食品药品监管局批准首款全自动细小病毒B19血清学检测 DiaSorin两项检测可在当日出结果
美国食品药品监管局（FDA）10月13日批准意大利诊断公司DiaSorin的两项细小病毒B19血清学检测上市——LIAISON Biotrin细小病毒B19 IgM Plus与IgG Plus，这是首批在LIAISON XL全自动免疫分析平台上运行的B19抗体检测。
细小病毒B19经呼吸道飞沫与密切接触传播，可引起儿童「第五病」（传染性红斑），对孕妇、免疫功能低下者与慢性溶血性贫血患者风险更高，孕期感染可能影响胎儿。两项检测分别识别提示近期感染的IgM抗体与提示既往感染的IgG抗体，公司称可实现当日出结果，帮助临床更快诊断与处置。
DiaSorin表示，两项检测获批后已即时在美国市场供应。B19没有特异性抗病毒治疗，准确、快速的血清学检测主要用于明确诊断、评估孕妇等高风险人群的感染状态。
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.
发布：GSM·美国（发布链接）
图片来源：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
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