FDA Approves New Test That Identifies Hepatitis C Genotypes

The U.S. Food and Drugs Administration has approved a new test developed by Abbott Laboratories (ABT), which claims to identify genotypes in patients infected with Hepatitis C virus (HCV).

Hepatitis C viruses are known to be of different genotypes and determining the type of HCV a person is infected with can help doctors provide patients with better health care and treatment. The U.S. Food and Drugs Administration has approved a new test developed by Abbott Laboratories (ABT) that will help doctors identify which genotype of Hepatitis C virus a patient is carrying, the administration revealed in a press release. RealTime HCV Genotype II, the name given to the test, is capable of identifying genotypes 1, 1a, 1b, 2, 3, 4, and 5 by analyzing samples of blood plasma or serum of an infected patient.

Centers for Disease Control and Prevention reported earlier that HCV is the most common blood-borne infection in the United States and is one of the major causes for the increase in number of liver transplants in the country. Nearly 3.2 million Americans have HCV infections and more than 15,000 people die from diseases caused by this infection every year.

A similar study also warned that all people born between 1945 and 1965, commonly known as baby boomers should get themselves checked for Hepatitis C infections as they are five times more likely to be infected with Hepatitis C than other adults. HCV is easily transmitted through blood and other body fluids. People are exposed to the virus when they reuse needles that have already been used by infected users.

FDA states that once a person is diagnosed with HCV, the doctor should order a hepatitis C genotype test approved for individuals known to be chronically infected with HCV.

The FDA confirms in a press statement that the test has not been approved "for use as a diagnostic test or as a screening test for the presence of HCV genetic material in blood, blood products or tissue donors and it hasn't been evaluated in newborns or pediatric patients, or in patients with compromised immune systems, such as people with AIDS."

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FDA, New, Test, Hepatitis
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