Facilitating the validation of novel protein biomarkers for dementia: An optimal workflow for the development of sandwich immunoassays

Frontiers in Neurology

Volumn 6, Issue SEP, 2015, Pages

  del Campo, Marta ^a   Jongbloed, Wesley ^a   Twaalfhoven, Harry A M ^a   Veerhuis, Robert ^a   Blankenstein, Marinus A ^a   Teunissen, Charlotte E ^a  

^a VU UNIVERSITY MEDICAL CENTER   (Netherlands)

Author keywords

AD; CSF; Dementia; ELISA; FTD; Guidelines; Novel biomarkers; Workflow

Indexed keywords

BIOLOGICAL MARKER; MONOCLONAL ANTIBODY; POLYCLONAL ANTIBODY;

ANTIBODY PRODUCTION; ANTIBODY SPECIFICITY; DEMENTIA; DIAGNOSTIC ACCURACY; DIAGNOSTIC TEST; ENZYME LINKED IMMUNOSORBENT ASSAY; HUMAN; IMMUNOASSAY; IMMUNOREACTIVITY; INTERMETHOD COMPARISON; MOLECULAR RECOGNITION; NONHUMAN; PROCESS DEVELOPMENT; REVIEW; SCREENING TEST; SENSITIVITY AND SPECIFICITY; VALIDATION PROCESS; WESTERN BLOTTING;

EID: 84944733159     PISSN: None     EISSN: 16642295     Source Type: Journal    
DOI: 10.3389/fneur.2015.00202     Document Type: Review

References (56)

1. Alzheimer's Disease International. World Alzheimer Report 2010. The Global Economic Impact of Dementia. London: Alzheimer's disease International (2010).
2. Tapiola T, Alafuzoff I, Herukka S-K, Parkkinen L, Hartikainen P, Soininen H, et al. Cerebrospinal fluid {beta}-amyloid 42 and tau proteins as biomarkers of Alzheimer-type pathologic changes in the brain. Arch Neurol (2009) 66:382-9. doi:10.1001/archneurol.2008.596
3. 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
4. Jack CR, Albert MS, Knopman DS, McKhann GM, Sperling RA, Carrillo MC, et al. Introduction to the recommendations from the National Institute on aging-Alzheimer's association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement (2011) 7:257-62. doi:10.1016/j.jalz.2011.03.004
5. Ahmed RM, Paterson RW, Warren JD, Zetterberg H, O'Brien JT, Fox NC, et al. Biomarkers in dementia: clinical utility and new directions. J Neurol Neurosurg Psychiatry (2014) 85:1426-34. doi:10.1136/jnnp-2014-307662
6. Craft GE, Chen A, Nairn AC. Recent advances in quantitative neuroproteomics. Methods (2013) 61:186-218. doi:10.1016/j.ymeth.2013.04.008
7. Schutzer SE. Rapidly maturing field of proteomics: a gateway to studying diseases. Proteomics (2014) 14:991-3. doi:10.1002/pmic.201400091
8. Frantzi M, Bhat A, Latosinska A. Clinical proteomic biomarkers: relevant issues on study design & technical considerations in biomarker development. Clin Transl Med (2014) 3:7. doi:10.1186/2001-1326-3-7
9. Zhang J, Goodlett DR, Montine TJ. Proteomic biomarker discovery in cerebrospinal fluid for neurodegenerative diseases. J Alzheimers Dis (2005) 8:377-86.
10. Kroksveen AC, Opsahl JA, Aye TT, Ulvik RJ, Berven FS. Proteomics of human cerebrospinal fluid: discovery and verification of biomarker candidates in neurodegenerative diseases using quantitative proteomics. J Proteomics (2011) 74:371-88. doi:10.1016/j.jprot.2010.11.010
11. Rifai N, Gillette MA, Carr SA. Protein biomarker discovery and validation: the long and uncertain path to clinical utility. Nat Biotechnol (2006) 24:971-83. doi:10.1038/nbt1235
12. Gao J, Garulacan L-A, Storm SM, Opiteck GJ, Dubaquie Y, Hefta SA, et al. Biomarker discovery in biological fluids. Methods (2005) 35:291-302. doi:10.1016/j.ymeth.2004.08.020
13. Meng Z, Veenstra TD. Targeted mass spectrometry approaches for protein biomarker verification. J Proteomics (2011) 74:2650-9. doi:10.1016/j.jprot.2011.04.011
14. Kroksveen AC, Aaseb� E, Vethe H, Van Pesch V, Franciotta D, Teunissen CE, et al. Discovery and initial verification of differentially abundant proteins between multiple sclerosis patients and controls using iTRAQ and SID-SRM. J Proteomics (2013) 78:312-25. doi:10.1016/j.jprot.2012.09.037
15. Cox KL, Devanarayan V, Kriauciunas A, Manetta J, Montrose C, Sittampalam S. Immunoassay methods. Assay Guidance Manual. Eli Lilly & Company and the National Center for Advancing Translational Sciences. Available from: http://www.ncbi.nlm.nih.gov/books/NBK92434/
16. Kelley M, DeSilva B. Key elements of bioanalytical method validation for macromolecules. AAPS J (2007) 9:E156-63. doi:10.1208/aapsj0902017
17. Ramos-Vara JA. Technical aspects of immunohistochemistry. Vet Pathol (2005) 42:405-26. doi:10.1354/vp.42-4-405
18. European Bioinformatics Institute (EMBL-EBI), SIB Swiss Institute of Bioinformatics, Protein Information Resource (PIR). Universal Protein Resource (UniProt). Available from: http://www.uniprot.org/help/about
19. Bank RPD. RCSB Protein Data Bank-RCSB PDB. Available from: http://www.rcsb.org/pdb/home/home.do
20. Omasits U, Ahrens CH, M�ller S, Wollscheid B. Protter: interactive protein feature visualization and integration with experimental proteomic data. Bioinformatics (2014) 30:884-6. doi:10.1093/bioinformatics/btt607
21. Bordeaux J, Welsh AW, Agarwal S, Killiam E, Baquero MT, Hanna JA, et al. Antibody validation. Biotechniques (2010) 48:197-209. doi:10.2144/000113382
22. Palomares LA, Estrada-Mondaca S, Ram�rez OT. Production of recombinant proteins: challenges and solutions. Methods Mol Biol (2004) 267:15-52. doi:10.1385/1-59259-774-2:015
23. Lipman NS, Jackson LR, Trudel LJ, Weis-Garcia F. Monoclonal versus polyclonal antibodies: distinguishing characteristics, applications, and information resources. ILAR J (2005) 46:258-68. doi:10.1093/ilar.46.3.258
24. Leenaars M, Hendriksen CFM. Critical steps in the production of polyclonal and monoclonal antibodies: evaluation and recommendations. ILAR J (2005) 46:269-79. doi:10.1093/ilar.46.3.269
25. Organization HP. Human Antibody Initiative. Available from: http://www.hupo.org/human-antibody-initiative/
26. Swedish Human Proteome Resource Program. Protein Atlas. Available from: http://www.proteinatlas.org/
27. 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
28. Koel-Simmelink MJA, Vennegoor A, Killestein J, Blankenstein MA, Norgren N, Korth C, et al. The impact of pre-analytical variables on the stability of neurofilament proteins in CSF, determined by a novel validated SinglePlex Luminex assay and ELISA. J Immunol Methods (2014) 402:43-9. doi:10.1016/j.jim.2013.11.008
29. Bjerke M, Portelius E, Minthon L, Wallin A, Anckars�ter H, Anckars�ter R, et al. Confounding factors influencing amyloid Beta concentration in cerebrospinal fluid. Int J Alzheimers Dis (2010) 2010:1-11. doi:10.4061/2010/986310
30. Teunissen CE, Verwey NA, Kester MI, van Uffelen K, Blankenstein MA. Standardization of assay procedures for analysis of the CSF biomarkers amyloid β((1-42)), tau, and phosphorylated tau in Alzheimer's disease: report of an international workshop. Int J Alzheimers Dis (2010) 2010:635053. doi:10.4061/2010/635053
31. Teunissen CE, Tumani H, Engelborghs S, Mollenhauer B. Biobanking of CSF: international standardization to optimize biomarker development. Clin Biochem (2014) 47:288-92. doi:10.1016/j.clinbiochem.2013.12.024
32. Del Campo M, Mollenhauer B, Bertolotto A, Engelborghs S, Hampel H, Simonsen AH, et al. Recommendations to standardize preanalytical confounding factors in Alzheimer's and Parkinson's disease cerebrospinal fluid biomarkers: an update. Biomark Med (2012) 6:419-30. doi:10.2217/bmm.12.46
33. Reiber H, Peter JB. Cerebrospinal fluid analysis: disease-related data patterns and evaluation programs. J Neurol Sci (2001) 184:101-22. doi:10.1016/S0022-510X(00)00501-3
34. Skliris G, Rowan B, Al-Dhaheri M, Williams C, Troup S, Begic S, et al. Immunohistochemical validation of multiple phospho-specific epitopes for estrogen receptor alpha (ERalpha) in tissue microarrays of ERalpha positive human breast carcinomas. Breast Cancer Res Treat (2009) 118:443-53. doi:10.1016/j.biotechadv.2011.08.021.Secreted
35. Del Campo M, Hoozemans JJM, Dekkers L-L, Rozemuller AJ, Korth C, M�ller-Schiffmann A, et al. BRI2-BRICHOS is increased in human amyloid plaques in early stages of Alzheimer's disease. Neurobiol Aging (2014) 35:1596-604. doi:10.1016/j.neurobiolaging.2014.01.007
36. Holmseth S, Zhou Y, Follin-Arbelet VV, Lehre KP, Bergles DE, Danbolt NC. Specificity controls for immunocytochemistry: the antigen preadsorption test can lead to inaccurate assessment of antibody specificity. J Histochem Cytochem (2012) 60:174-87. doi:10.1369/0022155411434828
37. Verwey NA, Veerhuis R, Twaalfhoven HAM, Wouters D, Hoozemans JJM, Bollen YJM, et al. Quantification of amyloid-beta 40 in cerebrospinal fluid. J Immunol Methods (2009) 348:57-66. doi:10.1016/j.jim.2009.06.011
38. Technical Guide for ELISA. Available from: http://www.kpl.com/docs/techdocs/KPL%20ELISA%20Technical%20Guide.pdf
39. Petzold A, Altintas A, Andreoni L, Bartos A, Berthele A, Blankenstein MA, et al. Neurofilament ELISA validation. J Immunol Methods (2010) 352:23-31. doi:10.1016/j.jim.2009.09.014
40. Smith BW, Strakova J, King JL, Erdman JW, O'Brien WD. Validated sandwich ELISA for the quantification of von Willebrand factor in rabbit plasma. Biomark Insights (2010) 2010:119-27. doi:10.4137/BMI.S6051
41. Wharf C, Kingdom U. Guideline on bioanalytical method validation. Eur Med Agency (2012) 44:1-23. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/document/document_detail.jsp?webContentId=WC500109686&mid=WC0b01ac058009a3dc
42. Food and Drug Administration. Guidance for Industry: Bioanalytical Method Validation. US Dep Heal Hum Serv (2001). p. 4-10. Available from: http://www.labcompliance.de/documents/FDA/FDA-Others/Laboratory/f-507-bioanalytical-4252fnl.pdf
43. 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
44. 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
45. Lee JW, Hall M. Method validation of protein biomarkers in support of drug development or clinical diagnosis/prognosis. J Chromatogr B Analyt Technol Biomed Life Sci (2009) 877:1259-71. doi:10.1016/j.jchromb.2008.11.022
46. BIOMARKAPD. Biomarkers for Alzheimer's and Parkinson Disease. Available from: http://www.neurodegenerationresearch.eu/initiatives/annual-calls-for-proposals/closed-calls/biomarkers-transnational-call/results-of-biomarker-call/biomarkapd/
47. Willemse EAJ, Teunissen CE. Importance of pre-analytical stability for CSF biomarker testing. Cerebrospinal Fluid in Clinical Neurology. p. 59-77. doi:10.1007/978-3-319-01225-4
48. Gnanapavan S, Hegen H, Khalil M, Hemmer B, Franciotta D, Hughes S, et al. Guidelines for uniform reporting of body fluid biomarker studies in neurologic disorders. Neurology (2014) 83:1210-6. doi:10.1212/WNL.0000000000000809
49. The Ronald and Nancy Reagean Research Institute of the Alzheimer's Association and The National Institute on Aging Working Group 123. Consensus report of the working group on: "molecular and biochemical markers of Alzheimer's disease". Neurobiol Aging (1998) 19:109-16.
50. Duits FH, Teunissen CE, Bouwman FH, Visser PJ, Mattsson N, Zetterberg H, et al. The cerebrospinal fluid "Alzheimer profile": easily said, but what does it mean? Alzheimers Dement (2014) 10(6):713-23.e2. doi:10.1016/j.jalz.2013.12.023
51. Humpel C. Identifying and validating biomarkers for Alzheimer's disease. Trends Biotechnol (2011) 29:26-32. doi:10.1016/j.tibtech.2010.09.007
52. Sackett D, Haynes R. The architecture of diagnostic research. Br Med J (2002) 324:593-541. doi:10.1136/bmj.324.7336.539
53. Tighe PJ, Ryder RR, Todd I, Fairclough LC. ELISA in the multiplex era: potentials and pitfalls. Proteomics Clin Appl (2015) 9(3-4):406-22. doi:10.1002/prca.201400130
54. Phillips KA, Van Bebber S, Issa AM. Diagnostics and biomarker development: priming the pipeline. Nat Rev Drug Discov (2006) 5:463-9. doi:10.1038/nrd2033
55. Food and Drug Administration. IVD Regulation. Available from: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/IVDRegulatoryAssistance/ucm123682.htm#1
56. European Commission. In Vitro Diagnostic Medical Devices. Directive 98/79/EC. Available from: http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/iv-diagnostic-medical-devices/index_en.htm