A practical guide to immunoassay method validation

Frontiers in Neurology

Volumn 6, Issue Aug, 2015, Pages

  Andreasson, Ulf ^a   Perret Liaudet, Armand ^b   van Waalwijk van Doorn, Linda J C ^c   Blennow, Kaj ^a   Chiasserini, Davide ^d   Engelborghs, Sebastiaan ^e,f   Fladby, Tormod ^g,h   Genc, Sermin ⁱ   Kruse, Niels ^j   Kuiperij, H Bea ^c   Kulic, Luka ^k   Lewczuk, Piotr ^l   Mollenhauer, Brit ^f,j   Mroczko, Barbara ^m   Parnetti, Lucilla ^d   Vanmechelen, Eugeen ⁿ   Verbeek, Marcel M ^c   Winblad, Bengt ^o   Zetterberg, Henrik ^a,p   Koel Simmelink, Marleen ^q   Teunissen, Charlotte E ^q   more..

^a UNIVERSITY OF GOTHENBURG   (Sweden)

^b UNIVERSITÉ LYON 1   (France)

^c RADBOUD UNIVERSITY   (Netherlands)

^d UNIVERSITY OF PERUGIA   (Italy)

^e UNIVERSITY OF ANTWERP   (Belgium)

^f Reference Center for Biological Markers of Dementia ^*  (Germany)

^g UNIVERSITY OF OSLO   (Norway)

^h AKERSHUS UNIVERSITY HOSPITAL   (Norway)

ⁱ DOKUZ EYLUL UNIVERSITY   (Turkey)

^j UNIVERSITY MEDICAL CENTER GÖTTINGEN   (Germany)

^k UNIVERSITY OF ZURICH   (Switzerland)

^l UNIVERSITY HOSPITAL ERLANGEN   (Germany)

^m MEDICAL UNIVERSITY OF BIALYSTOK   (Poland)

ⁿ ADX NEUROSCIENCES   (Belgium)

^o KAROLINSKA INSTITUTE   (Sweden)

^p UNIVERSITY COLLEGE LONDON   (United Kingdom)

^q VU UNIVERSITY MEDICAL CENTER   (Netherlands)

more..

Author keywords

Immunoassays; Limits of quantitation; Method validation; Precision; Robustness

Indexed keywords

BIOLOGICAL MARKER;

ALZHEIMER DISEASE; ANALYTICAL PARAMETERS; ARTICLE; DILUTION LINEARITY; ENZYME LINKED IMMUNOSORBENT ASSAY; IMMUNOASSAY; IMMUNOCHEMISTRY; LIMIT OF QUANTITATION; MEASUREMENT PRECISION; PARALLELISM; PROCESS CONTROL; PRODUCT RECOVERY; QUALITY CONTROL; RANDOM ERROR; ROBUSTNESS; SYSTEMATIC ERROR; TRUENESS; UNCERTAINTY; VALIDATION PROCESS;

EID: 84940975365     PISSN: None     EISSN: 16642295     Source Type: Journal    
DOI: 10.3389/fneur.2015.00179     Document Type: Article

References (20)

1. Blennow K, Hampel H, Weiner M, Zetterberg H. Cerebrospinal fluid and plasma biomarkers in Alzheimer disease. Nat Rev Neurol (2010) 6:131-44. doi: 10.1038/nrneurol.2010.4.
2. Lleo A, Cavedo E, Parnetti L, Vanderstichele H, Herukka SK, Andreasen N, et al. Cerebrospinal fluid biomarkers in trials for Alzheimer and Parkinson diseases. Nat Rev Neurol (2015) 11:41-55. doi:10.1038/nrneurol.2014.232.
3. ISO/IEC 17025. General Requirements for the Competence of Testing and Calibration Laboratories (2005).
4. Vassault A, Hulin A, Chapuzet E, Arnaud J, Giroud C; Membres Du Sous-Groupe 2 Analytique De La SFBC. [Verification/validation of the performances of analytical method]. Ann Biol Clin (Paris) (2010) 68(Spec No 1):247-94. doi:10.1684/abc.2011.0562.
5. Magnusson B, Örnemark U. Metodvalidering-Handbok för laboratoriet. Borås: SP Sveriges Tekniska Forskningsinstitut (2012).
6. Lee JW, Devanarayan V, Barrett YC, Weiner R, Allinson J, Fountain S, et al. Fit-for-purpose method development and validation for successful biomarker measurement. Pharm Res (2006) 23:312-28. doi:10.1007/s11095-005-9045-3.
7. ISO 5725-1. Accuracy (Trueness and Precision) of Measurement Methods and Results-Part 1: General Principles and Definitions (1994).
8. JCGM 100:2008. Evaluation of Measurement Data-Guide to the Expression of Uncertainty in Measurement (2008).
9. Guidance for Industry. Bioanalytical method validation. Fed Regist (2001) 66:28526-7.
10. Plackett RL, Burman JP. The design of optimum multifactorial experiments. Biometrika (1946) 33:305-25. doi:10.1093/biomet/33.4.305.
11. ISO 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 (1994).
12. CLSI. Evaluation of precision performance of quantitative measurement. methods; approved guideline-second edition. In: Wilhelm DM, editor. CLSI Document EP05-A2. Wayne, PA: Clinical and Laboratory Standards Institute (2004). p. 1-39.
13. Long GL, Winefordner JD. Limit of detection: a closer look at the IUPAC definition. Anal Chem (1983) 55:712A-24A. doi:10.1021/ac00258a001.
14. EMA. Guideline on Bioanalytical Method Validation (2011).
15. CLSI. Evaluation of the linearity of quantitative measurement procedures: a statistical approach; approved guideline. In: Polgar PE, editor. CLSI Document EP06-A. Wayne, PA: Clinical and Laboratory Standards Institute (2003). p. 1-47.
16. Desilva B, Smith W, Weiner R, Kelley M, Smolec J, Lee B, et al. Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules. Pharm Res (2003) 20:1885-900. doi:10.1023/B:PHAM.0000003390.51761.3d.
17. Plikaytis BD, Holder PF, Pais LB, Maslanka SE, Gheesling LL, Carlone GM. Determination of parallelism and nonparallelism in bioassay dilution curves. J Clin Microbiol (1994) 32:2441-7.
18. Valentin MA, Ma S, Zhao A, Legay F, Avrameas A. Validation of immunoassay for protein biomarkers: bioanalytical study plan implementation to support pre-clinical and clinical studies. J Pharm Biomed Anal (2011) 55:869-77. doi:10.1016/j.jpba.2011.03.033.
19. Westgard JO, Barry PL, Hunt MR, Groth T. A multi-rule Shewhart chart for quality control in clinical chemistry. Clin Chem (1981) 27:493-501.
20. ISO 15189:2003. Medical Laboratories-Particular Requirements for Quality and Competence (2003).