A-200 Advancing Parvovirus B19 Detection: A Fully Automated Solution for Today’s Clinical Demands

Abstract

Background Recent increases in confirmed parvovirus B19 activity in the United States—including a multi state outbreak reported between late 2024 and early 2025—have heightened clinical demand for rapid, reliable serologic testing to distinguish acute from past infection. This need is especially critical for pregnant individuals and immunocompromised patients, where timely identification of acute parvovirus B19 infection directly informs clinical management. Despite this increased disease burden, currently FDA cleared diagnostic options for parvovirus B19 IgM rely on historical, manually performed ELISA methods. These legacy methods require substantial hands on time, manual pipetting steps, batch dependent workflow constraints, and extended turnaround times that strain laboratory operations during periods of elevated test volume. Methods To address these challenges, the LIAISON® Biotrin Parvovirus B19 IgM Plus assay was clinically evaluated as a fully automated chemiluminescent immunoassay (CLIA) for use on the LIAISON® XL analyzer, complementing the FDA cleared LIAISON® Parvovirus B19 IgG assay. The U.S. clinical validation study included 1,247 serum specimens: 356 from pregnant individuals representing all trimesters, and 891 from patients for whom a physician ordered parvovirus B19 IgM testing during the confirmed outbreak period. Results Across both cohorts, the automated IgM assay demonstrated strong agreement with the predicate ELISA method, achieving a positive percent agreement of 96.3% and a negative percent agreement of 99.7%). In addition, the assay exhibits excellent intra-site reproducibility, supporting its robustness across routine clinical laboratory conditions. Conclusion These data underscore the value of transitioning parvovirus B19 serologic testing from manual ELISA workflows to a fully automated IgG + IgM testing solution. Automation reduces hands on labor, improves standardization, and provides on demand scalability during outbreak surges. The LIAISON® Parvovirus B19 IgM Plus assay offers clinical laboratories a reliable, operationally efficient method for detecting acute parvovirus B19 infection in both routine and high demand settings.