Validation and long term performance characteristics of a quantitative enzyme linked immunosorbent assay (ELISA) for human anti-PA IgG

Journal of Immunological Methods

Volumn 376, Issue 1-2, 2012, Pages 97-107

  Semenova, V A ^a   Schiffer, J ^a   Steward Clark, E ^a   Soroka, S ^a   Schmidt, D S ^a   Brawner, M M ^a   Lyde, F ^a   Thompson, R ^a   Brown, N ^a   Foster, L ^a   Fox, S ^a   Patel, N ^a   Freeman, A E ^a   Quinn, C P ^a  

^a CENTERS FOR DISEASE CONTROL AND PREVENTION   (United States)

Author keywords

Anti PA antibody; AVA; Bacillus anthracis; BioThrax ; ELISA; IgG

Indexed keywords

ANTHRAX VACCINE; ANTIBODY; IMMUNOGLOBULIN G ANTIBODY; PROTECTIVE ANTIBODY; UNCLASSIFIED DRUG;

ACCURACY; ANTHRAX; ARTICLE; BLOOD SAMPLING; ENZYME LINKED IMMUNOSORBENT ASSAY; HUMAN; HUMAN TISSUE; IMMUNE RESPONSE; IMMUNOTHERAPY; PRIORITY JOURNAL; TEMPERATURE; THERMOSTABILITY;

ANTHRAX; ANTHRAX VACCINES; ANTIBODIES, ANTI-IDIOTYPIC; ANTIGENS, BACTERIAL; BACILLUS ANTHRACIS; CLINICAL TRIALS, PHASE IV AS TOPIC; ENZYME-LINKED IMMUNOSORBENT ASSAY; HUMANS; LIMIT OF DETECTION; REGRESSION ANALYSIS; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY;

BACILLUS ANTHRACIS;

EID: 84863393717     PISSN: 00221759     EISSN: 18727905     Source Type: Journal    
DOI: 10.1016/j.jim.2011.12.002     Document Type: Article

References (47)

1. Baillie L.W., Huwar T.B., Moore S., Mellado-Sanchez G., Rodriguez L., Neeson B.N., Flick-Smith H.C., Jenner D.C., Alkins H.S., Ingram R.J., Altmann D.M., Nataro J.P., Passetti M.F. An anthrax subunit vaccine candidate based on protective regions of Bacillus anthracis protective antigen and lethal factor. Vaccine 2010, 28:6740.
2. Berthold I., Pombo M.L., Wagner L., Arciniega J.L. Immunogenicity in mice of anthrax recombinant protective antigen in the presence of aluminum adjuvants. Vaccine 2005, 23:1993.
3. Bienek D.R., Chang C.K., Cohen M.E. Detection of anti-protective antigen salivary IgG antibodies in recipients of the US licensed anthrax vaccine. Vaccine 2007, 25:5978.
4. Bienek D.R., Biagini R.E., Charlton D.G., Smith J.P., Sammons D.L., Robertson S.A. 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. Clin. Vaccine Immunol. 2008, 15:644.
5. Committee to Review the CDC Anthrax Vaccine Safety and Efficacy Research Program An Assessment of the CDC Anthrax Vaccine Safety and Efficacy Research Program 2002, National Academies Press, Washington, DC.
6. Dewan P.K., Fry A.M., Laserson K., Tierney B.C., Quinn C.P., Hayslett J.A., Broyles L.N., Shane A., Winthrop K.L., Walks I., Siegel L., Hales T., Semenova V.A., Romero-Steiner S., Elie C., Khabbaz R., Khan A.S., Hajjeh R.A., Schuchat A.A. Inhalational anthrax outbreak among postal workers, Washington, D.C., 2001. Emerg. Infect. Dis. 2002, 8:1066. The members of the Washington, D.C., Anthrax Response Team.
7. Fellows P.F., Linscott M.K., Ivins B.E., Pitt M.L., Rossi C.A., Gibbs P.H., Friedlander A.M. Efficacy of a human anthrax vaccine in guinea pigs, rabbits, and rhesus macaques against challenge by Bacillus anthracis isolates of diverse geographical origin. Vaccine 2001, 19:3241.
8. Fellows P.F., Linscott M.K., Little S.F., Gibbs P., Ivins B.E. Anthrax vaccine efficacy in golden Syrian hamsters. Vaccine 2002, 20:1421.
9. Food and Drug Administration Guidance for Industry: Bioanalytical Method Validation http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070107.pdf.
10. Food and Drug Administration December 11, 2008 Approval Letter http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm124462.htm.
11. Good K.M., Houser A., Arntzen L., Turnbull P.C. Naturally acquired anthrax antibodies in a cheetah (Acinonyx jubatus) in Botswana. J. Wildl. Dis. 2008, 44:721.
12. Gorse G.J., Keitel W., Keyserling K., Taylor D.N., Lock M., Alives K., Kenner J., Deans L., Gurwith M. Immunogenicity and tolerance of ascending doses of a recombinant protective antigen (rPA102) anthrax vaccine: a randomized, double-blinded, placebo controlled, multicenter trial. Vaccine 2006, 24:5950.
13. Grabenstein J.D. Anthrax vaccine: a review. Immunol. Allergy Clin. N. Am. 2003, 23:13.
14. Grunow R., Porsch-Ozcürümez M., Splettstoesser W., Buckendahl A., Hahn U., Beyer W., Böhm R., Huber M., vd Esche U., Bessler W., Frangoulidis D., Finke E.J. Monitoring of ELISA-reactive antibodies against anthrax protective antigen (PA), lethal factor (LF), and toxin-neutralising antibodies in serum of individuals vaccinated against anthrax with the PA-based UK anthrax vaccine. Vaccine 2007, 25:3679.
15. Gubbins M.J., Schmidt L., Tsang R.S., Berry J.D., Kabani A., Stewart D.I. Development of a competitive enzyme linked immunosorbent assay to identify epitope specific antibodies in recipients of the U.S. licensed anthrax vaccine. J. Immunoassay Immunochem. 2007, 28:213.
16. Hsu V.P., Lukacs S.L., Handzel T., Hayslett J., Harper S., Hales T., Semenova V.A., Romero-Steiner S., Elie C., Quinn C.P., Khabbaz R., Khan A.S., Martin G., Eisold J., Schuchat A., Hajjeh R.A. Opening a Bacillus anthracis-containing envelope, Capitol Hill, Washington, D.C.: the public health response. Emerg. Infect. Dis. 2002, 8:1039.
17. Hughes M.A., Burns D.L., Juris S.J., Tang W.J., Clement K.H., Eaton L.J., Kelly-Cirino C.D., McKee M.L., Powell B.S., Bishop B.L., Rudge T.L., Shine N., Verma A., Willis M.S., Morse S.A. The case for developing consensus standards for research in microbial pathogenesis: Bacillus anthracis toxins as an example. Infect. Immun. 2009, 77:4182.
18. Ivins B.E., Pitt M.L., Fellows P.F., Farchaus J.W., Benner G.E., Waag D.M., Little S.F., Anderson G.W., Gibs P.H., Friedlander A.M. Comparative efficacy of experimental anthrax vaccine candidates against inhalation anthrax in rhesus macaques. Vaccine 1998, 16:1141.
19. The Anthrax Vaccine: Is it Safe? Does It Work 2002, National Academy Press, Washington, DC. L.M. Joellenbeck, L.L. Zwanziger, J.S. Durch, B.L. Strom (Eds.).
20. Li H., Soroka S.D., Taylor T.H., Stamey K., Wallace Stinson K., Freeman A., Abramson D.R., Desai R., Cronin L.X., Oxford W., Caba J., Pleatman C., Pathak S., Schmidt D., Semenova V.A., Martin S.K., Wilkins P., Quinn C.P. Standardized, mathematical model-based and validated in vitro analysis of anthrax lethal toxin neutralization. J. Immunol. Methods 2008, 333:89.
21. Lininger L.A., Cullum M.E., Lyles M.B., Bienek D.R. The impact of incomplete vaccination schedules on the magnitude and duration of protective antigen-specific IgG responses in recipients of the US licensed anthrax vaccine. Vaccine 2007, 25:1619.
22. Little S.F., Ivins B.E., Webster W.M., Fellows P.E., Pitt M.L., Norris S.L., Andrews G.P. Duration of protection of rabbits after vaccination with Bacillus anthracis recombinant protective antigen vaccine. Vaccine 2006, 24:2530.
23. Madore D.V., Meade B.D., Rubin F., Deal C., Lynn F., Contributors Meeting Utilization of serologic assays to support efficacy of vaccines in nonclinical and clinical trials: meeting at the crossroads. Vaccine 2010, 23:4539.
24. Marano N., Plikaytis B.D., Martin S.W., Rose C., Semenova V.A., Martin S.K., Freeman A.E., Li H., Mulligan M.J., Parker S.D., Babcock J., Keitel W., Sahly H.E., Poland G.A., Jacobson R.M., Keyserling H.L., Soroka S.D., Fox S.F., Stamper J.L., Perkins B.A., Messonnier N., Quinn C.P. Effect of a reduced dose schedule and intramuscular administration of Anthrax Vaccine Adsorbed on immunogenicity and safety at 7 months: a randomized trial. JAMA 2008, 300:1532.
25. Martin R.F. General deming regression for estimating systematic bias and its confidence interval in method-comparison studies. Clin. Chem. 2000, 46:100.
26. O'Connell M.A., Belanger B.A., Haaland P.D. Calibration and assay development using the four-parameter logistic model. Chemom. Intell. Lab. Syst. 1993, 20:97.
27. Pittman P.R., Mangiafico J.A., Rossi C.A., Cannon T.L., Gibbs P.H., Parker G.W., Friedlander A.M. Anthrax vaccine: increasing intervals between the first two doses enhances antibody response in humans. Vaccine 2000, 15:213.
28. Pittman P.R., Kim-Ahn G., Pifat D.Y., Coonan K., Gibbs P., Little S., Pace-Templeton J.G., Myers R., Parker G.W., Friedlander A.M. Anthrax vaccine: immunogenicity and safety of a dose-reduction, route-change comparison study in humans. Vaccine 2002, 20:1412.
29. Pittman P.R., Leitman S.F., Oro J.G., Norris S.L., Marano N.M., Ranadive M.V., Sink B.S., McKee K.T. Protective antigen and toxin neutralization antibody patterns in anthrax vaccinees undergoing serial plasmapheresis. Clin. Diagn. Lab. Immunol. 2005, 12:713.
30. Plikaytis B.D., Holder P.F., Pais L.B., Maslanka S.E., Gheesling L.L., Carlone G.M. Determination of parallelism and nonparallelism in bioassay dilution curves. J. Clin. Microbiol. 1994, 32:2441.
31. Plikaytis, B.D, Carlone, G.M., Program ELISA for Windows User's Manual, version 2. Centers for Disease Control and Prevention, Atlanta, GA, U.S.A., 2005. Please add the link: http://www.cdc.gov/ncidod/dbmd/bimb/elisa.htm.
32. Purvis S., Freeman A., Semenova V., Steiner S., Simon L., Bedwell D., Wagner L., Nelson M., Lininger L., Bermudez C., Quinn C.P. Inter-laboratory Evaluation of an Anti-PA IgG ELISA Abstr. 44th Intersci. Conf. Antimicrob Agents Chemother. abstr. D-1376 2004.
33. Puziss M., Wright G.G. Gel Adsorbed Protective Antigen for Immunization of Man. J. Bacteriol. 1963, 85:230.
34. Quinn C.P., Semenova V.A., Elie C.M., Romero-Steiner S., Greene C., Li H., Stamey K., Steward-Clark E., Schmidt D.S., Mothershed E., Pruckler J., Schwartz S., Benson R.F., Helsel L.O., Holder P.F., Johnson S.E., Kellum M., Messmer T., Thacker W.L., Besser L., Plikaytis B.D., Taylor T.H., Freeman A.E., Wallace K.J., Dull P., Sejvar J., Bruce E., Moreno R., Schuchat A., Lingappa J.R., Martin S.K., Walls J., Bronsdon M., Carlone G.M., Bajani-Ari M., Ashford D.A., Stephens D.S., Perkins B.A. Specific, sensitive, and quantitative enzyme-linked immunosorbent assay for human Immunoglobulin G antibodies to anthrax protective antigen. Emerg. Infect. Dis. 2002, 8:1103.
35. Quinn C.P., Dull P.M., Semenova V.A., Li H., Crotty S., Taylor T.H., Steward-Clark E., Stamey K.L., Schmidt D.S., Stinson K.J., Freeman A.E., Elie C., Green C., Aubert R.D., Glidewell J., Perkins B.A., Ahmed R., Stephens D.S. Immune responses to Bacillus anthracis protective antigen in patients with bioterrorism-related cutaneous or inhalation anthrax. J. Infect. Dis. 2004, 190:1228.
36. Semenova V.A., Steward-Clark E., Stamey K.L., Taylor T.H., Schmidt D.S., Martin S.K., Marano N., Quinn C.P. Mass value assignment of total and subclass immunoglobulin G in a human standard anthrax reference serum. Clin. Diagn. Lab. Immunol. 2004, 11:919.
37. Semenova V.A., Schmidt D.S., Taylor T.H., Li H., Steward-Clark E., Soroka S.D., Ballard M.M., Quinn C.P. Analysis of anti-protective antigen IgG subclass distribution in recipients of anthrax vaccine adsorbed (AVA) and patients with cutaneous and inhalation anthrax. Vaccine 2007, 25:1780.
38. Shakya K.P., Hugh-Jones M.E., Elzer P.H. Evaluation of immune response to orally administered Sterne strain 34F2 anthrax vaccine. Vaccine 2007, 25:5374.
39. Singer D.E., Schneerson R., Bautista C.T., Rubertone M.V., Robbins J.B., Taylor D.N. Serum IgG antibody response to the protective antigen (PA) of Bacillus anthracis induced by anthrax vaccine adsorbed (AVA) among U.S. military personnel. Vaccine 2008, 26:869.
40. Slack S.M., Horbett T.A. Physiochemical and biochemical aspects of fibrinogen adsorption from plasma and binary proteins solutions onto polyethylene glass. J. Colloid Interface Sci. 1988, 124:535.
41. Slack S.M., Horbett T.A. Changes in fibrinogen adsorbed to segmented polyurethanes and hydroxyethylmethacrylate-ethylmethacrylate copolymers. J. Biomed. Mater. Res. 1992, 26:1633.
42. Soroka S.D., Schiffer J.M., Semenova V.A., Li H., Foster L., Quinn C.P. A two-stage, multilevel quality control system for serological assays in anthrax vaccine clinical trials. Biologicals 2010, 38:675.
43. Turnbull P.C., Broster M.G., Carman J.A., Manchee R.J., Melling J. Development of antibodies to protective antigen and lethal factor components of anthrax toxin in humans and guinea pigs and their relevance to protective immunity. Infect. Immun. 1986, 52:356.
44. Turnbull P.C., Diekmann M., Kilian J.W., Versfeld W., De Vos V., Arntzen L., Wolter K., Bartels P., Kotze A. Naturally acquired antibodies to Bacillus anthracis protective antigen in vultures of southern Africa. Onderstepoort J. Vet. Res. 2008, 75:95.
45. Walsh J.J., Pesik N., Quinn C.P., Urdaneta V., Dykewicz C.A., Boyer A.E., Guarner J., Wilkins P., Norville K.J., Barr J.R., Zaki S.R., Patel J.B., Reagan S.P., Pirkle J.L., Treadwell T.A., Messonnier N.R., Rotz L.D., Meyer R.F., Stephens D.S. A case of naturally acquired inhalation anthrax clinical care and analysis of anti-protective antigen immunoglobulin G and lethal factor. Clin. Infect. Dis. 2007, 44:968.
46. Welkos S.L., Friedlander A.M. Comparative safety and efficacy against Bacillus anthracis of protective antigen and live vaccines in mice. Microb. Pathog. 1988, 5:127.
47. Wright J.G., Quinn C.P., Shadomy S., Messonnier N. Use of anthrax vaccine in the United States: Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2009. MMWR Recomm. Rep. 2010, 59(RR-6):1.