The NGAL Test Application Note for Roche Modular P

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1 The NGAL Test Application Note for Roche Modular P NGAL Code (ACN) xxx ANALYZE Ser/Pl type Assay/Time/Point 2-Point-End Wave (2nd/Primary) 8 57 Volume Reagent Vol. Diluent BCN OBS Timing Normal 3,, R1 15 xxx Decrease 15, 3, 15 R2 T2 Increase 6,, R3 5 xxx T3 R4 Diluent Water Code OBS Diluent (Saline) Increase/Decrease Abs. Limit 32 Increase Upper/Lower Reagent Bottle Size Prozone Limit Lower A D Cell Detergent Detergent 1 B E Twin Test C CALIBRATION Auto Calibration Calibration Type SPLINE Timeout Blank Point 6 Span Span 6 2Point Weight Full Update Type Isozyme Q Channel none Change Over Module SD Limit 999 Lot full Duplicate Limit 99 % 32 Abs Bottle Sensitivity Limit S1-Abs Limit Version: 1 Revision date: The NGAL Test Application Note for Page.1 of 7

2 RANGE Expected Ranges Male App Code xxx Factor # Years # # Unit ng/ml Unit 2 # Years # # Unit 3 # # Report Name Data Mode NGAL Active Female Technical Limit 25 5 # Years # # Repeat Limit # Years # # Control Interval Time, # # Qualitative (1) -- Default (2) - Sex (3) +/- Male Female (4) ++ (5) +++ Range (6) ++++ Range 1 Range 2 Range 3 OTHERS Std (1) (2) (3) (4) (5) (6) Calib. Code 51 xxx xxx xxx xxx xxx Concentration, Position Conversion Factor Volume 3, 3, 3, 3, 3, 3, Diluent S. Volume,,,,,, Diluent Volume xxx: To be defined by operator. BioPorto Diagnostics A/S The Application Note applies to the quantitative determination of NGAL in human urine and EDTA plasma. The performance data shown were obtained by the manufacturer. Each individual laboratory should validate its test system. Version: 1 Revision date: The NGAL Test Application Note for Page.2 of 7

3 Sensitivity Reagent calibrator instrument parameter The NGAL Test Lot.RD23 Master 3/15/5 P /8nm Spline delta Abs*1 Lot. RD ng/ml 15 ng/ml 6 ng/ml 15 ng/ml 3 ng/ml 5 ng/ml -15,5 111, 546,5 1282, 192, 2245,5 Unit:delta Abs*1 Calibration Curve ng/ml, 15 ng/ml 146, 6 ng/ml 61,5 15 ng/ml 1539,5 3 ng/ml 323,5 5 ng/ml 487,5 Recovery ng/ml - 15 ng/ml 97% 6 ng/ml 1% 15 ng/ml 13% 3 ng/ml 11% 5 ng/ml 97% ng/ml 1 ng/ml 2 ng/ml 3 ng/ml 4 ng/ml 5 ng/ml NGAL conc. [ng/ml] Re-run Normal 4923, Re-run 531, Recovery 12% Version: 1 Revision date: Page.3 of 7

4 Within Run Imprecision / Specificity Reagent QC fluid -25ng/mL / Control Low,High / QC Panel Low, The NGAL Test Lot.RD23 Master 3/15/5 P /8nm Spline QC Fluid Control Low Control High 25ng/mL Lot.1831 Lot.1831 Specificity Roche H917 Modular-P Recovery Control Low 194,9 197,3 11% Control High 485,2 493,9 12% Panel Low 11,2 113,3 13% Panel Medium 313,4 321,4 13% Panel High 873,2 99,4 14% N Mean 22, 197,3 493,9 Max 26, 214, 55, Min 15, 192, 487, SD 3,2927 6,365 5,5867 CV% 14,97% 3,22% 1,13% Version: 1 Revision date: Page.4 of 7

5 Linearity ~ 15ng/mL Dilution Saline, diluent Master 3/15/5 P /8nm Spline Dil.levels Theoretical Measured Recovery Dil.levels Theoretical Measured Recovery 15ng/mL - Saline 15ng/mL - diluent 1,,,, 1,,, 4, 9, 1, 15, 137,5 92% 9, 1, 15, 146, 97% 8, 2, 3, 295, 98% 8, 2, 3, 293, 98% 7, 3, 45, 456, 11% 7, 3, 45, 447, 99% 6, 4, 6, 65, 11% 6, 4, 6, 61,5 1% 5, 5, 75, 766, 12% 5, 5, 75, 777, 14% 4, 6, 9, 924,5 13% 4, 6, 9, 99, 11% 3, 7, 15, 181,5 13% 3, 7, 15, 155,5 11% 2, 8, 12, 1238,5 13% 2, 8, 12, 122, 12% 1, 9, 135, 139,5 13% 1, 9, 135, 1361,5 11%, 1, 15, 1545,5 13%, 1, 15, 1518,5 11% Version: 1 Revision date: Page.5 of 7

6 Linearity ~ 5ng/mL & Prozone Dilution 6 4 2, QC fluid Saline, diluent Master 3/15/5 P /8nm Spline Dil.levels Theoretical Measured Recovery Dil.levels Theoretical Measured Recovery Dil.levels Theoretical Measured Mark 5ng/mL - Saline 5ng/mL - diluent Prozone - diluent 1,,,, 1,,,, 1,,,,5 9, 1, 5, 484,5 97% 9, 1, 5, 51, 12% 9, 1, ,5 8, 2, 1, 118, 12% 8, 2, 1, 118, 12% 8, 2, 8 636, >5 7, 3, 15, 1544,5 13% 7, 3, 15, 151,5 11% 7, 3, ,5 >5 6, 4, 2, 261,5 13% 6, 4, 2, 228, 11% 6, 4, , >5 5, 5, 25, 2569, 13% 5, 5, 25, 2518,5 11% 5, 5, ,5 Error 4, 6, 3, 39,5 13% 4, 6, 3, 3114, 14% 4, 6, , Error 3, 7, 35, 3655,5 14% 3, 7, 35, 3641,5 14% 3, 7, , Error 2, 8, 4, 421,5 15% 2, 8, 4, 4164, 14% 2, 8, ,5 Error 1, 9, 45, 479,5 16% 1, 9, 45, 4777, 16% 1, 9, ,5 Error, 1, 5, 5182,5 14%, 1, 5, 528,5 11%, 1, , Error Version: 1 Revision date: Page.6 of 7

Interferences Dilution Hemoglobin, Bilirubin, Intrafat diluent Master 3/15/5 P18-34 57/8nm Spline Hemoglobin: C-Bilirubin: F-Bilirubin: Intrafat: 2% 2% 2% 2% 1% % -1% 1% % -1% 1% % -1% 1% % -1% -2% 1

7 Interferences Dilution Hemoglobin, Bilirubin, Intrafat diluent Master 3/15/5 P /8nm Spline Hemoglobin: C-Bilirubin: F-Bilirubin: Intrafat: 2% 2% 2% 2% 1% % -1% 1% % -1% 1% % -1% 1% % -1% -2% % % % Hemoglobin [mg/dl] C-Bilirubin [mg/dl] F-Bilirubin [mg/dl] Intrafat [%] mg/dl Deviation mg/dl Deviation mg/dl Deviation %,%,%,% 1-1,% 6 -,3% 6 1,% 1 2 -,5% 12 1,1% 12-1,1% 2 3-2,9% 18,8% 18-1,4% 3 4-1,6% 24,% 24 2,7% 4 5-1,8% 3 2,3% 3 2,3% 5 Deviation,% -,6% -2,6% -2,7% -2,1% -1,4% Version: 1 Revision date: Page.7 of 7

The NGAL Test Application Note for Abbott Architect c8000

The NGAL Test Application Note for Abbott Architect c8 General parameters Name: NGAL Assay number: *1 Assay version: 1 Assay type: Photometric Assay availability: Enabled Cal version: 1 Reaction definition