title: Sensitivity and specificity of serologic assays for detection of human infection with 2009 pandemic H1N1 virus in U.S. populations.
abstract: Swine origin 2009 H1N1 influenza virus has spread globally to cause the first influenza pandemic of the 21st century. Serological studies can improve our understanding of the extent of human infection and risk factors associated with the transmission of this pandemic virus. The "gold standard" for serodiagnosis of human influenza virus infection is the detection of seroconversion between acute- and convalescent-stage samples. However, the timing of seroepidemiological investigations often precludes the collection of truly acute-phase sera, requiring development of serological criteria for evaluating convalescent-phase sera that optimize detection of true positives and true negatives. To guide seroepidemiological investigations into the spread of the novel 2009 pandemic H1N1 virus, we characterized serum antibody responses to 2009 H1N1 virus in 87 individuals with confirmed viral infection and 227 nonexposed U.S. individuals using microneutralization (MN) and hemagglutination inhibition (HI) assays. Sensitivity and specificity were determined for each assay alone and in combination for detection of 2009 H1N1 virus-specific antibodies in convalescent-phase sera. Although the HI assay was more specific for detecting antibody to 2009 H1N1, the MN assay was more sensitive, particularly for detecting low-titer seroconversions. A combination of titers (MN ≥ 40 and HI ≥ 20) provided the highest sensitivity (90%) and specificity (96%) for individuals aged <60 years and 92% specificity for adults aged ≥ 60 years for detection of serologically confirmed 2009 H1N1 infections in U.S. populations during the first pandemic waves. These studies provide an approach to optimize timely serological investigations for future pandemics or outbreaks of novel influenza viruses among humans.
authors.affiliation: Influenza Division, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, National Center for Immunization and Respiratory Diseases, Centers for Disease Control andPrevention,2 Atlanta, Georgia 30333, USA.
authors.forename: Vic
authors.initials: V
authors.lastname: Veguilla
authors.forename: Kathy
authors.initials: K
authors.lastname: Hancock
authors.forename: Jarad
authors.initials: J
authors.lastname: Schiffer
authors.forename: Paul
authors.initials: P
authors.lastname: Gargiullo
authors.forename: Xiuhua
authors.initials: X
authors.lastname: Lu
authors.forename: Darbi
authors.initials: D
authors.lastname: Aranio
authors.forename: Alicia
authors.initials: A
authors.lastname: Branch
authors.forename: Libo
authors.initials: L
authors.lastname: Dong
authors.forename: Crystal
authors.initials: C
authors.lastname: Holiday
authors.forename: Feng
authors.initials: F
authors.lastname: Liu
authors.forename: Evelene
authors.initials: E
authors.lastname: Steward-Clark
authors.forename: Hong
authors.initials: H
authors.lastname: Sun
authors.forename: Byron
authors.initials: B
authors.lastname: Tsang
authors.forename: David
authors.initials: D
authors.lastname: Wang
authors.forename: Melissa
authors.initials: M
authors.lastname: Whaley
authors.forename: Yaohui
authors.initials: Y
authors.lastname: Bai
authors.forename: Li
authors.initials: L
authors.lastname: Cronin
authors.forename: Peter
authors.initials: P
authors.lastname: Browning
authors.forename: Hanan
authors.initials: H
authors.lastname: Dababneh
authors.forename: Heather
authors.initials: H
authors.lastname: Noland
authors.forename: Leilani
authors.initials: L
authors.lastname: Thomas
authors.forename: Lydia
authors.initials: L
authors.lastname: Foster
authors.forename: Conrad P
authors.initials: CP
authors.lastname: Quinn
authors.forename: Stephen D
authors.initials: SD
authors.lastname: Soroka
authors.forename: Jacqueline M
authors.initials: JM
authors.lastname: Katz
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000818:Animals; D000914:Antibodies, Viral / Q000097:blood; D002648:Child; D002675:Child, Preschool; D006385:Hemagglutination Inhibition Tests; D006801:Humans; D007223:Infant; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology / Q000302:isolation & purification*; D007251:Influenza, Human / Q000175:diagnosis*; D008875:Middle Aged; D009500:Neutralization Tests; D012680:Sensitivity and Specificity; D012698:Serologic Tests / Q000379:methods; D014481:United States; D014773:Virology / Q000379:methods*; D055815:Young Adult
chemical_list: D000914:Antibodies, Viral