Multiplex STI assay for 10 sexually transmitted infections receives CE marking
02 March 2020
Multiplex assay for 10 sexually transmitted infections receives CE marking
CE marking has been granted to one of the most comprehensive cartridge-based STI tests.
The test, developed by the UK’s largest health diagnostics company, Randox Laboratories, tests simultaneously for 10 of the most common sexually transmitted infections, on the firm’s patented Biochip Technology.
Quickly and efficiently testing for multiple STIs, which often have mild symptoms if any at all, ensures early diagnosis at a stage when treatment is most successful, supports the targeted use of antibiotics, and ultimately reduces their mishandling.
Dr Peter FitzGerald, Managing Director of Randox Laboratories, commented;
“Antibiotic stewardship is a critical issue which we all have a responsibility to embrace and drive forward. The CE marking of the STI assay, which incorporates Randox Biochip Technology, will be a game-changer for clinicians and patients across Europe, by facilitating early, accurate and comprehensive diagnoses of STIs that allows for the best possible patient outcome. Never before has there been this level of accessibility and speed with regards to STI testing.”
The Randox STI assay is performed on the Vivalytic system, an intuitive point-of-care platform, developed in partnership with German technology company Bosch that provides the broadest range of test options ever seen for an analyser of its size.
Harnessing the application of multiplex assays to provide greater information from a single patient sample, the Vivalytic simplifies the testing process for otherwise complex laboratory testing procedures.
Marc Meier, Managing Director of Bosch Healthcare Solutions, a subsidiary of Bosch Group, said:
“We are enthusiastic about partnering with Randox to offer their assay technology on the Vivalytic platform. The core competencies of Bosch in automation, miniaturization, sensor technology and connectivity are complemented by Randox’s expertise in developing excellent biocontent for a wide range of assays and commercializing innovative diagnostic solutions.”
Benefits of the Randox STI assay technology on the Vivalytic system
- Fully automated, cartridge-based molecular diagnostics.
- Multiplex technology detects multiple STIs, including co-infections, from a single patient sample.
- Full molecular workflow of extraction, PCR amplification and detection.
- A hygiene and space-saving all-in-one solution that does not require additional peripherals such as laptop, keyboard, barcode scanner or filling stations.
- Ultimate protection of data and valuable sample material thanks to integration of software with instrument that ensures a safe and reliable run.
- Test results can be presented either in summary or in detailed raw data form.
- Instantly available results due to easy integration with popular standard IT systems.
The assay tests simultaneously, from one patient sample, for the STIs below;
- Chlamydia trachomatis (CT)
- Neisseria Gonorrhoeae (NG)
- Trichomonas vaginalis (TV)
- Mycoplasma genitalium (MG)
- Treponema pallidum (syphilis) (TP)
- Herpes simplex virus 1 (HSV-1)
- Herpes simplex virus 2 (HSV-2)
- Haemophilus ducreyl (HD)
- Mycoplasma hominis (MH)
- Ureaplasma urealyticum (UU)
For further information please contact the Randox PR team on 028 9442 2413 or email randoxpr@randox.com
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Randox actively testing samples for Coronavirus COVID-19
12 February 2020
Introducing the COVID-19 Coronavirus Test from Randox
A ground-breaking test for the potentially fatal COVID-19 strain of coronavirus, is available at global health diagnostics company Randox Laboratories.
The test, developed on Randox’s patented Biochip Technology, is as an enhanced multiplex array which includes tests for COVID-19 and nine other respiratory viruses which can display the same symptoms.
The new enhanced Biochip therefore allows clinicians to quickly and efficiently differentiate between potentially lethal and non-lethal infections.
Dr Peter FitzGerald, Managing Director of Randox Laboratories, commented;
“Current technologies for the diagnosis of coronavirus are designed simply to detect the presence or lack of COVID-19, and therefore neglect to differentiate between this strain and other respiratory infections.
“We have therefore developed an extended Viral Respiratory Infection Array that tests simultaneously for COVID-19 and nine other viruses. This will eliminate the need for multiple back-and-forth tests before the root cause of symptoms is found, and empower clinicians to make fast and informed decisions.”
The test is available on the Randox Evidence Investigator with a turnaround time of 5 hours.
Benefits of the new Randox COVID-19 test
- Quick Turnaround Times (5 hours on Evidence Investigator)
- Multiplex array differentiates between mild and serious infection
- Automated and Semi-Automated options available
- Medium to high throughput (54 samples in 5 hours)
For further information please visit www.randox.com/coronavirus-randox
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Coronavirus test available at Randox
26 January 2020
Introducing the COVID-19 Coronavirus Test from Randox
A ground-breaking test for the potentially fatal COVID-19 strain of coronavirus, is in the final stages of development at global health diagnostics company Randox Laboratories.
The soon-to-be-launched test, developed on Randox’s patented Biochip Technology, will be available for immediate COVID-19 testing, but an additional enhanced multiplex array will also include tests for other respiratory viruses which can display the same symptoms.
The new enhanced Biochip will therefore allow clinicians to quickly and efficiently differentiate between potentially lethal and non-lethal infections.
Dr Peter FitzGerald, Managing Director of Randox Laboratories, commented;
“Current technologies for the diagnosis of coronavirus are designed simply to detect the presence or lack of COVID-19, and therefore neglect to differentiate between this strain and other respiratory infections.
“Whilst we’re very quickly developing an efficient novel test for this new strain of coronavirus, we are therefore also working on an extended Viral Respiratory Infection Array that will test simultaneously for COVID-19 and a range of other viruses. This will eliminate the need for multiple back-and-forth tests before the root cause of symptoms is found, and empower clinicians to make fast and informed decisions.”
The test will be available for the Point of Care analyser, the Vivalytic, within 3 hours, and within 5 hours on the Randox Evidence Investigator.
Benefits of the new Randox COVID-19 test
- Quick Turnaround Times (3 hours on Vivalytic and 5 hours on Evidence Investigator)
- Multiplex array differentiates between mild and serious infection
- Automated and Semi-Automated options available
Randox also currently has available a Respiratory Tract Infection Array, which can test for 22 viral and bacterial respiratory infections simultaneously. The test therefore determines the exact cause of your symptoms and differentiates between mild and serious infections, such as coronavirus. This is also available from Randox Health as a Cold, Cough and Flu test.
For further information please visit www.randox.com/coronavirus-randox
For enquiries email marketing@randox.com or to book your Randox Health Cough, Cold and Flu test please ring 0800 2545 130.
Randox is committed to saving and improving lives on a global scale, and will bring you updates on developments on our test for COVID-19 as and when they happen.
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Vivalytic Powered by Randox Biochip Technology: Upper and Lower Respiratory Tract Testing
15 November 2019
Vivalytic Powered by Randox Biochip Technology: Upper and Lower Respiratory Tract Testing
Vivalytic will revolutionise the way laboratories and healthcare professionals access molecular diagnostics. A result of a collaboration between Bosch – providing innovative strength – and Randox Laboratories – dedicated to improving global healthcare – Vivalytic is the new innovative testing platform. It’s the perfect fit for any laboratory, with numerous benefits to enhance testing capabilities.
The Vivalytic is a fully-automated, cartridge-based platform capable of both Hi-Plex and Lo-Plex testing. Vivalytic cartridges are compact, utilising micro-fluidics to enable simple and accurate diagnostic testing. Hi-Plex tests utilise Randox patented Biochip Technology, enabling end-point qualitative PCR and providing multiple test results from each sample. Lo-Plex tests are based on a variety of detection methods including real-time qualitative PCR and melting curve analysis. Nucleic acid extraction, PCR amplification followed by a suite of detection methods are combined in a truly revolutionary platform. Manual preparation, cold chain reagents and the use of multiple devices are no longer required.
Vivalytic is the perfect fit for a healthcare professional in a point of care setting to a laboratory, which can implement the Vivalytic Up – modular and expandable testing system for higher throughput.
Benefits include:
- Fully Automated Platform
- Protected System
- Direct and Clear Results
- Hygienic and Space Saving
Vivalytic Test Menu
Vivalytic offers the most comprehensive multiplex screening test for infectious diseases including respiratory, genitourinary and hospital acquired infections; simultaneously detecting both viral and bacterial infections (please see figure 1.).
| Respiratory Tract Infection Array | Sexually Transmitted Infection Array | Hospital Acquired Infections | |
| Bacterial | Viral | ||
| Bordetella Pertussis | Influenza A | Chlamydia trachomatis (CT) | Methicillin-resistant
Staphylococcus aureus (MRSA) |
| Chlamydophila pneumoniae | Influenza B | Ureaplasma urealyticum (UU) | Methicillin-sensitive
Staphylococcus aureus (MSSA) |
| Haemophilus influenzae | Human adenovirus A/B/C/D/E | Neisseria gonorrhoea (NG) | Methicillin-resistant
coagulase-negative Staphylococci (MRCoNS) |
| Legionella pneumophila | Human bocavirus 1/2/3 | Mycoplasma genitalium (MG) | |
| Moraxella catarrhalis | Human coronavirus 229E/NL63 | Trichomonas vaginalis (TV) | |
| Mycoplasma pneumoniae | Human coronavirus OC43/HKU1 | Haemophilus ducreyi (HD) | |
| Streptococcus pneumoniae | Human enterovirus A/B/C | Mycoplasma hominis (MH) | |
| Bordetella parapertussis | Human Metapneumovirus | Treponema pallidum (TP) | |
| Human parainfluenza virus 1 | Herpes simplex Virus 1 (HSV-1) | ||
| Human parainfluenza virus 2 | Herpes simplex Virus 2 (HSV-2) | ||
| Human parainfluenza virus 3 | |||
| Human parainfluenza virus 4 | |||
| Human respiratory syncytial virus A & B | |||
| Human rhinovirus A/B/C | |||
Figure 1.
Lower and Upper Respiratory Tract Infections
The economic burden of respiratory illness in the UK costs a staggering £11 billion every year on lung disease alone1. Lower respiratory tract infections (LRIs) are a substantial public health problem and a leading cause of illness and death in people of all ages2. It is estimated that LRI causes nearly 4 million deaths annually3. Upper respiratory tract infections (URIs) account for an estimated 10 million outpatient appointments a year. Most of these appointments end with physicians needless writing of antibiotic prescriptions4.
Randox Biosciences offers a Respiratory Multiplex Array which rapidly detects and identifies the cause of 22 bacterial and viral pathogens helping to reduce the risk of antibiotic resistance. Given that only bacterial infections can be treated with antibiotics, rapid diagnostic tests are urgently needed to distinguish between bacterial and viral infections. This test will aid clinicians in their selection of the most appropriate antibiotic treatment for patients. GPs would have additional efficiency savings for the NHS, by eliminating the need for lengthy microbiology lab tests and unnecessarily writing prescriptions.
The test is performed utilising our Biochip Technology which enables the simultaneous detection of multiple results from one patient sample. Biochip Technology powers Vivalytic which is the all-one solution for molecular diagnostics.
The main benefits of the Respiratory Multiplex Array are:
- Turnaround time of 2 hours
- Validated for sputum, lavage and nasopharyngeal samples
- Panel includes viral and bacterial species to consolidate testing
Randox Biosciences are committed to the ongoing development of diagnostic tests, through our research into numerous disease areas, to improve health worldwide.
MEDICA World Forum for Medicine International Trade Fair
Randox Biosciences team will be attending Medica from the 18th – 21st of November 2019 at Messe Dusseldorf, Germany. Stop by and say hello to some of our team members at our stand, and to learn more about our latest game-changing partnership with Bosch – the innovative Vivalytic platform!
Medica is at the forefront of new approaches in laboratory medicine, addressing the complexity of an evolving healthcare landscape. This event attracts more than 5,100 exhibitors from 70 countries, engaging diverse professionals enabling them to discover new and innovative solutions to improving patient outcomes through effective lab testing, diagnosis and treatment.
To learn more about the Vivalytic offering, visit https://www.randoxbiosciences.com/clinical-laboratory/infectious-diseases/molecular-arrays/ or email us at info@randoxbiosciences.com
References:
- British Lung Foundation. (2019). Estimating the economic burden of respiratory illness in the UK. [online] Available at https://www.blf.org.uk/policy/economic-burden [Accessed 06 Nov. 2019].
- The Lancet Infectious Diseases. (2015). Estimates of the global, regional, and national morbidity, mortality, and aetiologies of lower respiratory tract infections in 195 countries: a systematic analysis for the Global Burden of Disease Study 2015. [online] Available at https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(17)30396-1/fulltext [Accessed 29 Oct. 2019].
- Forum of International Respiratory Societies. The Global Impact of Respiratory Disease – Second Edition. Sheffield, European Respiratory Society, 2017.
- Thomas, M. and Bomar, P. The National Centre for Biotechnology. Upper Respiratory Tract Infection. United States of America.
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Cystic Fibrosis Awareness Month at Randox Biosciences
May is National Cystic Fibrosis (CF) Awareness Month. The purpose of having the awareness month is to educate and raise additional awareness to the public about the horrible disease and how it affects those who suffer. According to the Cystic Fibrosis Foundation, more than 30,000 people are living with cystic fibrosis. More than 75% of these people are diagnosed in their early childhood 1.
What is CF?
Cystic Fibrosis is a genetic, life-threatening disease which affects the respiratory and digestive system. A person with CF is born with the condition and therefore it is not possible to catch it from someone else. The gene affected by CF controls the movement of salt and water in and out of cells, which results in a build-up of thick sticky mucus in the lungs, digestive system and other organs. This causes a wide range of challenging symptoms affecting the entire body.2
Symptoms of CF:
There are many symptoms to Cystic Fibrosis which can make life for someone who suffers with CF challenging. The build-up of sticky mucus in the lungs can make breathing difficult and clog up the pancreas which as a result can increase the risk of developing a lung infection or worse, death. This can make it difficult for those who have CF to absorb nutrients from food properly and therefore they must eat more calories to avoid malnutrition. Other symptoms include the following:3
- recurring chest infections
- wheezing, coughing, shortness of breath and damage to the airways (bronchiectasis)
- difficulty putting on weight and growing
- jaundice
- diarrhoea, constipation, or large, smelly poo
- a bowel obstruction in new-born babies (meconium ileus) – surgery may be needed
Complications of CF:
3People with CF also have a higher risk of developing other conditions. These include:
- weak and brittle bones (osteoporosis)– medicines called bisphosphonates can sometimes help
- diabetes– insulin and a special diet may be needed to control blood sugar levels
- nasal polyps and sinus infections – steroids, antihistamines, antibiotics or sinus flushes can help
- liver problems
- fertility problems – it’s possible for women with CF to have children, but men won’t be able to father a child without help from fertility specialists (see a doctor or fertility specialist for more advice)
4There is no cure for CF, but with improved treatment and management people with Cystic Fibrosis are living longer. It’s thought that children born with CF nowadays are likely to live to an average age of over 50 years old.
How we can help:
Randox Biosciences offer the Vivalytic with the Chronic Lung Disease cartridge, in combination with our intelligent Biochip Array Technology which detects 132 pathogens. The 132 species are simultaneously detected across this 320 Array including bacterial, viral, fungal targets and an antibiotic resistance marker from a single sputum sample!
For more information at info@randoxbiosciences.com or visit us at: wwww.randoxbiosciences.com
- https://www.cff.org/What-is-CF/About-Cystic-Fibrosis/
- https://www.blf.org.uk/support-for-you/cystic-fibrosis/what-is-it
- https://www.nhs.uk/conditions/cystic-fibrosis/
- https://www.nhsinform.scot/illnesses-and-conditions/lungs-and-airways/cystic-fibrosis
Raising awareness of sexual health on National STIQ Day
National STIQ Day
National STIQ day was introduced in 2010 and every year since then the 14th of January has been dedicated to raising awareness for STIQ. The purpose is to emphasize the importance of sexual health and to encourage everyone to get regular health checks.
Sexually Transmissible Infections (STIs) are infections passed from one person to another through unprotected vaginal, oral, or anal sex, or genital contact.
Lack of symptoms
More and more people in the UK are catching STIs and each year the infection rate is rising. According to The World Health Organization (WHO), more than 1 million STIs are acquired every day and the majority of these STIs have no symptoms.1 Therefore you could have an STI and not be aware. 70% of women and 50% of men show no symptoms after contracting Chlamydia which is the most common STI condition in the UK.2
Even though the majority of the time symptoms of STIs aren’t visible, there can be signs of having an STI, including unusual discharge from the vagina, penis or anus, pain when peeing, lumps or skin growth around the genitals, a rash, unusual bleeding, itchiness or blisters around the genitals.3
What to do when you catch an STI
Anyone can catch an STI regardless of what age you are, your sexuality or how many sexual partners you have, as it only takes one sexual encounter to put you at the risk of catching an STI. A shocking fact from Public Health England shows that a case of chlamydia or gonorrhea is diagnosed in a young person every 4 minutes in England, and over 144,000 diagnoses of these sexually transmitted infections are seen in people aged 15 to 24 in 2017. 4
It is extremely important to get routinely tested. The earlier the diagnosis is made and treated the less chance of having long-term effects including infertility.
Randox Biosciences 10-plex STI test
Randox Biosciences would like to take the opportunity to support STIQ day by offering our CE marked 10-plex STI test, a cost-effective solution for accurate STI testing. This test detects the following 10 infections simultaneously from a single patient urine sample.
- Neisseria gonorrhoea (NG)
- Mycoplasma genitalium (MG)
- Ureaplasma urealyticum (UU)
- Chlamydia trachomatis (CT)
- Trichomonas vaginalis (TV)
- Haemophilus ducreyi (HD)
- Mycoplasma hominis (MH)
- Treponema pallidum (TP)
- Herpes simplex virus 1 (HSV-1)
- Herpes simplex virus 2 (HSV-2)
Does your laboratory or clinic carry out STI testing? Our molecular analyser, the Bosch Vivalytic, powered by our award winning Biochip Array Technology, could be the diagnostic solution.
For more information about our STI Arrays or Vivalytic email: info@randoxbiosciences.com
- https://www.who.int/news-room/fact-sheets/detail/sexually-transmitted-infections-(stis)
- http://www.national-awareness-days.com/stiq-day/
- https://www.gov.uk/government/news/an-sti-is-diagnosed-in-a-young-person-every-4-minutes-in-england
- https://www.nhs.uk/conditions/sexually-transmitted-infections-stis/
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 randoxpr@randox.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.
Protected system
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 info@randoxbiosciences.com
