PEPFAR Quality Control and Method Validation Activity 7 Worksheet 2: Impact of Bias and Imprecision on TE

Worksheet 2: Impact of Bias and Imprecision on TE 704 Effective Date: 12/6/2016 HILS1746 Directions: Use the following key numbers to complete the table below. Please note there are 2ways to calculate %TE. The second way is introduced in this worksheet. On the back of this worksheet, illustrate the method performance of each laboratory. Include the target value, the Gaussian curve, an arrow representing SE (if applicable), an arrow representing RE, and an arrow representing TE Analyte: Platelet Count (cell * 109/L) Mean True Value SD (target) Lab A 150 150 Lab B 145 150 LO Lab C 150 150 10 Lab D 145 150 10 Analyte Bias I Bias I TE in units TE in % %CV Abs Bias % TE in % (abs bias) x -True | x -True Value| Abs Bias + (1.65*SD) (TE /True Value) (SD /x )* 100% (Abs Bias /True Value) Abs Bias % + (1.65* %CV) Value *100% *100% Lab A (8.3 / 150) *100% =5.5% Lab B Lab C Lab D 71