Validating dynex


02-Jan-2020 20:18

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Similar as to anti-TNFα drugs, measurement of vedolizumab drug concentrations supports a personalized dosing strategy in patients treated with vedolizumab.The RIDASCREEN® VDZ Monitoring and our other TDM assays are vital to personalize treatment of patients with Crohn’s disease and ulcerative colitis and better achieve therapeutic targets.Dr Paul Janssen, founder of Janssen Pharmaceutica, developed the compound fentanyl during the late 1950s and early 1960s (1).Compared with morphine, fentanyl is 50–100 times more potent (2) and is distributed under the brand names Sublimaze or Fentora™ (3).One is the low control that is generally set near the limit of detection (LOD) of the assay as determined in validation and the other is the mid control (or cutoff) that is set at an appropriate level for the analyte that can be confirmed in the laboratory with the mass spectrometric techniques available at the time of the ELISA validation.

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Two decision points are incorporated in the methods used in this laboratory.The laboratory's quality control criteria states that for an analysis to be acceptable the optical density (or absorbance) readings must be in decreasing order from the blank to the high control.Matrix-matched negative, low, mid and high controls are run with each analysis and the quality control criteria must be met in order for the run to pass.The empirically determined limit of detection was 0.25 ng/m L for blood and 0.5 ng/m L for urine.

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Precision was determined at five different concentrations ranging from 0.25 to 1.5 ng/m L with 15 replicates at each level for whole blood and demonstrated a -phenyl-propanamide, is a potent synthetic µ-opioid receptor agonist.The increase in the detection of fentanyl has provided the impetus to have a rapid, selective and sensitive screening procedure for both blood and urine specimens.