Method Performance Evaluation

Test or Analyte Analyst

Methodology Date

Quality Requirement Sigma Limits s

Allowable Total Error 5.0 6 0.83
Offset 0.0 5 1.00
Method Performance 4 1.25
Bias (% diff) 2.4 3 1.67
.

Imprecision (% CV) 1.9 2 2.50

Sigma Metric 1.4
A l l o w a b l e I n a c c u r a c y (b i a s , % )

Vectors
6 Sigma 0 5 0 0
6
Medical0.83
Decision Chart0 0.00 0
6 Sigma
5 Sigma 0 5 0 0
5 Sigma
5
1.00 0 0.00 0 4 Sigma
4 Sigma 0 5 0 0 3 Sigma
1.25 0 0.00 0 2 Sigma
4 Operating Point
3 Sigma 0 5 0 0
1.67 0 0.00 0
3
2 Sigma 0 5 0 0
2.50 0 0.00 0
2

0
0 0.5 1
Allowable 1.5
Imprecision (s, %)2 2.5 3

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

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Allowable Inaccuracy (bias, %)

Medical Decision Chart

6
6 Sigma
5 Sigma
4 Sigma
3 Sigma
5
2 Sigma
Operating Point

0
0 0.5 1 Allowable1.5
Imprecision (s, %) 2 2.5 3