A two-stage, multilevel quality control system for serological assays in anthrax vaccine clinical trials

Biologicals

Volumn 38, Issue 6, 2010, Pages 675-683

  Soroka, Stephen D ^a   Schiffer, Jarad M ^a   Semenova, Vera A ^a   Li, Han ^a   Foster, Lydia ^a   Quinn, Conrad P ^a  

^a NATIONAL CENTER FOR IMMUNIZATION AND RESPIRATORY DISEASES   (United States)

Author keywords

Anthrax vaccine adsorbed; AVRP; Bacillus anthracis; ELISA; Quality control; TNA

Indexed keywords

ANTHRAX TOXIN; ANTHRAX VACCINE; IMMUNOGLOBULIN G;

ACCURACY; ANALYTIC METHOD; ANALYTICAL ERROR; ANTHRAX LETHAL TOXIN NEUTRALIZATION ACTIVITY ASSAY; ARTICLE; CONTROL SYSTEM; CONTROLLED STUDY; ENZYME LINKED IMMUNOSORBENT ASSAY; MONITORING; PRIORITY JOURNAL; QUALITY CONTROL; QUANTITATIVE ASSAY; SEROLOGY; SERUM;

ANTHRAX VACCINES; ANTIGENS, BACTERIAL; BACTERIAL TOXINS; CENTERS FOR DISEASE CONTROL AND PREVENTION (U.S.); CLINICAL TRIALS AS TOPIC; ENZYME-LINKED IMMUNOSORBENT ASSAY; HUMANS; NEUTRALIZATION TESTS; QUALITY CONTROL; UNITED STATES;

BACILLUS ANTHRACIS;

EID: 78650239672     PISSN: 10451056     EISSN: 10958320     Source Type: Journal    
DOI: 10.1016/j.biologicals.2010.09.001     Document Type: Article

References (33)

1. Food_and_Drug_Administration Assuring the quality of test results Available from, [cited October 23, 2009]. http://www.fda.gov/downloads/ScienceResearch/FieldScience/UCM092168.pdf.
2. Food_and_Drug_Administration Guidance for industry: bioanalytical method validation Available from, [cited October 23, 2009]. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070107.pdf.
3. Gray J.J., Wreghitt T.G., McKee T.A., McIntyre P., Roth C.E., Smith D.J., et al. Internal quality assurance in a clinical virology laboratory. II. Internal quality control. Journal of Clinical Pathology 1995 Mar, 48(3):198-202.
4. Marano N., Plikaytis B.D., Martin S.W., Rose C., Semenova V.A., Martin S.K., et al. Effects of a reduced dose schedule and intramuscular administration of anthrax vaccine adsorbed on immunogenicity and safety at 7 months: a randomized trial. Jama 2008 Oct 1, 300(13):1532-1543.
5. Grabenstein J.D. Vaccines: countering anthrax: vaccines and immunoglobulins. Clinical Infectious Diseases 2008 Jan 1, 46(1):129-136.
6. Little S.F., Ivins B.E. Molecular pathogenesis of Bacillus anthracis infection. Microbes and Infection/Institut Pasteur 1999 Feb, 1(2):131-139.
7. Puziss M., Wright G.G. Studies on immunity in anthrax. X. Gel-adsorbed protective antigen for immunization of man. Journal of Bacteriology 1963 Jan, 85:230-236.
8. Li H., Soroka S.D., Taylor T.H., Stamey K.L., Stinson K.W., Freeman A.E., et al. Standardized, mathematical model-based and validated in vitro analysis of anthrax lethal toxin neutralization. Journal of Immunological Methods 2008 Apr 20, 333(1-2):89-106.
9. Quinn C.P., Semenova V.A., Elie C.M., Romero-Steiner S., Greene C., Li H., et al. Specific, sensitive, and quantitative enzyme-linked immunosorbent assay for human immunoglobulin G antibodies to anthrax toxin protective antigen. Emerging Infectious Diseases 2002 Oct, 8(10):1103-1110.
10. Semenova V.A., Steward-Clark E., Stamey K.L., Taylor T.H., Schmidt D.S., Martin S.K., et al. Mass value assignment of total and subclass immunoglobulin G in a human standard anthrax reference serum. Clinical and Diagnostic Laboratory Immunology 2004 Sep, 11(5):919-923.
11. ELISA for Windows 2.0: Available from, [cited October 23, 2009]. http://www.cdc.gov/ncidod/dbmd/bimb/ELISA/downloadelisa.htm.
12. 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. Journal of Clinical Microbiology 1994 Oct, 32(10):2441-2447.
13. Omland K.S., Brys A., Lansky D., Clement K., Lynn F. Interlaboratory comparison of results of an anthrax lethal toxin neutralization assay for assessment of functional antibodies in multiple species. Clinical and Vaccine Immunology 2008 Jun, 15(6):946-953.
14. Taylor TQC, Schmidt D, Freeman A, Li H, Semenova V, et al. Novel mathematical approach to TNA endpoints. Abstracts of the 5th International Meeting on Anthrax; 2003 March 31 to April 4, 2003. Nice, France: 2003.
15. Findlay J.W., Dillard R.F. Appropriate calibration curve fitting in ligand binding assays. The AAPS Journal 2007, 9(2):E260-E267.
16. Hering D., Thompson W., Hewetson J., Little S., Norris S., Pace-Templeton J. Validation of the anthrax lethal toxin neutralization assay. Biologicals 2004 Mar, 32(1):17-27.
17. Shewhart W.A. Economic control of quality of manufactured product 1931, D. Van Nostrand company, inc., New York.
18. Nelson L.S. The Shewhart control chart - tests for special causes. Journal of Quality Technology October 1984, 16(4):237-239.
19. Ren S., Frymier P.D. Reducing bioassay variability by identifying sources of variation and controlling key parameters in assay protocol. Chemosphere 2004 Oct, 57(2):81-90.
20. Finney D.J. Statistical method in biological assay 1978, Macmillan, New York. 3rd ed.
21. Plikaytis B.D., Turner S.H., Gheesling L.L., Carlone G.M. Comparisons of standard curve-fitting methods to quantitate Neisseria meningitidis group A polysaccharide antibody levels by enzyme-linked immunosorbent assay. Journal of Clinical Microbiology 1991 Jul, 29(7):1439-1446.
22. Rodbard D. Statistical quality control and routine data processing for radioimmunoassays and immunoradiometric assays. Clinical Chemistry 1974 Oct, 20(10):1255-1270.
23. Tan I.K., Jacob E., Lim S.H. Use of computers in quality assurance of laboratory testing. Annals of the Academy of Medicine, Singapore 1990 Sep, 19(5):724-730.
24. Banker C.A. Laboratory quality control: use of Shewhart charts and ANOVA. The American Journal of Medical Technology 1980 Apr, 46(4):274-279.
25. Blacksell S.D., Cameron A.R., Chamnanpood C., Chamnanpood P., Tatong D., Monpolsiri M., et al. Implementation of internal laboratory quality control procedures for the monitoring of ELISA performance at a regional veterinary laboratory. Veterinary Microbiology 1996 Jul, 51(1-2):1-9.
26. Goris N., De Clercq K. Quality assurance/quality control of foot and mouth disease solid phase competition enzyme-linked immunosorbent assay-Part II. Quality control: comparison of two charting methods to monitor assay performance. Revue scientifique et technique (International Office of Epizootics) 2005 Dec, 24(3):1005-1016.
27. Westgard J.O., Stein B., Westgard S.A., Kennedy R. QC Validator 2.0: a computer program for automatic selection of statistical QC procedures for applications in healthcare laboratories. Computer Methods and Programs in Biomedicine 1997 Jul, 53(3):175-186.
28. Levey S., Jennings E.R. The use of control charts in the clinical laboratory. American Journal of Clinical Pathology 1950 Nov, 20(11):1059-1066.
29. Westgard J.O., Barry P.L., Hunt M.R., Groth T. A multi-rule Shewhart chart for quality control in clinical chemistry. Clinical Chemistry 1981 Mar, 27(3):493-501.
30. Kazmierczak S.C. Laboratory quality control: using patient data to assess analytical performance. Clinical Chemistry and Laboratory Medicine 2003 May, 41(5):617-627.
31. Centers_for_Medicare_and_Medicaid_Services Clinical Laboratory Improvement Amendments (CLIA) Available from, [cited March 16, 2010]. http://www.cms.hhs.gov/clia/.
32. Food_and_Drug_Administration.CFR - Code of Federal Regulations Title 21 Part 58 Available from, [cited March 16, 2010]. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm%3FCFRPart%3D58.
33. Food_and_Drug_Administration.CFR - Code of Federal Regulations Title 21 Part 11 Available from, [cited March 16, 2010]. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm%3FCFRPart%3D11.