Optimized Standard Operating Procedures for the Analysis of Cerebrospinal Fluid Aβ42 and the Ratios of Aβ Isoforms Using Low Protein Binding Tubes

Journal of Alzheimer's Disease

Volumn 53, Issue 3, 2016, Pages 1121-1132

  Vanderstichele, Hugo Marcel Johan ^a   Janelidze, Shorena ^b   Demeyer, Leentje ^a   Coart, Els ^c   Stoops, Erik ^a   Herbst, Victor ^d   Mauroo, Kimberley ^a   Brix, Britta ^b   Hansson, Oskar ^b,e  

^a ADX NEUROSCIENCES   (Belgium)

^b LUND UNIVERSITY   (Sweden)

^c INTERNATIONAL DRUG DEVELOPMENT INSTITUTE   (Belgium)

^d Institute of Experimental Immunology   (Germany)

^e LUND UNIVERSITY HOSPITAL   (Sweden)

Author keywords

Amyloid; cerebrospinal fluid; ELISA; improvement; standard operating procedure

Indexed keywords

AMYLOID BETA PROTEIN; AMYLOID BETA PROTEIN[1-42]; BIOLOGICAL MARKER; POLYPROPYLENE; AMYLOID BETA PROTEIN[1-40]; AMYLOID BETA-PROTEIN (1-42); ISOPROTEIN; PEPTIDE FRAGMENT;

ALZHEIMER DISEASE; AMYLOID NEUROPATHY; ARTICLE; CEREBROSPINAL FLUID ANALYSIS; ENZYME LINKED IMMUNOSORBENT ASSAY; FREEZE THAWING; HUMAN; LOW PROTEIN BINDING TUBE; MEASUREMENT; PRIORITY JOURNAL; PROCEDURES; STANDARD OPERATING PROCEDURE; STORAGE; TUBE; VALIDATION PROCESS; BRAIN; CEREBROSPINAL FLUID; FEMALE; MALE; METABOLISM; PATHOLOGY; STATISTICAL MODEL;

ALZHEIMER DISEASE; AMYLOID BETA-PEPTIDES; BRAIN; ENZYME-LINKED IMMUNOSORBENT ASSAY; FEMALE; HUMANS; MALE; MODELS, STATISTICAL; PEPTIDE FRAGMENTS; PROTEIN ISOFORMS;

EID: 84981350366     PISSN: 13872877     EISSN: 18758908     Source Type: Journal    
DOI: 10.3233/JAD-160286     Document Type: Article

References (31)

1. European Medicines Agency (2011) Qualification opinion of Alzheimer's disease novel methodologies/biomarkers for BMS-708163. http://www.ema.europa.eu/docs/en GB/ document library/Regulatory and procedural guideline/ 2011/02/WC500102018.pdf.
2. U.S. Food and Drug Administration. Drug Development Tools (DDT) Letters of Support. http://www.fda. gov/Drugs/DevelopmentApprovalProcess/ucm434382.htm
3. Dubois B, Feldman HH, Jacova C, Hampel H, Molinuevo JL, Blennow K, DeKosky ST, Gauthier S, Selkoe D, Bateman R, Cappa S, Crutch S, Engelborghs S, Frisoni GB, Fox NC, Galasko D, Habert M-O, Jicha GA, Nordberg A, Pasquier F, Rabinovici G, Robert P, Rowe C, Salloway S, Sarazin M, Epelbaum S, de Souza LC, Vellas B, Visser PJ, Schneider L, Stern Y, Scheltens P, Cummings JL (2014) Advancing research diagnostic criteria for Alzheimer's disease: The IWG-2 criteria. Lancet Neurol 13, 614-629.
4. McKhann GM, Knopman DS, Chertkow H, Hyman BT, Jack CR Jr, Kawas CH, Klunk WE, Koroshetz WJ, Manly JJ, Mayeux R, Mohs RC, Morris JC, Rossor MN, Scheltens P, Carrillo MC, Thies B, Weintraub S, Phelps CH (2011) The diagnosis of dementia due to Alzheimer's disease: Recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement 7, 263-269.
5. Blennow K, Hampel H, Weiner M, Zetterberg H (2010) Cerebrospinal fluid and plasma biomarkers in Alzheimer disease. Nat Rev Neurol 6, 131-144.
6. Vanderstichele H, Bibl M, Engelborghs S, Le Bastard N, Lewczuk P, Molinuevo JL, Parnetti L, Perret-Liaudet A, Shaw LM, Teunissen C, Wouters D, Blennow K (2012) Standardization of preanalytical aspects of cerebrospinal fluid biomarker testing for Alzheimer's disease diagnosis: A consensus paper from the Alzheimer's Biomarkers Standardization Initiative. Alzheimers Dement 8, 65-73.
7. Engelborghs S, De Vreese K, Van de Casteele T, Vanderstichele H, Van Everbroeck B, Cras P, Martin J-J, Vanmechelen E, De Deyn PP (2008) Diagnostic performance of a CSF-biomarker panel in autopsy-confirmed dementia. Neurobiol Aging 29, 1143-1159.
8. Palmqvist S, Zetterberg H, Mattsson N, Johansson P Alzheimer's Disease Neuroimaging Initiative, Minthon L, BlennowK, Olsson M, Swedish BioFINDER, Study Group, HanssonO(2015) Detailed comparison of amyloid PET and CSF biomarkers for identifying early Alzheimer disease. Neurology 85, 1240-1249.
9. Parnetti L, Chiasserini D, Eusebi P, Giannandrea D, Bellomo G, De Carlo C, Padiglioni C, Mastrocola S, Lisetti V, Calabresi P (2012) Performance of A-1-40, A-1-42, total tau, and phosphorylated tau as predictors of dementia in a cohort of patients with mild cognitive impairment. J Alzheimers Dis 29, 229-238.
10. Janelidze S, ZetterbergH, Mattsson N, Palmqvist S,Vanderstichele H, Lindberg O, vanWesten D, Stomrud E, Minthon L, Blennow K for the Swedish BioFINDER study group, HanssonO(2016) CSFA-42/A-40 andA-42/A-38 ratios: Better diagnostic markers of Alzheimer disease. Ann Clin Transl Neurol 3, 154-165.
11. Struyfs H, Van Broeck B, Timmers M, Fransen E, Sleegers K, Van Broeckhoven C, De Deyn P, Streffer JR, Mercken M, Engelborghs S (2015) Diagnostic accuracy of cerebrospinal fluid amyloid-isoforms for early and differential dementia diagnosis. J Alzheimers Dis 45, 813-822.
12. Lewczuk P, Beck G, Esselmann H, Bruckmoser R, Zimmermann R, Fiszer M, Bibl M, Maler JM,Kornhuber J,Wiltfang J (2006) Effect of sample collection tubes on cerebrospinal fluid concentrations of tau proteins and amyloid peptides. Clin Chem 52, 332-334.
13. Bjerke M, Portelius E, Minthon L, Wallin A, Anckarsäter H, Anckarsäter R, Andreasen N, Zetterberg H, Andreasson U, Blennow K (2010) Confounding factors influencing amyloid Beta concentration in cerebrospinal fluid. Int J Alzheimers Dis 2010, pii:986310.
14. Cullen VC, Fredenburg RA, Evans C, Conliffe PR, Solomon ME (2012) Development and advanced validation of an optimized method for the quantitation of A-42 in human cerebrospinal fluid. AAPS J 14, 510-518.
15. Le Bastard N, De Deyn PP, Engelborghs S (2015) Importance and impact of preanalytical variables on Alzheimer disease biomarker concentrations in cerebrospinal fluid. Clin Chem 61,734-743.
16. Teunissen CE, Verwey NA, Kester MI, van Uffelen K, Blankenstein MA (2010) Standardization of assay procedures for analysis of the CSF biomarkers amyloid(1-42), tau, and phosphorylated tau in Alzheimer's disease: Report of an International Workshop. Int J Alzheimers Dis 2010, pii: 635053.
17. Zimmermann R, Lelental N, Ganslandt O, Maler JM, Kornhuber J, Lewczuk P (2011) Preanalytical sample handling and sample stability testing for the neurochemical dementia diagnostics. J Alzheimers Dis 25, 739-745.
18. Niemantsverdriet E, Goossens J, Struyfs H, Martin J-J, Goeman J, De Deyn PP,Vanderstichele H, Engelborghs S (2016) Diagnostic impact of cerebrospinal fluid biomarker (pre-) analytical variability in Alzheimer's disease. J Alzheimers Dis 51, 97-106.
19. Bjerke M, Andreasson U, Kuhlmann J, Portelius E, Pannee J, Lewczuk P, Umek RM, Vanmechelen E, Vanderstichele H, Stoops E, Lewis J,Vandijck M,KostanjeveckiV, Jeromin A, Salamone SJ, Schmidt O, Matzen A, Madin K, Eichenlaub U, Bittner T, Shaw LM, Zegers I, Zetterberg H, Blennow K (2015) Assessing the commutability of reference material formats for the harmonization of amyloid beta measurements. Clin Chem Lab Med. doi: 0.1515/cclm-2015-0733
20. Andreasen N, Hesse C, Davidsson P, Minthon L, Wallin A, Winblad B, Vanderstichele H, Vanmechelen E, Blennow K (1999) Cerebrospinal fluid-amyloid(1-42) in Alzheimer disease: Differences between early-and lateonset Alzheimer disease and stability during the course of disease. Arch Neurology 56, 673-680.
21. Vanderstichele H, Blennow K, D'Heuvaert N, Buyse MA, Wallin A, Andreasen N, Seubert P, Van de Voorde A, VanmechelenE(1998) Development of a specific diagnostic test for measurement of-amyloid (1-42) [-A4(1-42)] in CSF. In Progress in Alzheimer's and Parkinson's Diseases, Fisher A, Hanin I,Yoshida M, eds. Plenum Press, NewYork, pp. 773-778
22. Perret-Liaudet A, Pelpel M, Tholance Y, Dumont B, Vanderstichele H, Zorzi W, ElMoualij B, Schraen S, Moreaud O, Gabelle A, Thouvenot E, Thomas-Anterion C, Touchon J, Krolak-Salmon P, Kovacs GG, Coudreuse A, Quadrio I, Lehmann S (2012) Cerebrospinal fluid collection tubes: A critical issue for Alzheimer disease diagnosis. Clin Chem 58, 787-789.
23. Toombs J, Paterson RW, Schott JM, Zetterberg H (2014) Amyloid-beta 42 adsorption following serial tube transfer. Alzheimers Res Ther 6, 5.
24. Pica-Mendez AM, Tanen M, Dallob A, Tanaka W, Laterza OF (2010) Nonspecific binding of A-42 to polypropylene tubes and the effect of Tween-20. Clin Chim Acta 411, 1833.
25. Toombs J, PatersonRW, Nicholas JM, Petzold A, Schott JM, Zetterberg H (2015) The impact of Tween 20 on repeatability of amyloid and tau measurements in cerebrospinal fluid. Clin Chem Lab Med 53, e329-e332.
26. Berge G, Lauridsen C, Sando SB, Holder DJ, Møller I, Aasly JO, Brathen G, Savage MJ, White LR (2015) Effect of Tween-20 on core biomarkers measured in cerebrospinal fluid from patients with Alzheimer's disease, mild cognitive impairment, or healthy control individuals. J Alzheimers Dis 49, 493-502.
27. Mattsson N, Andreasson U, Persson S, Carrillo MC, Collins S, Chalbot S, Cutler N, Dufour-Rainfray D, FaganAM, Heegaard NHH, Hsiung G-YR, Hyman B, Iqbal K, Lachno DR, Lléo A, Lewczuk P, Molinuevo JL, Parchi P, Regeniter A, Rissman R, Rosenmann H, Sancesario G, Schröder J, Shaw LM, Teunissen CE, Trojanowski JQ, Vanderstichele H, Vandijck M, Verbeek MM, Zetterberg H, Blennow K, Käser SA Alzheimer's Association QC Program Work Group. (2013) CSF biomarker variability in the Alzheimer's Association QC program work group. Alzheimers Dement 9, 251-261.
28. Toombs J, Paterson RW, Lunn MP, Nicholas JM, Fox NC, Chapman MD, Schott JM, Zetterberg H (2013) Identification of an important potential confound in CSF AD studies: Aliquot volume. Clin Chem Lab Med 51, 2311-2317.
29. Leitao MJ, Baldeiras I, Herukka S-K, Pikkarainen M, Leinonen V, Simonsen AH, Perret-Liaudet A, Fourier A, Quadrio I, Veiga PM, de Oliveira CR (2015) Chasing the effects of pre-analytical confounders-a multicenter study on CSF-AD Biomarkers. Front Neurol 6, 153.
30. Vanderstichele H, DeMeyer G, Andreasen N,Kostanjevecki V,Wallin A, Olsson A, Blennow K, Vanmechelen E (2005) Amino-Truncated-amyloid42 peptides in cerebrospinal fluid and prediction of progression of mild cognitive impairment. Clin Chem 51, 1650-1660.
31. Lewczuk P, Lelental N, Spitzer P, Maler JM, Kornhuber J (2015) Amyloid-42/40 cerebrospinal fluid concentration ratio in the diagnostics of Alzheimer's disease: Validation of two novel assays. J Alzheimers Dis 43, 183-191.