Whole pathogen multiplex controls to support testing for cold, cough and COVID

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Whole pathogen multiplex controls to support testing for cold, cough and COVID

News       Coronavirus        Qnostics

 

27 October 2020

Whole pathogen multiplex controls to support testing for cold, cough and COVID

Just in time for flu season, global diagnostics company Randox Laboratories has unveiled a range of whole pathogen multiplex controls that cover multiple viral and bacterial pathogens which cause respiratory disease.

Inclusive of SARS-CoV-2, Influenza A & B, and Respiratory Syncytial Virus (RSV), the Qnostics Multiplex Respiratory Pathogen Controls (RTX) facilitate diagnosis of the likes of cold and flu, and importantly, the differentiation of these respiratory diseases from COVID-19.

Using a control line that covers a range of respiratory pathogens in this way will allow laboratories to streamline their testing, consolidate QC, and ultimately save time, money and resource.

Lynsey Adams, Randox Quality Control Manager, explained;     

“When the use of time and resources are critical such as in COVID-19 testing, the use of highly characterised controls enables laboratories to meet their daily QC needs and accreditation requirements.

“Accurate and reliable laboratory testing is an essential aspect of the management of COVID-19 and other respiratory diseases, so we are pleased to be able to offer these new controls which will crucially support the validation, verification and performance monitoring of molecular respiratory assays.”

The new RTX controls, which are whole pathogen for compatibility with the majority of commercial and in-house assays, are used to monitor the full testing process, from extraction to amplification and detection.

The Multiplex Respiratory Controls will support public health testing strategies during the incoming flu season and are suited for the test menus of most syndromic assays.

Lynsey continued;

“The Randox Qnostics Multiplex Respiratory Pathogen Controls are clinically relevant for full-process validation. Liquid frozen for user convenience and ease of use, the development of the controls using whole pathogen material ensures clinical relevance from extraction to amplification and detection.”

Randox Qnostics Multiplex Respiratory Pathogen Controls are manufactured to ISO 13485 standards and are in line with ISO 15189:2012 regulatory requirements.

Key Features and Benefits of the new RTX Controls:

  • Whole pathogen controls – the controls contain the entire genome meaning they are compatible with the majority of commercial and in-house assays.
  • Full process control – whole pathogen controls are the ideal material for full-process validation, monitoring the testing process from extraction to amplification and detection, to ensure ultimate quality assurance in laboratories.
  • Highly characterised – Qnostics controls are quantified by digital PCR to ensure batch to batch reproducibility and are traceable to an internal reference preparation, to ensure metrological traceability of test results obtained by different diagnostic workflows.
  • True Third Party – An independent, unbiased assessment of assay performance is ensured in line with ISO 15189:2012 regulatory requirements.
  • Superior ManufacturingQnostics controls are manufactured under ISO 13485 guidelines to ensure quality and traceability.
  • Liquid for Ease-of-Use – the controls are conveniently supplied in a liquid frozen format meaning there is no additional preparation or handling required.

For more information visit https://www.randox.com/molecular-infectious-disease-controls/respiratory-infection-testing/

For further enquiries please email marketing@randox.com

QNOSTICS

QCMD

CORONAVIRUS


New 39-minute COVID test available on Randox-Bosch Vivalytic

News       About Us       SARS-CoV-2 Rapid Test

 

02 October 2020

 

New 39-minute COVID test available on Randox-Bosch Vivalytic

  • The world’s fastest PCR based SARS-CoV-2 test for the point of care delivers reliable results in 39 minutes.
  • Has a sensitivity of 98 percent and a specificity of 100 percent.
  • Simultaneous testing of five people with one cartridge by pooling will be available from early October.
  • Work is in progress to further reduce time to result.

A rapid new coronavirus test, which provides results for Covid-19 in just 39 minutes, is now available on the Vivalytic, a point of care platform brought to market by Randox Laboratories and Bosch.

The test for detection of the SARS-CoV-2 pathogen, is currently the fastest PCR test (the gold standard of test methods) worldwide, and is predestined for decentralized use in mobile test centres at service stations or in airports, so that people who take the test can obtain a reliable result while at the testing site.

Available now in Europe, the CE-approved test, which has a sensitivity of 98 percent and a specificity of 100 percent, helps avoid time in quarantine, relieve laboratories, and make travel and work safer again.

“Rapid and accurate testing plays a crucial role in identifying cases of Covid-19 – to contain any outbreaks and limit the spread of the virus,” says Dr. Heather McMillan, Molecular R&D Manager at Randox Biosciences.

 “This new rapid test will be a game-changer in the coronavirus testing landscape by allowing patients to receive their results at the point of care faster than ever before.”

Randox and Bosch launched the first rapid test for the Vivalytic analyser at the end of March, after just six weeks’ development.

As a multiplex test, it simultaneously checks samples for the SARS-CoV-2 virus as well as nine other respiratory diseases in two and a half hours, whereas the new accelerated test is exclusively for SARS-CoV-2.

“With our different coronavirus tests and variable analysis strategies, we open up a range of testing scenarios with a Vivalytic device – from screening all the way to supporting differential diagnosis for similar symptoms,” says Marc Meier, president of Bosch Healthcare Solutions GmbH.

And development work for Covid tests on the Vivalytic is ongoing: as of early October 2020, by pooling samples together it will be possible to simultaneously evaluate five samples in one test cartridge and at a comparable speed – a world first.

This will increase available testing capacity, by enabling fully automated processing of more than 160 samples a day using a Vivalytic device.

Key Benefits of SARS-CoV-2 test on Vivalytic point of care platform

The advantages of the rapid SARS-CoV-2 test on Vivalytic lie not only in speedy analysis, but also in ease of use. A sample is taken from the nose or throat using a swab, and placed in the test cartridge. Then the cartridge, which contains all the reagents required for the test, is inserted into the Vivalytic device for automated analysis.

  • Turnaround time of 39 mins from sample entry to result.
  • The SARS-CoV-2 rapid test has recently received CE marking.
  • The SARS-CoV-2 pooling test can run up to 5 samples on-board one single cartridge.
  • Easy 4-step user-friendly process from sample entry to result. Minimal training required.
  • Detection from real-time PCR from Nasopharyngeal and/or Oropharyngeal swab.
  • Suitable for use in any laboratory and non-laboratory settings.

The development of the new Vivalytic PCR singleplex test is part of a research and development project funded by the German Federal Ministry of Education and Research (BMBF).

For more information please contact marketing@randox.com

RESEARCH

BIOPHARMA

CLINICAL LAB

BIOREAGENTS


Whole pathogen molecular controls for SARS-CoV-2 (COVID-19) receive CE marking

News       Coronavirus        Qnostics

 

25 May 2020

Whole pathogen molecular controls for SARS-CoV-2 (COVID-19) receive CE marking

CE marking has been granted to whole pathogen quality controls for SARS-CoV-2 (COVID-19), from global diagnostics company Randox Laboratories.

The molecular controls are currently being used alongside the firm’s pioneering COVID-19 tests, performed on its proprietary Biochip, as part of a nationwide UK testing programme.

Randox is using these third-party quality controls, which include a Positive Control, Negative Control, Analytical Q Panel and Molecular Q Panel, to ensure accurate coronavirus test and system performance, and ultimately, guarantee laboratory quality assurance.

Lynsey Adams, Randox Quality Control Manager, explained;     

Accurate and reliable laboratory testing is an essential aspect of COVID-19 disease management and outbreak control.

“Designed specifically for laboratories currently managing COVID-19 testing, Randox SARS-CoV-2 controls, which have been CE marked, help ensure the accuracy and reliability of molecular assays used in the testing of suspected coronavirus samples, and importantly, give clinicians absolute confidence in any COVID-19 diagnoses they may make.”

Available under the brand name Qnostics, the new SARS-CoV-2 controls are manufactured using whole pathogens. They therefore mimic the patient sample, providing the best sample matrix for laboratories.

Lynsey continued;

“The Randox Qnostics SARS-CoV-2 controls are clinically relevant for full-process validation. Liquid frozen for user convenience and ease of use, the development of the controls using whole pathogen material ensures clinical relevance from extraction to amplification and detection.”

The new coronavirus controls from Randox, which contain the entire SARS-CoV-2 genome, including the conserved regions recommended by CDC and WHO, are compatible for use with both commercial and in-house testing methods, and are quantified by digital PCR to ensure batch to batch reproducibility.

Lynsey added;

“We are proud to be able to support the high demand for coronavirus testing by delivering a full COVID-19 testing package – not only our Coronavirus Biochips but now also the corresponding molecular control material that will ensure the delivery of accurate, and reliable results.

 “The World Health Organization (WHO) has been very clear about the importance of testing in the global efforts to contain and delay COVID-19 and we are pleased that our new CE-marked controls comply with guidelines not only from the WHO but also from the Centres for Disease Control and Prevention.”

Randox Qnostics SARS-CoV-2 Controls are heat-inactivated to be non-infectious and are manufactured to ISO 13485 standards.

Key Features and Benefits of Randox SARS-CoV-2 Qnostics Controls:

  • Whole pathogen – the controls contain the entire SARS-CoV-2 genome meaning they are compatible with the majority of commercial and in-house assays, and target the CDC and WHO consensus sequences
  • Monitor the entire testing process – whole pathogen controls are the ideal clinically relevant material for full-process validation, from extraction to amplification and detection, to ensure ultimate quality assurance in laboratories.
  • Non-infectious – the controls are heat-inactivated and gamma-irradiation enabling safe handling of material.
  • Highly characterised – the controls are quantified by digital PCR to ensure batch to batch reproducibility.
  • Clinically relevant – performance data is available to support the clinical relevance and the compatibility with molecular assays currently in use in clinical laboratories.
  • High Quality – the controls are manufactured under ISO 13485 guidelines and are therefore suitable for a broad range of usage.
  • Liquid for Ease-of-Use – conveniently supplied in a liquid frozen format meaning there is no additional preparation or handling required.
  • Complete QC package – Analytical and Molecular Q Panels available for new assay validation as well as routine performance monitoring.

For more information visit www.randox.com/coronavirus-randox

 

QNOSTICS

QCMD

CORONAVIRUS


Randox unveils whole pathogen molecular controls for SARS-CoV-2 (COVID-19)

News       Coronavirus        Qnostics

 

16 April 2020

Randox unveils whole pathogen molecular controls for SARS-CoV-2 (COVID-19)

Whole pathogen quality controls to support accurate coronavirus testing have been developed by scientists in the UK.

The molecular controls, available from global diagnostics company Randox Laboratories, are currently being used as part of a nationwide testing programme for frontline NHS workers.

Alongside its pioneering COVID-19 tests, performed on its proprietary Biochip, Randox is using these third-party quality controls to ensure accurate coronavirus test and system performance, and ultimately, guarantee laboratory quality assurance.

Lynsey Adams, Randox Quality Control Manager, explained;     

Accurate and reliable laboratory testing is an essential aspect of COVID-19 disease management and outbreak control.

“Designed specifically for laboratories currently managing COVID-19 testing, Randox SARS-CoV-2 controls help ensure the accuracy and reliability of molecular assays used in the testing of suspected coronavirus samples, and importantly, give clinicians absolute confidence in any COVID-19 diagnoses they may make.”

Available under the brand name Qnostics, the new SARS-CoV-2 controls are manufactured using whole pathogens. They therefore mimic the patient sample, providing the best sample matrix for laboratories.

Lynsey continued;

“The Randox Qnostics SARS-CoV-2 controls are clinically relevant for full-process validation. Liquid frozen for user convenience and ease of use, the development of the controls using whole pathogen material ensures clinical relevance from extraction to amplification and detection.”

The new coronavirus controls from Randox, which contain the entire SARS-CoV-2 genome, including the conserved regions recommended by CDC and WHO, are compatible for use with both commercial and in-house testing methods, and are quantified by digital PCR to ensure batch to batch reproducibility.

Lynsey added;

“We are proud to be able to support the high demand for coronavirus testing by delivering a full COVID-19 testing package – not only our COVID-19 tests on the Randox Biochip, but now also the corresponding molecular control material that will ensure the delivery of accurate, and reliable results.

 “The World Health Organization (WHO) has been very clear about the importance of testing in the global efforts to contain and delay COVID-19 and we are pleased that our new controls comply with guidelines not only from the WHO but also from the Centres for Disease Control and Prevention.”

Randox Qnostics SARS-CoV-2 Controls are heat-inactivated to be non-infectious and are manufactured to ISO 13485 standards.

Key Features and Benefits of Randox SARS-CoV-2 Qnostics Controls:

  • Whole pathogen controls – the controls contain the entire SARS-CoV-2 genome meaning they are compatible with the majority of commercial and in-house assays, and target the CDC and WHO consensus sequences
  • Monitor the entire testing process – whole pathogen controls are the ideal clinically relevant material for full-process validation, from extraction to amplification and detection, to ensure ultimate quality assurance in laboratories.
  • Non-infectious – the controls are heat-inactivated and gamma-irradiation enabling safe handling of material.
  • Highly characterised – the controls are quantified by digital PCR to ensure batch to batch reproducibility.
  • Clinically relevant – performance data is available to support the clinical relevance and the compatibility with molecular assays currently in use in clinical laboratories.
  • High Quality – the controls are manufactured under ISO 13485 guidelines and are therefore suitable for a broad range of usage.
  • Liquid for Ease-of-Use – the controls are conveniently supplied in a liquid frozen format meaning there is no additional preparation or handling required.
  • Negative controls available – delivering a complete testing package.

For more information visit www.randox.com/coronavirus-randox

QNOSTICS

QCMD

CORONAVIRUS


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