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Volumn 4, Issue 12, 2010, Pages 892-903

Taking a new biomarker into routine use - A perspective from the routine clinical biochemistry laboratory

Author keywords

Analytical performance; Biomarker efficacy; Biomarker evaluation; Clinical biochemistry; Pre analytical requirements

Indexed keywords

BIOLOGICAL MARKER; C REACTIVE PROTEIN; PROSTATE SPECIFIC ANTIGEN;

EID: 78449290052     PISSN: 18628346     EISSN: 18628354     Source Type: Journal    
DOI: 10.1002/prca.201000073     Document Type: Review
Times cited : (57)

References (37)
  • 1
    • 75749130354 scopus 로고    scopus 로고
    • The clinical plasma proteome: a survey of clinical assays for proteins in plasma and serum
    • Anderson, N. L., The clinical plasma proteome: a survey of clinical assays for proteins in plasma and serum. Clin. Chem. 2010, 56, 177-185.
    • (2010) Clin. Chem. , vol.56 , pp. 177-185
    • Anderson, N.L.1
  • 3
    • 57049185388 scopus 로고    scopus 로고
    • The Modernisation of pathology and laboratory medicine in the UK: networking into the future
    • Beastall, G. H., The Modernisation of pathology and laboratory medicine in the UK: networking into the future. Clin. Biochem. Rev. 2008, 29, 3-10.
    • (2008) Clin. Biochem. Rev. , vol.29 , pp. 3-10
    • Beastall, G.H.1
  • 4
    • 77956634859 scopus 로고    scopus 로고
    • Improving the clinical value of laboratory information and permitting a common global approach to diseases. Foreword
    • Panteghini, M., Improving the clinical value of laboratory information and permitting a common global approach to diseases. Foreword. Scand. J. Clin. Lab. Invest. Suppl. 2010, 242, 3.
    • (2010) Scand. J. Clin. Lab. Invest. Suppl. , vol.242 , pp. 3
    • Panteghini, M.1
  • 6
    • 0023233060 scopus 로고
    • Prostate-specific antigen as a serum marker for adenocarcinoma of the prostate
    • Stamey, T. A., Yang, N., Hay, A. R., McNeal, J. E. et al., Prostate-specific antigen as a serum marker for adenocarcinoma of the prostate. N. Engl. J. Med. 1987, 317, 909-916.
    • (1987) N. Engl. J. Med. , vol.317 , pp. 909-916
    • Stamey, T.A.1    Yang, N.2    Hay, A.R.3    McNeal, J.E.4
  • 7
    • 0033816633 scopus 로고    scopus 로고
    • Reference reagents for prostate-specific antigen (PSA): establishment of the first international standards for free PSA and PSA (90:10)
    • Rafferty, B., Rigsby, P., Rose, M., Stamey, T., Gaines Das, R., Reference reagents for prostate-specific antigen (PSA): establishment of the first international standards for free PSA and PSA (90:10). Clin. Chem. 2000, 46, 1310-1317.
    • (2000) Clin. Chem. , vol.46 , pp. 1310-1317
    • Rafferty, B.1    Rigsby, P.2    Rose, M.3    Stamey, T.4    Gaines Das, R.5
  • 8
    • 73449107463 scopus 로고    scopus 로고
    • Managing demand for pathology tests: financial imperative or duty of care?
    • Fryer, A. A., Hanna, F. W., Managing demand for pathology tests: financial imperative or duty of care? Ann. Clin. Biochem. 2009, 46, 435-437.
    • (2009) Ann. Clin. Biochem. , vol.46 , pp. 435-437
    • Fryer, A.A.1    Hanna, F.W.2
  • 9
    • 78649701616 scopus 로고    scopus 로고
    • Department of Health. Equity and excellence: liberating the NHS. UK Dept of Health White Paper .
    • Department of Health. Equity and excellence: liberating the NHS. UK Dept of Health White Paper 2010.
    • (2010)
  • 10
    • 35848962931 scopus 로고    scopus 로고
    • How to improve reliability and efficiency of research about molecular markers: roles of phases, guidelines, and study design
    • Ransohoff, D. F., How to improve reliability and efficiency of research about molecular markers: roles of phases, guidelines, and study design. J. Clin. Epidemiol. 2007, 60, 1205-1219.
    • (2007) J. Clin. Epidemiol. , vol.60 , pp. 1205-1219
    • Ransohoff, D.F.1
  • 11
    • 77449127150 scopus 로고    scopus 로고
    • Sources of bias in specimens for research about molecular markers for cancer
    • Ransohoff, D. F., Gourlay, M. L., Sources of bias in specimens for research about molecular markers for cancer. J. Clin. Oncol. 2010, 28, 698-704.
    • (2010) J. Clin. Oncol. , vol.28 , pp. 698-704
    • Ransohoff, D.F.1    Gourlay, M.L.2
  • 12
    • 76249132458 scopus 로고    scopus 로고
    • Ten steps towards improving prognosis research
    • Hemingway, H., Riley, R. D., Altman, D. G., Ten steps towards improving prognosis research. Br. Med. J. 2009, 339, 410-414.
    • (2009) Br. Med. J. , vol.339 , pp. 410-414
    • Hemingway, H.1    Riley, R.D.2    Altman, D.G.3
  • 14
    • 77951759264 scopus 로고    scopus 로고
    • Banking of clinical samples for proteomic biomarker studies: a consideration of logistical issues with a focus on pre-analytical variation
    • Jackson, D. H., Banks, R. E., Banking of clinical samples for proteomic biomarker studies: a consideration of logistical issues with a focus on pre-analytical variation. Proteomics Clin. Appl. 2010, 4, 250-270.
    • (2010) Proteomics Clin. Appl. , vol.4 , pp. 250-270
    • Jackson, D.H.1    Banks, R.E.2
  • 15
    • 41849144111 scopus 로고    scopus 로고
    • On behalf of UK Biobank, The UK Biobank sample handling and storage protocol for the collection, processing and archiving of human blood and urine
    • Elliott, P., Peakman, T. C., On behalf of UK Biobank, The UK Biobank sample handling and storage protocol for the collection, processing and archiving of human blood and urine. Int. J. Epidemiol. 2008, 37, 234-244.
    • (2008) Int. J. Epidemiol. , vol.37 , pp. 234-244
    • Elliott, P.1    Peakman, T.C.2
  • 16
    • 4344570957 scopus 로고    scopus 로고
    • Inherent biological variation and reference values
    • Fraser, C. G., Inherent biological variation and reference values. Clin. Chem. Lab. Med. 2004, 42, 758-764.
    • (2004) Clin. Chem. Lab. Med. , vol.42 , pp. 758-764
    • Fraser, C.G.1
  • 17
    • 78649698349 scopus 로고    scopus 로고
    • The Immunoassay Handbook, 2nd Edn
    • in: Wild, D. (Ed.), Nature Publishing, Basingstoke
    • Davies, C., in: Wild, D. (Ed.), The Immunoassay Handbook, 2nd Edn, Nature Publishing, Basingstoke 2001, pp. 78-110.
    • (2001) , pp. 78-110
    • Davies, C.1
  • 18
    • 77953162857 scopus 로고    scopus 로고
    • Qualification versus validation of biomarkers
    • Doust, J., Qualification versus validation of biomarkers. Scand. J. Clin. Lab. Invest. Suppl. 2010, 242, 40-43.
    • (2010) Scand. J. Clin. Lab. Invest. Suppl. , vol.242 , pp. 40-43
    • Doust, J.1
  • 19
    • 33751243637 scopus 로고    scopus 로고
    • Standardization of FSH, LH and hCG - current position and future prospects
    • Sturgeon, C. M., Ellis, A. R., Standardization of FSH, LH and hCG - current position and future prospects. Mol. Cell. Endocrinol. 2007, 260-262, 301-309.
    • (2007) Mol. Cell. Endocrinol. , vol.260-262 , pp. 301-309
    • Sturgeon, C.M.1    Ellis, A.R.2
  • 20
    • 77953156154 scopus 로고    scopus 로고
    • Novel markers, a payer's perspective: commissioning a new service
    • Price, C. P., Martin, L., Novel markers, a payer's perspective: commissioning a new service. Scand. J. Clin. Lab. Invest. Suppl. 2010, 242, 103-108.
    • (2010) Scand. J. Clin. Lab. Invest. Suppl. , vol.242 , pp. 103-108
    • Price, C.P.1    Martin, L.2
  • 21
    • 77953144895 scopus 로고    scopus 로고
    • When do new biomarkers make economic sense?
    • Scott, M. G., When do new biomarkers make economic sense? Scand. J. Clin. Lab. Invest. Suppl. 2010, 242, 90-95.
    • (2010) Scand. J. Clin. Lab. Invest. Suppl. , vol.242 , pp. 90-95
    • Scott, M.G.1
  • 22
    • 78649690076 scopus 로고    scopus 로고
    • Measurement verification in the clinical laboratory [Association for Clinical Biochemistry]. UK Association for Clinical Biochemistry.,
    • Khatami, Z., Hill, R., Sturgeon, C. M., Kearney, E. et al., Measurement verification in the clinical laboratory [Association for Clinical Biochemistry]. UK Association for Clinical Biochemistry. 2005, .
    • (2005)
    • Khatami, Z.1    Hill, R.2    Sturgeon, C.M.3    Kearney, E.4
  • 23
    • 48949102516 scopus 로고    scopus 로고
    • National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines for use of tumor markers in clinical practice: quality requirements
    • Sturgeon, C. M., Hoffman, B. R., Chan, D. W., Ch'ng, S. L. et al., National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines for use of tumor markers in clinical practice: quality requirements. Clin. Chem. 2008, 54, e1-e10.
    • (2008) Clin. Chem. , vol.54
    • Sturgeon, C.M.1    Hoffman, B.R.2    Chan, D.W.3    Ch'ng, S.L.4
  • 24
    • 77953159063 scopus 로고    scopus 로고
    • Assessing the impact of biomarkers on patient outcome: an obligatory step
    • Bruns, D. E., Boyd, J. C., Assessing the impact of biomarkers on patient outcome: an obligatory step. Scand. J. Clin. Lab. Invest. Suppl. 2010, 242, 85-89.
    • (2010) Scand. J. Clin. Lab. Invest. Suppl. , vol.242 , pp. 85-89
    • Bruns, D.E.1    Boyd, J.C.2
  • 25
    • 74249084720 scopus 로고    scopus 로고
    • Reporting of prognostic studies of tumour markers: a review of published articles in relation to REMARK guidelines
    • Mallett, S., Timmer, A., Sauerbrei, W., Altman, D. G., Reporting of prognostic studies of tumour markers: a review of published articles in relation to REMARK guidelines. Br. J. Cancer 2010, 102, 173-180.
    • (2010) Br. J. Cancer , vol.102 , pp. 173-180
    • Mallett, S.1    Timmer, A.2    Sauerbrei, W.3    Altman, D.G.4
  • 26
    • 77952699981 scopus 로고    scopus 로고
    • Heart-type fatty acid-binding protein predicts long-term mortality and re-infarction in consecutive patients with suspected acute coronary syndrome who are troponin-negative
    • Viswanathan, K., Kilcullen, N., Morrell, C., Thistlethwaite, S. J. et al., Heart-type fatty acid-binding protein predicts long-term mortality and re-infarction in consecutive patients with suspected acute coronary syndrome who are troponin-negative. J. Am. Coll. Cardiol. 2010, 55, 2590-2598.
    • (2010) J. Am. Coll. Cardiol. , vol.55 , pp. 2590-2598
    • Viswanathan, K.1    Kilcullen, N.2    Morrell, C.3    Thistlethwaite, S.J.4
  • 27
    • 9444255722 scopus 로고    scopus 로고
    • Improving the quality of reporting of randomized controlled trials. The CONSORT statement
    • Begg, C., Cho, M., Eastwood, S., Horton, R. et al., Improving the quality of reporting of randomized controlled trials. The CONSORT statement. J. Am. Med. Assoc. 1996, 276, 637-639.
    • (1996) J. Am. Med. Assoc. , vol.276 , pp. 637-639
    • Begg, C.1    Cho, M.2    Eastwood, S.3    Horton, R.4
  • 28
    • 2642574977 scopus 로고    scopus 로고
    • Assessing the clinical impact of prostate-specific antigen assay variability and nonequimolarity: a simulation study based on the population of the United Kingdom
    • Roddam, A. W., Price, C. P., Allen, N. E., Ward, A. M., Assessing the clinical impact of prostate-specific antigen assay variability and nonequimolarity: a simulation study based on the population of the United Kingdom. Clin. Chem. 2004, 50, 1012-1016.
    • (2004) Clin. Chem. , vol.50 , pp. 1012-1016
    • Roddam, A.W.1    Price, C.P.2    Allen, N.E.3    Ward, A.M.4
  • 29
    • 71549156881 scopus 로고    scopus 로고
    • Monte Carlo simulation in establishing analytical quality requirements for clinical laboratory tests meeting clinical needs
    • Boyd, J. C., Bruns, D. E., Monte Carlo simulation in establishing analytical quality requirements for clinical laboratory tests meeting clinical needs. Methods Enzymol. 2009, 467, 411-433.
    • (2009) Methods Enzymol. , vol.467 , pp. 411-433
    • Boyd, J.C.1    Bruns, D.E.2
  • 30
    • 78649693109 scopus 로고    scopus 로고
    • Lord Carter of Coles. Report of the review of NHS pathology services in England, UK Dept of Health,
    • Lord Carter of Coles. Report of the review of NHS pathology services in England, UK Dept of Health 2006, .
    • (2006)
  • 31
    • 1042302201 scopus 로고    scopus 로고
    • Changing clinical behaviour by making guidelines specific
    • Michie, S., Johnston, M., Changing clinical behaviour by making guidelines specific. Br. Med. J. 2004, 328, 343-345.
    • (2004) Br. Med. J. , vol.328 , pp. 343-345
    • Michie, S.1    Johnston, M.2
  • 32
    • 64549110770 scopus 로고    scopus 로고
    • The rise and fall of C-reactive protein: managing demand within clinical biochemistry
    • Hutton, H. D., Drummond, H. S., Fryer, A. A., The rise and fall of C-reactive protein: managing demand within clinical biochemistry. Ann. Clin. Biochem. 2009, 46, 155-158.
    • (2009) Ann. Clin. Biochem. , vol.46 , pp. 155-158
    • Hutton, H.D.1    Drummond, H.S.2    Fryer, A.A.3
  • 33
    • 77953172129 scopus 로고    scopus 로고
    • Development of novel IVD assays: a manufacturer's perspective
    • Metcalfe, T. A., Development of novel IVD assays: a manufacturer's perspective. Scand. J. Clin. Lab. Invest. Suppl. 2010, 242, 23-26.
    • (2010) Scand. J. Clin. Lab. Invest. Suppl. , vol.242 , pp. 23-26
    • Metcalfe, T.A.1
  • 34
    • 18644375993 scopus 로고    scopus 로고
    • Usage of troponin in the real world: a lesson for the introduction of biochemical assays
    • Rajappan, K., Murphy, E., Amber, V., Meakin, F. et al., Usage of troponin in the real world: a lesson for the introduction of biochemical assays. Q. J. Med. 2005, 98, 337-342.
    • (2005) Q. J. Med. , vol.98 , pp. 337-342
    • Rajappan, K.1    Murphy, E.2    Amber, V.3    Meakin, F.4
  • 35
    • 66349111734 scopus 로고    scopus 로고
    • Criteria for evaluation of novel markers of cardiovascular risk: a scientific statement from the American Heart Association
    • Hlatky, M. A., Greenland, P., Arnett, D. K., Ballantyne, C. M. et al., Criteria for evaluation of novel markers of cardiovascular risk: a scientific statement from the American Heart Association. Circulation 2009, 119, 2408-2416.
    • (2009) Circulation , vol.119 , pp. 2408-2416
    • Hlatky, M.A.1    Greenland, P.2    Arnett, D.K.3    Ballantyne, C.M.4
  • 36
    • 11144297955 scopus 로고    scopus 로고
    • Can mass spectrometric protein profiling meet desired standards of clinical laboratory practice?
    • Hortin, G. L., Can mass spectrometric protein profiling meet desired standards of clinical laboratory practice? Clin. Chem. 2005, 51, 3-5.
    • (2005) Clin. Chem. , vol.51 , pp. 3-5
    • Hortin, G.L.1
  • 37
    • 0037006639 scopus 로고    scopus 로고
    • The architecture of diagnostic research
    • Sackett, D. L., Haynes, R. B., The architecture of diagnostic research. Br. Med. J. 2002, 324, 539-541.
    • (2002) Br. Med. J. , vol.324 , pp. 539-541
    • Sackett, D.L.1    Haynes, R.B.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.