FDA Approves New Hepatitis B Screening Process

Disclaimer: Results are not guaranteed*** and may vary from person to person***.

In another blow against hepatitis B, the Food and Drug Administration (FDA) has just announced that it has approved the first-ever fully automated test for hepatitis B that combines both screening and confirmation of the hepatitis B surface antigen (HbsAg). The test, the Abbott PRISM HBsAg assay, has been approved for testing people who have donated blood, blood components, or organs for the hepatitis B virus.

 Along with its primary uses, the test will also be used to screen blood from cadavers for the purpose of organ tissue donation. This alone could mean a great deal for individuals who are in dire need for organ transplants and other medical procedures where a living donor may not be available.

 The beauty of this new test is that it can be used concurrently for screening and confirmation, whereas in the past, two separate tests have always been needed. This will help medical professionals save time and expense, which could mean quicker help for the people who need it most.

 The Abbott PRISM HbsAg assay is an automated system that will bring a new and improved level of efficiency and convenience to the need for screening blood, tissue, and organ donors, according to the director of the FDA’s Center for Biologics Evaluation and Research, Jesse Goodman, MD, MPH.

 “Improvements in blood donor screening and testing over the last few years have helped make the nation’s blood supply safer from infectious diseases than it has been at any other time,” he said. This is good news, as in the past, many cases of accidental infection of individuals from hepatitis B had happened due to poor screening practices.

 Hepatitis B is a serious medical condition that is caused by a virus that infects a person’s liver. Transmitted by blood, the virus can cause lifelong infection in a person, as well as liver cancer, cirrhosis (scarring of the liver), liver failure, and even death. The way you can contract hepatitis B is when an infected person’s blood comes into contact with your blood, such as through sexual activity, needle sharing, and infected blood transfusions (such as through donors with undetected hepatitis).

 The scary reality is that 30% of people who have hepatitis B show no symptoms of the condition, which can include fatigue, jaundice, abdominal pain, loss of appetite, joint pain, and nausea. If you experience any of these symptoms, you may want to contact your health care provider.

 The only way doctors can be certain that a person has this deadly illness is to check their blood for it. Hence the reason this new test is great news for doctors, patients, and donors alike, as it could mean more people will be willing to participate in blood donation campaigns, for example.

 Because of this test, medical professionals can help screen individuals for hepatitis B faster and better than they ever could before, which means everybody can benefit in the end.

 Due to hepatitis B vaccinations, the rate of infection has been on the decline. In fact, from the average of 260,000 infections occurring in the 1980s, the rate in 2004 was at about 60,000. Thanks to routine childhood vaccination, the greatest decline has happened among children and adolescents. Hopefully, thanks to the approval of this new test, the rate can decline even further thanks to prevention

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