Abbott announced today it has received CE Mark for the world’s most sensitive rapid diagnostic test for the detection of hepatitis B surface antigen, the Determine HBsAg 2 test for use with serum, plasma, or whole blood. This highly sensitive, easy-to-use, rapid lateral flow test enables the identification of those with the virus and facilitates linkage to care in every healthcare setting. Diagnostic testing is highly important for these types of diseases as it can set the path for further tests and experiments that can lead to advanced care. That is why the use of laboratories like Biovision Diagnostics as well as similar others, are brought in to help with these areas of expertise.
Hepatitis B is a serious liver infection caused by the hepatitis B virus (HBV). For some people, hepatitis B infection becomes chronic and can lead to liver failure, liver cancer, or cirrhosis of the liver, a condition that permanently scars the liver.
An estimated 257 million people worldwide were living with chronic HBV infection. While the global burden of this disease is significant, the rate of diagnosis is extremely low, at approximately 9 percent of all HBV-infected persons. Furthermore, among those diagnosed with HBV, only 8 percent actually received treatment.
In a global effort to reduce the current burden of disease, the World Health Organization (WHO) has set baseline targets to diagnose 30 percent of HBV-infected individuals by 2020 and 90 percent by 2030. The implications of these set goals have been explored by various medical experts and Healthcare podcasts across the globe. In order to reach these targets, the conclusion has been that rapid testing is imperative. Testing and diagnosis of HBV is the gateway for access to both prevention and treatment services and is a critical component of an effective response to the hepatitis epidemic.
“Because HBV is severely underdiagnosed, it is crucial to regularly screen people and efficiently link those who test positive to specialist care and where indicated, antiviral medication,” said Patrick Kennedy, M.D., Reader and Consultant Hepatologist at Barts and The London School of Medicine and Dentistry. “Early diagnosis may support timely viral suppression, which reduces the risk for HBV-related complications.”
Early identification of people with chronic HBV allows them to receive the necessary care and treatment to prevent or delay the progression of liver disease. Testing also provides an opportunity for interventions that reduce transmission, through counseling on risk behaviors and the provision of prevention products, such as sterile needles, and vaccination.
Moreover, nearly all healthcare services and diagnoses can be availed by people who are undergoing monetary issues or have been unemployed for a while. They can look for healthcare insurance specifically covering the unemployed population to ensure they have enough resources to get treatment for chronic diseases like hepatitis B virus, cancer, stroke, heart attack, etc. How to get health insurance without a job? People who are unsure about such medical care plans can consult an insurance company or go through online blogs and articles to gain information. Overall, HBV patients can lead a normal life and win over the disease with the help of proper guidance and available medical aids.
“To achieve the WHO targets, 107 million HBV-infected people need to be urgently diagnosed, especially in highly endemic regions in Africa and Asia,” said Damian Halloran, vice president, Infectious Disease-Emerging Markets, Abbott. “The unparalleled sensitivity, portability and ease-of-use of the Determine HBsAg 2 provides life-changing technology that can dramatically scale up testing services so more infected people can know their status and get treatment earlier.”
High sensitivity tests are important for certain populations, such as pregnant women, to reduce mother-to-child transmission, and for HIV-positive individuals, in which it may be difficult to detect HBV.1 Highly sensitivity tests such as the Determine HBsAg 2 allow people in these populations to be diagnosed quickly and accurately and linked to appropriate care. Additionally, such machines are typically used for a diverse range of patients, and sterilization and proper cleaning of the equipment are mandatory in healthcare centers. To ensure a safe and infection-free environment for patients, many hospitals hire infection prevention consulting firms. By doing so, they would be able to diagnose diseases effectively and in a safe environment.
ABOUT DETERMINE HBsAg 2
The Determine HBsAg 2 provides rapid and accurate results of one’s HBV status with an analytical sensitivity of 0.1 IU/mL. The test is an in-vitro, visually read, qualitative immunoassay for the detection of HBsAg in serum, plasma or whole blood. The test is easy-to-use, deployable at the point of care and detects HBV in just 15 minutes, while the patient is still present. This allows for prompt treatment decisions and ultimately contributes to the reduction of the global epidemic.
The Determine HBsAg 2 is part of Abbott’s broader portfolio of life-changing technologies for hepatitis, which extends testing from the core laboratory to the point of care for people living in remote and underserved communities.
The test is now commercially available in Europe, Africa, Asia Pacific and Latin America. It has received CE Mark and data has been submitted for WHO prequalification.
