Whole pathogen multiplex controls to support testing for cold, cough and COVID
Whole pathogen multiplex controls to support testing for cold, cough and COVID
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 Manufacturing – Qnostics 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
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CORONAVIRUS
Troponin T Quality Control
Intended for use with the Roche system, this control is manufactured using only the highest quality material and offers an unrivalled 7-day thawed stability at +2ºC to +8ºC.
Features & Benefits
- Liquid frozen for enhanced stability
- Aqueous based material
- Ultra low levels of Troponin T
- Stable to expiry date at -18-24ºC storage
- Thawed stability of 7 days at 2°C – 8°C
| Description | Size | Analytes | Cat No | |
|---|---|---|---|---|
| Troponin T Control | 6 x 3 ml | 1 | CQ10450 | |
Analytes
- Ultra low Troponin T
Protected: Analysis of results from the QCMD Coronavirus Preparedness EQA Pilot Study
Linearity Verifier Sets
Challenge your Instrument Throughout the Reportable Range with Acusera Linearity Verifier Sets
- Complimentary data reduction software is provided delivering an immediate indication of performance.
- Samples are provided in a user-friendly format with both liquid and lyophilised options available.
- An extended open vial stability keeps waste to a minimum and ensures availability of product for troubleshooting.
- Supplied in a minimum of 5 levels to accurately challenge the AMR and remove the need for manual dilution.
- Ensure specific instrument requirements are met with the availability of dedicated solution for both Roche Cobas and Beckman systems.
- Multi-analyte calibration verifiers will reduce costs, storage space and the number of products required to cover your test menu.
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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CE marking granted to Quality Control for newborn infectious disease tests
08 June 2020
CE marking granted to Quality Control for newborn infectious disease tests
ToRCH Quality Controls to support the accuracy and reliability of infectious disease testing in newborns, have been granted CE marking.
The controls for ToRCH, which is a blood test screening to detect infectious diseases including toxoplasmosis, rubella, cytomegalovirus, and herpes simplex, are available from global diagnostics company Randox Laboratories, and are used to ensure accurate ToRCH test and system performance.
Manufactured from human plasma, each control is designed to react to the test system in the same manner as the patient sample, helping laboratories to meet ISO 15189:2012 for quality and competence.
Lynsey Adams, Randox Quality Control Manager, commented;
“The CE marking of the ToRCH controls from Randox will be a game-changer for clinicians and patients alike, by facilitating early, accurate and comprehensive diagnoses of infectious diseases in newborns, that allow for the best possible patient outcomes.
“Ultimately, these ToRCH controls will guarantee quality assurance in laboratories performing ToRCH screening in newborns.”
Randox ToRCH Controls are also multi-analyte and therefore, testing can be consolidated to just a small number of vials to save laboratories valuable space and time.
In addition to ToRCH, Randox Infectious Disease Quality Controls also include quality control material for Lyme Disease, Epstein-Barr virus, HIV, Hepatitis A virus, Human T-lymphotropic virus, Cytomegalovirus, and Varicella zoster virus (Chickenpox or Shingles).
Lynsey continued;
“Unlike analyser-specific tests, these controls can be used across a wide range of laboratory technologies, and complement our already existing RIQAS Serology EQA programmes to provide laboratories with a complete QC solution from a single supplier.
“With a working stability of 60 days at 2°c to 8°c which keeps waste and costs to a minimum, Randox Infectious Disease Controls are set to revolutionise serology testing and provide reliable, accurate results time and time again.”
Randox Infectious Disease Controls are ideal for microbiology and virology laboratories, blood banks, public health laboratories or clinical laboratories performing serology testing.
Key benefits of the Randox Infectious Disease Controls;
- User-friendly – all samples are provided in a liquid, ready-to-use format
- Commutable – manufactured from human plasma, each control reacts to the test system in the same manner as a patient sample
- Versatility – designed to deliver an independent, unbiased assessment of performance with any immunoassay instrument
- Stability – working stability of 60 days ensures waste and costs are kept to a minimum
- Multi-marker – helps reduce the number of individual controls required
- Clinical relevance – designed to challenge clinically-relevant levels, samples will ensure accurate and reliable instrument performance
For more information visit https://www.randox.com/torch-controls/
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Whole pathogen molecular controls for SARS-CoV-2 (COVID-19) receive CE marking
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
Qnostics SARS-CoV-2 Controls
Qnostics
Respiratory Target Multiplex (RTX) 1 Control
This multiplex control has been designed in response to the current Coronavirus pandemic. The control can be used to support the validation, verification and performance monitoring of molecular assays used in SARS-CoV-2 testing and other respiratory pathogens.
Meeting the requirements of various testing strategies, this 4-plex control covers multiple viral pathogens that cause respiratory diseases in various patient cohorts, in line with public health testing and the test menu of most syndromic assays.
Having a multiplex control, like the Qnostics RTX1, gives great flexibility to laboratories and allows them to meet laboratory requirements in terms of respiratory pathogens covered whilst keeping QC tests to a minimum.
Features & Benefits
- Whole Pathogen Control
Containing the entire SARS-CoV-2 genome, the RTX1 Control is compatible with the majority of commercial and in-house assays. As a whole pathogen control, it targets the whole viral genome.
- Full Process Control
Whole pathogen controls are ideal for full-process validation, monitoring the testing process from extraction to amplification and detection ensuring ultimate quality assurance in laboratories.
- Highly Characterised
Using highly characterised controls enable labs to meet their daily QC needs and accreditation requirements. Qnostic controls are quantified by digital PCR to ensure batch-to-batch reproducibility.
- True Third Party
An independent, unbiased assessment of assay performance is ensured in line with ISO 15189:2012 regulatory requirements.
- Liquid for Ease-of-Use
Conveniently supplied in liquid frozen format meaning there is no additional preparation or handling required.
Specification
Target Pathogen – Influenza A (H1N1), Influenza B (Victoria), Respiratory Syncytial Virus (A), Coronavirus (SARS-CoV-2)
Target – Whole Pathogen
Matrix – Transport Medium
Format – Liquid Frozen
Stability – Single use. Once thawed use immediately.
Regulatory Status – RUO
Ordering Information
| Catalogue Number | Product Description | Pack Size | Package Insert |
|---|---|---|---|
| RTX1QC | RTX1 Q Control | 5 x 0.6 ml | Kit Insert |
SARS-CoV-2 (COVID-19) Control
In response to the current Coronavirus outbreak, Qnostics, a world leading manufacturer of QC solutions for molecular infectious disease testing has developed a range of products designed to support the validation, verification and performance monitoring of molecular assays used in the testing of SARS-CoV-2 (COVID-19). Accurate and reliable laboratory testing is an essential aspect of COVID-19 disease management and outbreak control. The use of third-party controls will allow laboratories to effectively monitor the performance of diagnostic methods. For more information on Qnostics click here
Features & Benefits
- Whole Pathogen Control
Qnostics controls contain the entire SARS-CoV-2 genome meaning they are compatible with the majority of commercial and in-house assays.
- Full Process Control
Whole pathogen controls are ideal for full-process validation, monitoring the testing process from extraction to amplification and detection ensuring ultimate quality assurance in laboratories.
- Negative Control Available
Negative controls contain human cells/nucleic acids and therefore can be used as part of assay validation.
- True Third Party
An independent, unbiased assessment of assay performance is ensured in line with ISO 15189:2012 regulatory requirements.
- Complete QC Solution
Products available for new assay validation as well as routine performance monitoring.
Specification
Target Pathogen – SARS-CoV-2 (COVID-19)
Target – Whole Pathogen
Matrix – Transport Medium
Format – Liquid Frozen
Stability – Single use. Once thawed use immediately.
Regulatory Status – CE, RUO
Q Controls
Whole pathogen controls designed to monitor assay performance on a run to run basis. As true third party controls, assay drift is detected, monitored and managed helping to ensure accurate and reliable results.
Ordering Information
| Catalogue Number | Product Description | Pack Size |
|---|---|---|
| SCV2QC | SARS-CoV-2 Q Control | 5 x 0.5 ml |
| TMNQC | Negative Q Control | 5 x 0.5 ml |
Specification
Target Pathogen – SARS-CoV-2 (COVID-19)
Target – Whole Pathogen
Matrix – Transport Medium
Format – Liquid Frozen
Stability – Single use. Once thawed use immediately.
Regulatory Status – CE, RUO
Analytical Q Panels
Designed to span the analytical measuring range of an assay, allowing assessment of linearity, Limit of Detection (LOD) and Limit of Quantitation (LOQ).
Ordering Information
| Catalogue Number | Product Description | Pack Size |
|---|---|---|
| SCV2AQP | SARS-CoV-2 Analytical Q Panel | 9 x 0.5 ml |
Specification
Target Pathogen – SARS-CoV-2 (COVID-19)
Target – Whole Pathogen
Matrix – Transport Medium
Format – Liquid Frozen
Stability – Single use. Once thawed use immediately.
Regulatory Status – CE, RUO
Molecular Q Panels
Four individual levels including a negative are provided spanning the assays’ clinical range. Molecular Q Panels may be used to support laboratory training and in the performance assessment and validation of molecular diagnostic assays.
Ordering Information
| Catalogue Number | Product Description | Pack Size |
|---|---|---|
| SCV2MQP | SARS-CoV-2 Molecular Q Panel | 4 x 0.5 ml |
Specification
Target Pathogen – Novel Coronavirus SARS-CoV-2, SARS-CoV-2 (Delta, Alpha, Beta, Gamma, Eta, Alpha N variant, Omicron)
Matrix – Transport Medium (TM)
Format – Liquid Frozen
Stability – Single use. Once thawed use immediately
Regulatory Status – Research Use Only (RUO)
Evaluation Panel
Intended for research use only, this evaluation panel is designed to help laboratories develop their molecular procedures.
Suitable for use with most commercial and in-house molecular methods, this panel is characterised using real-time PCR and NGS. The panel contains variants of whole pathogen inactivated SARS-CoV-2 and is supplied in a liquid-frozen format.
Ordering Information
| Catalogue Number | Product Description | Pack Size |
|---|---|---|
| SCV2TEP | SARS-CoV-2 Typing Evaluation Panel | 8 x 1.0 ml |
Related Products
Randox unveils whole pathogen molecular controls for SARS-CoV-2 (COVID-19)
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
Bilirubin Linearity Verifier
Our Bilirubin verifier contains both Direct Bilirubin and Total Bilirubin so testing is fully covered. Dedicated for use on Roche
Cobas systems, this verifier spans five levels ensuring the instruments entire reportable range is measured.
Features & Benefits
- Lyophilised for enhanced stability
- 5 levels provided
- Open vial stability of 10 days at 2ºC to 8ºC
- Shelf life of up to 2 years from date of manufacture
| Description | Size | Analytes | Cat No | |
|---|---|---|---|---|
| Acusera Enzyme Linearity Verifier | 5 x 3mL | 10 | LV10366 | |
Analytes
- Direct Bilirubin
- Total Bilirubin
Enzyme Linearity Verifier
Our Enzyme Linearity Verifier contains 10 commonly tested enzymes in one unique multi-marker verifier allowing you to
consolidate testing. Spanning 5 clinical levels, this verifier ensures the systems entire reportable range is measured. Designed
specifically for use with Roche Cobas systems, our Verifier is available in a convenient liquid frozen format.
Features & Benefits
- Convenient, liquid frozen format
- 5 levels provided
- 14 day stability when stored at 2ºC to 8ºC
- Shelf life of up to 2 years from date of manufacture
| Description | Size | Analytes | Cat No | |
|---|---|---|---|---|
| Acusera Enzyme Linearity Verifier | 5 x 3mL | 10 | LV10366 | |
Analytes
- ALT
- ALP
- a-Amylase
- Pancreatic Anylase
- AST
- CK
- CKMB
- yGT
- LDH
- Lipase
