title: Specific, sensitive, and quantitative enzyme-linked immunosorbent assay for human immunoglobulin G antibodies to anthrax toxin protective antigen.
abstract: The bioterrorism-associated human anthrax epidemic in the fall of 2001 highlighted the need for a sensitive, reproducible, and specific laboratory test for the confirmatory diagnosis of human anthrax. The Centers for Disease Control and Prevention developed, optimized, and rapidly qualified an enzyme-linked immunosorbent assay (ELISA) for immunoglobulin G (IgG) antibodies to Bacillus anthracis protective antigen (PA) in human serum. The qualified ELISA had a minimum detection limit of 0.06 micro g/mL, a reliable lower limit of detection of 0.09 micro g/mL, and a lower limit of quantification in undiluted serum specimens of 3.0 micro g/mL anti-PA IgG. The diagnostic sensitivity of the assay was 97.8%, and the diagnostic specificity was 97.6%. A competitive inhibition anti-PA IgG ELISA was also developed to enhance diagnostic specificity to 100%. The anti-PA ELISAs proved valuable for the confirmation of cases of cutaneous and inhalational anthrax and evaluation of patients in whom the diagnosis of anthrax was being considered.
authors.affiliation: Centers for Desease Control and Prevention , Atlanta, Georgia 30333, USA. caq7@cdc.gov
authors.forename: Conrad P
authors.initials: CP
authors.lastname: Quinn
authors.forename: Vera A
authors.initials: VA
authors.lastname: Semenova
authors.forename: Cheryl M
authors.initials: CM
authors.lastname: Elie
authors.forename: Sandra
authors.initials: S
authors.lastname: Romero-Steiner
authors.forename: Carolyn
authors.initials: C
authors.lastname: Greene
authors.forename: Han
authors.initials: H
authors.lastname: Li
authors.forename: Karen
authors.initials: K
authors.lastname: Stamey
authors.forename: Evelene
authors.initials: E
authors.lastname: Steward-Clark
authors.forename: Daniel S
authors.initials: DS
authors.lastname: Schmidt
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Mothershed
authors.forename: Janet
authors.initials: J
authors.lastname: Pruckler
authors.forename: Stephanie
authors.initials: S
authors.lastname: Schwartz
authors.forename: Robert F
authors.initials: RF
authors.lastname: Benson
authors.forename: Leta O
authors.initials: LO
authors.lastname: Helsel
authors.forename: Patricia F
authors.initials: PF
authors.lastname: Holder
authors.forename: Scott E
authors.initials: SE
authors.lastname: Johnson
authors.forename: Molly
authors.initials: M
authors.lastname: Kellum
authors.forename: Trudy
authors.initials: T
authors.lastname: Messmer
authors.forename: W Lanier
authors.initials: WL
authors.lastname: Thacker
authors.forename: Lilah
authors.initials: L
authors.lastname: Besser
authors.forename: Brian D
authors.initials: BD
authors.lastname: Plikaytis
authors.forename: Thomas H
authors.initials: TH
authors.lastname: Taylor
authors.forename: Alison E
authors.initials: AE
authors.lastname: Freeman
authors.forename: Kelly J
authors.initials: KJ
authors.lastname: Wallace
authors.forename: Peter
authors.initials: P
authors.lastname: Dull
authors.forename: Jim
authors.initials: J
authors.lastname: Sejvar
authors.forename: Erica
authors.initials: E
authors.lastname: Bruce
authors.forename: Rosa
authors.initials: R
authors.lastname: Moreno
authors.forename: Anne
authors.initials: A
authors.lastname: Schuchat
authors.forename: Jairam R
authors.initials: JR
authors.lastname: Lingappa
authors.forename: Sandra K
authors.initials: SK
authors.lastname: Martin
authors.forename: John
authors.initials: J
authors.lastname: Walls
authors.forename: Melinda
authors.initials: M
authors.lastname: Bronsdon
authors.forename: George M
authors.initials: GM
authors.lastname: Carlone
authors.forename: Mary
authors.initials: M
authors.lastname: Bajani-Ari
authors.forename: David A
authors.initials: DA
authors.lastname: Ashford
authors.forename: David S
authors.initials: DS
authors.lastname: Stephens
authors.forename: Bradley A
authors.initials: BA
authors.lastname: Perkins
mesh_terms: D000881:Anthrax / Q000175:diagnosis / Q000276:immunology*; D000907:Antibodies, Bacterial / Q000276:immunology*; D000942:Antigens, Bacterial / Q000276:immunology*; D001408:Bacillus anthracis / Q000276:immunology*; D001427:Bacterial Toxins / Q000276:immunology*; D023482:Bioterrorism; D004196:Disease Outbreaks; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D006801:Humans; D007074:Immunoglobulin G / Q000276:immunology*; D012680:Sensitivity and Specificity
chemical_list: D000907:Antibodies, Bacterial; D000942:Antigens, Bacterial; D001427:Bacterial Toxins; D007074:Immunoglobulin G; C030325:anthrax toxin