Determination and stability of N-terminal pro-brain natriuretic peptide in saliva samples for monitoring heart failure.
Aged
Aged, 80 and over
Biomarkers
/ analysis
Diagnostic Tests, Routine
Enzyme-Linked Immunosorbent Assay
/ methods
Female
Healthy Volunteers
Heart Failure
/ diagnosis
Humans
Male
Middle Aged
Natriuretic Peptide, Brain
/ analysis
Peptide Fragments
/ analysis
Protein Stability
Saliva
/ chemistry
Specimen Handling
/ methods
Journal
Scientific reports
ISSN: 2045-2322
Titre abrégé: Sci Rep
Pays: England
ID NLM: 101563288
Informations de publication
Date de publication:
22 06 2021
22 06 2021
Historique:
received:
18
12
2020
accepted:
01
06
2021
entrez:
23
6
2021
pubmed:
24
6
2021
medline:
9
11
2021
Statut:
epublish
Résumé
Heart failure (HF) is the main cause of mortality worldwide, particularly in the elderly. N-terminal pro-brain natriuretic peptide (NT-proBNP) is the gold standard biomarker for HF diagnosis and therapy monitoring. It is determined in blood samples by the immunochemical methods generally adopted by most laboratories. Saliva analysis is a powerful tool for clinical applications, mainly due to its non-invasive and less risky sampling. This study describes a validated analytical procedure for NT-proBNP determination in saliva samples using a commercial Enzyme-Linked Immuno-Sorbent Assay. Linearity, matrix effect, sensitivity, recovery and assay-precision were evaluated. The analytical approach showed a linear behaviour of the signal throughout the concentrations tested, with a minimum detectable dose of 1 pg/mL, a satisfactory NT-proBNP recovery (95-110%), and acceptable precision (coefficient of variation ≤ 10%). Short-term (3 weeks) and long-term (5 months) stability of NT-proBNP in saliva samples under the storage conditions most frequently used in clinical laboratories (4, - 20, and - 80 °C) was also investigated and showed that the optimal storage conditions were at - 20 °C for up to 2.5 months. Finally, the method was tested for the determination of NT-proBNP in saliva samples collected from ten hospitalized acute HF patients. Preliminary results indicate a decrease in NT-proBNP in saliva from admission to discharge, thus suggesting that this procedure is an effective saliva-based point-of-care device for HF monitoring.
Identifiants
pubmed: 34158583
doi: 10.1038/s41598-021-92488-2
pii: 10.1038/s41598-021-92488-2
pmc: PMC8219749
doi:
Substances chimiques
Biomarkers
0
Peptide Fragments
0
pro-brain natriuretic peptide (1-76)
0
Natriuretic Peptide, Brain
114471-18-0
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Validation Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
13088Références
Benjamin, E. J. et al. Heart Disease and Stroke Statistics-2019 Update: A report from the American Heart Association. Circulation 139, e56–e528 (2019).
pubmed: 30700139
doi: 10.1161/CIR.0000000000000659
Virani, S. S. et al. Heart Disease and Stroke Statistics—2020 Update: A report from the American Heart Association. Circulation 141, e139–e596 (2020).
pubmed: 31992061
doi: 10.1161/CIR.0000000000000757
Savarese, G. & Lund, L. H. Global public health burden of heart failure. Card. Fail. Rev. 3, 7–11 (2017).
pubmed: 28785469
pmcid: 5494150
doi: 10.15420/cfr.2016:25:2
Ziaeian, B. & Fonarow, G. C. Epidemiology and aetiology of heart failure. Nat. Rev. Cardiol. 13, 368–378 (2016).
pubmed: 26935038
pmcid: 4868779
doi: 10.1038/nrcardio.2016.25
Guha, K. & McDonagh, T. Heart failure epidemiology: European perspective. Curr. Cardiol. Rev. 9, 123–127 (2013).
pubmed: 23597298
pmcid: 3682396
doi: 10.2174/1573403X11309020005
Lesyuk, W., Kriza, C. & Kolominsky-Rabas, P. Cost-of-illness studies in heart failure: A systematic review 2004–2016. BMC Cardiovasc. Disord. 18, 74 (2018).
pubmed: 29716540
pmcid: 5930493
doi: 10.1186/s12872-018-0815-3
Rohde, L. E., Bertoldi, E. G., Goldraich, L. & Polanczyk, C. A. Cost-effectiveness of heart failure therapies. Nat. Rev. Cardiol. 10, 338–354 (2013).
pubmed: 23609174
doi: 10.1038/nrcardio.2013.60
Bottle, A. et al. Routes to diagnosis of heart failure: Observational study using linked data in England. Heart 104, 600–605 (2018).
pubmed: 28982720
doi: 10.1136/heartjnl-2017-312183
Maisel, A. S. et al. Timing of immunoreactive B-type natriuretic peptide levels and treatment delay in acute decompensated heart failure: an ADHERE (Acute Decompensated Heart Failure National Registry) analysis. J. Am. Coll. Cardiol. 52, 534–540 (2008).
pubmed: 18687247
doi: 10.1016/j.jacc.2008.05.010
Ponikowski, P. et al. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Eur. Heart. J. 37, 2129–2200 (2016).
pubmed: 27206819
doi: 10.1093/eurheartj/ehw128
Biomarkers Definition Working Group, Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Clin. Pharmacol. Ther. 69, 89–95 (2001).
doi: 10.1067/mcp.2001.113989
Braunwald, E. Biomarkers in heart failure. N. Engl. J. Med. 358, 2148–2159 (2008).
pubmed: 18480207
doi: 10.1056/NEJMra0800239
Gaggin, H. K. & Januzzi, J. L. Jr. Biomarkers and diagnostics in heart failure. Biochim. Biophys. Acta 1832, 2442–2450 (2013).
pubmed: 23313577
doi: 10.1016/j.bbadis.2012.12.014
Chow, S. L. et al. Role of biomarkers for the prevention, assessment, and management of heart failure: A scientific statement from the American heart association. Circulation 135, e1054–e1091 (2017).
pubmed: 28446515
doi: 10.1161/CIR.0000000000000490
Magnussen, C. & Blankenberg, S. Biomarkers for heart failure: Small molecules with high clinical relevance. J. Intern. Med. 283, 530–543 (2018).
pubmed: 29682806
doi: 10.1111/joim.12756
Nadar, S. K. & Shaikh, M. M. Biomarkers in routine heart failure clinical care. Card. Fail. Rev. 5, 50–56 (2019).
pubmed: 30847246
pmcid: 6396063
doi: 10.15420/cfr.2018.27.2
Palazzuoli, A., Gallotta, M., Quatrini, I. & Nuti, R. Natriuretic peptides (BNP and NT-proBNP): Measurement and relevance in heart failure. Vasc. Health. Risk. Manag. 6, 411–418 (2010).
pubmed: 20539843
pmcid: 2882893
doi: 10.2147/VHRM.S5789
McKie, P. & Burnett, J. C. Jr. NT-proBNP: The gold standard biomarker in heart failure. J. Am. Coll. Cardiol. 68, 2437–2439 (2016).
pubmed: 27908348
doi: 10.1016/j.jacc.2016.10.001
Maisel, A. S. et al. Rapid measurement of B-type natriuretic peptide in the emergency diagnosis of heart failure. N. Engl. J. Med. 347, 161–167 (2002).
pubmed: 12124404
doi: 10.1056/NEJMoa020233
Ibrahim, N. & Januzzi, J. L. The potential role of natriuretic peptides and other biomarkers in heart failure diagnosis, prognosis and management. Expert. Rev. Cardiovasc. Ther. 13, 1017–1730 (2015).
pubmed: 26198476
doi: 10.1586/14779072.2015.1071664
Zile, M. R. et al. Prognostic implications of changes in N-terminal pro-B-type natriuretic peptide in patients with heart failure. J. Am. Coll. Cardiol. 68, 2425–2436 (2016).
pubmed: 27908347
doi: 10.1016/j.jacc.2016.09.931
Steiner, J. & Guglin, M. BNP or NTproBNP? A clinician’s perspective. Int. J. Cardiol. 129, 5–14 (2008).
pubmed: 18378336
doi: 10.1016/j.ijcard.2007.12.093
Cao, Z., Jia, Y. & Zhu, B. BNP and NT-proBNP as diagnostic biomarkers for cardiac dysfunction in both clinical and forensic medicine. Int. J. Mol. Sci. 20, 1820 (2019).
pmcid: 6515513
doi: 10.3390/ijms20081820
Williamson, S., Munro, C., Pickler, R., Grap, M. J. & Elswick, R. K. Comparison of biomarkers in blood and saliva in healthy adults. Nurs. Res. Pract. 2012, 246178 (2012).
pubmed: 22619709
pmcid: 3350846
Bellagambi, F. G. et al. Electrochemical biosensor platform for TNF-α cytokines detection in both artificial and real human saliva: Heart Failure. Sens. Actuator. B Chem. 251, 1026–1033 (2017).
doi: 10.1016/j.snb.2017.05.169
Barhoumi, L. et al. A novel chronoamperometric immunosensor for recombinant human TNF-α detection. Sens. Actuator. B Chem. 266, 477–484 (2018).
doi: 10.1016/j.snb.2018.03.135
Bellagambi, F. G. et al. Determination of salivary α-amylase and cortisol in psoriatic subjects undergoing the Trier Social Stress Test. Microchem. J. 136, 177–184 (2018).
doi: 10.1016/j.microc.2017.04.033
Lomonaco, T. et al. The effect of sampling procedures on the urate and lactate concentration in oral fluid. Microchem. J. 136, 255–262 (2018).
doi: 10.1016/j.microc.2017.02.032
Bellagambi, F. G. et al. Saliva sampling: methods and devices. An overview. TrAC 124, 115781 (2020).
Biagini, D. et al. Saliva as a non-invasive tool for monitoring oxidative stress in swimmers athletes performing a VO
pubmed: 32456903
doi: 10.1016/j.talanta.2020.120979
Ghimenti, S. et al. Salivary lactate and 8-isoprostaglandin F
pubmed: 32366899
pmcid: 7198483
doi: 10.1038/s41598-020-64112-2
Khan, R. S., Khurshid, Z. & Yahya Ibrahim Asiri, F. Advancing point-of-care (PoC) testing using human saliva as liquid biopsy. Diagnostics (Basel) 7, pii: E39 (2017).
doi: 10.3390/diagnostics7030039
Khurshid, Z. Salivary point-of-care technology. Eur. J. Dent. 12, 1–2 (2018).
pubmed: 29657517
pmcid: 5883458
doi: 10.4103/ejd.ejd_376_17
Clerico, A. et al. Analytical performance and diagnostic accuracy of immunometric assays for the measurement of plasma B-type natriuretic peptide (BNP) and N-Terminal proBNP. Clin. Chem. 1, 445–447 (2005).
doi: 10.1373/clinchem.2004.038281
Januzzi, J. L. et al. NT-proBNP testing for diagnosis and short-term prognosis in acute destabilized heart failure: An international pooled analysis of 1256 patients: The International Collaborative of NT-proBNP Study. Eur. Heart. J. 7, 330–337 (2006).
doi: 10.1093/eurheartj/ehi631
Vasile, V. C. & Jaffe, A. S. Natriuretic peptides and analytical barriers. Clin. Chem. 63, 50–58 (2017).
pubmed: 28062611
doi: 10.1373/clinchem.2016.254714
Yeo, K. T. et al. Multicenter evaluation of the Roche NT-proBNP assay and comparison to the Biosite Triage BNP assay. Clin. Chim. Acta. 338, 107–115 (2003).
pubmed: 14637274
doi: 10.1016/j.cccn.2003.08.016
Lewis, L. K. et al. Comparison of immunoassays for NTproBNP conducted on three analysis systems: Milliplex, Elecsys and RIA. Clin. Biochem. 46, 388–390 (2013).
pubmed: 23219736
doi: 10.1016/j.clinbiochem.2012.11.022
Masson, S. et al. Comparative measurement of N-terminal pro-brain natriuretic peptide and brain natriuretic peptide in ambulatory patients with heart failure. Clin. Chem. Lab. Med. 40, 761–763 (2002).
pubmed: 12392300
doi: 10.1515/CCLM.2002.130
Li, H. et al. Detection of NT-pro BNP using fluorescent protein modified by streptavidin as a label in immunochromatographic assay. Sens. Biosens. Res. 11, 1–7 (2016).
Berna, M. et al. Quantification of NTproBNP in rat serum using immunoprecipitation and LC/MS/MS: A biomarker of drug-induced cardiac hypertrophy. Anal. Chem. 80, 561–566 (2008).
pubmed: 18179251
doi: 10.1021/ac702311m
Hammerer-Lercher, A. et al. Analysis of circulating forms of proBNP and NT-proBNP in patients with severe heart failure. Clin. Chem. 54, 858–865 (2008).
pubmed: 18339696
doi: 10.1373/clinchem.2007.090266
Yeo, K. T. et al. Multicenter evaluation of the Roche NT-proBNP assay and comparison to the Biosite Triage BNP assay. Clin. Chim. Acta 338, 107–115 (2003).
pubmed: 14637274
doi: 10.1016/j.cccn.2003.08.016
Yeo, K.-T.J., Dumont, K. E. & Brough, T. Elecsys NT-ProBNP and BNP assays: Are there analytically and clinically relevant differences?. J. Card. Fail. 11, S84-88 (2005).
pubmed: 15948108
doi: 10.1016/j.cardfail.2005.04.017
Nakano, H. et al. The response of NT-proBNP to intensified medication in advanced chronic heart failure. IJC Metab. Endocr. 10, 24−29 (2016).
Prontera, C. et al. Comparison between analytical performances of polyclonal and monoclonal electrochemiluminescence immunoassays for NT-proBNP. Clin. Chim. Acta 400, 70–73 (2009).
pubmed: 18992732
doi: 10.1016/j.cca.2008.10.011
Foo, J. Y. Y. et al. NT-ProBNP levels in saliva and its clinical relevance to heart failure. PLoS ONE 7, e48452 (2012).
pubmed: 23119023
pmcid: 3485201
doi: 10.1371/journal.pone.0048452
Thomadaki, K. et al. Whole-saliva proteolysis and its impact on salivary diagnostics. J. Dent. Res. 90, 1325–1330 (2011).
pubmed: 21917601
pmcid: 3188460
doi: 10.1177/0022034511420721
Di Somma, S. et al. Decrease in NTproBNP plasma levels indicates clinical improvement of acute decompensated heart failure. Am. J. Emerg. Med. 25, 335–339 (2007).
pubmed: 17349910
doi: 10.1016/j.ajem.2006.08.012
Brunner-La Rocca, H. P. & Sanders-van Wijk, S. Natriuretic peptides in chronic heart failure. Card. Fail. Rev. 5, 44–49 (2019).
pubmed: 30847245
pmcid: 6396059
doi: 10.15420/cfr.2018.26.1
Spinar, J.et al. Prognostic value of NT-proBNP added to clinical parameters to predict two-year prognosis of chronic heart failure patients with mid-range and reduced ejection fraction – A report from FAR NHL prospective registry. PLoS One 14, e0214363 (2019).
Zar, J. Biostatistical Analysis, Chapter 18 2nd edn. (Prentice-Hall, 1984).