PEPFAR Quality Control and Method Validation Activity 8 Worksheet 4: Intended Use

Worksheet 4: Intended Use 810 X assigned 5.80 mmol/L SD assigned 0.10 mmol/L Target 5.60 mmol/L 6.20 +4SD 6.10 +3SD 6.00 + 2SD 5.90 + 1SD 5.80 X 5.70 -1SD 5.60 2SD - 5.50 -3SD 5.40 -4SD Day 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 24 25 26 27 28 29 30 Does this method produce glucose test results that are clinically acceptable for the intended use of this test if the allowable error limits for glucose at this concentration are 0.39 mmol/L? Explain your answer. Total Error(TE) for glucose is 0.37 mmol/L, which is less than the allowable error limit of 0.39mmol/L. This allowable error limit is called Total Allowable Error (TEA). Since TE TEA) Please describe the information the TEA must provide as our 4th key number for SQC. After your responses, proceed to Job Aid 1: Using TEA. HOOD05162002658134 Effective Date: 09/05/2017