The NGAL Test Application Note for Abbott Architect c8000

Transcription

1 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 Reaction mode: End Up Main read time: Primary wavelength: 572 Secondary wavelength: Color correction read time: - Last read required: 33 Blank read time: 19-2 Absorbance range:. -. blank type: Blank assay: Self blank Reagent/ Reagent: NGAL R1 reagent volume: 12 R1 water volume: R1 dispense mode: Type Diluent name: Saline R2 reagent volume: R2 water volume: R2 dispense mode: Diluent dispense mode: 4 Type Type Dilution name volume Diluted sample Diluent volume Water volume Dilution factor volume Normal 1 : 1, Rerun 1 15, 15, 1 : 8, Rerun 2 6, 1 : 1, Validity checks Reaction check type: Rate RATIO Read time A range: Read time B range: 19 - Calculation limit:,1-9,9 Minimum absorbance: Rate linearity %:,15 Maximum absobance variation: 2 *1: To be defined by operator. Version: 1 Revision date: The NGAL Test Application Note for Abbott Architect c8 Page 1 of 7

2 Calibration parameters Calibration method: Spline Use cal factor from: Factor: Full interval hours: Adjustment interval hours: Adjustment type: None Adjustment level: Expected cal factor:, Default ordering type: Full Expected factor tolerence %:, Blank absorbance range:. -. Span: Span absorbance range:, -, Maximum curve fit:, set name: *1 Replicates: 3 Cal level Concentration volume Diluted sample Diluent volume Water volume volume Blank Cal.1 Cal.2 Cal.3 Cal.4 Cal Smart wash Cal level Reagent/Assay Wash Volume Replicates Wash protocol Results parameters Flag range specification: Linearity range: 25-5 Gender Age Normal range Extreme range - - Interpretation parameters Result units Result concentration unit: Result decimal places: ng/ml Correlation factor: Intercept: 1,, *1: To be defined by operator. 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 Abbott Architect c8 Page 2 of 7

3 Performance for NGAL Test Reagent Kit Sensitivity Reagent calibrator instrument parameter Lot. RD23,3,25,2 The NGAL Test Lot.RD23 Abbott Architect c8 2.4/12/4 P19-2/ nm Spline ng/ml 15 ng/ml 6 ng/ml 15 ng/ml 3 ng/ml 5 ng/ml -,6,141,627,158,2341,2826 Unit:delta Abs Calibration Curve ng/ml -,3 15 ng/ml 151, 6 ng/ml 66,7 15 ng/ml 1515,3 3 ng/ml 334,7 5 ng/ml 5, delta Abs,15,1,5, ng/ml 1 ng/ml 2 ng/ml 3 ng/ml 4 ng/ml 5 ng/ml NGAL conc. [ng/ml] Recovery ng/ml - 15 ng/ml 11% 6 ng/ml 11% 15 ng/ml 11% 3 ng/ml 11% 5 ng/ml 1% Re-run Normal 4773, Re-run 413,5 (Saline) Recovery 87% Re-run ,5 ( diluent) Recovery 95% Version: 1 Revision date: The NGAL Test Performance on Abbott Architect c8 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 Abbott Architect c8 2.4/12/4 P19-2/ nm Spline QC Fluid Control Low Control High Specificity 25ng/mL Lot.1831 Lot H917 Architect c8 Recovery Control Low 194,9 29,4 17% Control High 485,2 59,1 15% Panel Low 11,2 121,9 111% Panel Medium 313,4 341,7 19% Panel High 873,2 951,9 19% N Mean 25,2 29,4 59,1 Max 3, 22, 52, Min 18, 22, 5, SD 3,3811 6,239 6,5566 CV% 13,42% 2,96% 1,29% Version: 1 Revision date: The NGAL Test Performance on Abbott Architect c8 Page 4 of 7

5 Linearity ~ 15ng/mL Dilution Saline, diluent Abbott Architect c8 2.4/12/4 P19-2/ nm Spline Dil.levels Theoretical Measured Recovery Dil.levels Theoretical Measured Recovery 15ng/mL - Saline 15ng/mL - diluent 1,,, 2, 1,,, 2,5 9, 1, 15, 128, 85% 9, 1, 15, 158, 15% 8, 2, 3, 269,5 9% 8, 2, 3, 39,5 13% 7, 3, 45, 426, 95% 7, 3, 45, 457, 12% 6, 4, 6, 569,5 95% 6, 4, 6, 611,5 12% 5, 5, 75, 735, 98% 5, 5, 75, 762, 12% 4, 6, 9, 879,5 98% 4, 6, 9, 922, 12% 3, 7, 15, 138, 99% 3, 7, 15, 171, 12% 2, 8, 12, 1191, 99% 2, 8, 12, 1227,5 12% 1, 9, 135, 1334, 99% 1, 9, 135, 1375, 12%, 1, 15, 1491,5 99%, 1, 15, 1523,5 12% Version: 1 Revision date: The NGAL Test Performance on Abbott Architect c8 Page 5 of 7

6 Linearity ~ 5ng/mL & Prozone Dilution 6 4 2, QC fluid Saline, diluent Abbott Architect c8 2.4/12/4 P19-2/ nm 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,,, -5, 1,,, 5, 1,,,, 9, 1, 5, 446,5 89% 9, 1, 5, 55,5 11% 9, 1, , 8, 2, 1, 884, 88% 8, 2, 1, 126,5 13% 8, 2, 8 5, >5 7, 3, 15, 1395,5 93% 7, 3, 15, 1518,5 11% 7, 3, 12 5, >5 6, 4, 2, 1925, 96% 6, 4, 2, 222, 11% 6, 4, 16 5, >5 5, 5, 25, 2468, 99% 5, 5, 25, 2541,5 12% 5, 5, 2 Error 4, 6, 3, 2994, 1% 4, 6, 3, 352, 12% 4, 6, 24 Error 3, 7, 35, 3525, 11% 3, 7, 35, 3617, 13% 3, 7, 28 Error 2, 8, 4, 438,5 11% 2, 8, 4, 4152, 14% 2, 8, 32 Error 1, 9, 45, 4618, 13% 1, 9, 45, 4661,5 14% 1, 9, 36 Error, 1, 5, 4998,5 1%, 1, 5, 5, 1%, 1, 4 Error Version: 1 Revision date: The NGAL Test Performance on Abbott Architect c8 Page 6 of 7

7 Interferences Dilution Hemoglobin, Bilirubin, Intrafat diluent Abbott Architect c8 2.4/12/4 P19-2/ nm Spline Hemoglobin: C-Bilirubin: F-Bilirubin: Intrafat: 2% 2% 2% 2% 1% % -1% 1% % -1% 1% % -1% 1% % -1% -2% Hemoglobin [mg/dl] -2% C-Bilirubin [dg/ml] -2% F-Bilirubin [dg/ml] mg/ml Deviation mg/ml Deviation mg/ml Deviation %,%,%,% 1-1,1% 6,% 6 -,6% 1 2 -,6% 12,2% 12,5% 2 3-1,3% 18,5% 18 1,3% 3 4-1,7% 24 1,1% 24 % 4 5,3% 3 3,2% 3 2,7% 5-2% Intrafat [%] Deviation,% 1,1% 2,3% 1,8%,8% -,3% Version: 1 Revision date: The NGAL Test Performance on Abbott Architect c8 Page 7 of 7