Dementia are natural partners.
In the pursuit of a cure for dementia, improved testing and diagnosis will both enhance patient management and greatly accelerate the race for treatment.
Dr Peter FitzGerald, Managing Director of Randox said:
“Randox is proud to partner with Race Against Dementia as our nominated charity for 2023.
“We understand the importance of taking action early regarding current and future health. As a global market leader within the clinical diagnostics field, it was an obvious choice for Randox to partner with a similarly ambitious organisation. Race Against Dementia is a cause very close to many of our hearts.”
Sir Jackie Stewart OBE, Founder of Race Against Dementia, said:
“Race Against Dementia is delighted to be supported by Randox Laboratories in our race to find a cure for dementia.
“It is a great privilege to partner with an organisation which is an active innovator and is supporting our mission to accelerate the progress of dementia research.
“We are confident that working together with Randox will help to raise funds that will allow us to break new ground in the search for a cure or prevention of dementia.
“On a personal front, I have raced at Aintree before – it is a pleasure to be back, with another ‘race’ in mind.”
Dickon White, Regional Director, The Jockey Club North West, said:
“We are proud to support Race Against Dementia at the Grand National Festival and extend our thanks to Randox for helping to bring this partnership to fruition.
“Being staged over the famous Grand National fences, the Randox Supports Race Against Dementia Topham Chase should prove a very suitable vehicle for helping to publicise the vital work of Race Against Dementia.”
About Randox Laboratories
With over 40 years of diagnostic experience, Randox is globally recognised as being at the forefront of diagnostic capability and understands the importance of comprehensive and reliable research.
Past research and development has identified key proteins associated with Alzheimer’s disease risk, stratifying at-risk populations, for early identification and assisting with clinical research.
Randox has recently made significant investment to deliver preventative, personalised testing packages across the nation and has opened over 20 new Randox Health clinics. Randox Health clinics focus on the provision of cost-effective, timely and accurate testing to identify risk to health, improve clinical diagnoses and promote preventative healthcare.
About Race Against Dementia
Race Against Dementia is a global charity, founded by Sir Jackie Stewart, OBE, to fund pioneering research into the prevention and cure of dementia.
RAD supports a number of Early Career Researchers in the UK, US, Australia, Europe and South Africa in order to accelerate dementia research.
RAD’s vision is a breakthrough in the prevention or treatment of dementia with the greatest of urgency.
For more information, please contact Market@randox.com