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An Improved and High Throughput Respiratory Syncytial Virus (RSV) Micro-neutralization Assay
Published on: January 26, 2019
Potential for palivizumab interference with commercially available antibody-antigen based respiratory syncytial virus
Damon J Deming1, Nita Patel, Michael P McCarthy
1From the *United States Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Office of Antimicrobial Products, Division of Antiviral Products, Silver Spring; and †MedImmune, LLC, Gaithersburg, MD.
Abstract:
Palivizumab is a monoclonal antibody indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus infection in infants. The potential for palivizumab to interfere with commercially available respiratory syncytial virus diagnostic tests was demonstrated. Negative test results in palivizumab-treated subjects should be interpreted with caution and confirmed by a nucleic acid amplification-based assay.

