[en] Evaluation of analytical results reliability is of core importance as crucial decisions
are taken with them. From the various methodologies to evaluate the fitness of
purpose of analytical methods, overall measurement uncertainty estimation is more
and more applied. Overall measurement uncertainty allows to combine
simultaneously the remaining systematic influences to the random sources of
uncertainty and allows assessing the reliability of results generated by analytical
methods. However there are various interpretations on how to estimate overall
measurement uncertainty, and thus various models for estimating it. Each model
together with its assumptions has great impacts on the risks to abusively declare that
analytical methods are suitable for their intended purpose. This review paper aims at
i) summarizing the various models used to estimate overall measurement uncertainty,
ii) provide their pros and cons, iii) review the main areas of application and iv) as a
conclusion provide some recommendations when evaluating overall measurement
uncertainty.
Disciplines :
Pharmacy, pharmacology & toxicology
Author, co-author :
Rozet, Eric ; Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Guidance for Industry: Bioanalytical Method Validation, US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Rockville, May 2001. (accessed on March 16th 2011). http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070107.pdf.
Thompson M., Ellison S.L.R., Wood R. Pure Appl. Chem. 2002, 74:835.
International Conference on Harmonization (ICH) of Technical Requirements for registration of Pharmaceuticals for Human Use, Topic Q2 (R1): Validation of Analytical Procedures: Text and Methodology, Geneva, 2005. (accessed on March 16th 2011). http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q2_R1/Step4/Q2_R1__Guideline.pdf.
EP21-A, Estimation of Total Analytical Error for Clinical Laboratory Methods; Approved Guideline, Clinical and Laboratory Standards Institute (CLSI21-A), Wayne, PA, 2003.
ISO/CEI 17025: General Requirements for the Competence of Testing and Calibration Laboratories, International Organization for Standardization (ISO), Geneva, 2005.
ISO 15189: Medical Laboratories - Particular Requirements for Quality and Competence, International Organization for Standardization (ISO), Geneva, 2007.
Method Validation and Quality Control procedures for Pesticide Residues Analysis in Food and Feed, in Doc. SANCO/2009/10684, 1 January 2010. (accessed on March 16th 2011). http://ec.europa.eu/food/plant/protection/resources/qualcontrol_en.pdf.
2002/657/EC: Commission Decision of 12 August 2002 implementing Council Directive 96/23/EC Concerning the Performance of Analytical Methods and the Interpretation of Results, Off. J. Eur. Commun. L221 (2002) 8. (accessed on March 16th 2011). http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2002:221:0008:0036:EN:PDF.
Quattrocchi O., Martin G., Runser D., Iser R., Xi F., Pappa H. Pharmacopeial Forum 2009, 35:1380.
EP9-A2 Method Comparison and Bias Estimation 2002, Clinical and Laboratory Standards Institute, Wayne, PA.
Rozet E., Ceccato A., Hubert C., Ziémons E., Oprean R., Rudaz S., Boulanger B., Hubert Ph. J. Chromatogr. A 2007, 1158:111.
Bouabidi A., Rozet E., Fillet M., Ziémons E., Chapuzet E., Mertens B., Klinkenberg R., Ceccato A., Talbi M., Streel B., Bouklouze A., Boulanger B., Hubert Ph. J. Chromatogr. A 2010, 1217:3180.
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. J. Pharm. Biomed. Anal. 2004, 36:579.
Rozet E., Hubert C., Ceccato A., Dewé W., Ziémons E., Moonen F., Michail K., Wintersteiger R., Streel B., Boulanger B., Hubert Ph. J. Chromatogr. A 2007, 1158:126.
Boulanger B., Rozet E., Moonen F., Rudaz S., Hubert Ph. J. Chromatogr. B 2009, 877:2235.
International Organization for Standardization (ISO), Guide to the Expression of Uncertainty in Measurement (GUM), ISO, Geneva, 1995.
JCGM 100:2008, Evaluation of Measurement Data - Guide to the Expression of Uncertainty in Measurement (GUM), 2008. (accessed on March 16th 2011). http://www.bipm.org/utils/common/documents/jcgm/JCGM_100_2008_F.pdf.
Hund E., Massart D.L., Smeyers-Verbeke J. Trends Anal. Chem. 2001, 20:394.
Maroto A., Boqué R., Riu J., Rius F.X. Trends Anal. Chem. 1999, 18:577.
Hund E., Massart D.L., Smeyers-Verbeke J. Anal. Chim. Acta 2003, 480:39.
Gonzalez A.G., Herrador M.A. Trends Anal. Chem. 2007, 26:227-238.
Feinberg M., Boulanger B., Dewé W., Hubert P. Anal. Bioanal. Chem. 2004, 380:502.
Marini R.D., Rozet E., Vander Heyden Y., Ziémons E., Boulanger B., Bouklouze A., Servais A.-C., Fillet M., Crommen J., Hubert Ph. J. Pharm. Biomed. Anal. 2007, 44:640.
Hubert Ph., Chiap P., Crommen J., Boulanger B., Chapuzet E., Mercier N., Bervoas-Martin S., Chevalier P., Grandjean D., Lagorce P., Lallier M., Laparra M.C., Laurentie M., Nivet J.C. Anal. Chim. Acta 1999, 391:135.
Satterthwaite F. Psychometrika 1941, 6:309.
Wilks S.S. Ann. Math. Statist. 1942, 13:400.
Vardeman S.B. Am. Stat. 1992, 46:193.
P. Dagnelie, Statistique théorique et appliqué, 2. Inférence statistique à une et deux dimensions, De Boeck Université, 2006, 737 p.
I. Guttman, Statistical Tolerance Regions: Classical and Bayesian, Hafner, Darian, 1969, 147 p.
Hahn G.J., Meeker W.Q. Statistical Intervals: A Guide for Practitioners 1991, Wiley Edition, 392 p.
Mee R.W. Technometrics 1984, 26:251.
Searle S.R., Casella G., McCulloch C.E. Variance Components 1992, John Wiley & Sons, New York.
Hoffman D., Kringle R. J. Biopharm. Stat. 2005, 15:283.
DeSilva B., Smith W., Weiner R., Kelley M., Smolec J., Lee B., Khan M., Tacey R., Hill H., Celniker A. Pharm. Res. 2003, 20:1885.
Lee J.W., Devanarayan V., Barrett Y.C., Weiner R., Allinson J., Fountain S., Keller S., Weinryb I., Green M., DUan L., Rogers J.A., Millham R., O'Brien P.J., Sailstad J., Khan M., Ray C., Wagner J.A. Pharm. Res. 2006, 23:312.
Viswanathan C.T., Bansal S., Booth B., DeStefano A.J., Rose M.J., Sailstad J., Shah V.P., Skelly J.P., Swann P.G., Weiner R. AAPS J. 2007, 9:E30.
Hubert Ph., Nguyen-Huu J.-J., Boulanger B., Chapuzet E., Cohen N., Compagnon P.-A., Dewé W., Feinberg M., Laurentie M., Mercier N., Muzard G., Valat L., Rozet E. J. Pharm. Biomed. Anal. 2007, 45:82.
Westgard J.O., Carey R.N., Wold S. Clin. Chem. 1974, 20:825.
Ricós C., Baadenhuijsen H., Libeer J.-K., Hyltoft Petersen P., Stöckl D., Thienpont L., et al. Eur. J. Clin. Chem. Clin. Biochem. 1996, 34:159.
Boyd J.C., Bruns D.E. Clin. Chem. 2001, 47:209.
Rbeida O., Christiaens B., Chiap P., Hubert Ph., Lubda D., Boos K.-S., Crommen J. J. Pharm. Biomed. Anal. 2003, 32:829.
Christiaens B., Chiap P., Rbeida O., Cello D., Crommen J., Hubert Ph. J. Chromatogr. B 2003, 795:73.
Goulay-Dufa S., Do B., Le Hoang M.D., Raust J.A., Graffard H., Guyon F., Pradeau D. J. Chromatogr. B 2004, 805:261.
Do B., Goulay-Dufa S., Le Hoang M.D., Adoui N., Graffard H., Guyon F., Pradeau D. J. Chromatogr. B 2007, 845:104.
Levert H., Odou P., Robert H. J. Pharm. Biomed. Anal. 2002, 28:517.
Thomas A., Widmer C., Hopfgartner G., Staub C. J. Pharm. Biomed. Anal. 2007, 45:495.
Chiap P., Evrard B., Bimazubute M.A., de Tullio P., Hubert Ph., Delattre L., Crommen J. J. Chromatogr. A 2000, 870:121.
Rudaz S., Souverain S., Schelling C., Deleers M., Klompb A., Norris A., Vu T.L., Ariano B., Veuthey J.-L. Anal. Chim. Acta 2003, 492:271.
Toussaint B., Duchateau A.L.L., van der Wal S.j., Albert A., Hubert Ph., Crommen J. J. Chromatogr. A 2000, 890:239.
Mantanus J., Ziémons E., Lebrun P., Rozet E., Klinkenberg R., Streel B., Evrard B., Hubert Ph. Anal. Chim. Acta 2009, 642:186.
Hubert C., Ziémons E., Rozet E., Breuer A., Lambert A., Jasselette C., Lejeune R., Hubert Ph. Talanta 2010, 80:1413.
Ziémons E., Mantanus J., Lebrun P., Rozet E., Evrard B., Hubert Ph. J. Pharm. Biomed. Anal. 2010, 53:510.
Marini R.D., Rozet E., Montes M.L.A., Rohrbasser C., Roht S., Rhème D., Bonnabry P., Schappler J., Veuthey J.-L., Hubert Ph., Rudaz S. J. Pharm. Biomed. Anal. 2010, 53:1278.
Staes E., Rozet E., Ucakar B., Hubert Ph., Préat V. J. Pharm. Biomed. Anal. 2010, 51:633.
Mantanus J., Ziémons E., Lebrun P., Rozet E., Klinkenberg R., Streel B., Evrard B., Hubert Ph. Talanta 2010, 80:1750.
Rozet E., Mertens B., Dewé W., Ceccato A., Govaerts B., Boulanger B., Chiap P., Streel B., Crommen J., Hubert Ph. J. Pharm. Biomed. Anal. 2006, 42:64.
Bodson C., Rozet E., Ziémons E., Evrard B., Hubert Ph., Delattre L. J. Pharm. Biomed. Anal. 2007, 45:356.
Gibelin N., Dupont D., Imbert S., Rozet E. J. Chromatogr. B 2009, 877:2407.
Bodson C., Dewé W., Hubert Ph., Delattre L. J. Pharm. Biomed. Anal. 2006, 41:783.
De Beer T.R.M., Baeyens W.R.G., Vermeire A., Broes D., Remon J.P., Vervaet C. Anal. Chim. Acta 2007, 589:192.
Jacobs P., Dewé W., Flament A., Gibella M., Ceccato A. J. Pharm. Biomed. Anal. 2006, 40:294.
Briône W., Herbots C., Köttgen C., Loix S., Gibella M., Bertrand M., Ceccato A. J. Pharm. Biomed. Anal. 2007, 44:615.
Hubert C., Houari S., Lecomte F., Houbart V., De Bleye C., Fillet M., Piel G., Rozet E., Hubert Ph. J. Chromatogr. A 2010, 1217:3275.
Martin G.B., Chiap P., Paquet P., Pierard G., de Tullio P., Martin Y., Rozet E., Hubert Ph., Crommen J., Fillet M. J. Chromatogr. A 2007, 1156:141.
Bimazubute M.A., Rozet E., Dizier I., Gustin P., Hubert Ph., Crommen J., Chiap P. J. Chromatogr. A 2008, 1189:456.
Bimazubute M.A., Rozet E., Dizier I., Van Heugen J.-Cl., Arancio E., Gustin P., Crommen J., Chiap P. J. Chromatogr. B 2009, 877:2349.
Rozet E., Wascotte V., Lecouturier N., Préat V., Dewé W., Boulanger B., Hubert Ph. Anal. Chim. Acta 2007, 591:239.
Zufía L., Aldaz A., Ibánez N., Viteri C. J. Pharm. Biomed. Anal. 2009, 49:547.
Hambye S., Stanicki D., Colet J.-M., Aliouat E.M., Vanden Eynde J.J., Blankert B. Talanta 2011, 83:832.
Kpoviéssi D.S.S., Gbaguidi F., Gbénou J., Accrombessi G., Moudachirou M., Rozet E., Hubert Ph., Quetin-Leclercq J. J. Pharm. Biomed. Anal. 2008, 48:1127.
Rafamantanana M.H., Rozet E., Raoelison G.E., Cheuk K., Ratsimamanga S.U., Hubert Ph., Quetin-Leclercq J. J. Chromatogr. B 2009, 877:2396.
Ziémons E., Barillaro V., Rozet E., Wandji Mbakop N., Lejeune R., Angenot L., Thunus L., Hubert Ph. Talanta 2007, 71:911.
Coran S.A., Bartolucci G., Bambagiotti-Alberti M. J. Chromatogr. A 2008, 1207:155.
Dencausse L., Galland A., Clamou J.L., Basso J. Int. J. Cosmet. Sci. 2008, 30:373.
Heuskin S., Rozet E., Lorge S., Farmakidis J., Hubert Ph., Verheggen F., Haubruge E., Wathelet J.-P., Lognay G. J. Pharm. Biomed. Anal. 2010, 53:962.
Feinberg M., San-Redon J., Assié A. J. Chromatogr. B 2009, 877:2388.
Moretton C., Crétier G., Nigay H., Rocca J.-L. J. Chromatogr. A 2008, 73:1198.
Laurentie M., Gaudin V. J. Chromatogr. B 2009, 877:2375.
Chéneau E., Henri J., Pirotais Y., Abjean J.-P., Roudaut B., Sanders P., Laurentie M. J. Chromatogr. B 2007, 850:15.
Feinberg M. J. Chromatogr. A 2007, 1158:174.
Gaudin V., Laurentie M. J. Chromatogr. B 2009, 877:2358.
Gonzalez A.G., Herrador M.A. Talanta 2006, 70:896.
Choong E., Rudaz S., Kottelat A., Guillarme D., Veuthey J.-L., Eap C.B. J. Pharm. Biomed. Anal. 2009, 50:1000.
Kharbouche H., Sporkert F., Troxler S., Augsburger M., Mangin P., Staub C. J. Chromatogr. B 2009, 877:2337.
Schappler J., Guillarme D., Prat J., Veuthey J.-L., Rudaz S. Electrophoresis 2008, 29:2193.
Cavalier E., Rozet E., Dubois N., Charlier C., Hubert Ph., Chapelle J.-P., Krzesinski J.-M., Delanaye P. Clin. Chim. Acta 2008, 396:80.
Boemer F., Bours V., Schoos R., Hubert Ph., Rozet E. J. Chromatogr. B 2009, 877:2412.
De Pauw P.E., Mackin R.B., Goubert P., Van Schravendijk C., Gorus F.K. J. Chromatogr. B 2009, 877:2403.