Direct Assessment of Plasma/Serum Sample Quality for Proteomics Biomarker Investigation.

Blood proteome analysis for biomarker discovery represents one of the most challenging tasks to be achieved through clinical proteomics due to the sample complexity, such as the extreme heterogeneity of proteins in very dynamic concentrations, and to the observation of proper sampling and storage conditions. Quantitative and qualitative proteomics profiling of plasma and serum could be useful both for the early detection of diseases and for the evaluation of pathological status. Two main sources of variability can affect the precision and accuracy of the quantitative experiments designed for biomarker discovery and validation. These sources are divided into two categories, pre-analytical and analytical, and are often ignored; however, they can contribute to consistent errors and misunderstanding in biomarker research. In this chapter, we review critical pre-analytical and analytical variables that can influence quantitative proteomics. According to guidelines accepted by proteomics community, we propose some recommendations and strategies for a proper proteomics analysis addressed to biomarker studies.

[1]  J. Barrett,et al.  Influences of blood sample processing on low-molecular-weight proteome identified by surface-enhanced laser desorption/ionization mass spectrometry. , 2005, Clinical chemistry.

[2]  B. Domon,et al.  Detection and quantification of proteins in clinical samples using high resolution mass spectrometry. , 2015, Methods.

[3]  Ingo Ruczinski,et al.  Plasma Proteome Biomarkers of Inflammation in School Aged Children in Nepal , 2015, PloS one.

[4]  S. Pennington,et al.  Discovery and Longitudinal Evaluation of Candidate Protein Biomarkers for Disease Recurrence in Prostate Cancer. , 2015, Journal of proteome research.

[5]  D. T. Wong,et al.  Human body fluid proteome analysis , 2006, Proteomics.

[6]  Frank Vitzthum,et al.  Effects of preanalytical variables on peptide and protein measurements in human serum and plasma: implications for clinical proteomics , 2006, Expert review of proteomics.

[7]  P. Scheltens,et al.  Effects of processing and storage conditions on amyloid beta (1-42) and tau concentrations in cerebrospinal fluid: implications for use in clinical practice. , 2005, Clinical chemistry.

[8]  G. Hortin,et al.  The dynamic range problem in the analysis of the plasma proteome. , 2010, Journal of proteomics.

[9]  Zhen Liu,et al.  Evaluation of the application of sodium deoxycholate to proteomic analysis of rat hippocampal plasma membrane. , 2006, Journal of proteome research.

[10]  A. Galande,et al.  Sample collection in clinical proteomics—Proteolytic activity profile of serum and plasma , 2014, Proteomics. Clinical applications.

[11]  G. Porro,et al.  Serum protein profiling of early and advanced stage Crohn's disease , 2014 .

[12]  Wenchuan Wu,et al.  ITRAQ-based quantitative proteomics reveals apolipoprotein A-I and transferrin as potential serum markers in CA19-9 negative pancreatic ductal adenocarcinoma , 2016, Medicine.

[13]  H. Tammen,et al.  Collection and handling of blood specimens for peptidomics. , 2011, Methods in molecular biology.

[14]  G. Donnan,et al.  A Pathway Proteomic Profile of Ischemic Stroke Survivors Reveals Innate Immune Dysfunction in Association with Mild Symptoms of Depression – A Pilot Study , 2016, Front. Neurol..

[15]  D. Speicher,et al.  A novel four‐dimensional strategy combining protein and peptide separation methods enables detection of low‐abundance proteins in human plasma and serum proteomes , 2005, Proteomics.

[16]  Bernadette F. Rodak,et al.  Hematology: Clinical Principles and Applications , 2007 .

[17]  Gilbert S Omenn,et al.  The Human Proteome Organization Plasma Proteome Project pilot phase: Reference specimens, technology platform comparisons, and standardized data submissions and analyses , 2004, Proteomics.

[18]  M. Mann,et al.  Trypsin Cleaves Exclusively C-terminal to Arginine and Lysine Residues*S , 2004, Molecular & Cellular Proteomics.

[19]  G. Hortin,et al.  Potential interferences from blood collection tubes in mass spectrometric analyses of serum polypeptides. , 2004, Clinical chemistry.

[20]  Pedro Abreu González,et al.  Variaciones diurnas de los biomarcadores en la medicina cardiovascular: importancia clínica , 2009 .

[21]  D. Chan,et al.  Proteomic cancer biomarkers from discovery to approval: it’s worth the effort , 2014, Expert review of proteomics.

[22]  M. Vujnić,et al.  The impact of time of sample collection on the measurement of thyroid stimulating hormone values in the serum. , 2015, Clinical biochemistry.

[23]  G. Lippi,et al.  Influence of hemolysis on routine clinical chemistry testing , 2006, Clinical chemistry and laboratory medicine.

[24]  M. Blüher,et al.  Plasma Proteins Modified by Advanced Glycation End Products (AGEs) Reveal Site-specific Susceptibilities to Glycemic Control in Patients with Type 2 Diabetes* , 2016, The Journal of Biological Chemistry.

[25]  Oliver FitzGerald,et al.  Developing clinically relevant biomarkers in inflammatory arthritis: A multiplatform approach for serum candidate protein discovery , 2016, Proteomics. Clinical applications.

[26]  Amanda G. Paulovich,et al.  An Automated and Multiplexed Method for High Throughput Peptide Immunoaffinity Enrichment and Multiple Reaction Monitoring Mass Spectrometry-based Quantification of Protein Biomarkers* , 2009, Molecular & Cellular Proteomics.

[27]  P. Tempst,et al.  Correcting common errors in identifying cancer-specific serum peptide signatures. , 2005, Journal of proteome research.

[28]  Roger L. Lundblad,et al.  Considerations for the Use of Blood Plasma and Serum for Proteomic Analysis , 2003 .

[29]  Hua Xiao,et al.  Differential Proteomic Analysis of Human Saliva using Tandem Mass Tags Quantification for Gastric Cancer Detection , 2016, Scientific Reports.

[30]  A. Gemma,et al.  Identification of haptoglobin peptide as a novel serum biomarker for lung squamous cell carcinoma by serum proteome and peptidome profiling , 2016, International journal of oncology.

[31]  Thomas A Neubert,et al.  Sample preparation for serum/plasma profiling and biomarker identification by mass spectrometry , 2006, Journal of Chromatography A.

[32]  M. Kim,et al.  Reproducibility of temperature-selected mass spectra in matrix-assisted laser desorption ionization of peptides. , 2012, Analytical chemistry.

[33]  D. Centonze,et al.  Oxidative modifications of cerebral transthyretin are associated with multiple sclerosis , 2013, Proteomics.

[34]  Stefani N. Thomas,et al.  Advances in mass spectrometry-based clinical biomarker discovery , 2016, Clinical Proteomics.

[35]  R. Tohtong,et al.  Novel Serum Biomarkers to Differentiate Cholangiocarcinoma from Benign Biliary Tract Diseases Using a Proteomic Approach , 2015, Disease markers.

[36]  G. Rice,et al.  An approach to remove albumin for the proteomic analysis of low abundance biomarkers in human serum , 2003, Proteomics.

[37]  Eugene A. Kapp,et al.  Overview of the HUPO Plasma Proteome Project: Results from the pilot phase with 35 collaborating laboratories and multiple analytical groups, generating a core dataset of 3020 proteins and a publicly‐available database , 2005, Proteomics.

[38]  E. Mariman,et al.  Development of a targeted selected ion monitoring assay for the elucidation of protease induced structural changes in cardiac troponin T. , 2016, Journal of proteomics.

[39]  Matthias Mann,et al.  Plasma Proteome Profiling to Assess Human Health and Disease. , 2016, Cell systems.

[40]  Weimin Zhu,et al.  Processing of serum proteins underlies the mass spectral fingerprinting of myocardial infarction. , 2003, Journal of proteome research.

[41]  Andrew N Hoofnagle,et al.  Quantitative clinical proteomics by liquid chromatography-tandem mass spectrometry: assessing the platform. , 2010, Clinical chemistry.

[42]  D. Gambi,et al.  Cleavage of cystatin C is not associated with multiple sclerosis , 2007, Annals of neurology.

[43]  Sanjeeva Srivastava,et al.  Proteomic technologies for the identification of disease biomarkers in serum: Advances and challenges ahead , 2011, Proteomics.

[44]  Aimin Li,et al.  iTRAQ-Based Proteomics Screen identifies LIPOCALIN-2 (LCN-2) as a potential biomarker for colonic lateral-spreading tumors , 2016, Scientific Reports.

[45]  W. Ens,et al.  The influence of laser fluence on ion yield in matrix-assisted laser desorption ionization mass spectrometry , 2002 .

[46]  Alptekin Aksan,et al.  State of the art in preservation of fluid biospecimens. , 2011, Biopreservation and biobanking.

[47]  H. Tammen,et al.  Peptidomic analysis of human blood specimens: Comparison between plasma specimens and serum by differential peptide display , 2005, Proteomics.

[48]  D. Hochstrasser,et al.  Quantitative Clinical Chemistry Proteomics (qCCP) using mass spectrometry: general characteristics and application , 2013, Clinical chemistry and laboratory medicine.

[49]  M. Ferrari,et al.  Clinical proteomics: Written in blood , 2003, Nature.

[50]  Sen-Yung Hsieh,et al.  Systematical evaluation of the effects of sample collection procedures on low‐molecular‐weight serum/plasma proteome profiling , 2006, Proteomics.

[51]  S. Djordjevic,et al.  The quest for improved reproducibility in MALDI mass spectrometry. , 2018, Mass spectrometry reviews.

[52]  V. Arolt,et al.  Molecular serum signature of treatment resistant depression , 2016, Psychopharmacology.

[53]  Chao You,et al.  Prospective randomized evaluation of therapeutic decompressive craniectomy in severe traumatic brain injury with mass lesions (PRECIS): study protocol for a controlled trial , 2016, BMC Neurology.

[54]  E. Marchiori,et al.  Sample handling for mass spectrometric proteomic investigations of human sera. , 2005, Analytical chemistry.

[55]  N. Anderson,et al.  The Human Plasma Proteome , 2002, Molecular & Cellular Proteomics.

[56]  A. V. D. Van Der Zee,et al.  A panel of regulated proteins in serum from patients with cervical intraepithelial neoplasia and cervical cancer. , 2014, Journal of proteome research.

[57]  Susan E Abbatiello,et al.  Evaluation of Large Scale Quantitative Proteomic Assay Development Using Peptide Affinity-based Mass Spectrometry* , 2011, Molecular & Cellular Proteomics.

[58]  R. Aebersold,et al.  Direct analytical sample quality assessment for biomarker investigation: Qualifying cerebrospinal fluid samples , 2014, Proteomics.

[59]  O. Dammann,et al.  Protein Detection in Dried Blood by Surface-Enhanced Laser Desorption/Ionization-Time of Flight Mass Spectrometry (SELDI-TOF MS) , 2006, Neonatology.

[60]  H. Rhode,et al.  Multidimensional proteomics of human serum using parallel chromatography of native constituents and microplate technology , 2006, Proteomics.

[61]  P. Bose,et al.  Altered glycosylation, expression of serum haptoglobin and alpha-1-antitrypsin in chronic hepatitis C, hepatitis C induced liver cirrhosis and hepatocellular carcinoma patients , 2016, Glycoconjugate Journal.

[62]  H. Griffiths,et al.  The use of proteomics for the assessment of clinical samples in research. , 2004, Clinical biochemistry.

[63]  Albert Sickmann,et al.  Systematic and quantitative comparison of digest efficiency and specificity reveals the impact of trypsin quality on MS-based proteomics. , 2012, Journal of proteomics.

[64]  T. Mizukoshi,et al.  The effects of pre-analysis sample handling on human plasma amino acid concentrations. , 2016, Clinica chimica acta; international journal of clinical chemistry.

[65]  Loïc Dayon,et al.  Proteomic Biomarker Discovery in 1000 Human Plasma Samples with Mass Spectrometry. , 2016, Journal of proteome research.

[66]  Fuchu He,et al.  Different immunoaffinity fractionation strategies to characterize the human plasma proteome. , 2006, Journal of proteome research.

[67]  Dante Mantini,et al.  Pre-analytical factors in clinical proteomics investigations: impact of ex vivo protein modifications for multiple sclerosis biomarker discovery. , 2010, Journal of proteomics.

[68]  C. Gelfand,et al.  Minimizing preanalytical variation of plasma samples by proper blood collection and handling. , 2011, Methods in molecular biology.

[69]  R. Linhardt,et al.  Heparin-protein interactions. , 2002, Angewandte Chemie.

[70]  M. Plebani Errors in clinical laboratories or errors in laboratory medicine? , 2006, Clinical chemistry and laboratory medicine.

[71]  J. Jiang,et al.  iTRAQ technology-based identification of human peripheral serum proteins associated with depression , 2016, Neuroscience.

[72]  S. Carr,et al.  Quantitative, Multiplexed Assays for Low Abundance Proteins in Plasma by Targeted Mass Spectrometry and Stable Isotope Dilution*S , 2007, Molecular & Cellular Proteomics.

[73]  S. LeVine Albumin and multiple sclerosis , 2016, BMC Neurology.

[74]  T. Hankemeier,et al.  The effect of preanalytical factors on stability of the proteome and selected metabolites in cerebrospinal fluid (CSF). , 2009, Journal of proteome research.

[75]  M. Straume,et al.  Diurnal protein expression in blood revealed by high throughput mass spectrometry proteomics and implications for translational medicine and body time of day. , 2007, American journal of physiology. Regulatory, integrative and comparative physiology.

[76]  F. Muntoni,et al.  Global serum glycoform profiling for the investigation of dystroglycanopathies & Congenital Disorders of Glycosylation , 2016, Molecular genetics and metabolism reports.

[77]  D. J. King,et al.  Clinical chemical values for some common laboratory animals. , 1980, Clinical chemistry.

[78]  Helmut E Meyer,et al.  Approaching clinical proteomics: current state and future fields of application in fluid proteomics , 2009, Clinical chemistry and laboratory medicine.

[79]  Christoph H Borchers,et al.  Absolute quantitation of proteins in human blood by multiplexed multiple reaction monitoring mass spectrometry. , 2013, Methods in molecular biology.

[80]  E. Diamandis Analysis of serum proteomic patterns for early cancer diagnosis: drawing attention to potential problems. , 2004, Journal of the National Cancer Institute.

[81]  P. Davidsson,et al.  Comparison of different depletion strategies for improved resolution in proteomic analysis of human serum samples , 2005, Proteomics.

[82]  Bo Xiao,et al.  Longitudinal study of circulating protein biomarkers in inflammatory bowel disease. , 2015, Journal of proteomics.

[83]  J. V. Van Eyk,et al.  A robust, streamlined, and reproducible method for proteomic analysis of serum by delipidation, albumin and IgG depletion, and two‐dimensional gel electrophoresis , 2005, Proteomics.

[84]  G. Lippi,et al.  Preanalytical variability in laboratory testing: influence of the blood drawing technique , 2005, Clinical chemistry and laboratory medicine.

[85]  Andrew J. Percy,et al.  Clinical translation of MS-based, quantitative plasma proteomics: status, challenges, requirements, and potential , 2016, Expert review of proteomics.

[86]  Hongbo Gu,et al.  Quantitative Profiling of Post-translational Modifications by Immunoaffinity Enrichment and LC-MS/MS in Cancer Serum without Immunodepletion , 2015, Molecular & Cellular Proteomics.

[87]  Juan Li,et al.  Screening and identification of apolipoprotein A-I as a potential hepatoblastoma biomarker in children, excluding inflammatory factors. , 2015, Oncology letters.

[88]  Y. S. Shin,et al.  Degree of Ionization in MALDI of Peptides: Thermal Explanation for the Gas-Phase Ion Formation , 2012, Journal of The American Society for Mass Spectrometry.

[89]  Xiu-juan Dong,et al.  Identification of phosphorylated MYL12B as a potential plasma biomarker for septic acute kidney injury using a quantitative proteomic approach. , 2015, International journal of clinical and experimental pathology.

[90]  Timothy Block,et al.  Efficient and Specific Removal of Albumin from Human Serum Samples* , 2003, Molecular & Cellular Proteomics.

[91]  Sung‐Min Ahn,et al.  Proteomic Strategies for Analyzing Body Fluids , 2007 .

[92]  Christoph H Borchers,et al.  Pre-analytical and analytical variability in absolute quantitative MRM-based plasma proteomic studies. , 2013, Bioanalysis.

[93]  Daniel C. Liebler,et al.  Global Stability of Plasma Proteomes for Mass Spectrometry-Based Analyses* , 2012, Molecular & Cellular Proteomics.

[94]  A DomínguezRodríguez,et al.  Diurnal variations in biomarkers used in cardiovascular medicine: clinical significance. , 2009 .

[95]  Ronald J. Moore,et al.  Toward a Human Blood Serum Proteome , 2002, Molecular & Cellular Proteomics.

[96]  J. White EDTA-induced changes in platelet structure and function: clot retraction , 2000, Platelets.

[97]  Vijay Kumar,et al.  Quantitative proteomics revealed novel proteins associated with molecular subtypes of breast cancer. , 2016, Journal of proteomics.

[98]  D. Marsh,et al.  Novel serum protein biomarker panel revealed by mass spectrometry and its prognostic value in breast cancer , 2014, Breast Cancer Research.

[99]  Hwee Tong Tan,et al.  Analysis of colorectal cancer glyco‐secretome identifies laminin β‐1 (LAMB1) as a potential serological biomarker for colorectal cancer , 2015, Proteomics.

[100]  M. I. Mora,et al.  Multicentric study of the effect of pre-analytical variables in the quality of plasma samples stored in biobanks using different complementary proteomic methods. , 2017, Journal of proteomics.

[101]  J. Tissot,et al.  Recent advances in blood‐related proteomics , 2005, Proteomics.

[102]  R. Simpson,et al.  Low-molecular weight plasma proteome analysis using centrifugal ultrafiltration. , 2011, Methods in molecular biology.

[103]  Brian L. Frey,et al.  Controlling gas-phase reactions for efficient charge reduction electrospray mass spectrometry of intact proteins , 2005, Journal of the American Society for Mass Spectrometry.

[104]  B. Honoré,et al.  Serum Proteomic Changes after Randomized Prolonged Erythropoietin Treatment and/or Endurance Training: Detection of Novel Biomarkers , 2015, PloS one.

[105]  Z. Ulger,et al.  Serum markers of inflammation and oxidative stress in sarcopenia , 2017, Aging Clinical and Experimental Research.

[106]  T. Veenstra,et al.  Analytical and preanalytical biases in serum proteomic pattern analysis for breast cancer diagnosis. , 2005, Clinical chemistry.

[107]  Andrew N Hoofnagle,et al.  The fundamental flaws of immunoassays and potential solutions using tandem mass spectrometry. , 2009, Journal of immunological methods.

[108]  M. Malaise,et al.  Biomarkers of inflammation and innate immunity in atrophic nonunion fracture , 2016, Journal of Translational Medicine.

[109]  Darryl B. Hardie,et al.  A quantitative study of the effects of chaotropic agents, surfactants, and solvents on the digestion efficiency of human plasma proteins by trypsin. , 2010, Journal of proteome research.

[110]  Gilbert S Omenn,et al.  THE HUPO Human Plasma Proteome Project , 2007, Proteomics. Clinical applications.

[111]  N. Heegaard,et al.  Characterization and stability of transthyretin isoforms in cerebrospinal fluid examined by immunoprecipitation and high-resolution mass spectrometry of intact protein. , 2012, Methods.

[112]  Simone Lista,et al.  Biological and methodical challenges of blood-based proteomics in the field of neurological research , 2013, Progress in Neurobiology.

[113]  Jiaxiang Wang,et al.  Identification of Apolipoprotein C-I Peptides as a Potential Biomarker and its Biological Roles in Breast Cancer , 2016, Medical science monitor : international medical journal of experimental and clinical research.

[114]  Harald Tammen,et al.  Specimen Collection and Handling , 2008 .

[115]  Graham B. I. Scott,et al.  HUPO Plasma Proteome Project specimen collection and handling: Towards the standardization of parameters for plasma proteome samples , 2005, Proteomics.

[116]  Frank Suits,et al.  The impact of delayed storage on the measured proteome and metabolome of human cerebrospinal fluid. , 2011, Clinical chemistry.

[117]  William E Grizzle,et al.  Standard operating procedures for serum and plasma collection: early detection research network consensus statement standard operating procedure integration working group. , 2009, Journal of proteome research.

[118]  R. Abbritti,et al.  Meningiomas and Proteomics: Focus on New Potential Biomarkers and Molecular Pathways. , 2016, Cancer genomics & proteomics.

[119]  E. Diamandis Mass Spectrometry as a Diagnostic and a Cancer Biomarker Discovery Tool , 2004, Molecular & Cellular Proteomics.

[120]  D. Karabel,et al.  Serum albumin and von Willebrand factor: possible markers for early detection of vascular damage in children undergoing peritoneal dialysis. , 2016, Clinical and investigative medicine. Medecine clinique et experimentale.