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Editorials |
Department of Laboratory Medicine, Warren Magnuson Clinical Center, NIH, Bldg. 10, Room 2C-407, Bethesda, MD 20892-1508, Fax 301-402-1885, E-mail ghortin@mail.cc.nih.gov
| The first 20% of the full text of this article appears below. |
This issue of Clinical Chemistry contains a report describing interlaboratory comparison of a prostate cancer test based on profiling of serum proteins by mass spectrometry (1). This report is relevant to the recent controversy regarding the diagnostic potential and reliability of this approach to the diagnosis of cancer or other diseases (2)(3)(4)(5)(6)(7)(8). This controversy has raised questions regarding whether mass spectrometric profiling of proteins can achieve standards of reproducibility and performance that are expected of clinical tests. Semmes et al. (1) examine whether different laboratories can achieve equivalent results on split specimens. These efforts are commendable starts to issues of standardization, calibration, and quality control (QC), all important elements in the transition of this technology from the discovery phase to clinical application. However, their report also exemplifies how initial efforts to apply this technology have not yet met the desired standards of clinical laboratory practice.
Although proteomic profiling has provided breakthroughs in the discovery of new disease markers, initial discovery methods generally have been poorly suited for clinical applications. Marker discovery methods typically have not incorporated principles applied to existing clinical laboratory applications of profiling methods, such as serum protein electrophoresis, amino acid analyses, or tandem mass spectrometric screening for inborn errors. Some lessons from clinical experience include the importance of (a) use of internal standards for mass spectrometry, (b) identifying measured components, (c) developing standards for calibration and QC, (d) identifying peaksets in spectra, and (e) applying established standards for method evaluation (9), e.g., measures of reproducibility, detection limits, linearity, and recovery; evaluation of calibration curves, potential interferences, reference intervals, and peak characteristics; and
The following articles in journals at HighWire Press have cited this article:
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  L. A. Liotta and E. F. Petricoin Putting the "Bio" back into Biomarkers: Orienting Proteomic Discovery toward Biology and away from the Measurement Platform Clin. Chem., January 1, 2008; 54(1): 3 - 5. [Full Text] [PDF]
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R. E. Banks Preanalytical Influences in Clinical Proteomic Studies: Raising Awareness of Fundamental Issues in Sample Banking Clin. Chem., January 1, 2008; 54(1): 6 - 7. [Full Text] [PDF]
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M. J. Bennett Untargeted Metabolomic Analysis Hits the Target Clin. Chem., December 1, 2007; 53(12): 2037 - 2039. [Full Text] [PDF]
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N. Seam, D. A. Gonzales, S. J. Kern, G. L. Hortin, G. T. Hoehn, and A. F. Suffredini Quality Control of Serum Albumin Depletion for Proteomic Analysis Clin. Chem., November 1, 2007; 53(11): 1915 - 1920. [Abstract] [Full Text] [PDF]
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 S. Hundt, U. Haug, and H. Brenner Blood Markers for Early Detection of Colorectal Cancer: A Systematic Review Cancer Epidemiol. Biomarkers Prev., October 1, 2007; 16(10): 1935 - 1953. [Abstract] [Full Text] [PDF]
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 B. Lumbreras, M. Porta, and I. Hernandez-Aguado Assessing the social meaning, value and implications of research in genomics J Epidemiol Community Health, September 1, 2007; 61(9): 755 - 756. [Full Text] [PDF]
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J. Albrethsen Reproducibility in Protein Profiling by MALDI-TOF Mass Spectrometry Clin. Chem., May 1, 2007; 53(5): 852 - 858. [Abstract] [Full Text] [PDF]
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G. L. Hortin A New Era in Protein Quantification in Clinical Laboratories: Application of Liquid Chromatography-Tandem Mass Spectrometry Clin. Chem., April 1, 2007; 53(4): 543 - 544. [Full Text] [PDF]
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G. M. Fiedler, S. Baumann, A. Leichtle, A. Oltmann, J. Kase, J. Thiery, and U. Ceglarek Standardized Peptidome Profiling of Human Urine by Magnetic Bead Separation and Matrix-Assisted Laser Desorption/Ionization Time-of-Flight Mass Spectrometry Clin. Chem., March 1, 2007; 53(3): 421 - 428. [Abstract] [Full Text] [PDF]
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G. L. Hortin The MALDI-TOF Mass Spectrometric View of the Plasma Proteome and Peptidome Clin. Chem., July 1, 2006; 52(7): 1223 - 1237. [Abstract] [Full Text] [PDF]
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G. L. Hortin, S. A. Jortani, J. C. Ritchie Jr, R. Valdes Jr, and D. W. Chan Proteomics: A New Diagnostic Frontier Clin. Chem., July 1, 2006; 52(7): 1218 - 1222. [Abstract] [Full Text] [PDF]
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R. E. Banks, A. J. Stanley, D. A. Cairns, J. H. Barrett, P. Clarke, D. Thompson, and P. J. Selby Influences of Blood Sample Processing on Low-Molecular-Weight Proteome Identified by Surface-Enhanced Laser Desorption/Ionization Mass Spectrometry Clin. Chem., September 1, 2005; 51(9): 1637 - 1649. [Abstract] [Full Text] [PDF]
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S. R. Master Diagnostic Proteomics: Back to Basics? Clin. Chem., August 1, 2005; 51(8): 1333 - 1334. [Full Text] [PDF]
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A. Karsan, B. J. Eigl, S. Flibotte, K. Gelmon, P. Switzer, P. Hassell, D. Harrison, J. Law, M. Hayes, M. Stillwell, et al. Analytical and Preanalytical Biases in Serum Proteomic Pattern Analysis for Breast Cancer Diagnosis Clin. Chem., August 1, 2005; 51(8): 1525 - 1528. [Full Text] [PDF]
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