Ep5 F316a

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APaulDurham

Baltimore

Technologie Business

IAEA Symposium, Berlin 1977 ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],*Sadler. Comput Methods Programs Biomed 2002;67:195.

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?

One-Way ANOVA: The Very Idea Redrawn from poster. Clin Chem 1986;32:1180. Suggests various “nonparametric” alternatives. . . .

Sources of Variation (“Trouble-makers”) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Some Observable Precision Types: PO*Set *PARTIALLY ORDERED by associated “Troublemakers” Note: Kit lot variations are not smoothly represented in most PT events.

Ep5~2005 Fuentes-Arderiu, et al. eJIFCC 2003 Mar;14(1). Fig 1a. [pdf]

Redrawn (SD inset) from: Fuentes-Arderiu, et al. eJIFCC 2003 Mar;14(1). Ep5~2005

Ep5~2005 Reportable Range (JJE) 3 – 1000 U/L

Ep5~2005 Reportable Range (JJE) 20 – 625 mg/dL

Response-Error Relationship: 2P or 3P* Ep5~2005 *Daniels. Clin Chem 1994;40:513.

Ep5~2005 Typical IA / IMA Calibration Curve: 4P

Indirect 6P (or 7P) Method requires at least 7 (or 8) well-spaced samples.

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)

Data from: Rawlins, Roberts. Clin Chem 2004;50(S6):A95. Ep5~2005

Sadler’s 3-Parameter Variance Function Redrawn from: Sadler. Variance Function Program [PDF]. Christchurch, May 2001.

Monique De Rae, De Blauw ogige Lady www.mderae.be

Andree et al. Clin Chem 2004;50(S6):A100.

Diagnostic Products Corporation www.DPCweb.com  technical documents [email_address] F316a Clinical and Laboratory Standards Institute — EP5 — Baltimore, 2005

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Ep5 F316a

1. Diagnostic Products Corporation From Berlin to Baltimore: Imprecision as a Continuous Function of Concentration A. Paul Durham Dir. Scientific Publications

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. . . .

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

Ep5 F316a

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Ep5 F316a