Viral Hepatitis Molecular Testing

Explore hepatitis molecular diagnostics testing products

Hepatitis infection diagnosis can be confounded by ambiguous serology test results
Molecular diagnostic testing for viral hepatitis can be used to confirm hepatitis infection when serology results are unclear and to monitor viral load levels of an infected individual's response to antivirals to assess therapeutic response and efficacy

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Find out more about our hepatitis testing products and the benefits of molecular testing.

Hepatitis overview

Viral hepatitis remains a liver disease of major global significance with appreciable rates of morbidity and mortality due to the insidious nature of the infection. As most viral hepatitis infections are asymptomatic, laboratory testing is key to mitigate the on-going transmission of these diseases, especially in areas of high endemicity.

Anyone can become infected with viral hepatitis as it is not limited to specific geographical areas or social or socioeconomic groups. With that said, each type of viral hepatitis may be of greater concern for a given population such as the greater prevalence of HBV in Asians/Pacific Islanders and people born outside the United States. As such, the control and diagnosis of viral hepatitis demand that healthcare providers, including public health officials, be aware of the:

Known and potential risks for acquiring the different types of viral hepatitis
Risk behavior histories of their patients
Appropriate molecular diagnostic tests for each type of hepatitis and their intended use
Appropriate preventive and therapeutic measures

Diagnosing the specific agent responsible for viral hepatitis can be difficult because the signs and symptoms of each type are similar. Furthermore, many individuals who contract the disease have few or no symptoms. Hepatitis presents a challenge to physicians who must try to integrate epidemiological, clinical, serological, and molecular diagnostic data in their patient management decisions.

Viral Hepatitis pathogens

There are five viruses that cause hepatitis. We will focus our discussion on viral hepatitis B (HBV) and hepatitis C (HCV).

Hepatitis B: HBV attacks the liver and can cause both acute and chronic disease. HBV is endemic in areas of Africa, Asia, Eastern Europe, and South America, with an estimated 296 million people (2019) with chronic HBV infections worldwide, 1.5 million new infections per year, and 820,000 deaths due mostly from cirrhosis and hepatocellular carcinoma.¹ Hepatitis B can be prevented by recombinant DNA vaccines. It can be transmitted percutaneously or permucosally and is most commonly transmitted from mother to child during birth and delivery, as well as through contact with blood or other body fluids during sex with an infected partner, unsafe injections, or exposures to sharp instruments.

HBV DNA quantitative assays detect the viral genome and measure the level of circulating virus in an infected individual. The level of HBV DNA in the blood is often referred to as “viral load.” Applications for hepatitis B virus DNA assays include:

Directly assess circulating virus in an infected individual
Predict response to antiviral therapy based on pretreatment viral load
Monitor the effectiveness of antiviral therapy (HBV DNA falls rapidly in patients who respond to treatment)
Provides additional information to help confirm a diagnosis in cases with ambiguous serology

If a physician can determine the HBV viral load, then they can better gauge whether to initiate therapy, as well as more accurately monitor its effect.

Hepatitis C: HCV is a bloodborne virus that causes inflammation of the liver that can be both acute and chronic, with severity ranging from mild illness to a serious, lifelong illness including liver cirrhosis and hepatocellular carcinoma. Globally, WHO estimates 58 million people have chronic hepatitis C virus infection (of which 3.2 million are adolescents and children), with about 1.5 million new infections occurring per year, with an estimated 290,000 deaths from HCV, mostly from cirrhosis and hepatocellular carcinoma (primary liver cancer).² Most HCV infections occur through exposure to blood from unsafe injection practices, unsafe health care, unscreened blood transfusions, injection drug use, and sexual practices that lead to exposure to blood. Although there is no effective vaccine against HCV, newer HCV antiviral therapies can now cure more than 95% of persons with chronic hepatitis C infection, but global access to diagnosis and treatment is low.²

HCV RNA quantitative assays detect the viral genome and measure the level of circulating virus in an infected individual. The level of HCV RNA in the blood is often referred to as the “viral load.” Applications for hepatitis C virus RNA assays include:

Directly assess circulating virus in an infected individual indicating viremia (active infection)
Evaluate suspected HCV infection before seroconversion occurs
Assess viral load before antiviral therapy is administered
Monitor the effectiveness of antiviral therapy and determine if a resolution of the infection has occurred, resulting in a cure

If a physician can determine the HCV viral load, then they can better gauge whether to initiate therapy, as well as more accurately monitor its effect.