Specific, Sensitive, and Quantitative Enzyme-Linked Immunosorbent Assay for Human Immunoglobulin G Antibodies to Anthrax Toxin Protective Antigen

نویسندگان

  • Conrad P. Quinn
  • Vera A. Semenova
  • Cheryl M. Elie
  • Sandra Romero-Steiner
  • Carolyn Greene
  • Han Li
  • Karen Stamey
  • Evelene Steward-Clark
  • Daniel S. Schmidt
  • Elizabeth Mothershed
  • Janet Pruckler
  • Stephanie Schwartz
  • Robert F. Benson
  • Leta O. Helsel
  • Patricia F. Holder
  • Scott E. Johnson
  • Molly Kellum
  • Trudy Messmer
  • W. Lanier Thacker
  • Lilah Besser
  • Brian D. Plikaytis
  • Thomas H. Taylor
  • Alison E. Freeman
  • Kelly J. Wallace
  • Peter Dull
  • Jim Sejvar
  • Erica Bruce
  • Rosa Moreno
  • Anne Schuchat
  • Jairam R. Lingappa
  • Sandra K. Martin
  • John Walls
  • Melinda Bronsdon
  • George M. Carlone
  • Mary Bajani-Ari
  • David A. Ashford
  • David S. Stephens
  • Bradley A. Perkins
چکیده

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.

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عنوان ژورنال:

دوره 8  شماره 

صفحات  -

تاریخ انتشار 2002