Analytical Performance of a FRET-Based Point-of-Care Immunoassay for the Quantitation of C-Reactive Protein in Serum and Finger Prick Capillary Whole Blood

07 April 2021, Version 1
This content is a preprint and has not undergone peer review at the time of posting.

Abstract

Time-resolved fluorescence resonance energy transfer (FRET) provides a useful technology for immunoassay measurement of proteins, This has been used to develop an immunoassay for C-reactive protein (Procise CRP™) that provides point-of-care measurement of CRP in less than 4 minutes using 20 µL of either whole blood or serum. Analytical studies of the assay on the ProciseDx™ analyzer were performed to characterize its measurement capabilities.


Sensitivity, specificity, linearity, and precision - including reproducibility of finger prick blood collection and testing, suitable for routine clinical use in a point-of-care setting were demonstrated for the CRP assay. It also showed excellent analytical agreement with a current commercial CRP test.


These results indicate the Procise CRP assay is useful for obtaining fast and accurate CRP quantitation in a point of care setting that can aid in the immediate assessment of patients’ inflammatory status.


Keywords

Crohn's disease
C-reactive protein concentrations
CRP concentration
FRET assay
Inflammatory bowel diseases
Lumiphore
point of care diagnostic test
Ulcerative Colitis

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