PEPFAR Quality Control and Method Validation Activity 8 Worksheet 1: Intended Use

Worksheet 1: Intended Use 805 Effective Date: 12/06/2016 HILS1764 Based on the following QC chart, does this method produce test results that are clinically acceptable for the intended use of this test? +4SD +3SD + 2SD + 1SD X -1SD 2SD - -3SD -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 2A. If no, explain your answer. Specify what other information do you believe you need. After your response, proceed to Worksheet 2B.