Analytical Validation of GFRNMR: A Blood-Based Multiple Biomarker Assay for Accurate Estimation of Glomerular Filtration Rate

Accurate and precise monitoring of kidney function is critical for a timely and reliable diagnosis of chronic kidney disease (CKD). The determination of kidney function usually involves the estimation of the glomerular filtration rate (eGFR). We recently reported the clinical performance of a new eG...

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Bibliographic Details
Published in:Diagnostics (Basel) 2022-04, Vol.12 (5), p.1120
Main Authors: Fuhrmann, Markus, Schwaeble Santamaria, Amauri, Scott, Renee, Meeusen, Jeffrey W., Fernandes, Marianna, Venz, John, Rothe, Victoria, Stämmler, Frank, Ehrich, Jochen, Schiffer, Eric
Format: Article
Language:English
Subjects:
analytical validation
Biomarkers
Blood & organ donations
Clinical medicine
Creatinine
eGFR
glomerular filtration rate
Hemodialysis
Kidney diseases
Laboratories
linearity
metabolite
Metabolites
NMR
Nuclear magnetic resonance
Reproducibility
Spectrum analysis
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Summary:Accurate and precise monitoring of kidney function is critical for a timely and reliable diagnosis of chronic kidney disease (CKD). The determination of kidney function usually involves the estimation of the glomerular filtration rate (eGFR). We recently reported the clinical performance of a new eGFR equation (GFRNMR) based on the nuclear magnetic resonance (NMR) measurement of serum myo-inositol, valine, and creatinine, in addition to the immunoturbidometric quantification of serum cystatin C, age and sex. We now describe the analytical performance evaluation of GFRNMR according to the Clinical and Laboratory Standards Institute guidelines. Within-laboratory coefficients of variation (CV%) of the GFRNMR equation did not exceed 4.3%, with a maximum CV% for repeatability of 3.7%. Between-site reproducibility (three sites) demonstrated a maximum CV% of 5.9%. GFRNMR stability was demonstrated for sera stored for up to 8 days at 2–10°C and for NMR samples stored for up to 10 days in the NMR device at 6 ± 2°C. Substance interference was limited to 4/40 (10.0%) of the investigated substances, resulting in an underestimated GFRNMR (for glucose and metformin) or a loss of results (for naproxen and ribavirin) for concentrations twice as high as usual clinical doses. The analytical performances of GFRNMR, combined with its previously reported clinical performance, support the potential integration of this NMR method into clinical practice.
ISSN:2075-4418
2075-4418
DOI:10.3390/diagnostics12051120