메뉴 건너뛰기




Volumn 4, Issue 1, 2010, Pages 75-83

A review of standards and statistics used to describe blood glucose monitor performance

Author keywords

Error grid; Glucose specification; ISO 15197; Mountain plot; Total error

Indexed keywords

AMBULATORY MONITORING; BLOOD; BLOOD GLUCOSE MONITORING; DIAGNOSTIC ERROR; EQUIPMENT; EVALUATION; GLUCOSE BLOOD LEVEL; HUMAN; HYPOGLYCEMIA; INSTRUMENTATION; METHODOLOGY; PRODUCTIVITY; REVIEW; SENSITIVITY AND SPECIFICITY; STANDARD; STATISTICAL ANALYSIS; STATISTICS;

EID: 77951733801     PISSN: None     EISSN: 19322968     Source Type: Journal    
DOI: 10.1177/193229681000400110     Document Type: Conference Paper
Times cited : (87)

References (39)
  • 1
    • 0016254486 scopus 로고
    • Criteria for judging precision and accuracy in method development and evaluation
    • Westgard JO, Carey RN, Wold S. Criteria for judging precision and accuracy in method development and evaluation. Clin Chem. 1974;20(7):825-33.
    • (1974) Clin Chem , vol.20 , Issue.7 , pp. 825-833
    • Westgard, J.O.1    Carey, R.N.2    Wold, S.3
  • 2
    • 33745201613 scopus 로고    scopus 로고
    • Recommendation to treat continuous variable errors like attribute errors
    • Krouwer JS. Recommendation to treat continuous variable errors like attribute errors. Clin Chem Lab Med. 2006;44(7):797-8.
    • (2006) Clin Chem Lab Med , vol.44 , Issue.7 , pp. 797-798
    • Krouwer, J.S.1
  • 3
    • 0023239559 scopus 로고
    • Consensus statement on self monitoring of blood glucose
    • ADA 1987 American Diabetes Association
    • ADA 1987 American Diabetes Association. Consensus statement on self monitoring of blood glucose. Diabetes Care. 1987;10(1):93-9.
    • (1987) Diabetes Care , vol.10 , Issue.1 , pp. 93-99
  • 5
    • 84887442481 scopus 로고    scopus 로고
    • Point-of-care blood glucose testing in acute and chronic care facilities approved guideline
    • CLSI/NCCLS. Wayne, PA: NCCLS
    • CLSI/NCCLS. Point-of-care blood glucose testing in acute and chronic care facilities approved guideline. CLSI/NCCLS document C30-A2. Wayne, PA: NCCLS; 2002.
    • (2002) CLSI/NCCLS Document C30-A2
  • 6
    • 76149105245 scopus 로고    scopus 로고
    • International vocabulary of metrology - basic and general concepts and associated terms VIM
    • 3rd.
    • International vocabulary of metrology - basic and general concepts and associated terms VIM, 3rd. JCGM 200:2008.
    • (2008) JCGM , vol.200
  • 7
    • 84887461769 scopus 로고    scopus 로고
    • revised and expanded. Pyzdek T, editor. McGraw-Hill
    • The six SIGMA handbook, revised and expanded. Pyzdek T, editor. McGraw-Hill; 2003. p 641-3.
    • (2003) The Six SIGMA Handbook , pp. 641-643
  • 9
    • 0036092613 scopus 로고    scopus 로고
    • Instruments for selfmonitoring of blood glucose: Comparisons of testing quality achieved by patients and a technician
    • Skeie S, Thue G, Nerhus K, Sandberg S. Instruments for selfmonitoring of blood glucose: comparisons of testing quality achieved by patients and a technician. Clin Chem. 2002;48(7):994-1003.
    • (2002) Clin Chem , vol.48 , Issue.7 , pp. 994-1003
    • Skeie, S.1    Thue, G.2    Nerhus, K.3    Sandberg, S.4
  • 10
    • 0030066052 scopus 로고    scopus 로고
    • Self-monitoring of blood glucose
    • American Diabetes Association
    • American Diabetes Association. Self-monitoring of blood glucose. Diabetes Care. 1996;19 Suppl 1:S62-6.
    • (1996) Diabetes Care , vol.19 , Issue.SUPPL. 1
  • 11
    • 0023205574 scopus 로고
    • Evaluating clinical accuracy of systems for self-monitoring of blood glucose
    • Clarke WL, Cox D, Goder-Frederick LA, Carter W, Pohl SL. Evaluating clinical accuracy of systems for self-monitoring of blood glucose. Diabetes Care. 1987;10(5):622-8.
    • (1987) Diabetes Care , vol.10 , Issue.5 , pp. 622-628
    • Clarke, W.L.1    Cox, D.2    Goder-Frederick, L.A.3    Carter, W.4    Pohl, S.L.5
  • 12
    • 0033855803 scopus 로고    scopus 로고
    • A new consensus error grid to evaluate the clinical significance of inaccuracies in the measurement of blood glucose
    • Parkes JL, Slatin SL, Pardo S, Ginsberg BH. A new consensus error grid to evaluate the clinical significance of inaccuracies in the measurement of blood glucose. Diabetes Care. 2000;23(8):1143-8.
    • (2000) Diabetes Care , vol.23 , Issue.8 , pp. 1143-1148
    • Parkes, J.L.1    Slatin, S.L.2    Pardo, S.3    Ginsberg, B.H.4
  • 14
    • 0025982085 scopus 로고
    • Multi-factor designs. IV. How multi-factor designs improve the estimate of total error by accounting for protocol specific bias
    • Krouwer JS. Multi-factor designs. IV. How multi-factor designs improve the estimate of total error by accounting for protocol specific bias. Clin Chem. 1991;37(1):26-9.
    • (1991) Clin Chem , vol.37 , Issue.1 , pp. 26-29
    • Krouwer, J.S.1
  • 15
    • 44349125832 scopus 로고    scopus 로고
    • Toward metrological traceability in the determination of prostate-specific antigen (PSA): Calibrating Beckman Coulter Hybritech Access PSA assays to WHO standards compared with the traditional Hybritech standards
    • Stephan C, Kahrs A, Klotzek S, Reiche J, Müller C, Lein M, Deger S, Miller K, Jung K. Toward metrological traceability in the determination of prostate-specific antigen (PSA): calibrating Beckman Coulter Hybritech Access PSA assays to WHO standards compared with the traditional Hybritech standards. Clin Chem Lab Med. 2008;46(5):623-9.
    • (2008) Clin Chem Lab Med , vol.46 , Issue.5 , pp. 623-629
    • Stephan, C.1    Kahrs, A.2    Klotzek, S.3    Reiche, J.4    Müller, C.5    Lein, M.6    Deger, S.7    Miller, K.8    Jung, K.9
  • 16
    • 36649016885 scopus 로고    scopus 로고
    • Glucose: A simple molecule that is not simple to quantify
    • Gambino R. Glucose: a simple molecule that is not simple to quantify. Clin Chem. 2007;53(12):2040-1.
    • (2007) Clin Chem , vol.53 , Issue.12 , pp. 2040-2041
    • Gambino, R.1
  • 17
    • 0026765468 scopus 로고
    • Estimating total analytical error and its sources. Techniques to improve method evaluation
    • Krouwer JS. Estimating total analytical error and its sources. Techniques to improve method evaluation. Arch Pathol Lab Med. 1992;116(7):726-31.
    • (1992) Arch Pathol Lab Med , vol.116 , Issue.7 , pp. 726-731
    • Krouwer, J.S.1
  • 18
    • 0025814770 scopus 로고
    • Laboratory process specifications for assuring quality in the U.S. National Cholesterol Education Program
    • Westgard JO, Petersen PH, Wiebe DA. Laboratory process specifications for assuring quality in the U.S. National Cholesterol Education Program. Clin Chem. 1991;37(5):656-61.
    • (1991) Clin Chem , vol.37 , Issue.5 , pp. 656-661
    • Westgard, J.O.1    Petersen, P.H.2    Wiebe, D.A.3
  • 20
    • 0028970546 scopus 로고
    • National Cholesterol Education Program recommendations for measurement of low-density lipoprotein cholesterol: Executive summary. The National Cholesterol Education Program Working Group on Lipoprotein Measurement
    • Bachorik PS, Ross JW. National Cholesterol Education Program recommendations for measurement of low-density lipoprotein cholesterol: executive summary. The National Cholesterol Education Program Working Group on Lipoprotein Measurement. Clin Chem. 1995;41(10):1414-20.
    • (1995) Clin Chem , vol.41 , Issue.10 , pp. 1414-1420
    • Bachorik, P.S.1    Ross, J.W.2
  • 21
    • 0035130886 scopus 로고    scopus 로고
    • Quality specifications for glucose meters: Assessment by simulation modeling of errors in insulin dose
    • Boyd JC, Bruns DE. Quality specifications for glucose meters: assessment by simulation modeling of errors in insulin dose. Clin Chem. 2001;47(2):209-14.
    • (2001) Clin Chem , vol.47 , Issue.2 , pp. 209-214
    • Boyd, J.C.1    Bruns, D.E.2
  • 22
    • 85049279454 scopus 로고    scopus 로고
    • How to improve total error modeling by accounting for error sources beyond imprecision and bias
    • Krouwer JS. How to improve total error modeling by accounting for error sources beyond imprecision and bias. Clin. Chem. 2001;47(7):1329-30.
    • (2001) Clin Chem , vol.47 , Issue.7 , pp. 1329-1330
    • Krouwer, J.S.1
  • 23
    • 84887441145 scopus 로고    scopus 로고
    • Drs. Boyd and Bruns respond
    • Boyd JC, Bruns DE. Drs. Boyd and Bruns respond. Clin Chem. 2001;47(7):1330-1.
    • (2001) Clin Chem , vol.47 , Issue.7 , pp. 1330-1331
    • Boyd, J.C.1    Bruns, D.E.2
  • 24
    • 0036177713 scopus 로고    scopus 로고
    • Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus
    • Sacks DB, Bruns DE, Goldstein DE, Maclaren NK, McDonald JM, Parrott M. Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus. Clin Chem. 2002;48(3):3436-72.
    • (2002) Clin Chem , vol.48 , Issue.3 , pp. 3436-3472
    • Sacks, D.B.1    Bruns, D.E.2    Goldstein, D.E.3    Maclaren, N.K.4    McDonald, J.M.5    Parrott, M.6
  • 25
    • 0018547465 scopus 로고
    • Statistical comparison of multiple analytic procedures: Application to clinical chemistry
    • Lawton WH, Sylvester EA, Young-Ferraro BJ. Statistical comparison of multiple analytic procedures: application to clinical chemistry. Technometrics. 1979;21:397-409.
    • (1979) Technometrics , vol.21 , pp. 397-409
    • Lawton, W.H.1    Sylvester, E.A.2    Young-Ferraro, B.J.3
  • 26
    • 84908219488 scopus 로고
    • Statistical methods for assessing agreement between two methods of clinical measurement
    • Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986;1(8476):307-10.
    • (1986) Lancet , vol.1 , Issue.8476 , pp. 307-310
    • Bland, J.M.1    Altman, D.G.2
  • 27
    • 84942963994 scopus 로고
    • A simple graphical method to evaluate laboratory assays
    • Krouwer JS, Monti KL. A simple graphical method to evaluate laboratory assays. Eur J Clin Chem Clin Biochem. 1995;33(8):525-7.
    • (1995) Eur J Clin Chem Clin Biochem , vol.33 , Issue.8 , pp. 525-527
    • Krouwer, J.S.1    Monti, K.L.2
  • 28
    • 21844526854 scopus 로고
    • Folded empirical distribution function curves - Mountain plots
    • Monti KL. Folded empirical distribution function curves - mountain plots. Am Stat. 1995;49;342-5.
    • (1995) Am Stat , vol.49 , pp. 342-345
    • Monti, K.L.1
  • 29
    • 84887489866 scopus 로고    scopus 로고
    • Estimation of total analytical error for clinical laboratory methods; approved guideline
    • CLSI/NCCLS. Wayne, PA: NCCLS
    • CLSI/NCCLS. Estimation of total analytical error for clinical laboratory methods; approved guideline. CLSI/NCCLS document EP21-A. Wayne, PA: NCCLS; 2003.
    • (2003) CLSI/NCCLS Document EP21-A
  • 30
    • 84887432874 scopus 로고    scopus 로고
    • How to construct and interpret an error grid for diagnostic assays EP27 proposed guideline
    • CLSI/NCCLS. Wayne, PA: NCCLS
    • CLSI/NCCLS. How to construct and interpret an error grid for diagnostic assays EP27 proposed guideline. CLSI/NCCLS document EP27-P. Wayne, PA: NCCLS; 2009.
    • (2009) CLSI/NCCLS Document EP27-P
  • 31
    • 16244379294 scopus 로고    scopus 로고
    • Evaluation of precision performance of quantitative measurement methods approved guideline
    • CLSI/NCCLS. 2nd ed. Wayne, PA: NCCLS
    • CLSI/NCCLS. Evaluation of precision performance of quantitative measurement methods approved guideline. 2nd ed. CLSI/NCCLS document EP05-A2. Wayne, PA: NCCLS; 2004.
    • (2004) CLSI/NCCLS Document EP05-A2
  • 32
    • 1842674489 scopus 로고    scopus 로고
    • Evaluation of the linearity of quantitative measurement procedures: A statistical approach approved guideline
    • CLSI/NCCLS. Wayne, PA: NCCLS
    • CLSI/NCCLS. Evaluation of the linearity of quantitative measurement procedures: a statistical approach approved guideline. CLSI/NCCLS document EP06-A. Wayne, PA: NCCLS; 2003.
    • (2003) CLSI/NCCLS Document EP06-A
  • 33
    • 84887443876 scopus 로고    scopus 로고
    • Interference testing in clinical chemistry approved guideline
    • CLSI/NCCLS. Wayne, PA: NCCLS
    • CLSI/NCCLS. Interference testing in clinical chemistry approved guideline. CLSI/NCCLS document EP07-A2. Wayne, PA: NCCLS; 2005.
    • (2005) CLSI/NCCLS Document EP07-A2
  • 34
    • 85039641608 scopus 로고    scopus 로고
    • Method comparison and bias estimation using patient samples; approved guideline
    • CLSI/NCCLS. 2nd ed. Wayne, PA: NCCLS
    • CLSI/NCCLS. Method comparison and bias estimation using patient samples; approved guideline. 2nd ed. CLSI/NCCLS document EP09-A2. Wayne, PA: NCCLS; 2002.
    • (2002) CLSI/NCCLS Document EP09-A2
  • 35
    • 84887444699 scopus 로고    scopus 로고
    • Evaluation of stability of in vitro diagnostic method products. Approved guideline
    • CLSI/NCCLS. Wayne, PA: NCCLS
    • CLSI/NCCLS. Evaluation of stability of in vitro diagnostic method products. Approved guideline. CLSI/NCCLS document EP25-A. Wayne, PA: NCCLS; 2009.
    • (2009) CLSI/NCCLS Document EP25-A
  • 36
    • 0033041850 scopus 로고    scopus 로고
    • Misuse of correlation and regression in three medical journals
    • Porter AM. Misuse of correlation and regression in three medical journals. J R Soc Med. 1999;92(3):123-8.
    • (1999) J R Soc Med , vol.92 , Issue.3 , pp. 123-128
    • Porter, A.M.1
  • 37
    • 38649115012 scopus 로고    scopus 로고
    • Evaluation of point-of-care glucose testing accuracy using locally-smoothed median absolute difference curves
    • Kost GJ, Tran NK, Abad VJ, Louie RF. Evaluation of point-of-care glucose testing accuracy using locally-smoothed median absolute difference curves. Clin Chim Acta. 2008;389(1-2):31-9.
    • (2008) Clin Chim Acta , vol.389 , Issue.1-2 , pp. 31-39
    • Kost, G.J.1    Tran, N.K.2    Abad, V.J.3    Louie, R.F.4
  • 39
    • 85039632395 scopus 로고    scopus 로고
    • Risk management techniques to identify and control laboratory error sources. Approved guideline
    • CLSI/NCCLS. 2nd ed. Wayne, PA: NCCLS
    • CLSI/NCCLS. Risk management techniques to identify and control laboratory error sources. Approved guideline. 2nd ed. CLSI/NCCLS document EP18-A2. Wayne, PA: NCCLS; 2009.
    • (2009) CLSI/NCCLS Document EP18-A2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.