Analytical Validation of GFR<sub>NMR</sub>: 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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MDPI AG
2022-04-01
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| Series: | Diagnostics |
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| Online Access: | https://www.mdpi.com/2075-4418/12/5/1120 |
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| author | Markus Fuhrmann Amauri Schwaeble Santamaria Renee Scott Jeffrey W. Meeusen Marianna Fernandes John Venz Victoria Rothe Frank Stämmler Jochen Ehrich Eric Schiffer |
| author_facet | Markus Fuhrmann Amauri Schwaeble Santamaria Renee Scott Jeffrey W. Meeusen Marianna Fernandes John Venz Victoria Rothe Frank Stämmler Jochen Ehrich Eric Schiffer |
| author_sort | Markus Fuhrmann |
| collection | DOAJ |
| description | 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 (GFR<sub>NMR</sub>) 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 GFR<sub>NMR</sub> according to the Clinical and Laboratory Standards Institute guidelines. Within-laboratory coefficients of variation (CV%) of the GFR<sub>NMR</sub> 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%. GFR<sub>NMR</sub> 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 GFR<sub>NMR</sub> (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 GFR<sub>NMR,</sub> combined with its previously reported clinical performance, support the potential integration of this NMR method into clinical practice. |
| first_indexed | 2024-03-10T03:03:22Z |
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| language | English |
| last_indexed | 2024-03-10T03:03:22Z |
| publishDate | 2022-04-01 |
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| record_format | Article |
| series | Diagnostics |
| spelling | doaj.art-e55a73dee02e498299f3a73557d9344c2023-11-23T10:39:38ZengMDPI AGDiagnostics2075-44182022-04-01125112010.3390/diagnostics12051120Analytical Validation of GFR<sub>NMR</sub>: A Blood-Based Multiple Biomarker Assay for Accurate Estimation of Glomerular Filtration RateMarkus Fuhrmann0Amauri Schwaeble Santamaria1Renee Scott2Jeffrey W. Meeusen3Marianna Fernandes4John Venz5Victoria Rothe6Frank Stämmler7Jochen Ehrich8Eric Schiffer9Department of Research and Development, numares AG, 93053 Regensburg, GermanyDepartment of Research and Development, numares AG, 93053 Regensburg, GermanyDepartment of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN 55905, USADepartment of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN 55905, USABoston Heart Diagnostics, Framingham, MA 01702, USADepartment of Research and Development, numares AG, 93053 Regensburg, GermanyDepartment of Research and Development, numares AG, 93053 Regensburg, GermanyDepartment of Research and Development, numares AG, 93053 Regensburg, GermanyChildren’s Hospital, Hannover Medical School, 30625 Hannover, GermanyDepartment of Research and Development, numares AG, 93053 Regensburg, GermanyAccurate 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 (GFR<sub>NMR</sub>) 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 GFR<sub>NMR</sub> according to the Clinical and Laboratory Standards Institute guidelines. Within-laboratory coefficients of variation (CV%) of the GFR<sub>NMR</sub> 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%. GFR<sub>NMR</sub> 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 GFR<sub>NMR</sub> (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 GFR<sub>NMR,</sub> combined with its previously reported clinical performance, support the potential integration of this NMR method into clinical practice.https://www.mdpi.com/2075-4418/12/5/1120glomerular filtration rateeGFRmetaboliteNMRanalytical validationlinearity |
| spellingShingle | Markus Fuhrmann Amauri Schwaeble Santamaria Renee Scott Jeffrey W. Meeusen Marianna Fernandes John Venz Victoria Rothe Frank Stämmler Jochen Ehrich Eric Schiffer Analytical Validation of GFR<sub>NMR</sub>: A Blood-Based Multiple Biomarker Assay for Accurate Estimation of Glomerular Filtration Rate Diagnostics glomerular filtration rate eGFR metabolite NMR analytical validation linearity |
| title | Analytical Validation of GFR<sub>NMR</sub>: A Blood-Based Multiple Biomarker Assay for Accurate Estimation of Glomerular Filtration Rate |
| title_full | Analytical Validation of GFR<sub>NMR</sub>: A Blood-Based Multiple Biomarker Assay for Accurate Estimation of Glomerular Filtration Rate |
| title_fullStr | Analytical Validation of GFR<sub>NMR</sub>: A Blood-Based Multiple Biomarker Assay for Accurate Estimation of Glomerular Filtration Rate |
| title_full_unstemmed | Analytical Validation of GFR<sub>NMR</sub>: A Blood-Based Multiple Biomarker Assay for Accurate Estimation of Glomerular Filtration Rate |
| title_short | Analytical Validation of GFR<sub>NMR</sub>: A Blood-Based Multiple Biomarker Assay for Accurate Estimation of Glomerular Filtration Rate |
| title_sort | analytical validation of gfr sub nmr sub a blood based multiple biomarker assay for accurate estimation of glomerular filtration rate |
| topic | glomerular filtration rate eGFR metabolite NMR analytical validation linearity |
| url | https://www.mdpi.com/2075-4418/12/5/1120 |
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