World Hepatitis Day 2023

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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

  1.  World Health Organization. World Health Statistics 2023. World Health Organization; 2023. https://www.who.int/publications/i/item/9789240074323
  2. World Health Organization. Hepatitis. https://www.who.int/news-room/fact-sheets/detail/hepatitis-a. Published 2017. Accessed June 9, 2023.
  3. Wan Z, Wang X. Bacterial Hepatitis. In: Encyclopedia of Medical Microbiology. Elsevier; 2020:110-117.
  4. Russo TA, McFadden DC. Bacterial and fungal infections in patients with cirrhosis. Clin Liver Dis. 2019;14(2):71-74.
  5. World Health Organization. Hepatitis E. https://www.who.int/news-room/fact-sheets/detail/hepatitis-e. Published 2018. Accessed June 9, 2023.
  6. Rakesh S, Pekamwar SS. Hepatitis A. In: StatPearls [Internet]. StatPearls Publishing; 2020.
  7. World Health Organization. Hepatitis B. https://www.who.int/news-room/fact-sheets/detail/hepatitis-b. Published 2021. Accessed June 9, 2023.
  8. World Health Organization. Hepatitis D. https://www.who.int/news-room/fact-sheets/detail/hepatitis-d. Published 2021. Accessed June 9, 2023.
  9. Alfaresi MS, Elkoush AA, Khan AS. Serological diagnosis of viral hepatitis. J Clin Transl Hepatol. 2017;5(4):343-359.
  10. European Association for the Study of the Liver. EASL Recommendations on Treatment of Hepatitis C. J Hepatol. 2017;66(1):153-194.
  11. 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.
  12. Vermehren J, Sarrazin C. New HCV therapies on the horizon. Clin Microbiol Infect. 2011;17(2):122-134.
  13. World Health Organization. Hepatitis A. https://www.who.int/news-room/fact-sheets/detail/hepatitis-a. Published 2020. Accessed June 9, 2023.
  14. Kim WR, Terrault NA. Hepatocellular carcinoma and liver transplantation. Clin Liver Dis. 2018;22(2):381-394.

SARS-CoV-2 (COVID-19) Antigen Testing Pilot Study from Randox Quality Control

News       Coronavirus       QCMD

 

SARS-CoV-2 (COVID-19) Antigen Testing Pilot Study

12 March 2020

SARS-CoV-2 (COVID-19) Antigen Testing Pilot Study

Randox, in partnership with QCMD, is pleased to announce a new QCMD EQA pilot study for SARS-CoV-2 (COVID-19) Antigen Testing. This new pilot is designed to evaluate a laboratory’s ability to detect SARS-CoV-2 (COVID-19) antigen and will provide an opportunity to assess performance against an international peer group.

QCMD is a world leading EQA / Proficiency Testing (PT) provider, 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 fi eld of infectious disease testing.

Features & Benefits

  • null

    Whole PathogenAvailability of whole pathogen samples containing the entire viral genome, ensures commutability with the majority of commercial assays.

  • null

    Smart-Phone App Results SubmissionResults can be returned via a smart-phone app so that participants using lateral flow devices can provide pictures of their device/result with the phone camera.

  • null

    Comprehensive ReportsA real-time rapid report will be provided on submission of results. An individual report is received after each challenge, summarising laboratory performance in comparison to an international peer group.

  • null

    EQA Management SystemIT 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.

  • null

    Not infectiousSamples containing SARS-CoV-2 antigens are inactivated and not infectious ensuring safe handling of material.

  • null

    Suitable for Point of CareSamples are supplied liquid ready-to-use ensuring they are ideal for use at the point care.

     

    For more information visit https://www.randox.com/qcmd-sars-antigen-testing/

    For further enquiries please email marketing@randox.com

    QCMD

    QNOSTICS

    CORONAVIRUS


    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

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