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

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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


Transplant Associated Diseases | Qnostics Molecular Controls

Randox Quality Contol Logo

Transplant Associated Diseases | Qnostics Molecular Controls

Advances in transplant medicine have greatly improved the prospects of transplant recipients. However, pathogen infection and in particular, viral reactivation remain significant contributors to transplant patient morbidity and mortality.

Qnostics’ Q Control and Analytical Q Panel ranges cover a number of viruses and fungal pathogens of particular concern, including: HSV, CMV, EBV, ADV, JCV and BKV, with Molecular Q Panels covering HSV, HHV6, CMV, EBV, ADV, JCV and BKV.

  • Q Controls
  • Analytical Q Panels
  • Molecular Q Panels
Transplant Associated Diseases

Adenovirus (ADV) Control

Pathogen – Adenovirus (ADV)
Genotype – Type 1
Matrix – Viral Transport Medium
Stability – Single use control designed to be used immediately minimising the risk of contamination
Shelf Life – Up to 2 years after date of manufacture
Regulatory Status – CE, IVD & RUO

__________

ADV Medium Q Control
Product code:
ADVMQC  |  Pack size: 5×1 ml

Enquire
Transplant Associated Diseases

BK Virus (BKV) Control

Pathogen – BK Virus (BKV)
Genotype – Type 1b-2
Matrix – Plasma
Stability – Single use control designed to be used immediately minimising the risk of contamination
Shelf life – Up to 2 years after date of manufacture
Regulatory Status – CE, IVD & RUO

__________

BKV Medium Q Control
Product code: BKVMQC  |  Pack size: 5×1 ml

BKV Low Q Control
Product code: BKVLQC  |  Pack size: 5×1 ml

BKV High Q Control
Product code: BKVHQC  |  Pack size: 5×1 ml

Enquire
Transplant Associated Diseases

Cytomegalovirus (CMV) Control

Pathogen – Cytomegalovirus (CMV)
Genotype – AD169
Matrix – Plasma
Stability – Single use control designed to be used immediately minimising the risk of contamination
Shelf Life – Up to 2 years after date of manufacture
Regulatory Status – CE, IVD & RUO

__________

CMV Medium Q Control
Product code:
CMVMQC | Pack size: 5×1 ml

Enquire
Transplant Associated Diseases

Epstein-Barr Virus (EBV) Control

Pathogen – Epstein-Barr Virus (EBV)
Genotype – B-95
Matrix – Plasma
Stability – Single use control designed to be used immediately minimising the risk of contamination
Shelf Life – Up to 2 years after date of manufacture
Regulatory Status – CE, IVD & RUO

__________

EBV Medium Q Control
Product code:
EBVMQC  |  Pack size: 5×1 ml

EBV Low Q Control
Product code:
EBVLQC  |  Pack size: 5×1 ml

EBV Low Q Control
Product code:
EBVLQC  |  Pack size: 5×1 ml

Enquire
Transplant Associated Diseases

Herpes Simplex Virus 1 (HSV1) Control

Pathogen – Herpes Simplex Virus 1 (HSV1)
Genotype – Type 95
Matrix – Viral Transport Medium
Stability – Single use control designed to be used immediately minimising the risk of contamination
Shelf Life – Up to 2 years after date of manufacture
Regulatory Status – CE, IVD & RUO

__________

HSV1 Medium Q Control CE
Product code:
HSV1MQC  |  Pack size: 5×1 ml

Enquire
Transplant Associated Diseases

Herpes Simplex Virus 2 (HSV2) Control

Pathogen – Herpes Simplex Virus 2 (HSV2)
Genotype – Type 09
Matrix – Viral Transport Medium
Stability – Single use control designed to be used immediately minimising the risk of contamination
Shelf Life – Up to 2 years after date of manufacture
Regulatory Status – CE, IVD & RUO

__________

HSV2 Medium Q Control
Product code:
HSV2MQC | Pack size: 5×1 ml

Enquire
Transplant Associated Diseases

JC Virus (JCV) Control

Pathogen – JC Virus (JCV)
Genotype – Type 1A
Matrix – Plasma
Stability – Single use control designed to be used immediately minimising the risk of contamination
Shelf Life – Up to 2 years after date of  manufacture
Regulatory Status – CE, IVD & RUO

__________

JCV Medium Q Control
Product code:
JCVMQC | Pack size: 5×1 ml

Enquire
Transplant Associated Diseases

Pneumocystis jirovecii pneumonia (PCP) Control

Pathogen – Pneumocystis jirovecii pneumonia (PCP)
Matrix – Saline
Stability – Single use control designed to be used immediately minimising risk of contamination
Shelf Life – Up to 2 years after date of  manufacture
Regulatory Status – RUO

__________

PCP Medium Q Control
Product code:
PCPMQC | Pack size: 5×0.25 ml

Enquire
Transplant Associated Diseases

Varicella Zoster Virus (VZV) Control

Pathogen – Varicella Zoster Virus (VZV)
Genotype – Type 9/84
Matrix – Viral Transport Medium
Stability – Single use control designed to be used immediately minimising the risk of contamination
Shelf Life – Up to 2 years after date of  manufacture
Regulatory Status – CE, IVD & RUO

__________

VZV Medium Q Control
Product code:
VZVMQC | Pack size: 5×1 ml

Enquire
Transplant Associated Diseases

Adenovirus (ADV) Analytical Q Panel

Pathogen – Adenovirus (ADV)
Genotype – Type 1
Matrix – Viral Transport Medium
Number of Levels – 8
Stability – Single use Q-Panel designed to be used immediately minimising the risk of contamination
Shelf Life – Up to 2 years after date of manufacture
Regulatory Status – IVD & RUO

__________

ADV Analytical Q Panel
Product code:
ADVAQP  |  Pack size: 8×1 ml

Enquire
Transplant Associated Diseases

BK Virus (BKV) Analytical Q Panel

Pathogen – BK Virus (BKV)
Genotype – Type 1b-2
Matrix – Plasma
Number of Levels – 10
Stability – Single use Q-Panel designed to be used immediately minimising the risk of contamination
Shelf life – Up to 2 years after date of manufacture
Regulatory Status – IVD & RUO

__________

BKV Analytical Q Panel
Product code: BKVAQP  |  Pack size: 10×1 ml

Enquire
Transplant Associated Diseases

Cytomegalovirus (CMV) Analytical Q Panel

Pathogen – Cytomegalovirus (CMV)
Genotype – AD169
Matrix – Plasma
Number of Levels – 9
Stability – Single use Q-Panel designed to be used immediately minimising the risk of contamination
Shelf Life – Up to 2 years after date of manufacture
Regulatory Status – IVD & RUO

__________

CMV Analytical Q Panel
Product code:
CMVAQP | Pack size: 9×1 ml

Enquire
Transplant Associated Diseases

Epstein-Barr Virus (EBV) Analytical Q Panel

Pathogen – Epstein-Barr Virus (EBV)
Genotype – B-95
Matrix – Plasma
Number of Levels – 10
Stability – Single use Q-Panel designed to be used immediately minimising risk of contamination
Shelf Life – Up to 2 years after date of manufacture
Regulatory Status – IVD & RUO

__________

EBV Analytical Q Panel
Product code:
EBVAQP  |  Pack size: 10×1 ml

Enquire
Transplant Associated Diseases

Herpes Simplex Virus 1 (HSV1) Analytical Q Panel

Pathogen – Herpes Simplex Virus 1 (HSV1)
Genotype – Type 95
Matrix – Viral Transport Medium
Number of Levels – 8
Stability – Single use Q-Panel deigned to be used immediately minimising the risk on contamination
Shelf Life – Up to 2 years after date of manufacture
Regulatory Status – IVD & RUO

__________

HSV1 Analytical Q Panel
Product code:
HSV1AQP | Pack size: 8×1 ml

Enquire
Transplant Associated Diseases

Herpes Simplex Virus 2 (HSV2) Analytical Q Panel

Pathogen – Herpes Simplex Virus 2 (HSV2)
Genotype – Type 09
Matrix – Viral Transport Medium
Number of Levels – 10
Stability – Single use Q-Panel designed to be used immediately minimising the risk of contamination
Shelf Life – Up to 2 years after date of manufacture
Regulatory Status – IVD & RUO

__________

HSV2 Analytical Q Panel
Product code:
HSV2AQ | Pack size: 10×1 ml

Enquire
Transplant Associated Diseases

JC Virus (JCV) Analytical Q Panel

Pathogen – JC Virus (JCV)
Genotype – Type 1A
Matrix – Plasma
Number of Levels – 10
Stability – Single use Q Panel designed to be used immediately minimising risk of contamination
Shelf Life – Up to 2 years after date of  manufacture
Regulatory Status – IVD & RUO

__________

JCV Analytical Q Panel
Product code:
JCVAQP | Pack size: 10×1 ml

Enquire
Transplant Associated Diseases

Varicella Zoster Virus (VZV) Analytical Q Panel

Pathogen – Varicella Zoster Virus (VZV)
Genotype – Type 9/84
Matrix – Viral Transport Medium
Number of Levels – 10
Stability – Single use Q Panel designed to be used immediately minimising the risk of contamination
Shelf Life – Up to 2 years after date of  manufacture
Regulatory Status – IVD & RUO

__________

VZV Analytical Q Panel
Product code:
VZVAQP | Pack size: 10×1 ml

Enquire
Transplant Associated Diseases

Adenovirus (ADV) Molecular Q Panel

Pathogen – Adenovirus (ADV)
Genotype – Type 1
Matrix – Viral Transport Medium
Stability – Single use Q-Panel designed to be used immediately minimising risk of contamination
Shelf Life – Up to 2 years after date of manufacture
Regulatory Status – CE, IVD & RUO

__________

ADV Molecular Q Panel
Product code:
ADVMQP | Pack size: 4×1 ml

Enquire
Transplant Associated Diseases

BK Virus (BKV) Molecular Q Panel

Pathogen – BK Virus (BKV)
Genotype – Type 1b-2
Matrix – Plasma
Stability – Single use Q-Panel designed to be used immediately minimising the risk of contamination
Shelf Life – Up to 2 years after date of manufacture
Regulatory Status – CE, IVD & RUO

__________

BKV Molecular Q Panel
Product code:
BKVMQP  |  Pack size: 4×1 ml

Enquire
Transplant Associated Diseases

Cytomegalovirus (CMV) Molecular Q Panel

Pathogen – Cytomegalovirus (CMV)
Genotype – AD169
Matrix – Plasma
Stability – Single use Q-Panel designed to be used immediately minimising risk of contamination
Shelf Life – Up to 2 years after date of manufacture
Regulatory Status – CE, IVD & RUO

__________

CMV Molecular Q Panel
Product code:
CMVMQP | Pack size: 4×1 ml

Enquire
Transplant Associated Diseases

Epstein-Barr Virus (EBV) Molecular Q Panel

Pathogen – Epstein-Barr Virus (EBV)
Genotype – B-95
Matrix – Plasma
Stability – Single use Q-Panel designed to be used immediately minimising risk of contamination
Shelf Life – Up to 2 years after date of manufacture
Regulatory Status – CE, IVD & RUO

__________

EBV Molecular Q Panel
Product code:
EBVMQP | Pack size: 4×1 ml

Enquire
Transplant Associated Diseases

Human Herpes Virus 6 (HHV6) Molecular Q Panel

Pathogen – Human Herpes Virus 6 (HHV6)
Genotype – Type A-GS
Matrix – Plasma
Stability – Single use Q-Panel designed to be used immediately minimising risk of contamination
Shelf Life – Up to 2 years after date of manufacture
Regulatory Status – IVD & RUO

__________

HHV6 Molecular Q Panel RUO
Product code:
HHV6MQP | Pack size: 4×1 ml

Enquire
Transplant Associated Diseases

Herpes Simplex Virus 1 (HSV1) Molecular Q Panel

Pathogen – Herpes Simplex Virus 1 (HSV1)
Genotype – Type 95
Matrix – Viral Transport Medium
Stability – Single use Q-Panel designed to be used immediately minimising risk of contamination
Shelf Life – Up to 2 years after date of manufacture
Regulatory Status – CE, IVD & RUO

__________

HSV1 Molecular Q Panel
Product code:
HSV1MQP  |  Pack size: 4×1 ml

Enquire
Transplant Associated Diseases

Herpes Simplex Virus 2 (HSV2) Molecular Q Panel

Pathogen – Herpes Simplex Virus 2 (HSV2)
Genotype – Type 09
Matrix – Viral Transport Medium
Stability – Single use Q-Panel designed to be used immediately minimising the risk of contamination
Shelf Life – Up to 2 years after date of manufacture
Regulatory Status – CE, IVD & RUO

__________

HSV2 Molecular Q Panel
Product code:
HSV2MQP  |  Pack size: 4×1 ml

Enquire
Transplant Associated Diseases

JC Virus (JCV) Molecular Q Panel

Pathogen – JC Virus (JCV)
Genotype – Type 1A
Matrix – Plasma
Stability – Single use Q-Panel designed to be used immediately minimising risk of contamination
Shelf Life – Up to 2 years after date of manufacture
Regulatory Status – CE, IVD & RUO

__________

JCV Molecular Q Panel
Product code:
JCVMQP  |  Pack size: 4×1 ml

Enquire
Transplant Associated Diseases

Varicella Zoster Virus (VZV) Molecular Q Panel

Pathogen – Varicella Zoster Virus (VZV)
Genotype – Type 9/84
Matrix – Viral Transport Medium
Stability – Single use Q-Panel designed to be used immediately minimising risk of contamination
Shelf Life – Up to 2 years after date of manufacture
Regulatory Status – CE, IVD & RUO

__________

VZV Molecular Q Panel
Product code:
VZVMQP  |  Pack size: 4×1 ml

Enquire

Want to know more?

Contact us or visit our Qnostics page to learn more.




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Molecular QC and EQA for Infectious Disease Testing

Molecular EQA / QC for Infectious Disease Testing

Earlier this year, Randox entered into a strategic partnership, bringing on-board Qnostics Molecular Controls and QCMD Molecular EQA which comprises hundreds of controls and EQA programmes for molecular infectious disease testing.

Background

The Global Molecular Diagnostics market is estimated to be worth 6.54 billion USD. This market is classified into infectious diseases, oncology, genetic tests and blood screening. Infectious diseases account for the largest share of the global market.

According to the World Health Organisation (WHO), Infectious Diseases are caused by pathogenic microorganisms, such as bacteria, viruses, parasites or fungi. These diseases can be spread – directly or indirectly – from one person to another.

Qnostics - Molecular Controls

Designed to meet the demands of today’s molecular diagnostics laboratory and laboratories carrying out Nucleic Acid Testing (NAT), the Qnostics range comprises hundreds of characterised viral, bacterial and fungal targets covering a wide range of Transplant Associated Diseased, Respiratory Diseases, Blood Borne Viruses, Sexually Transmitted Infections, Gastro-Intestinal Diseases and Central Nervous System Diseases.

Qnostics products can be used in the daily monitoring of assay performance, linearity assessment, assay evaluation, validation/verification of new assays and staff training.

There are five main product areas for Qnostics:

  • Product Groups (click to expand)

    Q Controls
    Independently manufactured, this range of positive run, whole pathogen, third party controls are designed to monitor the daily performance of a wide of range molecular assays used in the detection of infectious diseases. These controls help in supporting a laboratory’s accreditation requirements, in line with ISO 15189:2012.

    Analytical Q Panels
    Designed to cover the dynamic range of an assay, Analytical Q Panels allow assessment of an assays linearity, LOD and LOQ. Each panel contains a minimum of five samples, including a negative that spans the dynamic range of the assay in a linear progression.

    Molecular Q Panels
    Consisting of three levels (high, medium and low), Molecular Q Panels are intended to evaluate an assays analytical measuring range.  Molecular Q Panels can also be used to support training of laboratory staff and in the development of molecular diagnostic assays.

    Evaluation Panels
    Evaluation Panels cover a range of genotypes and may be used to evaluate assay characteristics, confirm performance claims and ultimately ensure the assay is fit for purpose. Evaluation Panels may also be used in the validation of molecular assays and development of new molecular diagnostic assays.

    QCMD Past Panels
    Available for use in assay evaluation and staff training, EQA samples are available from past QCMD challenges.

    Custom Manufacture

    Qnostics are specialists in the custom manufacture of quality control materials for use in the detection of infectious diseases using molecular based methods. Qnostics will work with you to develop a bespoke solution designed specifically to meet the individual and unique requirements of your lab.

    • Choose from hundreds of molecular characterised targets
    • Targets can be custom made into numerous different formats
    • The whole pathogen format accurately mimics clinical samples
    • All materials can be provided in a “ready-to-use” or liquid frozen format

    Qnostics custom made Molecular Infectious Disease Controls are designed to fit all stages of your assays product life cycle from product development to launch.

QCMD – Molecular External Quality Control

QCMD is a world leading External Quality Assessment (EQA) / Proficiency Testing (PT) scheme, dedicated to improving the quality of molecular diagnostic assays used in the detection of infectious diseases.

With an extensive database of over 2000 participants in over 100 countries, QCMD is one of the largest providers of molecular EQA in the field of infectious disease testing.

EQA participants receive an individual report outlining their performance relative to their method and technology groups. A supplementary report may be commissioned – this includes any additional relevant information regarding the annual EQA distribution, as well as scientific expert commentary and feedback on the overall results within that distribution.

  • Features & Benefits (click to expand)

    Frequency

    A variety of programme options are available. Choose the number of challenges that best suit your laboratory’s requirements.

    Online EQA Management System

    ITEMS provides an online tool to easily manage all EQA activities from programme registration to submission of results and provision of EQA reports. Different levels of user access are available so data can be accessed by whoever needs it.

    High level of participation

    Over 2000 participants in more than 100 countries ensuring peer group numbers are maximised.

    Comprehensive reports

    Receive individual reports for each challenge and a final supplementary report at the end of the cycle visual assessment of performance.

    International accreditation

    Programmes are accredited to ISO 17043.

Continue Reading

Qnostics

Contact Us


Product Spotlight: Molecular QC and EQA for Infectious Disease Testing

Molecular QC and EQA for Infectious Disease Testing

Earlier in the year, Randox entered into a strategic partnership, bringing on-board Qnostics Molecular Controls and QCMD Molecular EQA which comprises hundreds of controls and EQA programmes for molecular infectious disease testing.

Background

The Global Molecular Diagnostics market is estimated to be worth 6.54 billion USD. This market is classified into infectious diseases, oncology, genetic tests and blood screening. Infectious diseases account for the largest share of the global market.

According to the World Health Organisation (WHO), Infectious Diseases are caused by pathogenic microorganisms, such as bacteria, viruses, parasites or fungi. These diseases can be spread – directly or indirectly – from one person to another.

Qnostics - Molecular Controls

Designed to meet the demands of today’s molecular diagnostics laboratory and laboratories carrying out Nucleic Acid Testing (NAT), the Qnostics range comprises hundreds of characterised viral, bacterial and fungal targets covering a wide range of Transplant Associated Diseased, Respiratory Diseases, Blood Borne Viruses, Sexually Transmitted Infections, Gastro-Intestinal Diseases and Central Nervous System Diseases.

Qnostics products can be used in the daily monitoring of assay performance, linearity assessment, assay evaluation, validation/verification of new assays and staff training.

There are five main product areas for Qnostics:

  • Product Groups (click to expand)

    Q Controls
    Independently manufactured, this range of positive run, whole pathogen, third party controls are designed to monitor the daily performance of a wide of range molecular assays used in the detection of infectious diseases. These controls help in supporting a laboratory’s accreditation requirements, in line with ISO 15189:2012.

    Analytical Q Panels
    Designed to cover the dynamic range of an assay, Analytical Q Panels allow assessment of an assays linearity, LOD and LOQ. Each panel contains a minimum of five samples, including a negative that spans the dynamic range of the assay in a linear progression.

    Molecular Q Panels
    Consisting of three levels (high, medium and low), Molecular Q Panels are intended to evaluate an assays analytical measuring range.  Molecular Q Panels can also be used to support training of laboratory staff and in the development of molecular diagnostic assays.

    Evaluation Panels
    Evaluation Panels cover a range of genotypes and may be used to evaluate assay characteristics, confirm performance claims and ultimately ensure the assay is fit for purpose. Evaluation Panels may also be used in the validation of molecular assays and development of new molecular diagnostic assays.

    QCMD Past Panels
    Available for use in assay evaluation and staff training, EQA samples are available from past QCMD challenges.

    Custom Manufacture

    Qnostics are specialists in the custom manufacture of quality control materials for use in the detection of infectious diseases using molecular based methods. Qnostics will work with you to develop a bespoke solution designed specifically to meet the individual and unique requirements of your lab.

    • Choose from hundreds of molecular characterised targets
    • Targets can be custom made into numerous different formats
    • The whole pathogen format accurately mimics clinical samples
    • All materials can be provided in a “ready-to-use” or liquid frozen format

    Qnostics custom made Molecular Infectious Disease Controls are designed to fit all stages of your assays product life cycle from product development to launch.

QCMD – Molecular External Quality Control

QCMD is a world leading External Quality Assessment (EQA) / Proficiency Testing (PT) scheme, dedicated to improving the quality of molecular diagnostic assays used in the detection of infectious diseases.

With an extensive database of over 2000 participants in over 100 countries, QCMD is one of the largest providers of molecular EQA in the field of infectious disease testing.

EQA participants receive an individual report outlining their performance relative to their method and technology groups. A supplementary report may be commissioned – this includes any additional relevant information regarding the annual EQA distribution, as well as scientific expert commentary and feedback on the overall results within that distribution.

  • Features & Benefits (click to expand)

    Frequency

    A variety of programme options are available. Choose the number of challenges that best suit your laboratory’s requirements.

    Online EQA Management System

    ITEMS provides an online tool to easily manage all EQA activities from programme registration to submission of results and provision of EQA reports. Different levels of user access are available so data can be accessed by whoever needs it.

    High level of participation

    Over 2000 participants in more than 100 countries ensuring peer group numbers are maximised.

    Comprehensive reports

    Receive individual reports for each challenge and a final supplementary report at the end of the cycle visual assessment of performance.

    International accreditation

    Programmes are accredited to ISO 17043.

Continue Reading

Qnostics

Contact Us

Product Spotlight Home

Visit the Product spotlight Home to see past product spotlights


Randox Laboratories and Qnostics announce strategic partnership

Randox Laboratories and Qnostics have today announced that they have entered into a strategic partnership.  The partnership will provide Randox Laboratories with access to the Qnostics molecular range of products for sales and distribution purposes, complementing the established Randox Laboratories portfolio.

Access to the Randox Laboratories commercial capabilities will enhance Qnostics’ market penetration, whilst also maintaining their presence as an independent provider of molecular quality controls and custom services.

MD of Randox Laboratories, Dr Peter FitzGerald said;

“We are delighted to have agreed a strategic partnership with Qnostics, an arrangement we see as mutually beneficial.  We look forward to working together to strengthen the molecular service we provide to our global markets whilst enhancing the Qnostic brand and market penetration.”

Dr Frank Opdam, Head of Commercial of Qnostics said;

“We believe this is an ideal partnership. We look forward to working with Randox Laboratories and the growth that will result from the global access this partnership will provide to Qnostics for its expanding range of molecular quality control products.”

For further information please contact the Randox PR Team: phone 028 9442 2413 or email randoxpr@randox.com 


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