Therapeutic Drug Monitoring: Performance of a FRET-Based Point-Of-Care Immunoassay for the Quantitation of Infliximab and Adalimumab in Blood
2020
Two
fast (<5 min), time-resolved fluorescence resonance energy transfer
(FRET)-based immunoassays (Procise IFX™ and Procise ADL™) were developed for
the quantitative detection of infliximab (IFX), adalimumab (ADL), and their respective
biosimilars for use in therapeutic drug monitoring (TDM) using 20 µL of finger
prick whole blood at the point-of-care or whole blood/serum in a central lab. Studies were performed to characterize
analytical performance of the Procise IFX and the Procise ADL assays on the
ProciseDx™ analyzer.
The
Procise IFX and Procise ADL assays both showed good analytical performance with
respect to sensitivity, specificity, linearity, and precision suitable for
routine clinical use as well as excellent correlation to current commercial
ELISA IFX and ADL measurement methods.
Results
indicated that the Procise IFX and Procise ADL assays are sensitive, specific,
and precise yielding results in less than 5 minutes from either whole blood or
serum. This indicates the Procise IFX and Procise ADL assays are useful for
obtaining fast and accurate IFX or ADL quantitation, thus avoiding delays
inherent to current methods and enabling immediate drug level dosing decisions
to be made during a single patient visit.
Keywords:
- Correction
- Source
- Cite
- Save
- Machine Reading By IdeaReader
0
References
0
Citations
NaN
KQI