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Volumn 49, Issue 13-14, 2016, Pages 947-954

Quality management in clinical application of mass spectrometry measurement systems

Author keywords

Evaluation; Mass spectrometry; Quality assurance; Quality management; Validation

Indexed keywords

ANALYTIC METHOD; ANALYTICAL EQUIPMENT; ARTICLE; CLINICAL LABORATORY; DIAGNOSTIC TEST; HUMAN; LABORATORY DIAGNOSIS; LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; MEASUREMENT ACCURACY; PATIENT CARE; PRIORITY JOURNAL; PROCESS OPTIMIZATION; QUALITY CONTROL; SOLID PHASE EXTRACTION; STANDARDIZATION; TANDEM MASS SPECTROMETRY; CALIBRATION; PROCEDURES; RISK MANAGEMENT; VALIDATION STUDY;

EID: 84979609761     PISSN: 00099120     EISSN: 18732933     Source Type: Journal    
DOI: 10.1016/j.clinbiochem.2016.07.005     Document Type: Article
Times cited : (33)

References (28)
  • 1
    • 85011537287 scopus 로고    scopus 로고
    • Editors; Committee on Diagnostic Error in Health Care; Board on Health Care Services; Institute of Medicine; The National Academies of Sciences, Engineering, and Medicine
    • ISBN 978-0-309-37769-0
    • [1] Balogh, E.P., Miller, B.T., Ball, J.R., Editors; Committee on Diagnostic Error in Health Care; Board on Health Care Services; Institute of Medicine; The National Academies of Sciences, Engineering, and Medicine. Improving diagnosis in healthcare, 2015 ISBN 978-0-309-37769-0.
    • (2015) Improving diagnosis in healthcare
    • Balogh, E.P.1    Miller, B.T.2    Ball, J.R.3
  • 2
    • 84952050943 scopus 로고    scopus 로고
    • Improving diagnosis in health care – the next imperative for patient safety
    • [2] Singh, H., Graber, M.L., Improving diagnosis in health care – the next imperative for patient safety. N. Engl. J. Med. 373 (2015), 2493–2495.
    • (2015) N. Engl. J. Med. , vol.373 , pp. 2493-2495
    • Singh, H.1    Graber, M.L.2
  • 3
    • 0034716473 scopus 로고    scopus 로고
    • False diagnosis and needless therapy of presumed malignant disease in women with false-positive human chorionic gonadotropin concentrations
    • [3] Rotmensch, S., Cole, L.A., False diagnosis and needless therapy of presumed malignant disease in women with false-positive human chorionic gonadotropin concentrations. Lancet 355:9205 (2000), 712–715.
    • (2000) Lancet , vol.355 , Issue.9205 , pp. 712-715
    • Rotmensch, S.1    Cole, L.A.2
  • 5
    • 84948656251 scopus 로고    scopus 로고
    • Serum sample containing endogenous antibodies interfering with multiple hormone immunoasays. Laboratory strategies to detect interference
    • [5] Garcia-Gonzales, E., Aramendia, M., Alvarez-Ballano, D., Trincado, P., Rello, L., Serum sample containing endogenous antibodies interfering with multiple hormone immunoasays. Laboratory strategies to detect interference. Pract. Lab. Med. 4 (2016), 1–10.
    • (2016) Pract. Lab. Med. , vol.4 , pp. 1-10
    • Garcia-Gonzales, E.1    Aramendia, M.2    Alvarez-Ballano, D.3    Trincado, P.4    Rello, L.5
  • 6
    • 77955246441 scopus 로고    scopus 로고
    • Pitfalls associated with the use of liquid chromatography-tandem mass spectrometry in the clinical laboratory
    • [6] Vogeser, M., Seger, C., Pitfalls associated with the use of liquid chromatography-tandem mass spectrometry in the clinical laboratory. Clin. Chem. 56 (2010), 1234–1244.
    • (2010) Clin. Chem. , vol.56 , pp. 1234-1244
    • Vogeser, M.1    Seger, C.2
  • 7
    • 43449083749 scopus 로고    scopus 로고
    • A decade of HPLC-MS/MS in the routine clinical laboratory–goals for further developments
    • [7] Vogeser, M., Seger, C., A decade of HPLC-MS/MS in the routine clinical laboratory–goals for further developments. Clin. Biochem. 41 (2008), 649–662.
    • (2008) Clin. Biochem. , vol.41 , pp. 649-662
    • Vogeser, M.1    Seger, C.2
  • 8
    • 84856509500 scopus 로고    scopus 로고
    • The role of liquid chromatography-tandem mass spectrometry in the clinical laboratory
    • [8] Van den Ouweland, J.M.W., Kema, I.P., The role of liquid chromatography-tandem mass spectrometry in the clinical laboratory. J. Chromatogr. B 883-884 (2012), 18–32.
    • (2012) J. Chromatogr. B , vol.883-884 , pp. 18-32
    • Van den Ouweland, J.M.W.1    Kema, I.P.2
  • 9
    • 84878431473 scopus 로고    scopus 로고
    • The march of the masses
    • [9] Grant, R.P., The march of the masses. Clin. Chem. 59 (2013), 871–873.
    • (2013) Clin. Chem. , vol.59 , pp. 871-873
    • Grant, R.P.1
  • 11
    • 84954561702 scopus 로고    scopus 로고
    • Clinical mass spectrometry-achieving prominence in laboratory medicine
    • [11] Annesley, T.M., Cooks, R.G., Herold, D.A., Hoofnagle, A.N., Clinical mass spectrometry-achieving prominence in laboratory medicine. Clin. Chem. 62 (2016), 1–3.
    • (2016) Clin. Chem. , vol.62 , pp. 1-3
    • Annesley, T.M.1    Cooks, R.G.2    Herold, D.A.3    Hoofnagle, A.N.4
  • 12
    • 84954470372 scopus 로고    scopus 로고
    • Effective use of mass spectrometry in the clinical laboratory
    • [12] Jannetto, P.J., Fitzgerald, R.L., Effective use of mass spectrometry in the clinical laboratory. Clin. Chem. 62 (2016), 92–98.
    • (2016) Clin. Chem. , vol.62 , pp. 92-98
    • Jannetto, P.J.1    Fitzgerald, R.L.2
  • 13
    • 84965014046 scopus 로고    scopus 로고
    • Mass spectrometry methods in clinical diagnostics – state of the art and perspectives
    • (in press)
    • [13] Vogeser, M., Seger, C., Mass spectrometry methods in clinical diagnostics – state of the art and perspectives. Trends Anal. Chem., 2016, 10.1016/j.trac.2016.04.018 (in press).
    • (2016) Trends Anal. Chem.
    • Vogeser, M.1    Seger, C.2
  • 15
    • 84965125884 scopus 로고    scopus 로고
    • Comparative assessment of bioanalytical method validation guidelines for pharmaceutical industry
    • [15] Kadian, N., Raju, K.S., Rashid, M., Malik, M.Y., Taneja, I., Wahajuddin, M., Comparative assessment of bioanalytical method validation guidelines for pharmaceutical industry. J. Pharm. Biomed. Anal. 126 (2016), 83–97.
    • (2016) J. Pharm. Biomed. Anal. , vol.126 , pp. 83-97
    • Kadian, N.1    Raju, K.S.2    Rashid, M.3    Malik, M.Y.4    Taneja, I.5    Wahajuddin, M.6
  • 16
    • 78349274425 scopus 로고    scopus 로고
    • C50-A. Mass Spectrometry in the Clinical Laboratory: General Principles and Guidance; Approved Guidelines
    • (ISSN 0273–3099)
    • [16] Clinical and Laboratory Standards Institute, C50-A. Mass Spectrometry in the Clinical Laboratory: General Principles and Guidance; Approved Guidelines. 2007 (ISSN 0273–3099).
    • (2007)
  • 17
    • 84954509897 scopus 로고    scopus 로고
    • C62-A. Liquid Chromatography-Mass Spectrometry Methods; Approved Guideline
    • (ISSN 1558–6502)
    • [17] Clinical and Laboratory Standards Institute, C62-A. Liquid Chromatography-Mass Spectrometry Methods; Approved Guideline. 2014 (ISSN 1558–6502).
    • (2014)
  • 18
    • 84954497548 scopus 로고    scopus 로고
    • CLSI C62-A: a new standard for clinical mass spectrometry
    • [18] Lynch, K.L., CLSI C62-A: a new standard for clinical mass spectrometry. Clin. Chem. 62 (2016), 24–29.
    • (2016) Clin. Chem. , vol.62 , pp. 24-29
    • Lynch, K.L.1
  • 19
    • 84882270712 scopus 로고    scopus 로고
    • Target analyte quantification by isotope dilution LC-MS/MS directly referring to internal standard concentrations - validation for serum cortisol measurement
    • [19] Maier, B., Vogeser, M., Target analyte quantification by isotope dilution LC-MS/MS directly referring to internal standard concentrations - validation for serum cortisol measurement. Clin. Chem. Lab. Med. 51 (2013), 833–837.
    • (2013) Clin. Chem. Lab. Med. , vol.51 , pp. 833-837
    • Maier, B.1    Vogeser, M.2
  • 22
    • 84991536353 scopus 로고    scopus 로고
    • [22] U.S. Department of Health and Human Services Food and Drug Administration (FDA), Center for Drug Evaluation and Research, www.fda.gov, 2001.
    • (2001)
  • 24
    • 81055146012 scopus 로고    scopus 로고
    • Guideline on bioanalytical method validation
    • [24] European Medicines Agengy (EMA), Guideline on bioanalytical method validation. www.ema.europa.eu, 2011.
    • (2011)
  • 25
    • 84991552625 scopus 로고    scopus 로고
    • Scientific Working Group for Forensic Toxicology (SWGTOX) - standard practices for method validation in forensic toxicology
    • [25] Scientific Working Group for Forensic Toxicology (SWGTOX) - standard practices for method validation in forensic toxicology. www.swgtox.org/documents/Validation3.pdf, 2013.
    • (2013)
  • 26
    • 84930087775 scopus 로고    scopus 로고
    • Lights and shadows of the actual European guidelines on bioanalytical method validation: the case of raltegravir
    • [26] Baldelli, S., Cattaneo, D., Fucile, S., Clementi, E., Lights and shadows of the actual European guidelines on bioanalytical method validation: the case of raltegravir. Ther. Drug Monit. 36 (2014), 739–745.
    • (2014) Ther. Drug Monit. , vol.36 , pp. 739-745
    • Baldelli, S.1    Cattaneo, D.2    Fucile, S.3    Clementi, E.4
  • 27
    • 0037663202 scopus 로고    scopus 로고
    • Strategies for the assessment of matrix effect in quantitative bioanalytical methods based on HPLC-MS/MS
    • [27] Matuszewski, B.K., Constanzer, M.L., Chavez-Eng, C.M., Strategies for the assessment of matrix effect in quantitative bioanalytical methods based on HPLC-MS/MS. Anal. Chem. 75 (2003), 3019–3030.
    • (2003) Anal. Chem. , vol.75 , pp. 3019-3030
    • Matuszewski, B.K.1    Constanzer, M.L.2    Chavez-Eng, C.M.3
  • 28
    • 84863578726 scopus 로고    scopus 로고
    • Ionic cross talk can lead to overestimation of 3-methoxytyramine during quantification of metanephrines by mass spectrometry
    • [28] Twentyman, J.M., Cradic, K.W., Singh, R.J., Grebe, S.K., Ionic cross talk can lead to overestimation of 3-methoxytyramine during quantification of metanephrines by mass spectrometry. Clin. Chem. 58 (2012), 1156–1158.
    • (2012) Clin. Chem. , vol.58 , pp. 1156-1158
    • Twentyman, J.M.1    Cradic, K.W.2    Singh, R.J.3    Grebe, S.K.4


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.