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Clinical and Vaccine Immunology, April 2008, p. 644-649, Vol. 15, No. 4
1071-412X/08/$08.00+0     doi:10.1128/CVI.00473-07
Copyright © 2008, American Society for Microbiology. All Rights Reserved.

Rapid Point-of-Care Test To Detect Broad Ranges of Protective Antigen-Specific Immunoglobulin G Concentrations in Recipients of the U.S.-Licensed Anthrax Vaccine

Naval Institute for Dental and Biomedical Research, Great Lakes, Illinois,¹ General Dynamics Information Technology, Frederick, Maryland,² Biological Monitoring Laboratory Section, Biomonitoring and Health Assessment Branch, National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention, Cincinnati, Ohio³

Received 27 November 2007/ Returned for modification 21 January 2008/ Accepted 20 February 2008

Currently, there is no routine monitoring of an immune response to the anthrax vaccine. Simple on-site tests are needed to evaluate the antibody response of anthrax-vaccinated individuals in the Armed Forces and others at high risk. Using a prototype lateral flow assay (LFA) (R. E. Biagini, D. L. Sammons, J. P. Smith, B. A. MacKenzie, C. A. F. Striley, J. E. Snawder, S. A. Robertson, and C. P. Quinn, Clin. Vaccine Immunol. 13:541-546, 2006), we investigated the agreement between a validated anthrax protective antigen (PA) immunoglobulin G (IgG) enzyme-linked immunosorbent assay (ELISA) and the LFA for 335 unvaccinated and vaccinated subjects. We also investigated the performance of the LFA under the following conditions: thermal shock (i.e., thermal cycling between temperature extremes), high temperature/high relative humidity, high temperature/low relative humidity, and low temperature/low relative humidity. With the anti-PA ELISA used as a standard, the LFA was shown to be optimally diagnostic at 11 µg/ml anti-PA-specific IgG. At this concentration, the LFA specificity and sensitivity were 98% (95% confidence interval [CI], 97% to 100%) and 92% (CI, 88% to 97%), respectively. Receiver operating characteristic curve analysis yielded an area under the curve value of 0.988 (CI, 0.976 to 1.00), suggesting that the LFA is an extremely accurate diagnostic test. For 4 or 50 µg/ml PA-specific IgG, the LFA results for each environmental condition were identical to those obtained in the laboratory. These data indicate that this rapid point-of-care test would be a feasible tool in monitoring the serological antibody responses of individuals that have been vaccinated against anthrax.

Published ahead of print on 5 March 2008.