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 one of our previous articles, we talked about Hepatitis C, a serious liver disease caused by the hepatitis C virus (HCV) and exposed the severity of HCV and HIV co-infection. Today we discuss Hepatitis B, also a liver infection that is caused by the hepatitis B virus (HBV). Hepatitis B is a viral infection that attacks the liver and may result in acute and chronic diseases. Acute Hepatitis B can last less than six months. In its chronic form, the virus stays longer in the person’s body and goes untreated; it can endanger people’s lives by causing cirrhosis, fibrosis, hepatocellular carcinoma, and end-stage liver disease.
There is no cure for Hepatitis B. In some cases, the infection goes away on its own (in 4 to 8 weeks for more than 9 out of 10 adults). Some (about 1 in 20 people) that contract this virus as adults become “carriers, (a chronic condition) are likely to infect other people and can do so for the rest of their lives unknowingly. For those who suffer from CHB, lifelong treatment is necessary. Exposure to the virus in early life often results in chronic HBV and leads to the persistence of the virus due to the absence of cellular immune responses or strong antibodies.
Inhibiting viral replication, boosting immune defences against the virus, or a combination of the two are possible treatment goals for HBV carriers. The efficiency of the treatments depends entirely on regular testing and monitoring of the different phases of the disease. The HBV DNA (viral load test) is one of the blood tests crucial to ascertaining the viral activity in the infected patient’s body.
The natural course of chronic HBV infection can be determined into five phases, the last being the seroconversion of Hepatitis B Surface Antigen. At this stage, hepatitis B is not detected in your blood, or hepatitis B surface antigen (HBsAg) is negative or not detected in the blood.
Helvetica Health Care is a leader in the supply of seroconversion panels and blood screening assays that are crucial in monitoring and treating life-threatening diseases such as Hepatitis B, Hepatitis C and HIV. Below we attempt to expand your knowledge about HBV and the dynamics of 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?
The viral load test, also known as hepatitis B virus DNA quantification, is a blood test that quantifies the amount of hepatitis B virus DNA in the blood of a chronically infected patient. Usually, the viral load or viremia is measured in “international units per milliliter” (IU/mL); erstwhile, it was measured in “copies per milliliter” (cp/ml). The test is conducted using the Polymerase Chain Reaction (PCR) technique.
The information gathered through this test must be supported by other factors such as the Hepatitis B e-antigen (HBeAg) status, the results of the liver enzymes or serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) tests, and inflammation levels. To completely understand what stage of the infection you might be experiencing, it’s important to check your plasma viral load frequently. The results of numerous lab tests, including viral load, are used to establish the phase of the infection.
When studied, the quantitative understanding of HBV dynamics influences drug treatment and immunotherapy timing in chronic HBV infection. It can help in developing the best treatment plans for specific 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.
It’s crucial to monitor HBV DNA levels throughout treatment. Doctors detect HBV DNA when daily antiviral medications are administered to check if the drug is lowering your viral load and to ensure that the antiviral is effective.
To demonstrate “state of the art” assay performance for detecting bloodborne viruses such as HBV, testing of the International Standard and 10–30 seroconversion panels is necessary. Performance assessment of HBV-DNA and HBsAg assays is vital to understand the dynamics of Hepatitis B Virus (HBV)-DNA and Surface Antigen (HBsAg) in the Ramp-Up Phase of Viremia. Studies have shown that the viral doubling duration in the ramp-up phase (period of exponential growth in viral load) is equal above and below the viral load assay’s quantification limit.
Preventing hepatitis B infection is vital to eliminate the risk of developing chronic disease or liver cancer. Prevention is only possible through regular testing that produces high-quality and accurate results. Ensuring high quality test outcomes is not only beneficial to public health but is also an advantage to your lab’s reputation.
The QUALITY CONTROL PANELS supplied by HHC can challenge the sensitivity, specificity and working range of your assays or be used for diagnostic development or batch release in manufacturing. Panels include representative data from current assays on the market. Our range of VERIFICATION / VALIDATION Panels is designed to be used with assays to determine the presence of antigen, antibody RNA or DNA based upon the intended use of the panel.
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!