Ep5 F316a

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Ep5 F316a

  1. 1. Diagnostic Products Corporation From Berlin to Baltimore: Imprecision as a Continuous Function of Concentration A. Paul Durham Dir. Scientific Publications
  2. 2. IAEA Symposium, Berlin 1977 <ul><li>Radioimmunoassay and Related Procedures in Medicine </li></ul><ul><ul><li>Roger Ekins </li></ul></ul><ul><ul><li>David Rodbard and Peter Munson </li></ul></ul><ul><li>Later contributions to clinical chemistry </li></ul><ul><ul><li>Barry Nix </li></ul></ul><ul><ul><li>Phelim Daniels </li></ul></ul><ul><ul><li>Bill Sadler ... VFP v4.0 (May 2001)* </li></ul></ul>*Sadler. Comput Methods Programs Biomed 2002;67:195.
  3. 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. 4. One-Way ANOVA: The Very Idea Redrawn from poster. Clin Chem 1986;32:1180. Suggests various “nonparametric” alternatives. . . .
  5. 5. Sources of Variation (“Trouble-makers”) <ul><li>Pipetting (Assay) </li></ul><ul><li>Several Technicians </li></ul><ul><li>Gamma Counter </li></ul><ul><li>Reagent Stability </li></ul><ul><li>Lot-to-Lot Variation </li></ul><ul><li>Lab Equipment </li></ul><ul><li>Local Habits </li></ul><ul><li>Pipetting (Dilutions) </li></ul>
  6. 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. 7. Ep5~2005 Fuentes-Arderiu, et al. eJIFCC 2003 Mar;14(1). Fig 1a. [pdf]
  8. 8. Redrawn (SD inset) from: Fuentes-Arderiu, et al. eJIFCC 2003 Mar;14(1). Ep5~2005
  9. 9. Ep5~2005
  10. 10. Ep5~2005 Reportable Range (JJE) 3 – 1000 U/L
  11. 11. Ep5~2005
  12. 12. Ep5~2005 Reportable Range (JJE) 20 – 625 mg/dL
  13. 13. The Shrinking Range
  14. 14. Index Plots, 8 Samples Precision Profile
  15. 18. After Before
  16. 19. Response-Error Relationship: 2P or 3P* Ep5~2005 *Daniels. Clin Chem 1994;40:513.
  17. 20. Ep5~2005
  18. 21. Ep5~2005
  19. 22. Ep5~2005 Typical IA / IMA Calibration Curve: 4P
  20. 23. Translate SD(Response) to SD(Dose)
  21. 24. Indirect 6P (or 7P) Method requires at least 7 (or 8) well-spaced samples.
  22. 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)
  23. 28. Data from: Rawlins, Roberts. Clin Chem 2004;50(S6):A95. Ep5~2005
  24. 29. Sadler’s 3-Parameter Variance Function Redrawn from: Sadler. Variance Function Program [PDF]. Christchurch, May 2001.
  25. 30. Monique De Rae, De Blauw ogige Lady www.mderae.be
  26. 31. Ep5~2005
  27. 32. Ep5~2005
  28. 33. Ep5~2005
  29. 34. Andree et al. Clin Chem 2004;50(S6):A100.
  30. 35. Andree et al. Clin Chem 2004;50(S6):A100.
  31. 36. Andree et al. Clin Chem 2004;50(S6):A100.
  32. 37. Andree et al. Clin Chem 2004;50(S6):A100.
  33. 38. Diagnostic Products Corporation www.DPCweb.com  technical documents [email_address] F316a Clinical and Laboratory Standards Institute — EP5 — Baltimore, 2005

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