Randox Biochip Array (BAT) Technology free from Biotin-Streptavidin
Randox Biochip Array (BAT) Technology free from Biotin-Streptavidin
Biotin, also known as vitamin B7, is involved with fatty acid metabolism, amino acid degradation, and gluconeogenesis. The recommended daily intake for biotin is roughly 30-70µg, which is extremely low, meaning that biotin deficiency is rare. Recently, there has been a surge in biotin supplementation mainly for beauty reasons, including: stronger nails and healthier skin and hair, resulting in the biotin craze on Instagram. Currently 162K posts are attributed to the biotin hashtag (#biotin) on Instagram. Whilst biotin supplementation is beneficial for numerous health conditions, including: multiple sclerosis (MS), diabetes, elevated cholesterol, and metabolic dysfunction, the increasing use of biotin by patients has created a problem with in vitro diagnostic testing.
With numerous manufacturers using biotin-streptavidin technology to develop in vitro diagnostic tests, combined with the rise in biotin supplementation use, the FDA (food and drug administration) issued an alert regarding the potential for erroneous results triggered by high levels of biotin in patient samples, at the end of 2017. Clinical decisions based on these false results from biotin technology can lead to inaccurate diagnosis and inappropriate treatment prescribed. The FDA confirmed that a patient, who was consuming high levels of biotin, died when a troponin tested was skewed and failed to show that the patient was having a heart attack. Other tests that can produce erroneous results include: cardiac, pregnancy, cancer and iron-deficiency tests.
The image above highlights that in biotin-free patient samples, the analyte to be tested successfully binds to the biotinylated antibody and the labelled antibody ultimately ensuring accurate measurement. In the patient sample containing high levels of biotin, the biotin inhibits streptavidin’s ability to capture the analyte-antibody complex, generating falsely lowered results.
As 70% of all clinical decisions are based on results from in vitro diagnostic tests, it is vital that laboratories are selecting in vitro diagnostic tests that do not adopt the biotin-streptavidin technology to ensure accurate patient testing.
Randox do not utilise the biotin-streptavidin technology in the development of the Biochip Array Technology (BAT).
The Randox Biochip facilitates multiplex testing for faster, more comprehensive patient testing. This technology, free from biotin-streptavidin, uses capture antibodies bound to a solid substrate (biochip surface) as opposed to biotinylated antibodies used by other manufacturers. The Biochip also utilises enzyme labelled conjugate to enable chemiluminescent detection of the target in the patient sample.
Biochip test menu
The Biochip Array Technology (BAT) from Randox is capable of simultaneous multi-analyte diagnostic testing within the fields of clinical research and drugs of abuse testing. The technology works through combining a panel of related assays on a single biochip with a single set of reagents, controls and calibrators. An extensive range of Biochip panels are available, each optimised to provide the best performance.
The evidence analyser is the world’s first protein Biochip Array Technology system and has truly transformed laboratory diagnostics worldwide. As the first of its kind, the Evidence has introduced higher standards of quality efficiency and reliability to numerous sectors including hospitals and clinical laboratories, forensic and clinical toxicology, pharmaceutical/CRO applications, as well as veterinary laboratories.
The world’s first fully automated random access Biochip testing platform. The Evidence Evolution is set to revolutionise current diagnostic testing. With the capability to process up to 2,640 tests per hour, the Evidence Evolution utilises multiplexing technology, offering advanced test consolidation, patient profiling, a complete system integration, as well as the most comprehensive test menu on the market.
The #1 choice for research, clinical, forensic, and veterinary testing. Using the multiplexing technology, the semi-automated benchtop immunoanalyser Evidence Investigator is suitable for medium throughput laboratories. In addition to the current test menu for this analyser, Randox have new tests in development.
Halasey. S, 2018, “Inside Track: Biotin Gets a Safety Alert”. Available from URL: http://www.clpmag.com/2018/01/inside-track-biotin-gets-safety-alert/
Is Biomarker Multiplexing the future of kidney disease screening?
Chronic Kidney Disease (CKD) is both a cause and a consequence of cardiovascular diseases, and is an increasing burden on global health. As diabetes, obesity and hypertension incidences continue to rise and the world’s population steadily ages, CKD’s prevalence is already estimated to be between 11% and 13% globally for all five KDOQI stages, with a majority in Stage 3 (about 90% of all stages).
With early stages of CKD being asymptomatic and current diagnostic tools (proteinuria determined by albumin to creatinine ratio and decreased renal function estimated from GFR using the CKD-EPI equation) are insufficiently sensitive to detect most cases up to stage 3, it is likely that the true prevalence of CKD is still underestimated. Therefore the need to improve both early diagnostics and overall CKD outcome is all the more critical.
Accordingly, biomarker research has been intense in the field of renal disease for at least 10 years with a number of promising candidates emerging, some now well-known by specialists: Cystatin C, NGAL or KIM-1 for example.
However, further novel biomarkers, assessed in combination using a properly developed multiplex assays can allow superior insight into CKD than what their individual performance could achieve. This also largely stems from selecting the markers that are indicative of complementary mechanisms that contribute to the development of CKD.
When assayed together from a single serum sample and after combinatorial analysis has been applied, these biomarkers can open new avenues in the management of CKD, such as proper diagnosis of the condition from Stage 1, clear differentiation between stages and monitoring of the progression pace of the disease. Early screening of patients at risk of CKD is now within reach and it is expected that its systematic use will have a profound impact on health system economics.
Another area of interest in renal research is Acute Kidney Injury (AKI) which may arise as a result of cardiac surgery and can subsequently lead to CKD. AKI detection is also of significant interest in the field of drug development, where early stage toxicity is still a large cause of new drug marketing withdrawal. Hence selecting and qualifying kidney tissue damage biomarkers, and assembling them into a multiplex panel is a key priority to those involved in early stage clinical trials.
An AKI panel has been worked out using the same principles as those used in the development of the CKD panel: high individual diagnostic value and multiple, independent cellular targets. This panel is now ready for final clinical qualification and will be one of the first of several organ-targeted safety panels aiming to become standard for drug induced toxicity screening.
It is key to the adoption of multiplex testing that proper validation guidelines be published and that careful, matrix-based validation data is made available to potential users. It is essential that multiplexed testing comes to the front line of testing in the field, so it can deliver to its full potential and start translating into public health improvement and cost savings. Technology is ready, let’s make a start!
Dr Claire Huguet
Randox Biosciences – Head of Biomarkers
For further information about kidney disease screening from Randox Biosciences, please contact email@example.com
Randox / Bosch partnership delivers game-changing device in fight against antibiotic resistance
A partnership between Randox Laboratories, the UK’s largest manufacturer of in-vitro diagnostics, and the German technology giant Bosch is changing the way doctors will treat patients with antibiotics, with the launch of a revolutionary product – the Vivalytic.
It’s estimated that 20% of antibiotics currently prescribed are unnecessary, and fuel the growing threat of global antibiotic resistance. This threatens the ability to treat common infectious diseases, and a growing number are becoming harder, and in some cases impossible, to treat. The World Health Organisation warns that without action, we are heading towards a post-antibiotic era.
This problem is being addressed by the Vivalytic. The result of a decade of R&D, it is an intuitive point-of-care analyser that, depending on the complexity of the test, will deliver results from 30 minutes: enabling doctors to select the right course of therapy faster than before. In some cases, this will be life-saving.
The first tests available on the Vivalytic are Randox’s panels for respiratory and sexually-transmitted infections*.
Using Randox’s patented Biochip Array Technology, the Respiratory Multiplex Array simultaneously reports on 22 viral and bacterial pathogens including Bordetella pertussis and parapertussis which causes whooping cough – without the need for secondary or confirmatory testing to inform clinical treatment decisions. The STI array enables the detection of 10 STIs from a single sample. Every day more than 1 million STIs are acquired, and many have mild if any symptoms at all. Identifying these infections correctly first time reduces the misuse of antibiotics and supports their targeted use.
The Managing Director of Randox Dr Peter FitzGerald commented:
“Antibiotic stewardship is a critical issue which we all have a responsibility to embrace and drive forward. This partnership is ideal, combining our expertise in molecular laboratory diagnostics with Bosch’s cutting-edge engineering. The Vivalytic is a game-changer for clinicians and patients: never before has there been this level of accessibility to this range of molecular diagnostics.”
Marc Meier, General Manager of Bosch Healthcare Solutions, a wholly owned subsidiary of Bosch Group, said:
“We are enthusiastic about having gained Randox as the first partner on our platform with two initial panels available from the start. It´s the beginning of jointly expanding the Vivalytic test portfolio for our clients. In this partnership the core competencies of Bosch in automation, miniaturization, and networking are complemented by Randox’s expertise in developing and commercializing innovative diagnostic solutions.”
Vivalytic and the panels will be presented to industry professionals for the first time at the ECCMID 2018 Congress in Madrid, Spain, in hall 10, booth 55A between 21st – 24th April.
*CE pending and FDA planned.
For further information about the Vivalytic, please contact firstname.lastname@example.org
The rise of drug abuse in India – Randox Toxicology
A recent study completed by the Narcotics Control Bureau (NCB) reported an all-time high of 3.6 lakh kg narcotic drugs seized in India in 2017, this was an increase of over 300 percent in the last five years. Known as ganja, cannabis is the most widely abused drug in India, increasing from 40,113 in 1999 to 352,379 by 2017, according to The Times of India.
(Sourced: The Times of India: Drug abuse on the rise in India, Ganja most in demand)
A prevalent issue in the north of India is pharmaceutical drug abuse, both over the counter and prescription drugs. The Times of India reported that 566,450 bottles of cough syrup, 58,463 injections and more than 6,300,000 tablets were recovered across India in 2017. Among the drugs being smuggled out of India and into countries such as America and Canada is the opioid painkiller Tramadol, which is not covered under the Narcotic Drugs and Psychotropic Substances Act.
With daily drug seizures across the country, the situation in India has been described as akin to the US national opioid emergency. Therefore, it has been suggested that a harm-reduction approach be taken to educate the young and tackling substance abuse.
Using our revolutionary Biochip Array Technology, the Evidence MultiSTAT is a fully automated analyser that enables on-site simultaneous detection of up to 21 classical, prescription and synthetic drugs from a single sample. Designed to work across a variety of matrices and generate results in under 20 minutes, Randox Toxicology have changed the landscape of drug detection forever.
For further information about the Evidence MultiSTAT and our cutting-edge multiplex testing capabilities, contact email@example.com to be put in touch with a sales member or visit www.randoxtoxicology.com
Vivalytic: The all-in-one solution for Molecular Diagnostics
A game-changing partnership between Randox Laboratories and Bosch is changing the accessibility to molecular diagnostics with the launch of a revolutionary product – the innovative platform Vivalytic.
Using Randox-patented Biochip Array Technology, it is the easiest-to-use and most-comprehensive multiplex PCR platform on the market. It provides the broadest range of test options ever seen for an analyser of its size, and also supports single-plex and low-plex testing, simplifying the processes for otherwise-complex laboratory test procedures. Depending on the test application, results will be delivered from 30 minutes.
Biochip Array Technology, developed by Randox Laboratories, is the innovative multiplexing technology which is utilised within the cartridge aspect of the platform. The Biochip allows for the simultaneous detection of multiple analytes from a single sample.
The new platform will be initially released with two molecular arrays available including Respiratory Tract Infection and Sexually Transmitted Infection with other tests to follow.
The Vivalytic is the perfect fit for any laboratory with numerous benefits to enhance your laboratories testing capabilities.
Hygienic and space saving
No other peripherals such as laptop, keyboard, barcode scanner or filling stations are required. This makes Vivalytic a hygienic and space-saving all-in-one solution.
Direct and clear results
The test result is presented clearly in a summary, but also details on the raw data of each individual measurement can be displayed.
The Vivalytic integrates the software with the instrument to ensure a safe and reliable run. This is the ultimate protection of the data and the valuable sample material.
Networked and combinable
Easy integration with popular standard IT systems makes test results instantly available. An analyser device can be networked and combined with several other devices so that multiple series of tests can be performed simultaneously. All devices are based on the same hardware and software, so that the product family can be expanded quickly and without major development effort.
28th European Congress of Clinical Microbiology and Infectious Diseases
Randox Laboratories will be attending the 28th European Congress of Clinical Microbiology and Infections from the 21st – 24th April 2018.
Our innovative diagnostic solutions have been developed with consolidation and economy in mind, providing cost savings whilst using pioneering technology.
Diagnostics is our passion. We are dedicated to developing solutions that not only meet your needs, but are of the highest quality, the most reliable and the most cost-effective. We look forward to meeting you in Madrid at IFEMA – Feria de Madrid to launch the Vivalytic at our stand 55A.
For further information, visit https://goo.gl/S2Yj2c or email firstname.lastname@example.org
GPs are told to stop prescribing antibiotics for sore throats
Today, the National Institute for Health and Care Excellence has published guidelines that state doctors should not prescribe precious antibiotics for most people with sore throats and should instead recommend drugs like paracetamol.
The guidelines from NICE and Public Health England, which aim to limit the use of antibiotics, said doctors should only be prescribing the medicines for more severe cases that are most likely to have been caused by a bacterial infection.
This is despite recent research that suggests antibiotics are prescribed in 60% of sore throat cases, for which doctors are unable to tell if the infection is viral or bacterial.
The National Institute for Health and Care Excellence said most sore throats were caused by viral infections, which cannot be treated by antibiotics.
At Randox, our pioneering R&D teams have developed a revolutionary swab test for respiratory infections which indicates the cause of the infection and whether a patient needs antibiotics or not. This helps to limit the number of patients who are prescribed antibiotics unnecessarily.
The Randox test, which can rapidly detect and identify the cause of 21 respiratory infections in just 5 hours, assists the clinician in prescribing the appropriate antibiotic.
John Lamont, Lead Scientist at Randox Laboratories, said;
“Current diagnostic testing for respiratory infections takes at least 36 hours to confirm the nature of an infection, and they cannot name and categorise infections as bacterial or viral in the way our new respiratory test can.”
This test, if widely adopted, could allow medical practitioners to make the correct treatment choice on the same day as examination and before patients have already begun a precautionary course of inefficient antibiotics. It would also have additional efficiency savings for the NHS, by eliminating the need for lengthy microbiology lab tests and unnecessarily prescribing drugs which are not needed.
This new rapid and accurate test will give clinicians confidence in their diagnosis of respiratory infections and will allow for quicker treatment if necessary, which benefits patient outcomes.
The test is also available as a Randox Health Cough, Cold & Flu offering, and can be carried out by booking an appointment with Randox Health at our clinics in Crumlin, Holywood or London, or by arranging the mobile clinic to visit you at your home or place of work.
Find out more about the Cough, Cold & Flu Respiratory test here.
Book an appointment with one of our clinics, or arrange the mobile clinic, by phoning 0800 2545 130 or by clicking here.
For further information please contact the Randox PR team by email: email@example.com or phone 028 9442 2413
Evidence Investigator | Adaptable, Efficient & Comprehensive
The Evidence Investigator is a compact, semi-automated benchtop analyser that offers efficient and comprehensive testing across a range of applications including clinical diagnostics, molecular, research, toxicology and food diagnostics.
Renowned for its versatility, robustness and effective reporting methods, the Evidence Investigator has been used in a wide range of laboratory settings for over 15 years. This highly advanced yet simple to use analyser has only one moving part, giving the user peace of mind.
The Evidence Investigator contains a host of innovative on-board data analysis features ensuring manual processes are kept to a minimum.
By utilising the same multiplex technology as the other Evidence Series analysers, the Evidence Investigator can process up to 44 results from a single sample, with a maximum throughput of up to 2376 tests per hour. Offering efficiency without compromising on accuracy, the Evidence Investigator is the perfect fit for medium throughput laboratories seeking maximum use of bench space.
Accurate and Robust
Like all the Evidence Series analysers, what sets it apart is technology. The Evidence Investigator is extremely well equipped to provide reliable results, while simultaneously robust enough to withstand frequent, heavy use.
Results are generated using a Charge Coupled Device (CCD) camera, which quantifies chemiluminescent light. This light measures the degree of binding between the patient sample and specific biochip bound ligands, generating highly accurate and reliable results.
The Evidence Investigator is the world’s first platform allowing consolidation of immunoassay and molecular diagnostics. This is achieved through utilising protein and DNA based biochips. By giving the user the ability to consolidate tests, the Evidence Investigator improves laboratory efficiency and reduces costs.
The Evidence Investigator image processing software translates light signal generated from chemiluminescent reactions into analyte concentration. This removes the need for any manual processing of data.
Previously unreported tests can also be retrieved, so they can be tested retrospectively. This saves time, labour costs and reduces any reagents wastage. All data is then analysed on-board, removing issues related to human error and result manipulation.
About the Randox Evidence Series
The Evidence Series is set to revolutionise diagnostic testing forever. Offering unrivalled capabilities across all analysers, we truly believe that the Evidence Series range of immunoassay analysers can meet your diagnostic testing capabilities.
For more information on the Evidence Investigator, or any of the Evidence Series analysers, visit https://www.randox.com/evidence-series/ or contact us firstname.lastname@example.org.
The Effect of Drug Deliveries and MDMA
A recent report by the Independent discussed how buying drugs has become as easy as buying ice cream. The report comes after experts named London as a city where cocaine is now delivered faster than pizza. According to the NHS, in the UK 2.7 million people between the ages of 16 and 59 took an illicit drug in 2015 and 2016 (roughly one in 12 adults). As a result, the Global Drug Survey are now looking at the impact of encrypted mobile phone messaging services and other methods that have enabled quick drug deliveries.
However, the drug problem is worldwide. In the US, life expectancy has fallen for the second consecutive year amid concerns of increased drug related deaths, the first multi-year drop since 1962 and 1963 according to the US National Centre for Health Statistics (NCHS). The NCHS documented that more than 63,600 US deaths in 2016 were due to drug related overdoses, a number that continues to increase.
MDMA has continued to appear in the news, after the deadly substance was responsible for the recent deaths of multiple teenagers in the UK. Also known as Ecstasy, MDMA is often described as the original designer drug due to its link with the dance culture in the late 80s and early 90s. Randox Toxicology’s DoA II panel tests for common drugs of abuse, including MDMA and generic opioids.
With the use of Biochip Array Technology, we have made multiplex testing capabilities possible. Our level of expertise in toxicology research and development allows us to adapt quickly to the ever-changing drug market influences and develop assays for current and novel drug trends.
|Analyte||Compound||Cross Reactivity %|
Purity is a concern with MDMA, which is regularly sold containing other fatal drugs. Newshub released information from Wendy Allison at KnowYourStuffNZ, who stated that only 20 percent of the drugs they tested in New Zealand contained MDMA. KnowYourStuffNZ’s website advises people to avoid certain pressed pills containing large amounts of MDMA. Theses pills include “Green Guccis”, a rectangular green pill with the Gucci logo and “Yellow Rolexes”, a yellow pill shaped like the Rolex crown logo. The comedown of Ecstasy can cause users to feel depression, whilst long term users can suffer from memory problems and anxiety. The use of the Class A drug has also been linked to liver, kidney and heart problems.
For further information on our DoA II panel and how Randox Toxicology are advancing the future of toxicology, email email@example.com
Molecular Diagnostics from Randox Biosciences
Our Randox Biosciences division is a trusted partner in supplying quality diagnostic solutions to the Clinical, Life Science, Pharmaceutical, Research and BioPharma industries.
Our molecular product range offers diagnostic, prognostic and predictive solutions across a variety of disease areas including sexually transmitted infections (STI), respiratory tract infection, colorectal cancer, familial hypercholesterolemia (FH) and cardiovascular disease (CVD).
Additionally, we can provide a wide range of assay formats including single nucleotide polymorphisms (SNP) genotyping, pathogen detection and mutation detection. The arrays are optimised for use with the Randox Evidence Investigator semi-automated, medium throughput bench-top biochip analyser.
One test, 10 results.
Our STI multiplex array II simultaneously detects 10 bacterial, viral and protozoan infections including primary, secondary and asymptomatic co-infections for a complete infection profile. The assay is based on a combination of multiplex, PCR and biochip array hybridisation. Innovative PCR priming technology permits high discrimination between multiple targets. A unique primer set is designed for each target which will hybridise to a complimentary oligo-nucleotide probe spotted on a biochip discrete test region (DTR).
The combination of priming and spatially organised biochip array technology enables enhanced specificity of the assay. Analysis can be completed from template DNA through PCR to data readout in less than 6 hours. The array is validated for urine and swab sample matrices with up to 53 patient samples being processed simultaneously. The array is CE marked for routine clinical use.
Our STI Multiplex Array II includes tests for the following STIs;
Neisseria Gonnorrhoea (NG) Mycoplasma Genitalium (MG)
Ureaplasma Urealyticum (UU) Chlamydia Trachhomatis (CT)
Tricomonas Vaginalis (TV) Haemophilus Ducreyi (HD)
Mycoplasma Hominis (MH) Treponema Pallidum (TP)
Herpes Simplex virus I (HSV-1) Herpes Simplex Virus 2 (HSV-2)
Randox Biosciences also offer four additional Molecular arrays.
For more information on our Molecular arrays please contact us by sending an email to Info@randoxbiosciences.com
Powering the Evidence Series – Biochip Array Technology
In 2002, Randox invented a worlds first; Biochip Array Technology, instantly changing the landscape of diagnostic testing forever. Biochip Array Technology is a multi-analyte platform which provides an unrivalled increase in patient information per sample. Instead of a patient sample needing to be subdivided for each test result, or in some cases re-collected, Biochip Array Technology offers a diagnostic patient profile with each patient sample.
How does it work?
Biochip Array Technology is a precision multiplex testing platform allowing for the simultaneous quantitative or qualitative detection of a wide range of analytes 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 DTR is simultaneously detected and quantified using a Charge-Coupled Device (CCD) Camera.
Each biochip has up to 49 Discrete Test Regions (DTR). This means that up to 44 tests can be carried out simultaneously. The additional DTR are reserved for internal quality control and visual reference, a unique Biochip Array Technology feature.
How is the technology applied?
With over £250 million invested into Biochip Array Technology research and development, Randox have launched a range of Biochip Array Technology immunoanalysers – The Evidence Series. This includes the Evidence, the Evidence Evolution, the Evidence Investigator and the Evidence MultiSTAT. Each analyser is developed with boundary pushing engineering, designed to make financial, labour and time savings for the end user.
The Evidence Series has truly revolutionised diagnostic testing forever. Offering unrivalled capabilities across all analysers, we truly believe that the Evidence Series range of immunoassay analysers can meet your diagnostic testing capabilities.
For more information on any of the Evidence Series, please visit https://www.randox.com/evidence-series/ or contact us firstname.lastname@example.org.