FDA Clears First Fully Automated Parvovirus B19 Serology Tests on DiaSorin's LIAISON XL
The U.S. Food and Drug Administration (FDA) on October 13 cleared two parvovirus B19 serology tests from Italian diagnostics company DiaSorin — the LIAISON Biotrin Parvovirus B19 IgM Plus and IgG Plus — the first fully automated B19 antibody tests for the company's LIAISON XL immunoassay platform.
Parvovirus B19 spreads mainly through respiratory droplets and close contact. It causes fifth disease in children and poses higher risks to pregnant women, immunocompromised people and patients with chronic hemolytic anemia; infection during pregnancy can affect the fetus. The two tests detect IgM antibodies, which suggest recent infection, and IgG antibodies, which indicate past infection, and the company says they deliver same-day results to support faster diagnosis and patient management.
DiaSorin said the tests became available in the United States immediately upon clearance. There is no specific antiviral treatment for B19, so fast, accurate serology is used chiefly to confirm diagnosis and assess infection status in high-risk patients such as pregnant women.
Published by GSM · USA (original Chinese edition)
Photo: 图：医学实验室技术人员进行检测工作。摄影：Erin O'Shea，美国空军，公共领域，来源：Wikimedia Commons / Photo: Medical laboratory technicians at work. Credit: Erin O'Shea, U.S. Air Force, public domain, via Wikimedia Commons
