title: Detecting 2009 pandemic influenza A (H1N1) virus infection: availability of diagnostic testing led to rapid pandemic response.
abstract: Diagnostic tests for detecting emerging influenza virus strains with pandemic potential are critical for directing global influenza prevention and control activities. In 2008, the Centers for Disease Control and Prevention received US Food and Drug Administration approval for a highly sensitive influenza polymerase chain reaction (PCR) assay. Devices were deployed to public health laboratories in the United States and globally. Within 2 weeks of the first recognition of 2009 pandemic influenza H1N1, the Centers for Disease Control and Prevention developed and began distributing a new approved pandemic influenza H1N1 PCR assay, which used the previously deployed device platform to meet a >8-fold increase in specimen submissions. Rapid antigen tests were widely used by clinicians at the point of care; however, test sensitivity was low (40%-69%). Many clinical laboratories developed their own pandemic influenza H1N1 PCR assays to meet clinician demand. Future planning efforts should identify ways to improve availability of reliable testing to manage patient care and approaches for optimal use of molecular testing for detecting and controlling emerging influenza virus strains.
authors.affiliation: Influenza Division, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA.
authors.forename: D B
authors.initials: DB
authors.lastname: Jernigan
authors.forename: S L
authors.initials: SL
authors.lastname: Lindstrom
authors.forename: J R
authors.initials: JR
authors.lastname: Johnson
authors.forename: J D
authors.initials: JD
authors.lastname: Miller
authors.forename: M
authors.initials: M
authors.lastname: Hoelscher
authors.forename: R
authors.initials: R
authors.lastname: Humes
authors.forename: R
authors.initials: R
authors.lastname: Shively
authors.forename: L
authors.initials: L
authors.lastname: Brammer
authors.forename: S A
authors.initials: SA
authors.lastname: Burke
authors.forename: J M
authors.initials: JM
authors.lastname: Villanueva
authors.forename: A
authors.initials: A
authors.lastname: Balish
authors.forename: T
authors.initials: T
authors.lastname: Uyeki
authors.forename: D
authors.initials: D
authors.lastname: Mustaquim
authors.forename: A
authors.initials: A
authors.lastname: Bishop
authors.forename: J H
authors.initials: JH
authors.lastname: Handsfield
authors.forename: R
authors.initials: R
authors.lastname: Astles
authors.forename: X
authors.initials: X
authors.lastname: Xu
authors.forename: A I
authors.initials: AI
authors.lastname: Klimov
authors.forename: N J
authors.initials: NJ
authors.lastname: Cox
authors.forename: M W
authors.initials: MW
authors.lastname: Shaw
mesh_terms: D002487:Centers for Disease Control and Prevention, U.S.; D019411:Clinical Laboratory Techniques / Q000379:methods; D003140:Communicable Disease Control / Q000379:methods*; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype / Q000302:isolation & purification*; D007251:Influenza, Human / Q000175:diagnosis* / Q000453:epidemiology* / Q000517:prevention & control / Q000821:virology; D058873:Pandemics / Q000517:prevention & control*; D016133:Polymerase Chain Reaction / Q000379:methods*; D014481:United States / Q000453:epidemiology; D014773:Virology / Q000379:methods*