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  • 1. Diagnostic Products Corporation From Berlin to Baltimore: Imprecision as a Continuous Function of Concentration A. Paul Durham Dir. Scientific Publications
  • 2. IAEA Symposium, Berlin 1977
    • Radioimmunoassay and Related Procedures in Medicine
      • Roger Ekins
      • David Rodbard and Peter Munson
    • Later contributions to clinical chemistry
      • Barry Nix
      • Phelim Daniels
      • Bill Sadler ... VFP v4.0 (May 2001)*
    *Sadler. Comput Methods Programs Biomed 2002;67:195.
  • 3. Nested, Bowl-Shaped Precision Contours Redrawn from: Munson, Rodbard. IAEA 1977: Radioimmunoassay, v.2, pp.109, 111. Precision types? . . . or components? Working Range: How much do we see?
  • 4. One-Way ANOVA: The Very Idea Redrawn from poster. Clin Chem 1986;32:1180. Suggests various “nonparametric” alternatives. . . .
  • 5. Sources of Variation (“Trouble-makers”)
    • Pipetting (Assay)
    • Several Technicians
    • Gamma Counter
    • Reagent Stability
    • Lot-to-Lot Variation
    • Lab Equipment
    • Local Habits
    • Pipetting (Dilutions)
  • 6. Some Observable Precision Types: PO*Set *PARTIALLY ORDERED by associated “Troublemakers” Note: Kit lot variations are not smoothly represented in most PT events.
  • 7. Ep5~2005 Fuentes-Arderiu, et al. eJIFCC 2003 Mar;14(1). Fig 1a. [pdf]
  • 8. Redrawn (SD inset) from: Fuentes-Arderiu, et al. eJIFCC 2003 Mar;14(1). Ep5~2005
  • 9. Ep5~2005
  • 10. Ep5~2005 Reportable Range (JJE) 3 – 1000 U/L
  • 11. Ep5~2005
  • 12. Ep5~2005 Reportable Range (JJE) 20 – 625 mg/dL
  • 13. The Shrinking Range
  • 14. Index Plots, 8 Samples Precision Profile
  • 15.  
  • 16.  
  • 17.  
  • 18. After Before
  • 19. Response-Error Relationship: 2P or 3P* Ep5~2005 *Daniels. Clin Chem 1994;40:513.
  • 20. Ep5~2005
  • 21. Ep5~2005
  • 22. Ep5~2005 Typical IA / IMA Calibration Curve: 4P
  • 23. Translate SD(Response) to SD(Dose)
  • 24. Indirect 6P (or 7P) Method requires at least 7 (or 8) well-spaced samples.
  • 25.  
  • 26.  
  • 27. X=TSH, mIU/L — Y=CV% Graphs from: Rawlins, Roberts. Clin Chem 2004;50(S6):A95. Six Automated Third Generation TSH Assays 3 Weeks, 2 Days/Week, 2 Reps/Day — for 2 Kit Lots (Total: 24 Reps)
  • 28. Data from: Rawlins, Roberts. Clin Chem 2004;50(S6):A95. Ep5~2005
  • 29. Sadler’s 3-Parameter Variance Function Redrawn from: Sadler. Variance Function Program [PDF]. Christchurch, May 2001.
  • 30. Monique De Rae, De Blauw ogige Lady www.mderae.be
  • 31. Ep5~2005
  • 32. Ep5~2005
  • 33. Ep5~2005
  • 34. Andree et al. Clin Chem 2004;50(S6):A100.
  • 35. Andree et al. Clin Chem 2004;50(S6):A100.
  • 36. Andree et al. Clin Chem 2004;50(S6):A100.
  • 37. Andree et al. Clin Chem 2004;50(S6):A100.
  • 38. Diagnostic Products Corporation www.DPCweb.com  technical documents [email_address] F316a Clinical and Laboratory Standards Institute — EP5 — Baltimore, 2005