FDA Approval Adds Automated Testing Option for Parvovirus B19 Serology

Diagnosis relies on IgM antibodies to detect active infection and IgG antibodies to indicate previous exposure and immune status. To support faster clinical decisions, a newly approved automated serology testing option provides same-day results for diagnosis, treatment, and patient guidance.

Diasorin has obtained U.S. Food and Drug Administration (FDA) approval for the LIAISON Biotrin Parvovirus B19 IgM Plus and LIAISON Biotrin Parvovirus B19 IgG Plus assays. The assays run on the Diasorin LIAISON XL immunoassay system and are available in the United States. They are described as the first fully automated diagnostic tests for Parvovirus B19 serology on the LIAISON XL.

The assays support serologic diagnosis by detecting Parvovirus B19-specific antibodies. The IgM assay is used to identify active infection, while the IgG assay indicates previous exposure and immune status. Together, the tests address a gap in FDA-approved automated Parvovirus B19 testing and expand access through the LIAISON family of analyzers.

This added testing capacity is clinically relevant because Parvovirus B19 infection can cause serious complications in pregnant women, immunocompromised individuals, and patients with chronic hemolytic disorders. Maternal infection can cross the placenta in approximately 30–50% of cases and may lead to severe fetal anemia, hydrops fetalis, miscarriage, or stillbirth. Although most infected pregnancies have favorable outcomes, high-risk cases may require intrauterine blood transfusion.

By providing same-day results, the new assays may support faster diagnosis and more timely treatment and patient guidance. The approval adds an automated option for clinical laboratories performing Parvovirus B19 serology in the United States. The available information did not report analytical performance metrics such as sensitivity, specificity, accuracy, or area under the curve.

“Because maternal Parvovirus B19 infection may result in serious fetal complications, timely serological testing of exposed pregnant women is critical to assess immune status, identify recent infection, and support appropriate clinical follow-up. We are excited to bring in another first automated testing solution to offer our clinicians same day results,” said Gabriele Allegri, Diasorin President, Immuno Division.