PEPFAR Quality Control and Method Validation Activity 14 Worksheet: Comparison of Methods

Comparison of Methods Worksheet 14C04 HILS1746 Effective Date: 12/6/2016 Analyte: AST Units of Measure U/L Test Method: Cobas c501 Chemistry Analyzer Comparative Method: XYZ Chemistry Analyzer Manufacturer Roche Manufacturer: XYZ Company 1 5 2nd Mean Time Initials 15 2n Mean Run Date Time Initials Specimen ID Replicate Replicate (Y ) Replicate Replicate ( X) # 19 18 18.5 0645 LS 16 16 16 6-Nov-13 0700 LS 06111323 22 0645 LS 20 20 20 6-Nov-13 0700 LS 06111343 22 22 LS 31 33 32 6-Nov-13 0700 LS 06111325 37 33 35 0645 8.5 m 6-Nov-13 0700 06111382 10 10 0645 7-Nov-13 07111353 7 7 0645 LS 7 5 0700 7-Nov-13 0700 LS 07111356 85 87 86 0645 LS 82 84 83 6 150 146 148 0645 LS 148 140 144 7-Nov-13 0700 LS 07111317 LS 07111323 184 184 184 0645 177 183 180 7-Nov-13 0700 393 390 9 8-Nov-13 1030 AN 08111323 386 374 380 1000 AM 387 1000 AM 38 37 37.5 10 8-Nov-13 1030 AM 08111323 40 40 40 AM 10 10 11 8-Nov-13 1030 AM 08111323 10 10 10 1000 10 AM 300 308 304 8-Nov-13 1030 AM 08111323 312 308 310 1000 0715 LS 15 14 14.5 13 9-Nov-13 0800 LS 09111323 16 16 16 33 35 34 0715 LS 31 33 32 14 9-Nov-13 0800 LS 09111323 154 150 152 0715 LS 146 150 148 15 9-Nov-13 0800 LS 09111323 LS 570 590 580 16 9-Nov-13 0800 LS 09111323 568 572 570 0715 1420 TZ 38 38 38 17 12-Nov-13 1500 TZ 12111323 39 39 39 12-Nov-13 1500 TZ 12111323 9 8 8.5 1420 TZ 8 18 1420 TZ 229 231 230 19 12-Nov-13 1500 TZ 12111323 235 233 234 23 23 20 12-Nov-13 1500 12111323 25 25 25 1420 41 41 41 21 13-Nov-13 1030 AM 13111323 43 45 44 1015 AM 620 22 13-Nov-13 1030 AM 13111323 608 612 610 1015 AM 610 630 376 364 370 1015 AM 377 383 380 23 13-Nov-13 1030 AM 13111323 16 17 16.5 1015 AM 15 14 14.5 24 13-Nov-13 1030 AM 13111323 AM 48 52 50 25 14-Nov-13 1120 AM 14111323 51 53 52 1100 14111323 664 676 670 1100 AM 670 690 680 26 14-Nov-13 1120 AM 10 10 27 14-Nov-13 1120 AM 14111323 11 11 11 .100 AM 10 28 28 28 14-Nov-13 1120 AM 14111323 29 29 29 1100 AM 28 15111323 45 45 45 1505 TZ 43 43 43 29 15-Nov-13 1530 TZ TZ 15111323 260 260 260 1505 TZ 248 262 255 30 15-Nov-13 1530 185 Mean Dat Initials Specimen ID 1 st 2nd Initials 1 st 2nd Run Time Mean Time Replicate Replicate (Y) Replicate Replicate ( X) HILS1746 Effective Date: 12/6/2016 # TZ 32 1505 TZ 30 29 31 15-Nov-13 1530 15111323 32 32 15111323 27 27 27 1505 TZ 25 24 24.5 32 15-Nov-13 1530 TZ 33 18-Nov-13 1215 TZ 18111323 39 41 40 1145 TZ 40 40 40 31 31 34 18-Nov-13 1215 TZ 18111323 31 31 31 1145 TZ 31 35 18-Nov-13 1215 TZ 18111323 9 9 1145 TZ 9 8 8.5 270 260 36 18-Nov-13 1215 TZ 18111323 270 260 265 1145 TZ 250 TZ 26 25 25.5 37 19-Nov-13 1220 TZ 19111323 27 27 27 1200 38 19-Nov-13 1220 TZ 19111323 388 392 1200 TZ 390 410 400 390 65 65 39 19-Nov-13 1220 TZ 19111323 67 66 67.5 1200 TZ 65 564 572 568 1200 TZ 570 580 575 40 19-Nov-13 1220 TZ 19111323 Slope (m) Correlation Coefficient (r) Y-intercept (b) Ordinary linear regression can be used (r > 0.975) S (Sy/x) Linear Regression Equation (Y = mx +b) XC Regression Equation SE or Bias at Xc % Bias at Xc (Y' - XC) (SE/Xc)*100 35 U/L 120 U/L 186