메뉴 건너뛰기




Volumn 53, Issue 8, 2015, Pages 1161-1171

Permissible limits for uncertainty of measurement in laboratory medicine

Author keywords

measurement uncertainty; permissible bias; permissible imprecision

Indexed keywords

ALGORITHM; FALSE POSITIVE RESULT; LABORATORY; LIMIT OF DETECTION; MAXIMUM PERMISSIBLE DOSE; MEASUREMENT PRECISION; MEASUREMENT UNCERTAINTY; PRIORITY JOURNAL; QUALITY CONTROL; REFERENCE VALUE; REPRODUCIBILITY; REVIEW; STANDARD; CLINICAL MEDICINE; DIAGNOSTIC PROCEDURE; HUMAN; LABORATORY DIAGNOSIS; PROCEDURES; STANDARDS; UNCERTAINTY;

EID: 84929098713     PISSN: 14346621     EISSN: 14374331     Source Type: Journal    
DOI: 10.1515/cclm-2014-0874     Document Type: Review
Times cited : (39)

References (45)
  • 3
    • 84868514714 scopus 로고    scopus 로고
    • Reducing preanalytical laboratory sampling errors through educational and technological interventions
    • Lillo R, Salinas M, Lopez-Carrigos M, Naranjo-Santana Y, Gutierrez M, Marin MD, et al. Reducing preanalytical laboratory sampling errors through educational and technological interventions. Clin Lab 2012;38:911-7.
    • (2012) Clin Lab , vol.38 , pp. 911-917
    • Lillo, R.1    Salinas, M.2    Lopez-Carrigos, M.3    Naranjo-Santana, Y.4    Gutierrez, M.5    Marin, M.D.6
  • 6
    • 58549091951 scopus 로고    scopus 로고
    • Richtlinie der Bundesaerztekammer zur Qualitätssicherung laboratoriumsmedizinischer Untersuchungen
    • Richtlinie der Bundesaerztekammer zur Qualitätssicherung laboratoriumsmedizinischer Untersuchungen. Dt Aerzteblatt 2008;105:C301-13. Available from: http://www.aerzteblatt.de/plus1308.
    • (2008) Dt Aerzteblatt , vol.105 , pp. C301-C313
  • 8
    • 79954479647 scopus 로고    scopus 로고
    • A new concept to derive permissible limits for analytical imprecision and bias considering diagnostic requirements and technical state-of-the-art
    • Haeckel R, Wosniok W. A new concept to derive permissible limits for analytical imprecision and bias considering diagnostic requirements and technical state-of-the-art. Clin Chem Lab Med 2011;49:623-35.
    • (2011) Clin Chem Lab Med , vol.49 , pp. 623-635
    • Haeckel, R.1    Wosniok, W.2
  • 9
    • 80052247980 scopus 로고    scopus 로고
    • Gross overestimation of total allowable error based on biological variation
    • Oosterhuis WP. Gross overestimation of total allowable error based on biological variation. Clin Chem 2011;57:1334-6.
    • (2011) Clin Chem , vol.57 , pp. 1334-1336
    • Oosterhuis, W.P.1
  • 11
    • 77958155921 scopus 로고    scopus 로고
    • Observed, unknown distributions of clinical chemical quantities should be considered to be lognormal: A proposal
    • Haeckel R, Wosniok W. Observed, unknown distributions of clinical chemical quantities should be considered to be lognormal: a proposal. Clin Chem Lab Med 2010;48:1393-6.
    • (2010) Clin Chem Lab Med , vol.48 , pp. 1393-1396
    • Haeckel, R.1    Wosniok, W.2
  • 12
    • 77958172084 scopus 로고
    • The determination of glucose concentration in 20 microliter capillary blood, liquor and urine by the hexokinase method with the endpoint analyzer 5030 (Eppendorf)
    • Haeckel R, Haeckel H. The determination of glucose concentration in 20 microliter capillary blood, liquor and urine by the hexokinase method with the endpoint analyzer 5030 (Eppendorf). Z Klin Chem Klin Biochem 1972;10:453-61.
    • (1972) Z Klin Chem Klin Biochem , vol.10 , pp. 453-461
    • Haeckel, R.1    Haeckel, H.2
  • 13
    • 0016317765 scopus 로고
    • A two-point method for the determination of urea with the Gemsaec analyzer
    • Haeckel R, Mathias D. A two-point method for the determination of urea with the Gemsaec analyzer. Z Klin Chem Klin Biochem 1974;12:515-20.
    • (1974) Z Klin Chem Klin Biochem , vol.12 , pp. 515-520
    • Haeckel, R.1    Mathias, D.2
  • 15
    • 13844322269 scopus 로고    scopus 로고
    • Richtlinie der Bundesärztekammer zur Qualitätssicherung quantitativer laboratoriumsmedizinischer Untersuchungen
    • Richtlinie der Bundesärztekammer zur Qualitätssicherung quantitativer laboratoriumsmedizinischer Untersuchungen. Dt Aerzteblatt 2003;100:B2775-8. Available from: www.aerzteblatt. de/plus1308.
    • (2003) Dt Aerzteblatt , vol.100 , pp. B2775-B2778
  • 16
    • 51849114222 scopus 로고    scopus 로고
    • A practical approach to instrument selection, evaluation, basic financial management and implementation in pathology and research
    • Mina A, Favaloro EJ, Koutts J. A practical approach to instrument selection, evaluation, basic financial management and implementation in pathology and research. Clin Chem Lab Med 2008;46:1223-9.
    • (2008) Clin Chem Lab Med , vol.46 , pp. 1223-1229
    • Mina, A.1    Favaloro, E.J.2    Koutts, J.3
  • 17
    • 0036271429 scopus 로고    scopus 로고
    • Setting performance goals and evaluating total analytical error for diagnostic assays
    • Krouwer JS. Setting performance goals and evaluating total analytical error for diagnostic assays. Clin Chem 2002;48:919-27.
    • (2002) Clin Chem , vol.48 , pp. 919-927
    • Krouwer, J.S.1
  • 19
    • 0027181486 scopus 로고
    • Tolerance limits for short-term analytical bias and analytical imprecision derived from clinical assay specificity
    • Klee GG. Tolerance limits for short-term analytical bias and analytical imprecision derived from clinical assay specificity. Clin Chem 1993;39:1514-8.
    • (1993) Clin Chem , vol.39 , pp. 1514-1518
    • Klee, G.G.1
  • 20
    • 33746473545 scopus 로고    scopus 로고
    • Quality assessment of quantitative analytical results in laboratory medicine by root mean square of measurement deviation
    • Macdonald R. Quality assessment of quantitative analytical results in laboratory medicine by root mean square of measurement deviation. J Lab Med 2000;30:111-7.
    • (2000) J Lab Med , vol.30 , pp. 111-117
    • Macdonald, R.1
  • 21
    • 74249116046 scopus 로고    scopus 로고
    • Basics of estimating measurement uncertainty
    • White GH. Basics of estimating measurement uncertainty. Clin Biochem Rev 2008;29:S53-60.
    • (2008) Clin Biochem Rev , vol.29 , pp. S53-60
    • White, G.H.1
  • 22
    • 15444379201 scopus 로고    scopus 로고
    • Precision and accuracy in internal quality control of German laboratories - A survey performed by DGKL
    • Geilenkeuser WJ. Precision and accuracy in internal quality control of German laboratories - a survey performed by DGKL. J Lab Med 2005;29:11-6.
    • (2005) J Lab Med , vol.29 , pp. 11-16
    • Geilenkeuser, W.J.1
  • 23
    • 84867810684 scopus 로고    scopus 로고
    • A pragmatic approach for permissible limits in external assessment schemes with a compromise between biological variation and the state of the art
    • Haeckel R, Wosniok W, Kratochvila J, Carobene A. A pragmatic approach for permissible limits in external assessment schemes with a compromise between biological variation and the state of the art. Clin Chem Lab Med 2012;50:833-9.
    • (2012) Clin Chem Lab Med , vol.50 , pp. 833-839
    • Haeckel, R.1    Wosniok, W.2    Kratochvila, J.3    Carobene, A.4
  • 24
    • 81555219186 scopus 로고    scopus 로고
    • Correction of unexpected increasing trend in glucose measurements during 7 years recruitment to a cohort study
    • Froslie KF, Godang K, Bollerslev J, Henriksen T, Roislien J, Veierod MB, et al. Correction of unexpected increasing trend in glucose measurements during 7 years recruitment to a cohort study. Clin Biochem 2011;44:1483-6.
    • (2011) Clin Biochem , vol.44 , pp. 1483-1486
    • Froslie, K.F.1    Godang, K.2    Bollerslev, J.3    Henriksen, T.4    Roislien, J.5    Veierod, M.B.6
  • 25
    • 37549037111 scopus 로고    scopus 로고
    • Treatment of uncorrected measurement bias in uncertainty estimation for chemical measurements
    • Magnusson B, Ellison SL. Treatment of uncorrected measurement bias in uncertainty estimation for chemical measurements. Anal Bioanal Chem 2008;390:201-13.
    • (2008) Anal Bioanal Chem , vol.390 , pp. 201-213
    • Magnusson, B.1    Ellison, S.L.2
  • 26
    • 77952470321 scopus 로고    scopus 로고
    • A new statistical method for evaluating long-term analytical performance of laboratories applied to an external quality assessment scheme for flow cytometry
    • Coucke W, van Blerk M, Libeer JC, van Campenhout C, Albert A. A new statistical method for evaluating long-term analytical performance of laboratories applied to an external quality assessment scheme for flow cytometry. Clin Chem Lab Med 2010;48:645-50.
    • (2010) Clin Chem Lab Med , vol.48 , pp. 645-650
    • Coucke, W.1    Van Blerk, M.2    Libeer, J.C.3    Van Campenhout, C.4    Albert, A.5
  • 27
    • 34548729197 scopus 로고    scopus 로고
    • A plea for intra-laboratory decision limits. Part 2. A bimodal deductive concept for determining decision limits from intra-laboratory data bases demonstrated by catalytic activity concentrations of enzymes
    • Arzideh F, Wosniok W, Gurr E, Hinsch W, Schumann G, Weinstock N, et al. A plea for intra-laboratory decision limits. Part 2. A bimodal deductive concept for determining decision limits from intra-laboratory data bases demonstrated by catalytic activity concentrations of enzymes. Clin Chem Lab Med 2007;45:1043-57.
    • (2007) Clin Chem Lab Med , vol.45 , pp. 1043-1057
    • Arzideh, F.1    Wosniok, W.2    Gurr, E.3    Hinsch, W.4    Schumann, G.5    Weinstock, N.6
  • 28
    • 72449131347 scopus 로고    scopus 로고
    • Reference limits of plasma and serum creatinine concentrations from intra-laboratory data bases of several German and Italian medical centres. Comparison between direct and indirect procedures
    • Arzideh F, Wosniok W, Haeckel R. Reference limits of plasma and serum creatinine concentrations from intra-laboratory data bases of several German and Italian medical centres. Comparison between direct and indirect procedures. Clin Chem Acta 411;2010:215-21.
    • (2010) Clin Chem Acta , vol.411 , pp. 215-221
    • Arzideh, F.1    Wosniok, W.2    Haeckel, R.3
  • 29
    • 84941836684 scopus 로고
    • Detection of drift effects before calculating the standard deviation as a measure of analytical imprecision
    • Haeckel R, Schneider B. Detection of drift effects before calculating the standard deviation as a measure of analytical imprecision. J Clin Chem Clin Biochem 1983;21:491-7.
    • (1983) J Clin Chem Clin Biochem , vol.21 , pp. 491-497
    • Haeckel, R.1    Schneider, B.2
  • 30
    • 0000243943 scopus 로고
    • A study of the accuracy and precision of clinical chemistry determinations in 170 Canadian laboratories
    • Tonks DB. A study of the accuracy and precision of clinical chemistry determinations in 170 Canadian laboratories. Clin Chem 1963;9:217-31.
    • (1963) Clin Chem , vol.9 , pp. 217-231
    • Tonks, D.B.1
  • 31
    • 0014912813 scopus 로고
    • Biological and analytic components of variation in long-term studies of serum constituents in normal subjects
    • Cotlove E, Harris EK, Williams GZ. Biological and analytic components of variation in long-term studies of serum constituents in normal subjects. Clin Chem 1970;16:1028-32.
    • (1970) Clin Chem , vol.16 , pp. 1028-1032
    • Cotlove, E.1    Harris, E.K.2    Williams, G.Z.3
  • 33
    • 84888115451 scopus 로고    scopus 로고
    • Standardization and analytical goals for glycated hemoglobin measurement
    • Braga F, Panteghini M. Standardization and analytical goals for glycated hemoglobin measurement. Clin Chem Lab Med 2013;51:1719-26.
    • (2013) Clin Chem Lab Med , vol.51 , pp. 1719-1726
    • Braga, F.1    Panteghini, M.2
  • 34
    • 0027517770 scopus 로고
    • Evaluating a new, fully automated HPLC-ion exchange system (Merck-Hitachi L-9100) for determination of glycated hemoglobin
    • Niederau CM, Reinauer H. Evaluating a new, fully automated HPLC-ion exchange system (Merck-Hitachi L-9100) for determination of glycated hemoglobin. J Lab Med 1993;17:388-94.
    • (1993) J Lab Med , vol.17 , pp. 388-394
    • Niederau, C.M.1    Reinauer, H.2
  • 36
    • 0030948606 scopus 로고    scopus 로고
    • A conceptual model for establishing tolerance limits for analytic bias and imprecision based on variations in population test distributions
    • Klee G. A conceptual model for establishing tolerance limits for analytic bias and imprecision based on variations in population test distributions. Clin Chem Acta 1997;260:175-88.
    • (1997) Clin Chem Acta , vol.260 , pp. 175-188
    • Klee, G.1
  • 37
    • 34247151020 scopus 로고    scopus 로고
    • Benefits of combining bias and imprecision in quality assurance of clinical chemistry procedures
    • Haeckel R, Wosniok W. Benefits of combining bias and imprecision in quality assurance of clinical chemistry procedures. J Lab Med 2007;31:87-9.
    • (2007) J Lab Med , vol.31 , pp. 87-89
    • Haeckel, R.1    Wosniok, W.2
  • 38
    • 84891654051 scopus 로고    scopus 로고
    • Influence of analytical bias and imprecision on the number of false positive results using Guideline-Driven Medical Decision Limits
    • Hylthoft Petersen P, Klee P. Influence of analytical bias and imprecision on the number of false positive results using Guideline-Driven Medical Decision Limits. Clin Chim Acta 2014;430:1-8.
    • (2014) Clin Chim Acta , vol.430 , pp. 1-8
    • Hylthoft Petersen, P.1    Klee, P.2
  • 39
    • 77951752784 scopus 로고    scopus 로고
    • Establishment of outcome-related analytic performance goals
    • Klee GG. Establishment of outcome-related analytic performance goals. Clin Chem 2010;56:714-22.
    • (2010) Clin Chem , vol.56 , pp. 714-722
    • Klee, G.G.1
  • 40
    • 39749145797 scopus 로고    scopus 로고
    • Cautions in the adoption of common reference intervals
    • Boyd JC. Cautions in the adoption of common reference intervals. Clin Chem 2008;54:238-9.
    • (2008) Clin Chem , vol.54 , pp. 238-239
    • Boyd, J.C.1
  • 45
    • 3142685345 scopus 로고    scopus 로고
    • Descriptive analytical data and consequences for calculation of common reference intervals in the Nordic reference interval project 2000
    • Rustad P, Felding P, Lahti A, Hyltoft Petersen P. Descriptive analytical data and consequences for calculation of common reference intervals in the Nordic reference interval project 2000. Scand J Clin Lab Invest 2004;64:343-70.
    • (2004) Scand J Clin Lab Invest , vol.64 , pp. 343-370
    • Rustad, P.1    Felding, P.2    Lahti, A.3    Hyltoft Petersen, P.4


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.