PEPFAR Quality Control and Method Validation Activity 14 Worksheet: Linearity Experiment

Linearity Experiment Worksheet 14A03 HILS1746 Effective Date: 12/6/2016 Method Being Evaluated: Cobas c501 Date: 4-Nov-13 Analyte: AST Analyst : Lisa Johnson Units: U/L Total Allowable Error (TEa): Concentration: Percent: 20% Manufacturer's stated analytical measurement range: Low: 5 High: 700 Sample Assigned Result Mean Predicted Y Value (X) Result 1 Result 2 (Y) (Y"" + Diff % Diff + Limit % Limit Acceptability m Pool 1 5.60 0.40 7.1 0.56 10% acceptable O Pool 2 177 180 180 180 180 180.83 -0.83 -0.46 18.08 10% acceptable m Pool 3 354 355 354 353 354 356.06 -2.06 -0.58 35.61 10% acceptable Pool 4 529 528 527 Pool 5 704 706 702 Intercept 5.60 Linearity range is Slope 0.99 AMR (analytical measurement range) is 175