World Hepatitis Day 2023
World Hepatitis Day 2023
Introduction
World Hepatitis Day, observed on July 28th, serves as a crucial reminder of the ongoing battle against hepatitis (HBV), a viral infection that affects millions of people worldwide. In 2019, it was estimated that 296 million people were living with chronic hepatitis B, resulting in over 800,000 fatalities1. In this article, we will delve into the intricate mechanisms behind hepatitis, explore the viral species responsible for its occurrence, discuss methods for diagnosis, and shed light on treatment and management strategies.
Understanding Hepatitis
Hepatitis refers to the inflammation of the liver, often caused by viral infections. Among the primary hepatitis viruses are Hepatitis A, B, C, D, and E, each with distinct modes of transmission and characteristics2.
Mechanisms of Hepatitis Infection
Hepatitis A and E: Hepatitis A and E viruses are primarily transmitted via the faecal-oral route, often through contaminated food or water. Ingestion of these viruses leads to acute infection, and while self-limiting in most cases, they can cause significant morbidity and mortality in certain populations5,6.
Hepatitis B, C, and D: Hepatitis B, C, and D viruses are predominantly spread through blood and bodily fluids. Hepatitis B can also be transmitted from mother to child during childbirth which in endemic areas, HBV infection from mother to child transmission accounted for approximately half of chronic infections. These viruses can cause chronic infections, leading to long-term liver damage, cirrhosis, and an increased risk of hepatocellular carcinoma7,8.
Diagnosis of Hepatitis
Accurate and timely diagnosis of hepatitis is crucial for appropriate management. Diagnostic methods include:
Serology: Serological tests, such as enzyme immunoassays, are employed to detect specific viral antigens or antibodies in blood samples, aiding in the identification of different hepatitis viruses and determining the stage of infection9.
Nucleic Acid Testing: Highly sensitive molecular techniques like polymerase chain reaction (PCR) enable the detection and quantification of viral genetic material, aiding in the diagnosis and monitoring of chronic hepatitis10.
Treatment and Management of Hepatitis
The management of hepatitis depends on several factors, including the virus involved, the stage of infection, the presence of co-infections, and the individual patient’s health status. Treatment strategies encompass:
Antiviral Medications: For hepatitis B and C, antiviral drugs such as interferons and direct-acting antivirals have revolutionized the treatment landscape, offering higher cure rates and improved outcomes11,12.
Supportive Care: Hepatitis patients may require supportive care to alleviate symptoms, maintain proper nutrition, and manage complications. Vaccination against hepatitis A and B is highly recommended for prevention13.
Liver Transplantation: In cases of end-stage liver disease or hepatocellular carcinoma resulting from chronic hepatitis, liver transplantation may be considered a lifesaving option14.
Randox Hepatitis Solutions
Acusera
Acusera provides a range of positive and negative serology controls comprising various infectious diseases including Hepatitis. The table below details the suitable controls, and more information can be found on our website: Serology Quality Controls – Randox Laboratories
RIQAS
The RIQAS HIV/Hepatitis EQA programme is designed to monitor the performance of tests used to detect HIV/Hepatitis antibodies and specific antigens. All samples are conveniently supplied liquid ready-to-use and are suitable for qualitative methods of analysis.
Parameters:
- Anti-HIV-1
- Anti-HCV
- Anti-HTLV-II
- HBsAg
- Anti-HIV-2
- Anti-HBc
- Anti-HTLV-1&2 (combined)
- Anti-HIV-1&2 (combined)
- Anti-HTLV-I
- Anti-CMV
- Anti-HAV IgM
- Anti-HAV (Total)
- Anti-HBc (Total)
- Anti-HBe (Total)
- Anti-HBs (Total)
- P24
For more information, please visit our website at: HIV Hepatitis EQA | RIQAS (randox.com)
Qnostics
Monitoring for the presence of Blood Borne Virus (BBV) nucleic acid is an essential parameter in guiding clinical treatment and patient outcomes. The use of appropriate quality control measures is important in ensuring the appropriate daily performance of the molecular assay used in the laboratory independent of the technology.
Qnostics’ Blood Borne Virus Molecular Controls comprises a range of pathogens which are classically detected directly from the blood including those related to hepatitis. The table below lists the Qnostics products related to hepatitis testing. For more information visit our website: Qnostics | Molecular Infectious Disease Controls – Randox Laboratories
QCMD
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 molecular diagnostics. QCMD programmes related to hepatitis testing are listed below:
- HBV Drug resistance Typing EQA programme.
- HCV Drug resistance Typing EQA programme.
- Hepatitis B Virus DNA EQA Programme
- Hepatitis B Virus Dried Blood Spot EQA Pilot Study
- Hepatitis B virus Genotype EQA Programme
- Hepatitis C Virus Dried Blood Spot EQA Pilot Study
- Hepatitis C Virus RNA EQA Programme
- Hepatitis C virus Genotype EQA Programme
- Hepatitis D Virus EQA Programme
- Hepatitis E virus RNA EQA Programme
For more information on any of these EQA programmes please visit: QCMD – Molecular EQA Scheme | Randox Quality Control
Conclusion
World Hepatitis Day serves as a reminder of the global impact of hepatitis and the urgent need to raise awareness, prevent transmission, and improve the diagnosis and management of this disease. By understanding the mechanisms, bacterial species involved, diagnostic techniques, and treatment approaches, we can work towards a future free from the burden of hepatitis. Let us unite in our efforts to combat this disease and strive for a healthier world.
If you’d like to find out more about hepatitis or the diagnosis and testing of hepatitis, please visit our website. If you’d like more information on how Randox can improve hepatitis testing in your laboratory, please reach out to marketing@randox.com.
References
- World Health Organization. World Health Statistics 2023. World Health Organization; 2023. https://www.who.int/publications/i/item/9789240074323
- World Health Organization. Hepatitis. https://www.who.int/news-room/fact-sheets/detail/hepatitis-a. Published 2017. Accessed June 9, 2023.
- Wan Z, Wang X. Bacterial Hepatitis. In: Encyclopedia of Medical Microbiology. Elsevier; 2020:110-117.
- Russo TA, McFadden DC. Bacterial and fungal infections in patients with cirrhosis. Clin Liver Dis. 2019;14(2):71-74.
- World Health Organization. Hepatitis E. https://www.who.int/news-room/fact-sheets/detail/hepatitis-e. Published 2018. Accessed June 9, 2023.
- Rakesh S, Pekamwar SS. Hepatitis A. In: StatPearls [Internet]. StatPearls Publishing; 2020.
- World Health Organization. Hepatitis B. https://www.who.int/news-room/fact-sheets/detail/hepatitis-b. Published 2021. Accessed June 9, 2023.
- World Health Organization. Hepatitis D. https://www.who.int/news-room/fact-sheets/detail/hepatitis-d. Published 2021. Accessed June 9, 2023.
- Alfaresi MS, Elkoush AA, Khan AS. Serological diagnosis of viral hepatitis. J Clin Transl Hepatol. 2017;5(4):343-359.
- European Association for the Study of the Liver. EASL Recommendations on Treatment of Hepatitis C. J Hepatol. 2017;66(1):153-194.
- European Association for the Study of the Liver. EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection. J Hepatol. 2017;67(2):370-398.
- Vermehren J, Sarrazin C. New HCV therapies on the horizon. Clin Microbiol Infect. 2011;17(2):122-134.
- World Health Organization. Hepatitis A. https://www.who.int/news-room/fact-sheets/detail/hepatitis-a. Published 2020. Accessed June 9, 2023.
- Kim WR, Terrault NA. Hepatocellular carcinoma and liver transplantation. Clin Liver Dis. 2018;22(2):381-394.
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
QNOSTICS
QCMD
CORONAVIRUS
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
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
Transplant Associated Diseases | Qnostics Molecular Controls
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.
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
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
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
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
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
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
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
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
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 – CE, ICD & RUO
__________
PCP Medium Q Control
Product code: PCPMQC | Pack size: 5×0.25 ml
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 – CE, IVD & RUO
__________
ADV Analytical Q Panel
Product code: ADVAQP | Pack size: 8×1 ml
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 – CE, IVD & RUO
__________
BKV Analytical Q Panel
Product code: BKVAQP | Pack size: 10×1 ml
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
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 – CE, IVD & RUO
EBV Analytical Q Panel
Product code: EBVAQP | Pack size: 10×1 ml
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
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 – CE, IVD & RUO
__________
HSV2 Analytical Q Panel
Product code: HSV2AQ | Pack size: 10×1 ml
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 – CE, IVD & RUO
__________
JCV Analytical Q Panel
Product code: JCVAQP | Pack size: 10×1 ml
Human Herpes Virus 6 (HHV6) Analytical Q Panel
Pathogen – Human Herpes Virus 6 (HHV6)
Genotype – Type A-GS
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
__________
Human Herpes Virus 6 (HHV6) Analytical Q Panel
Product code: HHV6AQP | Pack size: 10×1 ml
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 – CE, IVD & RUO
__________
VZV Analytical Q Panel
Product code: VZVAQP | Pack size: 10×1 ml
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
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
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
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
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
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
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
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
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
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Contact us or visit our Qnostics page to learn more.
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Molecular QC and EQA 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.
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.
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 ManufactureQnostics 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 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.
Qnostics
QCMD
Contact Us
Product Spotlight: 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.
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.
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 ManufactureQnostics 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 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.
Qnostics
QCMD
Contact Us
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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
