Part 3 of IVD Hall of Fame
« HIV Viral Load
Glucose Monitoring »
Hepatitis B and C are viral infections that cause potentially life-threatening liver infections. The virus is transmitted through contact with the blood or other body fluids of an infected person. Hepatitis C is the most common blood-borne infection in the United States. Hepatitis blood screening assays detect if Hepatitis B or C virus is present in blood (samples provided by blood donors. The plasma may be from an individual or samples may be pooled together for testing.
Hepatitis B virus surface antigen (HbsAg) testing of donated blood began in 1971. FDA approved total antibody to hepatitis B core antigen testing beginning in 1986. FDA approved the first nucleic acid test (NAT) for Hepatitis B DNA in 2009. The first test to screen for Hepatitis C was approved by FDA in 1990. FDA approved the first nucleic acid test (NAT) for Hepatitis C in 1999.
Before 1992, when widespread screening of the blood supply began in the United States, Hepatitis C was commonly spread through blood transfusions and organ transplants. Prior to the blood screening assay, potential donors were screened using questionnaires to identify individuals at high risk of having Hepatitis. However, many people with Hepatitis do not know they are infected because they don’t look or feel sick and the source of the infection can not always be determined.
Hepatitis blood screening assays improve the safety of blood transfusions. Testing the blood supply in the United States for Hepatitis B began in 1971. However, a test for Hepatitis C was only available beginning in 1990. The yearly incidence of HCV infection averaged more than 200,000 cases per year in the 1980s, but by 2001 had declined to around 25,000 cases per year.
As a result of Hepatitis blood screening assays, the risk of acquiring Hepatitis through a blood transfusions or organ transplant has been largely eliminated. The risk of a Hepatitis B infection through blood transfusion is now between 1 in 800,000 and 1 in 1,000,000 per transfused unit and Hepatitis C infection through blood transfusion is now approximately 1 in 1,000,000 per transfused unit.