The first commercial test to screen for both parvovirus B19 and the hepatitis A virus (HAV) in human plasma is now available in the U.S. The cobas® TaqScreen DPX Test, manufactured by Switzerland-based Roche, uses nucleic acid amplification technology (NAT) to comprehensively screen for all human genotypes of parvovirus B19 (genotypes 1, 2 and 3 DNA) and HAV (genotypes I, II and III RNA) in human plasma.
The test is particularly relevant for the makers of human plasma-based therapies. The patients who take these therapies often have serious, chronic disorders including primary immunodeficiency diseases and bleeding disorders such as hemophilia. During manufacturing of plasma products, enhanced viral inactivation is used to kill viruses, such as hepatitis C and HIV. However, parvovirus B19 and HAV have proven resistant; they can be transmitted by certain blood components and plasma derivatives.
Parvovirus B19 can cause “fifth disease,” a mild illness with a characteristic rash on the cheeks, which spreads to the trunk, arms and legs. Some patients experience joint pain and swelling, which can last for several weeks. People who are immunocompromised by cancer, HIV, leukemia or who have had an organ transplant can develop chronic anemia after exposure to parvovirus B19. However, disease transmission of the virus by transfusion is rare.
HAV is spread via contaminated food and water, and by people with the disease who do not wash their hands properly. It can be asymptomatic or cause flulike symptoms, such as fever, nausea and vomiting, fatigue and joint aches. It also causes inflammation of the liver. Symptoms usually subside after several weeks.
“The launch of this test is an important part of our strategy,” said Paul Brown, Head of Roche Molecular Diagnostics. “Not only is it an important test for the continued safety of plasma products, but it also indicates our continued commitment to this vital area.”
Source: PRNewswire, February 4, 2011