Application Manual ILab 600/650 IL Test TM Magnesium Kit Configuration P/N 0018256240 5 x 20 mL Magnesium Reagent Preparation P/N 0018256240: The reagents is supplied ready-to-use. Uncap and place container into reagent tray. In Use Stability On board: 30 days Specimen Serum. Prompt separation of red cells is essential. Magnesium in serum is stable for several days if the specimen is separated from the red cells and stored at 2-8°C. Calibration Use ReferrILTM G Calibrator (Cat. No.0018257000).See calibrator chart for lot and instrument specific concentration. Recalibrate every 7 days. Reagent blanking should be performed daily or before patient assays if the reagent is used less frequently. Quality Control Serachem® Level 1 (Cat. No. 0018162412) and SeraChem® Level 2 (Cat. No 0018162512). Calculation and Analytical Results The results concentration is automatically calculated by the instrument against the Calibrator. For detailed description, refer to the Instrument settings and to the ILab 600/650 Operator Manual. To convert mg/dL to SI units (mmol/L) multiply by 0.4114. Reference Interval Male: 1.6 – 2.6 mg/dL (0.66 – 1.07 mmol/L). It is recommended that each laboratory establish its own reference range since ranges may vary with age, diet, gender, and geographical area. References / Literatur / Bibliografía / Bibliographie / Bibliografia / See package insert enclosed in the kit Performance Characteristics Limitation/Interfering Substances No interference from lipemia up to sample absorbances/cm of 3.5 at 660 nm (440 mg/dL, 5 mmol/L triglycerides). No interference up to 400 mg/dL (0.24 mmol/L) hemoglobin. No interference up to 14 mg/dL (240 µmol/L) bilirubin. 1 For a comprehensive review of interfering substances, refer to the publication by Young. Precision Samples/Runs Mean (mg/dL) CV(%) Mean (mg/dL) CV(%) Within Run 5/10 1.98 1.4 3.64 1.7 Total 5/10 1.98 2.5 3.64 2.7 Method Comparison Comparison Method (x) Comparison Instrument Slope Intercept Range x (mg/dL) Mean x (mg/dL) Mean y (mg/dL) r2 SE n Linearity no rerun with rerun Calmagite reagent PN 0018251040 ILab 600 1.040 -0.11 0.75 – 4.83 2.27 2.25 0.997 0.06 79 0.05 - 5.00 mg/dL (0.02 – 2.06 mmol/L) 0.05 - 7.50 mg/dL (0.02 – 3.09 mmol/L) Sensitivity milliabsorbance change per 1 mg/dL: 120 milliabsorbance change per 1 mmol/L 292 Minimun Detection Limit 0.05 mg/dL (0.02 mmol/L). Instrumentation Laboratory SpA – V.le Monza 338 – 20128 Milano (Italy)) Instrumentation Laboratory Company - Lexington, MA 02421-3125 (USA) 54 of 117 Application Manual ILab 600/650 IL Test TM Magnesium Instrument Settings Photometric Test Parameters Test No. Test Name, Test Code Sample Type Reporting Unit, Decimal Points Reation Cycle Twin Analysis Methodology Type, Measuring Point Photometric Methodology Primary/Secondary Wavelenght Sampling Conditions Sampling 1 Sample Vol. Sample/Diluent Vol. Sampling 2 Sample Vol. Sample/Diluent Vol. Sampling 3 Sample Vol. Sample/Diluent Vol. Sampling 4 Diluent Code Diluent Warning Limit First Run Below/Above Normal Range Panic L Panic H Noise Prozone High!, ABS! Sample Volume Reduction Reagent Volumes R1 Code Rgt/Dil. Vol. Stirring Low Vol. Warning Limit Stability (days) R2 Code Rgt/Dil. Vol. Stirring Low Vol. Warning Limit Stability (days) Serum 2 Magnesium, Mg Serum mg/dL (mmol/L), 2 (2) Standard OFF End Point, 21 2 Wavelength 510/700 3 0/0 2 0/0 *** 0/0 *** N/A N/A Sampling 1 *** *** Sampling 2 Sampling 1 N/A Sampling 2 ** Ranges and Evaluation Criteria Normal Range-Male Normal Range-Female Normal Range-Other Valid Range Hemolysis/Icterus/Lipemia Limit Reaction Slope Absorbance Limit Prozone Limit Non Linear Limit Slope/Intercept Correction Qualitative Report Calibration Conditions Calibration Stability (days) Calibrator, Concentration R-Blank Limit (mAbs) Cal. Reps Range (%) Min Cal. Response (mAbs) Cal. Factor Change (%) M-Point Curve Fit (%) Reagent Blank Auto R-Blank by Bottle * ** *** N/A Serum 1.60 - 2.60 (0.66 - 1.07) 1.60 - 2.60 (0.66 - 1.07) ** 0.05-5.00 (0.02-2.06) *** Positive Above, 3500 N/A N/A 1/0 OFF 1 Point, Linear, 3 Reps 7 Ref G, * *** *** *** *** N/A ON ON Lot dependent operator definable optional not applicable to this test 01021 350/10, ON *** 30 N/A N/A N/A N/A Instrumentation Laboratory SpA – V.le Monza 338 – 20128 Milano (Italy)) Instrumentation Laboratory Company - Lexington, MA 02421-3125 (USA) 55 of 117
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