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PEPFAR Quality Control and Method Validation Activity 9 Worksheet 1: Calculating Sec and Sigma

This PDF contains information needed to complete Activity 9.

Worksheet 1: Calculating SEc and Sigma 906 Effective Date: 12/6/2016 HILS1746 Directions: Use the following key numbers to complete the table below. Each site analyzes three controls (low, normal, and high) for each analytical run. Analyte: Platelet Mean True Value SD % TEA Sigma-metric Rule Selection Guide Count (cell * 109/L) (target) 6 sigma - any QC will do (just don't use 2 SD limits) . . Lab A 150 150 13.4% 5 sigma - single-rules such as 1:3s or 1:2.5s m 4 sigma - multirules < 4 sigma - multirules with look-back to previous Lab B 145 150 13.4% m runs, increase the number of controls analyzed 3 or less - look for better analytical methods Lab C 150 150 13.4% Lab D 148 150 13.4% Un Lab E 145 150 10 13.4% Analyte: I Bias I TE in units TEA in units SEC Sigma QC Rules Based on the Sigma-metric Platelet [(TEA - |Bias|)/SD] Count | x -True Value| Abs Bias + (1.65*SD) (TEA %/100%)* Target Value [(TEA - |Bias|)/SD] - 1.65 ( cell * SEc + 1.65 109/L) Lab A Lab B Lab C Lab D Lab E 93

  • TEA
  • sigma-metric
  • critical systematic error
  • SEC
  • SLIPTA
  • SLIPTA checklist
  • benchmarking methods
  • sigma scale
  • sigma
  • method performance