Skip to content
BY-NC-ND 3.0 license Open Access Published by De Gruyter Open Access June 9, 2013

Comparison of two commercial enzyme-linked immunosorbent assays for cerebrospinal fluid measurement of amyloid β1–42 and total tau

  • Mirjana Babić EMAIL logo , Željka Vogrinc , Andrea Diana , Nataša Klepac , Fran Borovečki , Patrick Hof and Goran Šimić

Abstract

Amyloid β1–42 (Aβ1–42), total tau (t-tau), and phosphorylated tau (p-tau) are the main cerebrospinal fluid (CSF) biomarkers for early diagnosis of Alzheimer’s disease (AD). Detection of AD is critically important in view of the growing number of potential new drugs that may influence the course of the disease in its early phases. However, cut-off levels for these CSF biomarkers have not yet been established. Variability in absolute concentrations of AD biomarkers is high among studies and significant differences were noticed even within the same datasets. Variability in biomarkers levels in these assays may be due to many aspects of operating procedures. Standardization of pre-analytical and analytical procedures in collection, treatment, and storage of CSF samples is crucial because differences in sample handling can drastically influence results. Multicenter studies showed that usage of ELISA kits from different manufacturers also affects outcome. So far only very few studies tested the efficiency of ELISA kits produced by different vendors. In this study, the performance of Innogenetics (Gent, Belgium) and Invitrogen (Camarillo, CA, USA) ELISA kits for t-tau and Aβ1–42 was tested. Passing-Bablok analysis showed significant differences between Invitrogen and Innogenetics ELISA methods, making it impossible to use them interchangeably.

[1] Ferri C.P., Prince M., Brayne C., Brodaty H., Fratiglioni L., Ganguli M., et al., Global prevalence of dementia: a Delphi consensus study, Lancet, 2005, 366, 2112–2117 http://dx.doi.org/10.1016/S0140-6736(05)67889-010.1016/S0140-6736(05)67889-0Search in Google Scholar

[2] Cummings J.L., Khachaturian Z.S., Definitions and diagnostic criteria, In: Gauthier S. (ed.) Clinical diagnosis and management of Alzheimer’s disease, 2nd ed., Martin Dunitz, London, 2002, 3–13 10.3109/9780203931714-3Search in Google Scholar

[3] Wiltfang J., Esselman H., Maler J.M., Bleich S., Huther G., Kornhuber J., Molecular biology of Alzheimer’s dementia and its clinical relevance to early diagnosis and new therapeutic strategies, Gerontology, 2001, 47, 65–71 http://dx.doi.org/10.1159/00005277510.1159/000052775Search in Google Scholar

[4] Hansson O., Zetterberg H., Buchhave P., Londos E., Blennow K., Minthon L., Association between CSF biomarkers and incipient Alzheimer’s disease in patients with mild cognitive impairment: a follow-up study, Lancet Neurol., 2006, 5, 228–234 http://dx.doi.org/10.1016/S1474-4422(06)70355-610.1016/S1474-4422(06)70355-6Search in Google Scholar

[5] Mattsson N., Zetterberg H., Hansson O., Andreasen N., Parnetti L., Jonsson M., et al., CSF biomarkers and incipient Alzheimer disease in patients with mild cognitive impairment, J. Am. Med. Assoc., 2009, 302, 385–393 http://dx.doi.org/10.1001/jama.2009.106410.1001/jama.2009.1064Search in Google Scholar

[6] Šimić G., Boban M., Šarac H., Grbić K., Hof P.R., Hamann C., et al., CSF tau proteins in evaluation of patients with suspected dementia, Neurodegen. Dis., 2007, 4, 135–136 http://dx.doi.org/10.1159/00010252910.1159/000102529Search in Google Scholar

[7] Šimić G., Boban M., Hof P.R., Cerebrospinal fluid phosphorylated tau proteins as predictors of Alzheimer’s disease in subjects with mild cognitive impairment, Period. Biol., 2008, 110, 27–30 Search in Google Scholar

[8] Boban M., Grbić K., Mladinov M., Hof P.R., Süβmair C., Ackl N., et al., Cerebrospinal fluid markers in differential diagnosis of Alzheimer’s disease and vascular dementia, Coll. Antropol., 2008, 32, 31–36 Search in Google Scholar

[9] Boban M., Šarac H., Mimica N., Mladinov M., Süβmair C., Ackl N., et al., CSF tau proteins in differential diagnosis of dementia, Transl. Neurosci., 2010, 1, 43–48 http://dx.doi.org/10.2478/v10134-010-0013-z10.2478/v10134-010-0013-zSearch in Google Scholar

[10] Spies P.E., Slats D., Sjögren J.M., Kremer B.P., Verhey F.R., Rikkert M.G., et al., The cerebrospinal fluid amyloid beta42/40 ratio in the differentiation of Alzheimer’s disease from non-Alzheimer’s dementia, Curr. Alzheimer Res., 2010, 7, 470–476 http://dx.doi.org/10.2174/15672051079138379610.2174/156720510791383796Search in Google Scholar

[11] Motter R., Vigo-Pelfrey C., Kholodenko D., Barbour R., Johnson-Wood K., Galasko D., et al., Reduction of β-amyloid peptide 42 in the cerebrospinal fluid of patients with Alzheimer’s disease, Ann. Neurol., 1995, 38, 643–648 http://dx.doi.org/10.1002/ana.41038041310.1002/ana.410380413Search in Google Scholar

[12] Blennow K., Hampel H., CSF markers for incipient Alzheimer’s disease, Lancet Neurol., 2003, 2, 605–613 http://dx.doi.org/10.1016/S1474-4422(03)00530-110.1016/S1474-4422(03)00530-1Search in Google Scholar

[13] Sunderland T., Linker G., Mirza N., Putnam K.T., Friedman D.L., Kimmel L.H., et al., Decreased beta-amyloid1–42 and increased tau levels in cerebrospinal fluid of patients with Alzheimer disease, J. Am. Med. Assoc., 2003, 289, 2094–2103 http://dx.doi.org/10.1001/jama.289.16.209410.1001/jama.289.16.2094Search in Google Scholar PubMed

[14] Verwey N.A., van der Flier W.M., Blennow K., Clark C., Sokolow S., De Deyn P.P., et al., A worldwide multicentre comparison of assays for cerebrospinal fluid biomarkers in Alzheimer’s disease, Ann. Clin. Biochem., 2009, 46, 235–240 http://dx.doi.org/10.1258/acb.2009.00823210.1258/acb.2009.008232Search in Google Scholar PubMed

[15] Hort J., Bratos A., Pirttila T., Scheltens P., Use of cerebrospinal fluid biomarkers in diagnosis of dementia across Europe, Eur. J. Neurol., 2010, 17, 90–96 http://dx.doi.org/10.1111/j.1468-1331.2009.02753.x10.1111/j.1468-1331.2009.02753.xSearch in Google Scholar PubMed

[16] Mattsson N., Andreasson U., Persson S., Arai H., Batish S.D., Bernardini S., et al., The Alzheimer’s Association external quality control program for cerebrospinal fluid biomarkers, Alzheimers Dement., 2011, 7, 386–395 http://dx.doi.org/10.1016/j.jalz.2011.05.224310.1016/j.jalz.2011.05.2243Search in Google Scholar PubMed PubMed Central

[17] Vanderstichele H., Bibl M., Engelborghs S., Le Bastard N., Lewczuk P., Molinuevo J.L., et al., 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., 2012, 8, 65–73 http://dx.doi.org/10.1016/j.jalz.2011.07.00410.1016/j.jalz.2011.07.004Search in Google Scholar PubMed

[18] Teunissen C.E., Verwey N.A., Kester M.I., van Uffelen K., Blankenstein M.A., Standardization of assay procedures for analysis of the CSF biomarkers amyloid beta (1–42), tau, and phosphorylated tau in Alzheimer’s disease: report of an international workshop, Int. J. Alzheimers Dis., 2010, pii: 635053 10.4061/2010/635053Search in Google Scholar PubMed PubMed Central

[19] Boban M., Malojčić B., Mimica N., Vuković S., Zrilić I., Hof P.R., et al., The reliability and validity of the Mini-Mental State Examination in the elderly Croatian population, Dement. Geriatr. Cogn. Disord., 2012, 33, 385–392 http://dx.doi.org/10.1159/00033959610.1159/000339596Search in Google Scholar PubMed

[20] McKhann G., Drachman D., Folstein M., Katzman R., Price D., Stadlan E.M., Clinical diagnosis of Alzheimer’s disease: report of the NINCDSADRDA Work Group under the auspices of Department of Health and Human Services Task Force on Alzheimer’s Disease, Neurology, 1984, 34, 939–944 http://dx.doi.org/10.1212/WNL.34.7.93910.1212/WNL.34.7.939Search in Google Scholar PubMed

[21] Petersen R.C., Smith G.E., Waring S.C., Ivnik R.J., Tangalos E.G., Kokmen E., Mild cognitive impairment: clinical characterization and outcome, Arch. Neurol., 1999, 56, 303–308 http://dx.doi.org/10.1001/archneur.56.3.30310.1001/archneur.56.3.303Search in Google Scholar PubMed

[22] Bablok W., Passing H., Application of statistical procedures in analytical instrument testing, J. Automat. Chem., 1985, 7, 74–79 http://dx.doi.org/10.1155/S146392468500017710.1155/S1463924685000177Search in Google Scholar PubMed PubMed Central

[23] Bilić-Zulle L., Comparison of methods: Passing and Bablok regression, Biochem. Med., 2011, 21, 49–52 http://dx.doi.org/10.11613/BM.2011.01010.11613/BM.2011.010Search in Google Scholar PubMed

[24] Mattsson N., Blennow H., Zetterberg H., Inter-laboratory variation in cerebrospinal fluid biomarkers for Alzheimer’s disease: united we stand, divided we fall, Clin. Chem. Lab. Med., 2010, 48, 603–607 http://dx.doi.org/10.1515/cclm.2010.13110.1515/CCLM.2010.131Search in Google Scholar PubMed

[25] Verwey N.A., Bouwman F.H., van der Flier W.M., Veerhuis R., Scheltens P., Blankenstein M.A., Variability in longitudinal cerebrospinal fluid tau and phosphorylated tau measurements, Clin. Chem. Lab. Med., 2008, 46, 1300–1304 http://dx.doi.org/10.1515/CCLM.2008.24110.1515/CCLM.2008.241Search in Google Scholar PubMed

[26] Bjerke M., Portelius E., Minthon L., Wallin A., Anckarsäter H., Anckarsäter R., et al., Confounding factors influencing amyloid beta concentration in cerebrospinal fluid, Int. J. Alzheimers Dis., 2010, pii: 986310 10.4061/2010/986310Search in Google Scholar PubMed PubMed Central

[27] Teunissen C.E., Petzold A., Bennett J.L., Berven F.S., Brundin L., Comabella M., et al., A consensus protocol for the standardization of cerebrospinal fluid collection and biobanking, Neurology, 2009, 73, 1914–1922 http://dx.doi.org/10.1212/WNL.0b013e3181c47cc210.1212/WNL.0b013e3181c47cc2Search in Google Scholar PubMed PubMed Central

[28] Fialova L., Bartos A., Svarcova J., Dolezil D., Malbohan I., Stanovení tau proteinu v mozkomíšním moku pacientů s roztroušenou sklerózou dvěma soupravami ELISA [Tau protein determination in cerebrospinal fluid in patients with multiple sclerosis by two ELISA kits], Klin. Biochem. Metab., 2011, 19, 113–118 Search in Google Scholar

[29] Regeniter A., Kuhle J., Baumann J., Sollberger M., Herdener M., Kunze U., et al., Biomarkers of dementia: comparison of electrochemiluminescence results and reference ranges with conventional ELISA, Methods, 2012, 56, 494–499 http://dx.doi.org/10.1016/j.ymeth.2012.03.01910.1016/j.ymeth.2012.03.019Search in Google Scholar PubMed

[30] Olsson A., Vanderstichele H., Andreasen N., De Meyer G., Wallin A., Holmberg B., et al., Simultaneous measurement of β-amyloid(1–42), total tau, and phosphorylated tau (Thr181) in cerebrospinal fluid by the xMAP technology, Clin. Chem., 2005, 51, 336–345 http://dx.doi.org/10.1373/clinchem.2004.03934710.1373/clinchem.2004.039347Search in Google Scholar PubMed

[31] Reijn T.S., Rikkert M.O., van Geel W.J., de Jong D., Verbeek M.M., Diagnostic accuracy of ELISA and xMAP technology for analysis of amyloid beta (42) and tau proteins, Clin. Chem., 2007, 53, 859–865 http://dx.doi.org/10.1373/clinchem.2006.08167910.1373/clinchem.2006.081679Search in Google Scholar PubMed

[32] Fagan A.M., Shaw L.M., Xiong C., Vanderstichele H., Mintun M.A., Trojanowski J.Q., et al., Comparison of analytical platforms for cerebrospinal fluid measures of Aβ1–42, total tau and p-tau181 for identifying Alzheimer’s disease amyloid plaque pathology, Arch. Neurol., 2011, 68, 1137–1144 http://dx.doi.org/10.1001/archneurol.2011.10510.1001/archneurol.2011.105Search in Google Scholar PubMed PubMed Central

[33] Wang L.-S., Leung Y.Y., Chang S.-K., Leight S., Knapik-Czajka M., Baek Y., et al., Comparison of xMAP and ELISA assays for detecting cerebrospinal fluid biomarkers of Alzheimer’s disease, J. Alzheimers Dis., 2012, 31, 439–445 10.3233/JAD-2012-120082Search in Google Scholar PubMed PubMed Central

[34] Le Bastard N., Coart E., Vanderstichele H., Vanmechelen E., Martin J.J., Engelborghs S., Comparison of two analytical platforms for the clinical qualification of Alzheimer’s disease biomarkers in pathologically-confirmed dementia, J. Alzheimers Dis., 2013, 33, 117–131 10.3233/JAD-2012-121246Search in Google Scholar PubMed

[35] Sjögren M., Vanderstichele H., Agren H., Zachrisson O., Edsbagge M., Wikkelsø C., et al., Tau and Abeta42 in cerebrospinal fluid from healthy adults 21–93 years of age: establishment of reference values, Clin. Chem., 2001, 47, 1776–1781 10.1093/clinchem/47.10.1776Search in Google Scholar

[36] Lewczuk P., Kornhuber J., Vanderstichele H., Vanmechelen E., Esselmann H., Bibl M., et al., Multiplexed quantification of dementia biomarkers in the CSF of patients with early dementias and MCI: a multicenter study, Neurobiol. Aging, 2008, 29, 812–818 http://dx.doi.org/10.1016/j.neurobiolaging.2006.12.01010.1016/j.neurobiolaging.2006.12.010Search in Google Scholar PubMed

[37] Shaw L.M., Vanderstichele H., Knapik-Czajka M., Figurski M., Coart E., Blennow K., et al., Qualification of the analytical and clinical performance of CSF biomarker analyses in ADNI, Acta Neuropathol., 2011, 121, 597–609 http://dx.doi.org/10.1007/s00401-011-0808-010.1007/s00401-011-0808-0Search in Google Scholar PubMed PubMed Central

[38] Shaw L.M., Korecka M., Clark C.M., Lee V.M.-Y., Trojanowski J.Q., Biomarkers of neurodegeneration for diagnosis and monitoring therapeutics, Nat. Rev. Drug Discov., 2007, 6, 295–303 http://dx.doi.org/10.1038/nrd217610.1038/nrd2176Search in Google Scholar PubMed

Published Online: 2013-6-9
Published in Print: 2013-6-1

© 2013 Versita Warsaw

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

Downloaded on 5.6.2024 from https://www.degruyter.com/document/doi/10.2478/s13380-013-0123-4/html
Scroll to top button