Automated Homogeneous Immunoassay for Gentamicin on the Dimension Clinical Chemistry System

Author:

Wei Tie Q,Chu Victor P,Craig Alan R,Duffy James E,Obzansky David M,Kilgore Daniel,Masulli Ignazio S,Sanders Connie M,Thompson John C

Abstract

Abstract Background: Monitoring of the concentration of gentamicin in serum and plasma during therapy is widely recommended and practiced in hospitals. Our aim was to develop a homogeneous immunoassay based on particle-enhanced turbidimetric inhibition immunoassay technology to quantify gentamicin on the Dimension® clinical chemistry system. Methods: Assay performance was assessed on each of the Dimension models in a 15-instrument interlaboratory comparison study. A split-sample comparison (n = 1171) was also performed between the gentamicin methods on the Dimension system and the Abbott®TDx® analyzer, using multiple reagent and calibrator lots on multiple instruments. Results: The Dimension method was linear to 25.1 μmol/L (12.0 μg/mL) with a detection limit of 0.63 μmol/L (0.3 μg/mL). Calibration was stable for 30 days. The within-run imprecision (CV) was <1.3%, and total imprecision ranged from 1.8% to 3.2% between 4.2 μmol/L (2.0 μg/mL) and 16.7 μmol/L (8.0 μg/mL) gentamicin. Linear regression analysis of the results on the Dimension method (DM) vs the Abbott TDx yielded the following equation: DM = 0.98TDx − 0.42; r = 0.987. Minimal interference was observed from structurally related compounds such as sagamicin, netilmicin, and sisomicin. Conclusion: The monoclonal antibody used in this method has similar reactivities toward the individual gentamicin subspecies C1, C1a, and C2, thus providing analytical recovery not significantly dependent on relative subspecies concentrations.

Publisher

Oxford University Press (OUP)

Subject

Biochemistry (medical),Clinical Biochemistry

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