Guidelines for the statistical analysis of a collaborative study of a laboratory method for testing disinfectant product performance

Journal of AOAC International

Volumn 96, Issue 5, 2013, Pages 1138-1151

  Hamilton, Martin A ^a   Hamilton, Gordon Cord ^a   Goeres, Darla M ^b   Parker, Albert E ^b  

^a Big Sky Statistical Analysts LLC   (United States)

^b MONTANA STATE UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

COMPUTER CODES; LABORATORY METHODS; LABORATORY STUDIES; PRODUCT PERFORMANCE; REPRODUCIBILITIES; STATISTICAL TECHNIQUES; SUSPENSION TEST; VIABLE CELLS;

BACTERIA; STATISTICS;

DISINFECTANTS;

DISINFECTANT AGENT;

COOPERATION; PRACTICE GUIDELINE; REPRODUCIBILITY; STATISTICAL ANALYSIS; ARTICLE;

COOPERATIVE BEHAVIOR; DATA INTERPRETATION, STATISTICAL; DISINFECTANTS; GUIDELINES AS TOPIC; REPRODUCIBILITY OF RESULTS;

EID: 84892146211     PISSN: 10603271     EISSN: None     Source Type: Journal    
DOI: 10.5740/jaoacint.12-217     Document Type: Article

References (50)

1. ISO (1994) 5725-1, Accuracy (Trueness and Precision) of Measurement Methods and Results-Part 1: General Principles and Definitions, International Organization for Standardization, Geneva, Switzerland (Cor. 1:1998)
2. ISO (1994) 5725-2, Accuracy (Trueness and Precision) of Measurement Methods and Results-Part 2: Basic Method for the Determination of Repeatability and Reproducibility of a Standard Measurement Method, International Organization for Standardization, Geneva, Switzerland (Cor. 1:2002)
3. ISO (1994) 5725-3, Accuracy (Trueness and Precision) of Measurement Methods and Results-Part 3: Intermediate Measures of the Precision of a Standard Measurement Method, International Organization for Standardization, Geneva, Switzerland (Cor. 1:2001)
4. Official Methods of Analysis (2005) 18th Ed., AOAC INTERNATIONAL, Gaithersburg, MD, Appendix D
5. ASTM International (2009) Standard E691-09 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method, ASTM International, West Conshohocken, PA
6. ISO (2003) 16140, Microbiology of Food and Animal Feeding Stuffs-Protocol for the Validation of Alternative Methods, International Organization for Standardization, Geneva, Switzerland
7. ISO (2006) 19036, Microbiology of Food and Animal Feeding Stuffs-Guidelines for the Estimation of Measurement Uncertainty for Quantitative Determinations, International Organization for Standardization, Geneva, Switzerland
8. Niemi, R.M., & Niemela, S.I. (2001) Accred. Qual. Assur. 6, 372-275. http://dx.doi.org/10.1007/s007690100360
9. Tillett, H.E., & Sartory, D. (2004) Accred. Qual. Assur. 9, 629-632. http://dx.doi.org/10.1007/s00769-004-0798-x
10. Hamilton, M. (2010) How the Differences Between Disinfectant Tests and Chemical Assays Affect Method Evaluation Criteria, KSA-SM-05, 2010-08-19, Center for Biofilm Engineering at Montana State University, Bozeman, MT, http://www.biofilm.montana.edu/resources/knowledge-sharing-articles (accessed on July 3, 2013)
11. Hamilton, M. (2011) Testing Surface Disinfectants: Quantitative, Semiquantitative, Quantal, and Alternative Methods, KSA-SM-02, 2011-10-25, Center for Biofilm Engineering at Montana State University, Bozeman, MT, http://www.biofilm.montana.edu/resources/knowledge-sharing-articles (accessed on July 3, 2013)
12. Hamilton, M. (2010) Testing Surface Disinfectants: Desirable Attributes of a Standardized Method, KSA-SM-03, 2010-06-10, Center for Biofilm Engineering at Montana State University, Bozeman, MT, http://www.biofilm.montana.edu/ resources/knowledge-sharing-articles (accessed on July 3, 2013)
13. Youden, W.J., & Steiner, E.H. (1975) Statistical Manual of the AOAC-Statistical Techniques for Collaborative Tests, AOAC INTERNATIONAL, Gaithersburg, MD
14. Tomasino, S.F., & Hamilton, M.A. (2006) J. AOAC Int. 89, 1373-1397
15. Tomasino, S.F., & Hamilton, M.A. (2007) J. AOAC Int. 90, 456-464
16. Tomasino, S.F., Pines, R.M., Cottrill, M.P., & Hamilton, M.A. (2008) J. AOAC Int. 91, 833-852
17. AOAC Official Method 965.13, Disinfectants (Water) for Swimming Pools (1970) AOAC INTERNATIONAL, Gaithersburg, MD
18. Bloomfield, S.F., & Looney, E. (1992) J. Appl. Bacteriol. 73, 87-93. http://dx.doi.org/10.1111/j.1365-2672.1992.tb04975.x
19. Hamilton, M., Buckingham-Meyer, K., & Goeres, D. (2009) J. AOAC Int. 92, 1755-1762
20. Neter, J., Kutner, M.H., Wasserman, W., & Nachtsheim, C.J. (1996) Applied Linear Statistical Models, 4th Ed., McGraw-Hill, Boston, MA
21. Forster, L.I. (2003) J. AOAC Int. 86, 1089-1094
22. Jarvis, B. (2008) Statistical Aspects of the Microbiological Examination of Foods, 2nd Ed., Elsevier, San Diego, CA
23. Eaton, A.D., Clesceri, L.S., Greenberg, A.E., & Franson, M.A.H. (1995) Standard Methods for the Examination of Water and Wastewater-Section 9020, American Public Health Association, Washington, DC
24. DeVries, T.A., & Hamilton, M.A. (1999) Quant. Microbiol. 1, 29-45. http://dx.doi.org/10.1023/A:1010072226737
25. Zelver, N., Hamilton, M., Goeres, D., & Heersink, J. (2001) in Methods Enzymol. Biofilms II, Vol. 337, R.J. Doyle (Ed.), Academic Press, New York, NY, pp 363-376
26. Hamilton, M. (2011) The Log Reduction (LR) Measure of Disinfectant Efficacy, KSA-SM-07, 2011-11-07, Center for Biofilm Engineering at Montana State University, Bozeman, MT, http://www.biofilm.montana.edu/resources/knowledge- sharing-articles (accessed on July 13, 2013)
27. Cochran, W.G. (1950) Biometrics 6, 105-116. http://dx.doi.org/10.2307/ 3001491
28. Blodgett, R.J. (2006) in Bacteriological Analytical Manual, Appendix 2, FDA. http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/default.htm (accessed on July 3, 2013)
29. Garthright, W.E. (1993) Biom. J. 35, 299-314. http://dx.doi.org/10.1002/ bimj.4710350306
30. Hamilton, M. (2011) The P/N Formula for the Log Reduction When Using a Semiquantitative Disinfectant Test of Type SQ1, KSA-SM-08, 2011-02-01, Center for Biofilm Engineering at Montana State University, Bozeman, MT. http://www.biofilm.montana.edu/resources/knowledge-sharing-articles (accessed on July 3, 2013)
31. ASTM International (2102) Standard E2799-12 Standard Test Method for Testing Disinfectant Efficacy Against Pseudomonas aeruginosa Biofilm Using the MBEC Assay, ASTM International, West Conshohocken, PA
32. ASTM International (2007) Standard E2562-07 Standard Test Method for Quantification of Pseudomonas aeruginosa Biofilm Grown with High Shear and Continuous Flow Using the CDC Biofilm Reactor, ASTM International, West Conshohocken, PA
33. AOAC Official Method 2008.05, Efficacy of Liquid Sporicides Against Spores of Bacillus subtilis on a Hard Nonporous Surface, Quantitative Three-Step Method (2008) AOAC INTERNATIONAL, Gaithersburg, MD
34. Garthright, W.E., & Blodgett, R.J. (2003) Food Microbiol. 20, 439-445. http://dx.doi.org/10.1016/S0740-0020(02)00144-2
35. AOAC INTERNATIONAL (2004) Official Method 966.04, Sporicidal Activity of Disinfectants. AOAC INTERNATIONAL, Gaithersburg, MD
36. EPA (2008) Protocol for Testing the Efficacy of Disinfectants Used to Inactivate Duck Hepatitis B Virus and to Support Corresponding Label Claims, ver. August 2002, Developed by MicroBioTest, Inc. and submitted to the U.S. Environmental Protection Agency, http://www.epa.gov/oppad001/pdf-files/ hbvprotocol.pdf (accessed on July 3, 2013)
37. Haas, C.N., & Scheff, P.A. (1990) Environ. Sci. Technol. 24, 912-919, http://dx.doi.org/10.1021/es00076a021
38. EPA (2006) Data Quality Assessment: Statistical Methods for Practitioners EPA QA/G-9S, EPA/240/B-06/003, February 2006, U.S. Environmental Protection Agency, Office of Environmental Information, Washington, DC. http://www.epa.gov/quality/qs-docs/g9s-final.pdf (accessed on July 3, 2013)
39. Antweiler, R.C., & Taylor, H.E. (2008) Environ. Sci. Technol. 42, 3732-3738. http://dx.doi.org/10.1021/es071301c
40. Lorimer, M.F., & Kiermeier, A. (2007) Int. J. Food Microbiol. 116, 313-318. http://dx.doi.org/10.1016/j.ijfoodmicro.2007.02.001
41. Shorten, P.R., Pleasants, A.B., & Soboleva, T.K. (2006) Int. J. Food Microbiol. 108, 369-375
42. Haas, C.N., & Heller, B. (1988) Appl. Environ. Microbiol. 54, 2069-2072
43. Blodgett, R.J. (2008) Food Microbiol. 25, 92-98. http://dx.doi.org/10. 1016/j.fm.2007.07.006
44. Gastwirth, J.L., Gel, Y.R., & Miao, W. (2009) Stat. Sci. 24, 343-360. http://dx.doi.org/10.1214/09-STS301
45. Rubino, J.R., Bauer, J.M., Clarke, P.H., Woodward, B.B., Porter, F.C., & Hilton, H.G. (1992) J. AOAC Int. 75, 635-645
46. Arlea, C., King, S., Bennie, B., Kemp, K., Mertz, E., & Staub, R. (2008) J. AOAC Int. 91, 152-158
47. Marcuse, S. (1949) Biometrics 5, 189-206. http://dx.doi.org/10.2307/ 3001935
48. Hamilton, M. (2011) Testing Surface Disinfectants: How to Decide Whether the Reproducibility Standard Deviation is Small Enough, KSA-SM-11, 2011-09-11, Center for Biofilm Engineering at Montana State University, Bozeman, MT, http://www.biofilm.montana.edu/resources/knowledge-sharing-articles (accessed on July 3, 2013)
49. Tilt, N., & Hamilton, M. (1999) J. AOAC Int. 82, 384-389
50. Hubert, Ph., Nguyen-Huu, J.-J., Boulanger, B., Chapuzet, E., Chiap, P., Cohen, N., Compagnon, P.-A., Dewé, W., Feinberg, M., Lallier, M., Laurentie, M., Mercier, N., Muzard, G., Nivet, C., & Valat, L. (2004) J. Pharm. Biomed. Anal. 36, 579-586