Differentiating Viral from Bacterial Infections

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Differentiating Viral from Bacterial Infections

Estimates claim that over 1.2 million people died in 2019 as a direct result of an antibiotic-resistant bacterial infection. Statistics show that up to 4.95 million deaths in the same year were associated with antimicrobial resistance (AMR)1. The overuse and misuse of antibiotics is considered to be the largest contributing factor to the rise of AMR. Antibiotics are effective at treating a wide range of bacterial infections, however, when used to treat viral infections, they have little to no effect. Even still, many physicians continue to prescribe so-called empirical antibiotics as an all-encompassing treatment strategy. In their defence, differentiating viral from bacterial infections can be troublesome. Traditional testing takes the form of paired serology, which requires patients to visit a healthcare facility twice during a 2–4-week period. Many of these infections have distressing symptoms, making this an unreasonable time-to-diagnosis period. Novel molecular techniques can reduce the time to result in the determination of many infections. However, some of these methods are associated with high false positive rates and low specificity resulting in further misuse of antibiotics.

Mxyovirus resistance protein A (MxA) is a biomarker associated with viral infections. It displays antiviral activity against positive, double-stranded RNA viruses and some DNA viruses2. In a study from earlier this year, MxA was used to differentiate viral from bacterial infections in a cohort of 61 adults with an AUROC of 0.9 and a sensitivity and specificity of 92.3% and 84.6% respectively3. An additional study, known as the TREND study, found that a cut-off of 430μg/L could effectively differentiate bacterial and viral infections with an AUROC of 0.9, a sensitivity of 92% and a specificity of 100%4.

C-reactive protein (CRP) is a non-specific acute phase protein which is associated with bacterial infection. However, CRP levels have also been shown to be elevated in response to various viral infections such as Influenza virus, malaria5 and SARS-COV-26, limiting its utility in differentiating the aetiology of an infection.

Using both biomarkers in combination can help physicians determine the true aetiology of infection with high specificity, supporting antimicrobial stewardship and reducing the harmful use of these drugs. Available on the VeraSTAT, Randox provides tests for MxA and CRP, which together provide a fast and accurate method of detection and differentiation of bacterial and viral infections from a small sample.

We have provided an educational guide which describes these biomarkers and their usefulness in the arena of viral and bacterial detection. If you’re interested in learning more, you can find our educational guide here.

Differentiating Viral from Bacterial Infections

Alternatively, don’t hesitate to browse our range on our website or get in touch with one of our team at marketing@randox.com who will be happy to help with any query you have!

References

  1. Murray CJL, Ikuta KS, Sharara F, et al. Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis. The Lancet. 2022;399(10325):629-655. doi:10.1016/S0140-6736(21)02724-0
  2. Liao S, Gao S. MxA: a broadly acting effector of interferon-induced human innate immunity. Visualized Cancer Medicine. 2022;3:2. doi:10.1051/vcm/2022002
  3. Metz M, Gualdoni GA, Winkler HM, et al. MxA for differentiating viral and bacterial infections in adults: a prospective, exploratory study. Infection. Published online February 3, 2023. doi:10.1007/s15010-023-01986-0
  4. Rhedin S, Eklundh A, Ryd-Rinder M, et al. Myxovirus resistance protein A for discriminating between viral and bacterial lower respiratory tract infections in children – The TREND study. Clinical Microbiology and Infection. 2022;28(9):1251-1257. doi:10.1016/j.cmi.2022.05.008
  5. Joseph P, Godofsky E. Outpatient Antibiotic Stewardship: A Growing Frontier—Combining Myxovirus Resistance Protein A With Other Biomarkers to Improve Antibiotic Use. Open Forum Infect Dis. 2018;5(2). doi:10.1093/ofid/ofy024
  6. Paranga TG, Pavel-Tanasa M, Constantinescu D, et al. Comparison of C-reactive protein with distinct hyperinflammatory biomarkers in association with COVID-19 severity, mortality and SARS-CoV-2 variants. Front Immunol. 2023;14. doi:10.3389/fimmu.2023.1213246

RX Imola: Inflammatory Biomarkers in COVID-19

Over the course of human history, few events have had such a dramatic impact as the COVID-19 pandemic. According to the World Health Organization (WHO), as of 12th July 2023, the SARS-CoV-2 virus has claimed almost 7 million lives and figures continue to rise1. While many who become infected are only subject to mild symptoms, those who develop a more severe form of the infection are encumbered with a debilitating flu-like condition, often requiring days, if not weeks of bed rest. In a paper from June 20232, the Rx Imola was used to study C reactive protein concentrations, along with other biomarkers, in mild and severe COVID-19 patients in order to develop novel risk stratification methods for this potentially life-threatening viral infection.

The impact on healthcare services around the world cannot be understated. In developed countries, access to services for both COVID-related and other conditions took a catastrophic hit. In low-to-middle-income countries, the impact has been even more distressing, all but eliminating basic medical care in favour of combating COVID-19, partly due to inferior resources and facilities3.

“The COVID-19 pandemic has changed the world socially, economically and politically.”
Jain, 2023

In times of medical emergency, it is crucial to have an efficient and effective means of stratifying the risk to patients and a process for suitably categorising those into the least and most at risk of severe complications or death. Due to the rate at which COVID-19 spread, unfortunately, the world lacked these mechanisms for SARS-CoV-2, resulting in mass hospital overpopulation, cancelled appointments for other life-threatening conditions and ultimately the staggering mortality statistics we’ve been bombarded with since January 2022. This prompted an unprecedented surge in medical research and major advances in testing capabilities, giving us new methods of detecting SARS-CoV-2 and determining the risk posed to individuals.

One such investigation, by Paranga et al., (2023) studied a total of 13 biomarkers to determine which could accurately differentiate mild, moderate, and severe cases and identify biomarkers which were good predictors of fatality2. C reactive protein (CRP) was the best-described biomarker relating to COVID-19 throughout the pandemic. This paper compares it to 12 other biomarkers including suPAR, sTREM-1, ferritin, MCP-1 and Lactate dehydrogenase. Of these, it was discovered that CRP was clearly the most effective biomarker for differentiating mild from severe cases, with concentrations in those with severe infection being, on average, 45% higher than in those with mild symptoms2. Additionally, the authors discovered that CRP levels were not significantly affected by age, a factor known to affect the inflammation and immune responses, providing a powerful and inclusive risk stratification tool. Some of the additional conclusions drawn from this paper can be seen below2:

  • Lactate dehydrogenase, sTREM-1 and HGF were good predictors of mortality in COVID-19.
  • suPAR was identified as a crucial molecule in characterising Delta variant infection and mortality.
  • The initial values of inflammatory biomarkers were good to excellent predictors of disease severity in COVID-19 patients.
  • Disease severity and mortality are associated with a higher rate of comorbidities including thrombocytopenia and other blood diseases, circulatory and respiratory system diseases and liver diseases such as cirrhosis.

So, what is CRP and how does it become elevated in response to a SARS-CoV-2 infection? CRP is a non-specific, acute-phase protein, meaning its concentration is altered in response to inflammation4. The acute respiratory distress syndrome induced by SARS-CoV-2 is, in part, a result of the hyperinflammation caused by the virus2. CRP is a well-characterised inflammatory biomarker and is therefore well-suited for identification and risk stratification in an emerging disease.

This investigation2 utilised the RX Imola, a rapid, comprehensive clinical chemistry platform, to quantify CRP. With the RX Imola, laboratories can gain access to the world’s largest clinical chemistry test menu covering routine chemistries as well as specific proteins, lipids, and more providing a cost-effective and user-friendly platform. With 60 cooled reagent positions and a sample carousel with 20 cooled positions for controls and calibrators, the RX Imola is an ideal solution for small to medium-throughput laboratories seeking an innovative and reliable clinical chemistry system. Randox also supplies suitable, high-quality reagents, and through Acusera, state-of-the-art controls and calibrators, completing the clinical chemistry portfolio.

References
1. World Health Organisation. WHO Coronavirus (COVID-19) Dashboard. https://covid19.who.int/.
2. Paranga TG, Pavel-Tanasa M, Constantinescu D, et al. Comparison of C-reactive protein with distinct hyperinflammatory biomarkers in association with COVID-19 severity, mortality and SARS-CoV-2 variants. Front Immunol. 2023;14. doi:10.3389/fimmu.2023.1213246
3. Jain P. Impact of COVID-19 Pandemic on Global Healthcare Systems and the role of a new era of global collaborations. Sushruta Journal of Health Policy & Opinion. 2021;14(3):1-5. doi:10.38192/14.3.2
4. Nehring S. C Reactive Protein . https://www.statpearls.com/articlelibrary/viewarticle/18744/.


Randox Covid-19 Testing: Evaluating the health, social and economic impacts

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3rd April 2023: COVID-19 Report Reveals How Randox’s 25 Million PCR Tests Averted Thousands of Hospitalisations and Deaths And Delivered Billions of Pounds Of Economic Benefits

A new report on the work of leading diagnostics company Randox shows that its COVID-19 PCR testing in the public and private sectors averted more than 3,000 UK deaths and 14,100 additional hospitalisations during the pandemic emergency.

That assessment is contained in an evidence-based report into the performance and delivery of Randox during the crisis, compiled by internationally respected economic development consultants OCO Global.

As well as illustrating the impact of PCR testing on deaths and hospitalisations, the report provides an assessment of the wider economic benefit of the test and trace programme.

It reveals that Randox testing delivered £8.3 billion of benefits to the UK economy, by reducing transmission and expediting the return to work for key workers, as well as facilitating social engagement and international travel, crucial to economic recovery.

The report is believed to be one of the most comprehensive analyses of any company awarded government Covid-19 contracts.  It will also be provided to the COVID-19 Public Inquiry to assist their considerations regarding future evidence that may be required.

In total, the OCO Global report confirms that Randox processed over 17 million PCR tests as part of the government’s national testing programme between March 2020 and June 2022. The company also provided a further 7.7 million PCR tests plus around 1.8 million lateral flow tests to corporate clients and international travelers.

The report estimates that Randox’s private testing facilitated 4.4 million international return journeys, many of them crucial to support the economy in a time of medical and financial emergency. Other tests supported the nation’s social fabric, enabling people to travel for leisure purposes and to meet families.

The evidence highlights the Northern Ireland-based company’s 40 years experience as one of the world’s leading diagnostic testing companies. This experience, says the OCO report, coupled with the company’s ability and willingness as a private business to innovate and invest its own resources in rapidly upscaling to meet the crisis enabled it successfully to deliver testing on a vast scale. The report also says that innovation in software, automation and robotics, in particular, helped ensure that Randox optimised laboratory efficiency and drove down costs to the benefit of contracting parties.

The report sets out the high level of financial risk taken by Randox during the pandemic and their rapid expansion of laboratories, staff levels and capacity to meet the emergency demand for testing.

In just ten months, Randox increased its capacity to process PCR tests – from 300 tests per day on March 30th 2020, to 120,000 per day by January 2021.

This involved building, equipping and staffing 80,000 square feet of PCR testing laboratory space at the Randox Science Park in County Antrim – the equivalent of a football pitch of new laboratory space.

Overall, the report confirms these improvements and development enabled Randox to deliver 12 per cent of the UK’s PCR testing – and a considerably higher percentage at times when Covid-19 cases, hospitalisations and deaths rocketed to their highest levels. It also notes that the Randox rate of void samples was 15 per cent below the average for the testing programme as a whole.

The report adds: “These improvements would be passed on to the UK Treasury as Randox was able to drive down the cost of testing from £49.60 to £18.00.

“Private individuals also benefited from Randox process improvement as the company was at the forefront of driving down the price of private testing. By October 2021 the cost of a PCR test (click and collect) would be £34.99, a 70 percent decrease from December 2020.”  This price included the sample collection kits and all logistics and services, not within the government contracts.

In assessing Randox’s performance the report goes on to say:  “Randox is a privately owned company that can make decisions quickly and this proved invaluable in the frenetic early stages of the pandemic when companies and governments across the world were scrambling for supplies and consumables.

“Randox’s willingness to invest came with significant risk: through the majority of the National Testing Programme, Randox were only paid for tests completed and there were no guarantees that payment for the number of tests indicatively contracted for would be received.

“This placed considerable risk with Randox who were having to purchase vast quantities of consumables, despite the uncertainty around how long the pandemic would last or how government policy might change.

“It was this successful risk management which enabled Randox to be one of the best performing laboratories across the National Testing Programme.”

Gareth Hagan, CEO of OCO Global said:

“OCO Global was commissioned by Randox to compile a full, open and comprehensive report into the value of the company’s work, performance and delivery of PCR testing during the pandemic. Randox was a cooperative partner, providing access both to data and to personnel from across the organisation.

“We were able to use external interviews and data sources to corroborate our research. We are satisfied that the facts and the evidence-based findings of our report accurately reflect the work of Randox  during the Covid-19 emergency.”

A spokesman for Randox said:

“We believe this report delivers clear evidence of the performance, outcomes and value of the work which Randox is proud to have carried out during one of the greatest peacetime emergencies to have hit the world and the UK.

Editors Notes

Gareth Hagan is interview for media interview

OCO Global is a leading specialist provider of trade and investment services. Headquartered in Northern Ireland, OCO Global has offices in the UK, Ireland, Germany, France, Japan, UAE, China and the U.S.

OCO Global’s clients include leading national, state and regional economic development organizations such as The Department For International Trade (DIT), Enterprise Florida and The Japan External Trade Organization (JETRO), as well as private companies seeking to enter new markets or grow their domestic base, including EY, PWC, Siemens, Smiley Monroe, Pepsico and Santander.

Media Enquiries to Ian Monk /Heather Vernon

Ian.monk@woburnpartners.com                  +44 7970 026072

Heather.vernon@woburnpartners.com      +44 7747 097821

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Vivalytic | SARS-CoV-2 Dual Target, Flu A/B and RSV

Vivalytic | SARS-CoV-2 Dual Target, Influenza A/B and RSV

Rapid differentiation between SARS-CoV-2, Flu A/B, and RSV

SARS-CoV-2 Dual Target, Influenza A/B and RSV Rapid Test

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    Detection from real-time PCR via Nasopharyngeal and/or Oropharyngeal swab
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    Targets the E gene and N gene sequences for COVID-19 detection, as well as Influenza A and Influenza B and human Respiratory Syncytial Virus

     

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    The SARS-CoV-2 DT, Flu A/B and RSV rapid test has recently received CE marking
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    Simple and easy to use analyser with a small footprint making it suitable for use in laboratory and non-laboratory settings
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    Rapid turnaround time of 53 minutes from sample entry to result
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    Convenient 4 step process from sample entry to results. No laboratory training required

Clinical Significance

Patients afflicted with SARS-CoV-2, Influenza A (Flu A), Influenza B (Flu B), and/or Respiratory Syncytial Virus (RSV) often exhibit similar symptoms, yet necessitate distinct approaches to management. The SARS-CoV-2, Flu A/B, and RSV qualitative test streamlines the rapid triage and patient management process, swiftly identifying various viruses in under 1 hour.

This panel enables healthcare professionals to administer pathogen-specific treatments and targeted interventions effectively. By combining these tests, healthcare facilities not only streamline costs but also address the complexities of respiratory infections directly at the point of care. This integrated approach facilitates infection control measures and enhances risk assessment, ultimately contributing to more efficient and tailored patient care.

Features

Sample Type: Nasopharyngeal or Oropharyngeal Swab (eNAT)

Sample Volume: 300 μl

Detection Method: Real-Time PCR

Time to result: 53 minutes

Detectable Pathogens
SARS-CoV-2 (E gene)
Influenza A and Influenza B
Human Respiratory Syncytial Virus

“AWARD-WINNING DESIGN DELIVERS
AN UNCOMPLICATED USER EXPERIENCE”

Vivalytic Workflow

Intuitive engineering of Vivalytic ensures the analyser is user friendly. The process of patient sample to result comprises a very simple 4 step workflow.

To begin the test, the user scans or enters sample information. The cartridge code is then scanned into the embedded Vivalytic software. The user then adds sample into the dedicated cartridge slot, closes the lid and inserts the cartridge into the Vivalytic.

The touchscreen display will countdown the time remaining to test completion. Results will be displayed on the screen. Multiple Vivalytics can be wirelessly connected allowing the user to control multiple tests at one time all reporting to a master Vivalytic platform.

Download Vivalytic Brochure

Want to know more?

Contact us or visit our COVID-19 Monitoring & Management page

Related Products

Viral Respiratory Infection Array

SARS-CoV-2 Pooling Test

Vivalytic

Vivalytic Test Menu


Vivalytic | MG, MH, UP/UU Rapid Test

Vivalytic | MG, MH, UP/UU Rapid Test

 

Detection of Mycoplasma genitalium, Mycoplasma hominis & Ureaplasma parvum/urealyticum

RT-PCR detection of common STI pathogenic bacterial species

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    Quick turnaround time of 53 minutes, beneficial for both the patient and for the containment of STIs
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    Convenient 4 step process from sample entry to results. Suitable for use in laboratory and non-laboratory settings
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    Detection from a wide range of sample types including urine, urethral, vaginal, cervical and rectal swabs

Clinical Significance

Aiding in the diagnosis and containment of sexually transmitted infections (STIs) of symptomatic and asymptomatic individuals, the Vivalytic portfolio of tests has now expanded to complement current comprehensive screening.

The Mycoplasma genitalium (MG), Mycoplasma hominis (MH) & Ureaplasma parvum (UP)/urealyticum (UU) test guides appropriate treatment decisions at the earliest opportunity for improved patient management, prevention of transmission and supporting emerging macrolide resistance. MG, MH, UP/UU belong to the group of human pathogenic bacterial species associated with STIs even though particularly Ureaplasma ssp. are primarily considered as commensal organisms.

All four bacterial species can be detected simultaneously with the Vivalytic MG, MH, UP/UU test cartridge. 

* Detailed information on the determination of analytical performance can be found in instructions for use provided with the testing kit.

 

Features

Sample Type: Swab (Urethral, Vaginal, Cervical, Rectal), Urine

Sample Volume: 300 μl

Detection Method: Real-Time PCR

Time to result: 53 minutes

 

Detectable Bacteria
Mycoplasma genitalium
Mycoplasma hominis
Ureaplasma parvum/urealyticum

“AWARD-WINNING DESIGN DELIVERS
AN UNCOMPLICATED USER EXPERIENCE”

Vivalytic Workflow

Intuitive engineering of Vivalytic ensures the analyser is user friendly. The process of patient sample to result comprises a very simple 4 step workflow.

To begin the test, the user scans or enters sample information. The cartridge code is then scanned into the embedded Vivalytic software. The user then adds sample into the dedicated cartridge slot, closes the lid and inserts the cartridge into the Vivalytic.

The touchscreen display will countdown the time remaining to test completion. Results will be displayed on the screen. Multiple Vivalytics can be wirelessly connected allowing the user to control multiple tests at one time all reporting to a master Vivalytic platform.

Download Vivalytic Brochure

Want to know more?

Contact us or visit our COVID-19 Monitoring & Management page

Related Products

Viral Respiratory Infection Array

SARS-CoV-2 Pooling Test

Vivalytic

Vivalytic Test Menu


Vivalytic | SARS-CoV-2 Rapid Dual Target

Vivalytic | SARS-CoV-2 Dual Target Rapid Test

Detecting E & N gene sequence for SARS-CoV-2

SARS-CoV-2 Dual Target Detection

  • null
    Detection from real-time PCR via Nasopharyngeal and/Oropharyngeal swab or lollipop swab collection
  • null
    The SARS-CoV-2 rapid test targets the E gene & N gene sequence for COVID-19 detection
  • null
    The SARS-CoV-2 rapid test has recently received CE marking
  • null
    Simple and easy to use analyser with a small footprint making it suitable for use in laboratory and non-laboratory settings
  • null
    Rapid turnaround time of just 53 minutes from sample entry to result
  • null
    Convenient 4 step process from sample entry to results. No laboratory training required

Clinical Significance

SARS-CoV-2 dual target is a rapid real time PCR test cartridge, providing clear and concise results in a timely manner, direct at the point of care. This enables the patient to take the recommended safety precautions without delay.

The SARS-CoV-2 dual target rapid test allows for detection of both the E-gene and N-gene sequence for SARS-CoV-2 with minimal workflow required, suitable for laboratory and non-laboratory settings. The SARS-CoV-2 dual target test also contains a Human and Internal PCR control for convenience.

In collaboration with Bosch, we are proud to release not only a rapid testing solution for the detection of SARS-CoV-2 but an accelerated mass testing solution to effectively and efficiently monitor and detect viral infection from the offset with an aim of minimising the rise in infections globally. The new SARS-CoV-2 pooling test will allow users to test up to 160 samples a day and has sensitivity of 98% and a specificity of 100% – a world’s first!*

* Detailed information on the determination of analytical performance can be found in instructions for use provided with SARS-CoV-2 kit.

* Test Termination: If one of the target genes is clearly detected, the test can be terminated prematurely with the valid positive result.

 

Features

Sample Type: Nasopharyngeal or Oropharyngeal Swab (eNAT)

Sample Volume: 300 μl

Detection Method: Real-Time PCR

Time to result: 53 minutes

Detectable Virus
SARS-CoV-2 (E-gene and N-gene sequence)

“AWARD-WINNING DESIGN DELIVERS
AN UNCOMPLICATED USER EXPERIENCE”

Vivalytic Workflow

Intuitive engineering of Vivalytic ensures the analyser is user friendly. The process of patient sample to result comprises a very simple 4 step workflow.

To begin the test, the user scans or enters sample information. The cartridge code is then scanned into the embedded Vivalytic software. The user then adds sample into the dedicated cartridge slot, closes the lid and inserts the cartridge into the Vivalytic.

The touchscreen display will countdown the time remaining to test completion. Results will be displayed on the screen. Multiple Vivalytics can be wirelessly connected allowing the user to control multiple tests at one time all reporting to a master Vivalytic platform.

Download Vivalytic Brochure

Want to know more?

Contact us or visit our COVID-19 Monitoring & Management page

Related Products

Viral Respiratory Infection Array

SARS-CoV-2 Pooling Test

Vivalytic

Vivalytic Test Menu


CDx & BioPharma Services

CDx & BioPharma Services

Offering a collaborative CDx partnership approach.

 

As an established IVD company, Randox Biosciences offers tailored development and testing solutions to support faster, more effective and safe development of new drugs.

We have a wide range of in-house capabilities, ranging from the selection and patenting of novel biomarkers; manufacture of bio reagents; production of single and multiplex RUO and IVD grade tests; quality control; provision of clinical laboratory services; regulatory expertise and worldwide distribution.

Pharmaceutical and biotech companies are increasingly investing in the research and development of new therapies to address the world’s growing need for earlier and more effective patient treatment.

Randox Biosciences is dedicated to the improvement of personalised diagnostic, prognostic, and predictive assays. We aim to help Pharma Biotechs and CROs move away from a “one treatment fits all” approach and help get a better understanding of the complexity and variability of diseases and increase efficacy of treatment. A key element to realizing the potential for personalized medicine is companion diagnostic (CDx) development. Randox have key expertise in all elements of CDx and diagnostic development and offer a fully flexible partnership to accommodate your needs, providing you with tailored protein & molecular assays.

Randox Biosciences can be your CDx and biomarker assay development partner from early phase trials through to drug launch, addressing all assay requirements in the process, including development of raw materials and assays, verification and validation studies, clinical trial sample analysis, regulatory submissions and co-commercialisation.

Accreditation List

Complete CDx Partner Approach

Drug and Diagnostic Development Process Timeline

Randox Biosciences offers an extensive portfolio of over 900 products for a multitude of R&D applications manufactured under ISO13485 accreditation, including more than 500 monoclonal and polyclonal antibodies, 140 human recombinant proteins, as well as antibody fragments such as sdAbs and scFvs. In addition to our range of off-the-shelf raw materials, Randox can custom develop antibodies and proteins for use in new assays.

By using Randox antibodies, the raw material supply chain is controlled in-house which is highly beneficial for CDx development.

 

Randox offers a range of technologies and platforms for use in clinical trials, including our proprietary multiplex biochip technology that can be used in early exploratory biomarker stages and can be brought through to IVD/CDx grade. Biochip from high throughput to point of care technologies.

With comprehensive Original Equipment Manufacturing (OEM) capabilities, Randox can develop assays on any platform to ensure global reach.
All assays intended for IVD or CDx grade are developed under full design control and ISO13485 accreditation, and we have expertise in a wide range of disease areas and assay formats.

Randox have ISO17025, ISO15189 and GCP accredited laboratories located throughout the UK and Ireland, with US laboratories being mobilised in 2022 and 2023. Our laboratories can be utilised to meet your clinical trial and post approval sample analysis needs. We also have a strong global network with 3rd party laboratories to ensure your clinical trial requirements are met across the world.

Randox performs in depth multi lot verifications following CLSI guidelines to ensure full performance requirements are met and to support regulatory submissions and approvals. We will validate assay performance and reproducibility across multiple sites.

Highly experienced regulatory teams inhouse at Randox can prepare IVD/CDx submissions and applications for approval, thus, providing full regulatory support to help get your drug to the market as quickly as possible.

Development and regulatory teams will work hand-in-hand throughout the whole process and in collaboration with the Pharma partner, to ensure a timely submission while also keeping in line with country specific requirements.

We currently have 954 licenses across the globe and over 3800 licensed products to date, with continuous expansion ongoing including progression to IVDR regulation.

Randox endeavors to start commercialization planning early on in development to ensure all market access requirements are addressed, providing both pre and post-launch support with laboratory, clinician, patient and KOL engagement and can also conduct sample analysis at our clinical laboratories.

We have strong global laboratory and distribution networks, in-house sales and marketing teams, with operations and partners in over 145 countries.

We have capabilities in manufacturing customised sample collection kits and offer CDx specific proficiency testing programmes.

We can provide pre- and post-launch support with laboratory, clinician, patient and KOL engagement and can also conduct sample analysis at our clinical laboratories.

Randox Platforms

 


Randox response to the Public Accounts Committee (PAC) report, ‘Government’s contracts with Randox Laboratories Ltd’

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27th July 2022: Randox response to the Public Accounts Committee (PAC) report, ‘Government’s contracts with Randox Laboratories Ltd’

A spokesperson for Randox said:

“The PAC report is deeply flawed and wrong in assumptions it makes and the conclusions it draws about Randox.

“As the UK’s largest diagnostic company, with four decades of experience, over 2,000 professional staff on hand at the start of the pandemic and more than £350m of prior investment in diagnostic and engineering innovation, Randox was uniquely situated to respond to the national need when COVID-19 emerged in early 2020.

“In supporting the UK’s urgent requirement for coronavirus testing Randox reacted with speed, efficiency and flexibility in delivering value. The company developed and built, in record time, the UK’s largest COVID-19 laboratories and testing services. It provided the Department of Health and Social Care with a PCR testing capacity at the time of greatest need, rising from 300 tests per day to 120,000 per day by January 2021.

“Altogether Randox processed over 25 million samples for UK’s National Testing Programme and in support of international travel for business and personal reasons. This played a crucial role in keeping vital elements of the UK economy functioning during lockdowns.

“In adapting to rapidly changing DHSC and Department of Transport requirements, Randox delivered unique value to the government, the national economy and to individuals.

“At no stage, either during its deliberations or in its preparation of this report, did the PAC make any contact whatsoever with Randox. Consequently many elements of its report relating to Randox are false, based as they are, on wrong and unchecked assumptions about the company. For that reason, they and any publications arising from them are the subject of a legal complaint.”

“The issues the report raises around internal DHSC record keeping are clearly a matter for DHSC”

For all media enquiries, please contact Ian Monk on ian@ianmonk.com or  +44 7970 026072 / + 44 203 011 1933

 

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Response to release of specified minutes, notes and correspondence relating to Government contracts awarded to Randox

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4th February 2022: Response to release of specified minutes, notes and correspondence relating to Government contracts awarded to Randox

A spokesperson for Randox said:

“It is clear from these papers that Randox contracts were awarded in full compliance with government procedures and protocols in place at a time of the emerging pandemic.

“The awarding of the contracts reflected Randox’s extensive diagnostics capabilities within the UK and 40 years of experience in that field. As Secretary of State, Sajid Javid says in his statement, the service Randox provided was integral to the rapid building, from scratch, of the largest ever testing industry in UK history.

“Randox’s laboratories expanded rapidly in order to operate at scale and were the first laboratory to report over 100,000 PCR results in a day. It is clear from these papers that the company has delivered a vital and core part of the UK’s testing capacity.

“Randox remains proud of its performance and delivery of Covid 19 testing throughout the pandemic. To date Randox has reported almost 24 million PCR results and has played a key role in both keeping people safe and sustaining vital national infrastructure.

“Unlike other laboratories Randox was able from the outset to provide whole-system capabilities to deliver the tests. Both the World Health Organisation and the UK government agreed this capability was crucial to combating the pandemic.”

For all media enquiries, please contact Ian Monk on ian@ianmonk.com or  +44 7970 026072 / + 44 203 011 1933

Randox in the media

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