PEPFAR Quality Control and Method Validation Activity 14 Worksheet: Precision Experiment

179 Precision Experiment Worksheet 14B03 Short Term (Within-run) Method Serial#12345 Manufacturer XYZ Analyte AST Units of Measure U/L Sample Name/Description: Material 1 QC Multi 1; Lot# QC123; exp 30-Aug 20XX Material 2 QC Multi 2; ; Lot# QC223; exp 30-Aug 20XX Material 3 Analyst Lisa Johnson Date November 5, 2013 Experiment Results Preliminary Estimate of Precision, Short Term Run Material Material Material Material Material Material # 1 2 3 1 2 3 1 35 120 User 2 34 119 Mean 35.0 U/L 120.0 U/L 3 35 120 SD | 0.8 U/L 1.5 U/L 4 35 12 %CV 5 35 120 6 36 121 Manufacturer's Claims 7 35 120 Mean | 36.6 U/L | 128 U/L 8 34 118 SD | 0.3 U/L 1.0 U/L 9 36 120 %CV 0.8% 0.4% 10 35 122 11 35 119 25% of CLIA Allowable error is _ 5% 12 35 Short term precision is 120 acceptable / unacceptable 13 35 121 14 35 117 15 34 119 16 35 118 17 35 120 18 37 122 19 36 123 20 34 120 HILS1746 Effective Date: 12/6/2016 180 Precision Experiment Worksheet 14B04 Long Term (Between-run) Method Serial#12345 Manufacturer XYZ Analyte AST Units of Measure U/L Sample Name/Description: Material 1 QC Multi 1; Lot# QC123; exp 30-Aug 20XX Material 2 QC Multi 2; ; Lot# QC223; exp 30-Aug 20XX Material 3 Experiment Results Run Date Time Analyst's Material 1 Material 2 Material 3 # Initials 1 6-Nov-13 0700 LS 35 122 2 7-Nov-13 0700 LS 34 119 3 8-Nov-13 0800 AM 34 120 4 9-Nov-13 1100 LS 37 121 5 10-Nov-13 1030 TZ 35 116 6 11-Nov-13 1000 TZ 36 121 12-Nov-13 1700 TZ 33 120 13-Nov-13 1400 AM 33 118 9 14-Nov-13 0800 AM 36 118 10 15-Nov-13 1500 TZ 35 122 11 16-Nov-13 1300 LS 35 119 12 17-Nov-13 0700 LS 34 120 13 18-Nov-13 0730 TZ 37 121 14 19-Nov-13 1000 TZ 35 117 15 20-Nov-13 0900 LS 35 119 16 21-Nov-13 1600 AM 35 118 17 22-Nov-13 1600 AM 35 124 18 23-Nov-13 0900 AM 36 122 19 24-Nov-13 0730 LS 36 123 20 25-Nov-13 1000 TZ 34 120 Preliminary Estimate of Precision, Long Term User Mean 35.0 U/L 120 U/L SD 1.1 U/L 2.1 U/L %CV Manufacturer's Claims Mean 36.7 U/L 130 U/L SD 0.5 U/L 1.0 U/L %CV| 1.3 0.8% 33% of CLIA Allowable error is 6.6%. Long term precision is acceptable / unacceptable HILS1746 Effective Date: 12/6/2016