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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.

Authors
Bienek-DR; Biagini-RE; Charlton-DG; Smith-JP; Sammons-DL; Robertson-SA
Source
Clin Vaccin Immunol 2008 Apr; 15(4):644-649
NIOSHTIC No.
20033667
Abstract
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 mu g/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 < or equal to 4 or > or equal to 50 mu g/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.
Keywords
Immune-reaction; Antibody-response; Military-personnel; Vaccines; Antigens; Temperature-effects; Diagnostic-techniques
Contact
Diane R. Bienek, Naval Institute for Dental and Biomedical Research, 310A B Street, Bldg. 1-H, Great Lakes, IL 60088-5259
Publication Date
20080401
Document Type
Journal Article
Email Address
diane.bienek@med.navy.mil
Fiscal Year
2008
NTIS Accession No.
NTIS Price
Issue of Publication
4
ISSN
1556-6811
NIOSH Division
DART
Priority Area
Healthcare and Social Assistance; Manufacturing
Source Name
Clinical and Vaccine Immunology
State
OH; MD; IL
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