Partly nonparametric approach for determining the limit of detection

Clinical Chemistry

Volumn 50, Issue 4, 2004, Pages 732-740

  Linnet, Kristian ^a   Kondratovich, Marina ^b  

^a AARHUS UNIVERSITY HOSPITAL   (Denmark)

^b CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANALYTIC METHOD; ANALYTICAL ERROR; ARTICLE; CALIBRATION; CLINICAL CHEMISTRY; LIMIT OF DETECTION; NONPARAMETRIC TEST; SAMPLE SIZE; SIMULATION; STANDARD;

CALIBRATION; CHEMISTRY, CLINICAL; RESEARCH DESIGN; SENSITIVITY AND SPECIFICITY; STATISTICS, NONPARAMETRIC;

EID: 1842503865     PISSN: 00099147     EISSN: None     Source Type: Journal    
DOI: 10.1373/clinchem.2003.029983     Document Type: Article

References (26)

1. International Organization for Standardization. Capability of detection - part 1: terms and definitions (11843-1). Geneva, Switzerland: ISO, 1997.
2. International Organization for Standardization. Capability of detection - part 2: methodology in the linear calibration case (11843-2). Geneva, Switzerland: ISO, 2000.
3. International Organization for Standardization. Capability of detection - part 3: methodology for determination of the critical value for the response variable when no calibration data are used (11843-3). Geneva, Switzerland: ISO, 2001.
4. International Organization for Standardization. Capability of detection - part 4: methodology for comparing the minimum detectable value with a given value (11843-4). Geneva, Switzerland: ISO, 2001.
5. Currie LA. Nomenclature in evaluation of analytical methods including detection and quantification capabilities (IUPAC recommendations 1995). Pure Appl Chem 1995;67:1699-723.
6. Davenport JM, Schlain B. Testing claimed minimal detectable concentrations of in vitro medical diagnostic devices. Clin Chem 2000;46:1669-80.
7. Brown EN, McDermott TJ, Bloch KJ, McCollom AD. Defining the smallest analyte concentration an immunoassay can measure. Clin Chem 1996;42:893-903.
8. Conover WJ. Practical nonparametric statistics, 2nd ed. New York: Wiley, 1980:29-30.
9. Hahn GJ, Meeker WQ. Statistical intervals: a guide for practitioners. New York: Wiley, 1991:319.
10. Linnet K. Nonparametric estimation of reference intervals by simple and bootstrap-based procedures. Clin Chem 2000;46:867-9.
11. Kaiser H. Quantitation in elemental analysis. Anal Chem 1970;42:26-59.
12. Altshuler B, Pasternack B. Statistical measures of the lower limit of detection of a radioactivity counter. Health Physics 1963;9:293-8.
13. Currie LA. Limits for qualitative detection and quantitative determination: application to radiochemistry. Anal Chem 1968;40:586-93.
14. Hubaux A, Vos G. Decision and detection limits for linear calibration curves. Anal Chem 1970;42:849-55.
15. Clayton CA, Hines JW, Elkine PD. Detection limits with specified assurance probabilities. Anal Chem 1987;59:2506-14.
16. Harris EK, Boyd J. Statistical bases of reference values in laboratory medicine. New York: Marcel Dekker, 1995:23-39.
17. Harrell FE, Davis CE. A new distribution-free quantile estimator. Biometrika 1982;69:635-40.
18. Shultz EK, Willard KE, Rich SS, Connelly DP, Critchfield GC. Improved reference interval estimation. Clin Chem 1985;31:1974-8.
19. International Organization for Standardization. International vocabulary of basic and general terms in metrology. Geneva, Switzerland: ISO, 1993.
20. Zweig MH, Kroll MH. Linear regression estimation of minimal detectable concentration. Thyrotropin as an example. Arch Pathol Lab Med 1997;121:948-55.
21. Stamey TA. Lower limits of detection, biological detection limits, functional sensitivity, or residual cancer detection limit? Sensitivity reports on prostate-specific antigen assays mislead clinicians. Clin Chem 1996;42:849-52.
22. Lentner C, ed. Geigy scientific tables. Introduction to statistics; statistical tables; mathematical formulae, 8th ed., Vol. 2. Basel, Switzerland: Ciba-Geigy, 1982:197.
23. International Federation of Clinical Chemistry. Approved recommendation (1987) on the theory of reference values. Part 5. Statistical treatment of collected reference values. Determination of reference limits. J Clin Chem Clin Biochem 1987;25:645-56.
24. David HA. Order statistics. New York: Wiley, 1981:80-2.
25. Kendall MG, Stuart A. The advanced theory of statistics, 4th ed., Vol. 1. London: C. Griffin & Co., 1977:258, 352.
26. Johnson NJ, Kotz S. Distributions in statistics, Vol. 2: continuous univariate distributions-1. New York: Wiley, 1972:196-7.