1. Specific, Sensitive, and Quantitative Enzyme-Linked Immunosorbent Assay for Human Immunoglobulin G Antibodies to Anthrax Toxin Protective Antigen
- Author
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Conrad P. Quinn, Vera A. Semenova, Cheryl M. Elie, Sandra Romero-Steiner, Carolyn M. 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, and Bradley A. Perkins
- Subjects
anthrax ,antibody ,assay ,Bacillus anthracis ,bioterrorism ,ELISA ,Medicine ,Infectious and parasitic diseases ,RC109-216 - 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 µg/mL, a reliable lower limit of detection of 0.09 µg/mL, and a lower limit of quantification in undiluted serum specimens of 3.0 µg/mL anti-PA IgG. The diagnostic sensitivity of the assay was 97.8%, and the diagnostic specificity was 94.2%. 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.
- Published
- 2002
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