Vivalytic’s rapid coronavirus test delivers results for positive samples in less than 30 minutes

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Vivalytic’s rapid coronavirus test delivers results for positive samples in less than 30 minutes

   

18th December 2020

Cloud-based software update means a faster PCR test for SARS-CoV-2

We are happy to announce that due to improved software for the Vivalytic analysis device, the CE marked Vivalytic SARS-CoV-2 rapid coronavirus test, which uses polymerase chain reactions (PCR), now delivers its results even faster. By applying optimized evaluation strategies, the Vivalytic analysis device can detect a positive SARS-CoV-2 sample through its high viral load in less than 30 minutes, right where the sample is collected.

This modified product is part of a research and development project relating specifically to COVID-19, funded by the German Federal Ministry of Education and Research (BMBF) to the tune of 4.97 million euros. The project’s aim is to expand the options for detecting acute infections of the coronavirus, looking particularly at on-the-spot testing in which the sample is analyzed in a fully automatic PCR process, as this offers rapid yet reliable results.

  • Improved software for Vivalytic: turnaround time for positive SARS-CoV-2 samples reduced to under 30 minutes.
  • Update from the cloud: Vivalytic analysis devices are updated over the internet.

Dr. Volkmar Denner, chairman of the board of management of Robert Bosch GmbH said;

“In the fight to contain the coronavirus pandemic, speed is of the essence. With Vivalytic, we are delivering cutting-edge medical technology. Our IT and software expertise have helped to make the Bosch Corona test for positive samples even faster – all within a short period of time.”

The new update is available for the SARS-CoV-2 singleplex test and the SARS-CoV-2 pooled test. Updating the Vivalytic testing devices is simple and straightforward – all that is required is an internet connection to access the Bosch cloud platform Vivasuite. Developed in-house at Bosch, the Vivasuite cloud platform allows users to digitally manage and update all their Bosch Healthcare Solutions devices. This is also an advantage when Vivalytic devices are in use in the field. The platform meets the strictest security standards and data privacy is guaranteed at all times: for example, there is no remote access to Vivalytic devices, and no possibility of accessing patient data.

The turnaround time for samples negative for SARS-CoV-2 is still 39 minutes. PCR tests are considered the gold standard, and Bosch’s rapid coronavirus tests have a sensitivity of 98 percent and a specificity of 100 percent.

Contact marketing@randox.com for further information on the latest vivalytic software update for SARS-CoV-2 testing. 

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India Must Stop Misusing Antibiotics in Dairy Sector, According to CSE Report

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India Must Stop Misusing Antibiotics in Dairy Sector, According to CSE Report

The Centre for Science and Environment (CSE) has raised concerns over whether the milk we consume is safe. Hosting a virtual meeting in July, the CSE discussed the use of antibiotics with the world’s largest producer of milk, India. Over 188 million tonnes of milk was produced by India over the period of 2018-2019 and lead with 22% of global milk production.

A recent assessment by the CSE has found indication of antibiotic abuse in milk producing cattle.

“We have found that antibiotics are extensively misused in the dairy sector; antibiotic residues remain largely untested in milk, an integral part of Indian diets, particularly of children,” said CSE Director General Sunita Narain. “While we continue to struggle against COVID-19, we are staring at another pandemic like situation – that of antibiotic resistance fueled by the way we are producing our food, which has become chemical-intensive.”

Antibiotics such as penicillin, aminoglycosides and fluroquinolones are being ‘indiscriminately’ used by dairy farmers according to the CSE. These antibiotics are among the most important in human health. The World Health Organisation (WHO) has warned as we face growing concerns over an antibiotic resistance, such antibiotics should be preserved.

Despite laws stating that antibiotics should only be prescribed and administered by a registered veterinarian, the CSE said that some farmers are illegally attaining and injecting animals themselves without the supervision of veterinarians.

“Farmers often sell milk while the animal is under treatment, which increases the chances of antibiotic residues in the milk,” explained Amit Khurana, the CSE’s Food Safety and Toxins Programme Director. “While milk sold directly to consumers is not tested, contrary to what one would expect, processed milk sold in packets is also largely unchecked for antibiotic residues.

“This explains why, despite pooling and processing, packed milk samples from several states had antibiotic residues in the FSSAI’s [Food Safety and Standards Authority of India] milk quality survey of 2018.”

However, CSE noted the virtual meeting has encouraged positive signs of action in the diary industry in India.

“The issues highlighted by the CSE assessment have been well recognised by the experts and stakeholders. These experts have also recommended several measures for minimising antibiotic misuse in the Indian dairy sector.”

In order to minimise the threat of antibiotic resistance, the CSE have recommended “preventative measures” such as;

  • Routine observation of drugs residues in milk
  • Modifying the existing standards for antibiotic residues in milk
  • Limiting misuse of essential antibiotics such as penicillin

Such measures, Khurana noted, are showing some success. “Information shared by various organisations, agencies and experts suggest that ethno-veterinary medicines, better management of sub-clinical mastitis, and good farm management are contributing towards reducing antibiotic misuse.”

“India is now talking about antibiotic resistance in the one-health perspective,” noted Narain. “There is a shared concern, and all voices are now together in expressing that concern.” As such he believes further (and necessary) action will be taken.

“We must ramp up surveillance and testing, put a complete stop to the use of critically important antibiotics and penalise their use,” he added, “and work with farmers and the agriculture-dairy sectors to innovate on solutions.”

Randox Food Diagnostics

Randox Food Diagnostics recognise the pressure the dairy industry is under to mass produce high quality products whilst complying with regulations and have developed the solution. A comprehensive range of easy to use, accurate milk analysis methods for the qualitative and quantitative detection of contaminants in milk.

With 6 Biochip arrays available including the revolutionary InfiniPlex for Milk, Randox Food provide the highest quality testing platforms for the screening of antimicrobials and are the only commercial supplier of a multiplexing anthelmintics array in milk.

Biochip Array Technology saves time and money whilst enabling users to get a deeper insight into milk quality and ensure a safe supply chain.

Contact us at info@randoxfooddiagnostics.com, or visit https://www.randoxfood.com/milk-analysis/ to find out more about our milk testing solutions.

 

 

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Randox & Bosch Healthcare – Collaboratively Combating COVID-19

   

29th October 2020

Randox & Bosch Healthcare – Collaboratively Combating COVID-19

A game-changing partnership between Randox Laboratories and Bosch Healthcare Solutions continues to change the testing landscape and capabilities of both laboratory and non-laboratory settings in rapidly detecting COVID-19.

Providing clear and concise results, direct at the point of care, the Randox and Bosch Healthcare Solutions collaborative approach not only allows patients to take the recommended safety precautions without delay, but also provides a solution to both analyse and differentiate COVID-19 from other viral respiratory diseases. Multiple testing approaches with the same aim – to overcome COVID-19!

Combining science & technology, timing is of the essence in the fight against coronavirus. Together, we have combined efforts in successfully launching the Vivalytic – the all in one solution for molecular diagnostics consolidating nucleic acid extraction, polymerase chain reaction (PCR) and detection onto one small platform.

These efforts reflect a global partnership of both cooperation’s working together to deliver world-class diagnostic solutions, harnessing the power of innovation to improve health worldwide, providing an all in one approach minimising the spread of COVID-19 globally.

Launched after just six weeks at the beginning of the COVID-19 pandemic back in March 2020, the Viral Respiratory Infection array (VRI) set the benchmark for rapidly detecting SARS-CoV-2 (COVID-19) whilst simultaneously differentiating between nine other respiratory diseases, in under two and a half hours.

Proactively working together to combat the spread of COVID-19, Randox, Bosch Healthcare Solutions and R-Biopharm are proud to offer variable analysis strategies to detect SARS-CoV-2 (COVID-19). Capable of providing reliable results in just 39 minutes, with a sensitivity of 98% and specificity of 100%, the Vivalytic SARS-CoV-2 rapid test is currently among one of the fastest PCR tests worldwide.

Since the outbreak of COVID-19, we have significantly combined our efforts to provide a diverse range of testing solutions and approaches to meet the need of the rise in global cases. Our approaches have been utilised at all possible levels and together we open up a range of different testing strategies, with developments still underway with the upcoming release of the SARS-CoV-2 Pooling test.

The SARS-CoV-2 Pooling test is a rapid solution for the detection of SARS-CoV-2 (COVID-19) offering an accelerated decentral testing approach to effectively and efficiently monitor and detect viral infection from the offset. Capable of detecting SARS-CoV-2 (COVID-19) from up to five pooled samples simultaneously with a capacity to process more than 160 patient samples a day. The pooling could be done at the level of a ward, medical specialty, social bubble, or group of colleagues. It has potential for use in other settings, such as pre-operative screening, schools & universities, prisons, nursing homes, primary care, and large workplaces. Sample pooling allows more people to be tested quickly using fewer testing resources.

Partnering together, we continue to increase our testing capacity, enabling fully automated processing of patient samples to rapidly combat COVID-19.

Please contact marketing@randox.com for further information.

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Female Bladder Cancer Array

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Female Bladder Cancer Array

Improved Risk Stratification of Haematuria Patients

Identify Individuals at Greatest Risk of Bladder Cancer

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    Improve management of patients with haematuria, reduce unnecessary investigations and refer those at greatest risk of bladder cancer for urgent cystoscopy.
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    Simultaneous detection of four novel biomarkers from a single urine sample to determine an individuals biomarker risk score.
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    Determine overall bladder cancer risk by combining biomarker risk scores with clinical risk scores generated using our complex algorithms.

There is an urgent critical need for additional evidence-based risk stratification models to inform triage and/or management decisions for patients presenting with haematuria. Current diagnostic methods such as cystoscopy  and cytology are invasive, carry risks for the patient and have several limitations.

In addition, existing biomarkers lack specificity and may fail to differentiate between all possible causes of haematuria. Utilising patented biochip technology, the female bladder cancer array will allow accurate risk stratification of female patients presenting with haematuria. Bladder cancer is the 8th most common cancer in females, although more common in males mortality is twice as high in females highlighting the need for alternative diagnostic methods.

Clinical patient pathway using the Randox Biochip Technology to reduce cystoscopy burden allowing patients at greatest risk to be triaged for urgent cystoscopy.
Clinical patient pathway using the Randox Biochip Technology to reduce cystoscopy burden allowing patients at greatest risk to be triaged for urgent cystoscopy.

Biomarkers Tested 

  • IL12p70
  • IL13
  • Midkine
  • Clusterin

Interleukin-12 p70 (IL12p70) is a disulphide linked heterodimeric cytokine which regulates inflammation by linking innate and adaptive immune responses and potent inducer of antitumor immunity.  

Interleukin-13 (IL-13) is an immunoregulatory cytokine which plays an important role in carcinogenesis through affecting tumor 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 was 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 in cancer metastasis, which is particularly important to design the strategies for treating metastatic patients.

 

 

 

The Evidence Investigator

Meet the Evidence Investigator

Developed for use on the Evidence Investigator, a semi-automated benchtop immunoassay analyser.

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    Cost effective and efficient multiplex testing solution
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    Comprehensive immunoassay & molecular test menu available
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Evidence Investigator: One Analyser for Multiple Food Testing Industries

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28 September 2020

The Randox Evidence Investigator: One Analyser for Multiple Food Diagnostic Industries

The Randox Evidence Investigator has been validated for Randox Food Diagnostics across various food matrices including tissue, feed and cereals, honey, aquaculture, and milk, making it the perfect testing equipment solution for any food testing laboratory.

How can the Randox Evidence Investigator benefit me?

  • The Randox Evidence Investigator is a multi-analyte quantitative drug residue screening analyser. Using Randox’s patented Biochip Technology, the analyser ensures screening food for drug residues is accurate and efficient, offering a range of laboratories comparable results to LC-MS/MS.
  • Using multiplex technology, the Evidence Investigator can provide simultaneous detection for a wide range of analytes from a single sample, saving you time and resource, and getting the reliable results you need.
  • The analyser uses unique image processing software to translate the Relative Light Units (RLU) generated from the chemiluminescent reactions into an analyte concentration.
  • No manipulation of results is required, which reduces the scope for any operator error. The Randox Evidence Investigator provides excellent sensitivity with a quantitative concentration result (ppb) for each analyte tested.
  • The analyser boasts an extensive test menu with tests for the most widely used drug residues and the most commonly detected mycotoxins in the feed production industry.
  • When purchasing the Randox Evidence Investigator, you will receive the complete package required for sample analysis which includes the analyser, PC and imaging software, a thermoshaker and a barcode scanner.

Visit the Randox Food Diagnostics website for more information on this technology.

For all enquiries relating to food testing on any of our Randox analysers, please contact us via email at: info@randoxfooddiagnostics.com

 

Want to know more?

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Preparing Your Vineyard for Harvest: A Randox Food Diagnostics Blog

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28 August 2020

Preparing your vineyard for harvest: Excellence in every glass

Each year from August through October and maybe a little later, the Northern Hemisphere comes alive with the excitement and rush of harvest as wine makers celebrate with festivals, dinners and get together as the yearlong grape growing season comes to an end and harvest begins.

Producing the highest quality wine grapes is dependent upon many factors – mainly the right amount of sun and rain. The growing process can be stressful for winemakers as they anxiously keep a close eye on weather conditions, in hope that it’s clear of frosts, heatwaves and hail. These can all have detrimental impacts on the vineyard.

However, this year it hasn’t been weather conditions that have been a worry for winemakers. Instead, many vineyards have been significantly impacted by the ongoing COVID-19 pandemic and events that once brought life to local communities and vineyards are now taking place online. Channels for selling wine such as hotels, restaurants and airports have dried up with current restrictions, and online and supermarket sales have never been more important.

Like many industries the food and beverage sector has continued to operate through one of the most challenging times. Using a combination of expert knowledge and technology has ensured that the expectation put upon winemakers to create excellent wine is regularly achieved even in the toughest conditions.

Did you know that a wide range of elements are measured to ensure perfection in every bottle, including levels of acidity and sugar ripeness relevant to the desired style of wine? Technology has been giving winemakers a helping hand in ensuring the quality of each harvest for many years including Randox Food‘s RX misano – a compact, fast and efficient benchtop spectrophotometer capable of gaining results in 8-15 minutes.

For more information please visit Randox Food Diagnostics or email: info@randoxfooddiagnostics.com

Want to know more?

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We Are Randox | Staff Newsletter January – July 2020 Edition

Staff Newsletter January - July 2020 Edition

We are delighted to be able to share with you the January – July 2020 edition of our We Are Randox staff newsletter.

Click here to view our news from 2020 so far – including of course our vital work in testing for COVID-19, but also a range of staff announcements including engagements, births and retirements.

** Please note that this newsletter works most efficiently in your Google Chrome browser**

 


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Challenge your Instrument Throughout the Reportable Range with Acusera Linearity Verifier Sets

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Calibration verification or linearity assessment is defined as the testing of materials of known concentration in the same manner as patient specimens to ensue the test system is accurately measuring samples throughout the reportable range.

CLIA recommend calibration verification once every six months and/or in the event of; a reagent lot change, major preventative maintenance, replacement of critical parts, when QC materials are outside acceptable limits or reflect an unusual trend and as part of new instrument validation.

Our Acusera range of instrument dedicated verifiers are designed to challenge the entire analytical measuring range whilst helping to meet the CLIA requirements. Our range covers Clinical Chemistry, Bilirubin, Apolipoproteins, Enzymes, CRP, Esoterics, Lipids, TDM‘s and more.

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Ergot Alkaloids ELISA now available from Randox Food Diagnostics

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28 July 2020

Ergot Alkaloid ELISA now available from Randox Food Diagnostics

Available now, the Randox Food Diagnostics Ergot Alkaloid ELISA (Catalogue Number EA3491) is:

Compliant with the lowest proposed maximum levels being considered by the European Commission for the total of 12 main ergot alkaloids applicable from July 2020, including the stricter drafted limits from July 2022, for cereal-based feed, wheat and rye milling products.

Accurately detects the sum of 12 main ergot alkaloids to test the most affected type of cereal – rye flour. Randox’s ELISA results show an excellent 95% correlation with the assigned concentration within FAPAS Proficiency Test scheme.

Unrivalled in the detection of low contamination levels. The Z-score of FAPAS PT of -0.6 for baby multigrain food was obtained using Randox Ergot Alkaloids ELISA.

Validated based on Commission Regulation (EC) No 519/2014 as a semi-quantitative screening method for cereal-based feed, wheat and rye milling products. The same regulation was followed for fit-for-purpose approach assessment for confirmatory method, which approves Randox Ergot Alkaloids ELISA as being a method for official control. It is successfully assessed by fit-for-purpose approach according to Commission Regulation (EC) No 401/2006 as approved method of analysis.

Evaluated by third-party laboratory (Wageningen Food Safety research / WFSR, 2019) and proved to be able to distinguish between negative and positive samples. Randox’s ELISA displayed no false-negatives and no false-positives in this study. Across all commercially available ELISA tests, Randox Food Diagnostics Ergot Alkaloids ELISA was the only test which showed good performance with all 3 sample types, including 11 matrices and a total of 24 samples.

      Reference reports are available upon request.

      For more information visit https://www.randoxfood.com/feed-and-cereals-analysis/ergot-alkaloids/ or email us directly at info@randoxfooddiagnostics.com

       

       

      Want to know more?

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      FAQs for Media

      Frequently Asked Media Questions

      Randox have almost 40 years of experience as a primary manufacturer in the IVD (in vitro diagnostics) industry. Last year we manufactured over 3 billion tests and exported to 145 countries. Randox are an ISO 13485 accredited manufacturer of in-vitro diagnostic medical devices, are a provider of a global laboratory accreditation scheme (RIQAS) accredited to ISO 17043, and run a number of ISO 17025 accredited laboratories. As an exporter to 145 countries and a manufacturer to other diagnostic companies we undergo multiple external audits each year, in order to remain engaged with our global markets.

      At the time of the emergence of the COVID-19 threat, Randox had already developed seven CE marked assays for a range of viruses, including a number of other coronaviruses.

      Upon identifying the latest strain of coronavirus as a significant global threat, Randox was able to harness our R&D capability, and some 40 years’ in diagnostics, including viral tests, to develop an effective COVID-19 assay with the same rigorous validation processes that we applied to all our other assays.

      The Randox COVID-19 test underwent evaluation within, and was accepted by, Public Health England.

      In its evaluation of the Randox COVID-19 test, Public Health England’s report noted that the assay correctly identified all positive and negative samples without exception.

       

      As one of the UK’s major life sciences companies, providing diagnostic capabilities both within the UK and globally for almost 40 years, Randox has maintained regular contact with senior officials directly responsible for Life Sciences in the UK, particularly in the fields of diagnostic capability and innovation. We had developed our COVID-19 testing capability by mid-February 2020, and notified officials as such.

      Over a number of weeks, we worked collaboratively with government to determine how best we might be able to support the national testing programme.

      Our contribution to this programme, which was announced on 27th March, was the culmination of significant engagement, from the identification of the threat, until that date.

      The UK Government showed significant confidence in Randox’s capability and conducted full engagement and planning subject to PHE acceptance of the Randox test. When PHE acceptance was granted, the Randox part in the national plan had been prepared and was quickly initiated.

      Randox are providing high volume testing within our laboratories.

      It should be noted that Randox is only one partner within a multi-partner, national testing programme being run and coordinated by the Department of Health and Social Care.

      In order for the testing programme to work efficiently, all partners work to ensure effective processes at each stage of the testing journey – from testing kit distribution and sample collection to transportation and delivery, and finally, the testing of the sample.

      For our part, we are focused diligently on processing all tests in a timely manner after receipt of sample at our laboratory.

      It is our priority to ensure that we support the national effort to fight COVID-19, by testing at scale, as we know that this is the most effective way to save lives and promote a timely return to a more normal society.

      PHE managed the validation process for each of England, Wales, Scotland and Northern Ireland.

      We understand that the national plan for COVID-19 testing is exactly that, a national plan, inclusive of Northern Ireland. The planning for the national distribution of test kits is being managed by the various statutory agencies however Randox made the case that tests should be made available locally.

      Following that engagement, Randox tests were made directly available within Northern Ireland, and sent, for example, to the drive-through test centre at the SSE arena.

      Randox will continue to support Northern Ireland within the UK national plan.

      The Randox COVID-19 test is a molecular-based test which looks for SARS-CoV-2 (the virus that causes COVID-19) within the body.  PCR (Polyamerase Chain Reaction) techniques are used to detect viral RNA (ribonucleic acid) contained inside the SARS-CoV-2 virus.

      The Randox COVID-19 assay conducts two tests – one specific and one confirmatory – as recommended by the World Health Organisation and the Centres for Disease Control and Prevention.

      The majority of results are reported within 24 hours of receipt of sample at our laboratories.

      The Health Secretary, Matthew Hancock, acknowledged that it was the lack of a significant domestic diagnostic industry that had impeded the Government’s initial efforts on testing, which helps explain the variation between the UK and other countries.

      Read an Opinion Piece from our Managing Director, Dr Peter FitzGerald, on the Telegraph Online, by clicking here.

      In support of our role within the national testing programme we have invested £85m since March 2020 in the building and equipping of over 80,000 sq ft of molecular laboratory space and the development of new innovations in testing technology in our COVID-19 testing facilities at the Randox Science Park in Northern Ireland.

      We have hired more than 850 new staff, and are recruiting for an additional 400 across science, accessioning, customer support and manufacturing.

      Find out more here.

       

      On 9th April 2021, Randox processed its 12 millionth sample within the UK COVID-19 National Testing Programme, representing approximately 21% of all PCR tests executed in the UK.

      As we continue to ramp up our testing capabilities, and work alongside the government to offer this testing to an increasing list of individuals, we also recognize a demand for testing from the general public – for COVID-safe travel and business.

      The Randox COVID-19 test is available to purchase as part of our ‘Get Back to Business’ COVID-19 testing service, for staff screening.

      On 13th April 2021 Randox announced its support for British holidaymakers and the travel industry by reducing the cost of its PCR travel test to £60. In order to achieve the £60 price, purchasers will need to apply a discount code which can be obtained from airlines when booking travel. Major airlines including British Airways, Jet2, Easyjet and Ryanair have signed up to provide discount codes for their passengers.⠀

      Yes, Randox can conduct antibody testing.

      Find out more here.

      For COVID-19 press enquiries please email randox@newcenturymedia.co.uk

      Want to know more?

      Contact us or visit our news page.

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