PERFORMANCE ASSESSMENT OF BLOOD SCREENING ASSAYS: EARLY DYNAMICS OF HEPATITIS B VIRUS (HBV)-DNA AND SURFACE ANTIGEN (HBSAG) IN RAMP-UP PHASE OF VIREMIA

Performance Assessment of Blood Screening Assays: Early Dynamics of Hepatitis B Virus (HBV)-DNA and Surface Antigen (HBsAg) in Ramp-Up Phase of Viremia

In a previous article, we discussed Hepatitis C, a serious liver disease caused by the hepatitis C virus (HCV), and the dangers of HCV and HIV co-infection. Today’s topic is Hepatitis B, which is a liver infection caused by the hepatitis B virus (HBV). Hepatitis B is a viral infection that affects the liver and can cause both acute and chronic disease. Acute Hepatitis B can last for as little as six months. In its chronic form, the virus remains in the person’s body for a longer period of time and goes untreated; it can endanger people’s lives by causing cirrhosis, fibrosis, hepatocellular carcinoma, and end-stage liver disease.

Hepatitis B has no known cure. In some cases, the infection will resolve on its own (in 4 to 8 weeks for more than 9 out of 10 adults). Some adults who contract this virus as adults become “carriers,” (a chronic condition) and are likely to infect others for the rest of their lives unknowingly. CHB patients must be treated for the rest of their lives. Early HBV exposure frequently results in chronic HBV and the virus’s persistence due to the lack of cellular immune responses or strong antibodies.

HBV carriers may benefit from treatment that inhibits viral replication, boosts immune defences against the virus, or a combination of the two. The effectiveness of the treatments is entirely dependent on regular testing and monitoring of the various stages of the disease. One of the blood tests used to determine viral activity in an infected patient’s body is the HBV DNA (viral load test).

The natural progression of chronic HBV infection can be divided into five stages, the last of which is seroconversion of Hepatitis B Surface Antigen. Hepatitis B is not detected in your blood at this stage, or hepatitis B surface antigen (HBsAg) is negative or not detected in the blood.

Helvetica Health Care is a market leader in the provision of seroconversion panels and blood screening assays, which are critical in the monitoring and treatment of life-threatening diseases such as Hepatitis B, Hepatitis C, and HIV. We hope that the information provided below will help you learn more about HBV and the dynamics of the Hepatitis B Virus (HBV)-DNA viral load test and Surface Antigen (HBsAg) in the Ramp-Up Phase of Viremia (the presence of virus in the blood).

WHAT IS THE HBV-DNA VIRAL LOAD TEST?

Performance assessment of HBV-DNA and HBsAg assays is vital to understand the dynamics of Hepatitis B Virus

The viral load test, also known as hepatitis B virus DNA quantification, is a blood test that determines the amount of hepatitis B virus DNA in a chronically infected patient’s blood. Viremia is typically measured in “international units per millilitre” (IU/mL); previously, it was measured in “copies per millilitre” (cp/ml). The Polymerase Chain Reaction (PCR) technique is used for the test.

Other factors, such as Hepatitis B e-antigen (HBeAg) status, liver enzymes or serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) tests, and inflammation levels, must support the information gathered through this test. It is critical to monitor your plasma viral load on a regular basis in order to determine the stage of your infection. Several lab tests, including viral load, are used to determine the stage of the infection.

In chronic HBV infection, quantitative understanding of HBV dynamics influences drug treatment and immunotherapy timing. It can aid in the development of the best treatment plans for individual patients.

The five stages of Hepatitis B infection are

  • Immune tolerance,
  • Immune active,
  • Inactive HBV carrier state,
  • HBeAg-negative chronic hepatitis B, and
  • Hepatitis B surface antigen (HBsAg)-negative

Chronic hepatitis B (CHB) is when hepatitis B surface antigen (HBsAg) persists for six months or more. Most infected persons are unaware of their HBV infection and present advanced disease.

Annually, between 0·5% and 3% of inactive HBV carriers lose HBsAg. Spontaneous HBsAg clearance usually confers a good prognosis if there is no pre-existing hepatocellular carcinoma or cirrhosis at the time of HBsAg seroclearance (the clearance or removal of an antigen from the blood.) Following the loss of HBsAg, seroconversion to antibody against hepatitis B surface antigen (anti-HBs) is more likely to stop the development of cirrhosis and hepatocellular cancer, and it shows immunity to HBV and may suggest a better prognosis.

Throughout treatment, it is critical to monitor HBV DNA levels. Doctors detect HBV DNA when administering daily antiviral medications to see if the drug is lowering your viral load and to ensure that the antiviral is effective.

Testing of the International Standard and 10-30 seroconversion panels is required to demonstrate “state of the art” assay performance for detecting bloodborne viruses such as HBV. The evaluation of HBV-DNA and HBsAg assay performance is critical for understanding the dynamics of Hepatitis B Virus (HBV)-DNA and Surface Antigen (HBsAg) in the Ramp-Up Phase of Viremia. According to research, the viral doubling duration in the ramp-up phase (period of exponential growth in viral load) is the same above and below the quantification limit of the viral load assay.

It is critical to avoid hepatitis B infection in order to reduce the risk of developing chronic disease or liver cancer. Regular testing that yields high-quality and accurate results is the only way to prevent disease. Ensuring high-quality test results is not only good for public health but also good for your lab’s reputation.

HHC’s QUALITY CONTROL PANELS can be used to test the sensitivity, specificity, and working range of your assays, as well as for diagnostic development and batch release in manufacturing. Panels include representative data from current market assays. Depending on the intended use of the panel, our VERIFICATION / VALIDATION Panels are designed to be used with assays to determine the presence of antigen, antibody, RNA, or DNA.

In addition, we have an extensive range of SEROCONVERSION PANELS for detecting asymptomatic donors infected with HIV, HCV, HBV and EBV, and SURVEILLANCE PANELS and LONGITUDINAL PANELS. Our panels are run on as many different diagnostic kits as possible to measure relevant markers of seroconversion. All testing is performed by Certified Reference Laboratories and Domestic and International Regulatory Bodies.For more information, contact us now!

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