title: Potential for palivizumab interference with commercially available antibody-antigen based respiratory syncytial virus diagnostic assays.
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.
authors.affiliation: From 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.
authors.forename: Damon J
authors.initials: DJ
authors.lastname: Deming
authors.forename: Nita
authors.initials: N
authors.lastname: Patel
authors.forename: Michael P
authors.initials: MP
authors.lastname: McCarthy
authors.forename: Lalji
authors.initials: L
authors.lastname: Mishra
authors.forename: Alan M
authors.initials: AM
authors.lastname: Shapiro
authors.forename: JoAnn A
authors.initials: JA
authors.lastname: Suzich
mesh_terms: D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000737:chemistry*; D000914:Antibodies, Viral / Q000097:blood; D000998:Antiviral Agents / Q000008:administration & dosage / Q000737:chemistry; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D009296:Nasal Cavity / Q000276:immunology / Q000821:virology; D000069455:Palivizumab; D011933:Reagent Kits, Diagnostic; D018357:Respiratory Syncytial Virus Infections / Q000175:diagnosis* / Q000188:drug therapy / Q000276:immunology / Q000821:virology; D012136:Respiratory Syncytial Viruses / Q000276:immunology / Q000302:isolation & purification*; D012680:Sensitivity and Specificity; D014773:Virology / Q000379:methods*
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000914:Antibodies, Viral; D000998:Antiviral Agents; D011933:Reagent Kits, Diagnostic; D000069455:Palivizumab