PEPFAR Quality Control and Method Validation Activity 8 Worksheet 2B: Intended Use

Worksheet 2B: Intended Use Based on the same QC chart, which now includes the assigned mean, the assigned SD, and the target value, does this method produce test results that are clinically acceptable for the intended use of this test? 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 If yes, explain your answer. After your response, proceed to Worksheet 3A If no, explain your answer. Specify what other information do you believe you will need. After your response, proceed to Worksheet 3B HOOD05162002658134 Effective Date: 09/05/2017