Method Performance Evaluation

Test or Analyte Methodology Quality Requirement Allowable Total Error 15.0 Offset 0.0 Method Performance Bias (% diff) 2.4 Imprecision (% CV) 1.9 Sigma Metric 6.6 cacium mss Analyst Date Sigma Limits 6 5 4 3 2 s 2.50 3.00 3.75 5.00 7.50

Medical Decision Chart

16.0 14.0 12.0 10.0 8.0 6.0 4.0 2.0 0.0 0.0 1.0 2.0 3.0 4.0 5.0 6.0 7.0 8.0 Allowable Imprecision (s, %) .
6 Sigma 5 Sigma 4 Sigma

Allowable Inaccuracy (bias, %)

6 Sigma 5 Sigma 4 Sigma 3 Sigma 2 Sigma

0 2.50 0 3.00 0 3.75 0 5.00 0 7.50

Vectors 15 0 15 0 15 0 15 0 15 0

0 0.00 0 0.00 0 0.00 0 0.00 0 0.00

0 0 0 0 0 0 0 0 0 0

3 Sigma 2 Sigma Operating Point

Spreadsheet Template Courtesy of Alexander Bragat -- Westgard Class of 2003

Medical Decision Chart

16.0
6 Sigma 5 Sigma

14.0

4 Sigma 3 Sigma 2 Sigma Operating Point

12.0 . Allowable Inaccuracy (bias, %) 10.0 8.0 6.0

4.0

2.0

0.0 0.0 1.0 2.0 3.0 4.0 Allowable Imprecision (s, %) 5.0 6.0 7.0 8.0