Have you ever wondered if you can get more precise and accurate results in kidney function diagnostics?
One of the keys to assess the kidney function greater as accurate as possible is the integration of GFR Measurement in clinical routine. Measured Glomerular Filtration Rate (mGFR) based on Iohexol-Plasma-Clearance ist considered by the European Medicines Agency (EMA) as the benchmark in kidney function diagnostics:
“The gold standard for assessment of renal function is a measured GFR using an exogenous substance as a filtration marker (e.g., … iohexol). Methods for estimating GFR (eGFR) using endogenous markers have different drawbacks and are not considered as accurate as measured GFR”.
Nephrolyx IVDx: GFR Measurement in Clinical Routine
Nephrolyx GmbH, a German company, has developed an innovative tool for measuring GFR in clinical routine. The Nephrolyx IVDx combines an IVD kit with a digital GFRx software module which can be integrated into LIMS systems and is ready to use. For research use, Nephrolyx offers the digital platform DNPx.
Applying Nephrolyx IVDx, it empowers physicians to precisely assess the renal function.
Nephrolyx IVDx is recommended for laboratory settings that use semi-automatic processing in a UHPLC or HPLC device.
Precise
Nephrolyx IVDx delivers robust and reproducible results over the GFR range, enabling sensitive detection of early changes in kidney function. The measurement is based on applied iohexol,
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an exogenous marker that is neither metabolized nor biochemically modified in the body and is excreted unchanged and almost 100% renal. These properties allow for direct, unadulterated quantification in serum and ensure highly accurate determination of glomerular filtration rate. In addition, the procedure is independent of patient-specific influencing factors such as muscle mass, nutrition or inflammatory processes.
Affordable
Nephrolyx IVDx stands out as a cost-effective option when compared to other mGFR solutions, including 99mTc-DTPA, lab-developed mGFR tests (LDTs), and even several biomarker-based estimates (eGFR).
Rapid
Nephrolyx IVDx provides clinical results within the same day, with a turnaround time of less than 6 hours, which is significantly quicker than LDTs for mGFR.
Obtaining diagnostic results more quickly accelerates and simplifies sample processing.
GFR Measurement in Clinical Routine: Benefits
For physicians
- Confidence in accurate results
- Ability to identify early changes in GFR
- Easy access to mGFR
For laboratories
- Higher workflow automation and better performance compared to LDTs
- Regulatory compliance
- Seamless software integration
- Access to mGFR for all clinical departments
Nephrolyx DNPx Demo Trial
The GFR is calculated using pharmacokinetic algorithms integrated into the Digital Nephrology Platform – DNPx, developed by Nephrolyx. Multiple-sample protocols (two-sample minimum) and the single-sample protocol can be utilized by the user in DNPx. Patient samples are used to calculate the mGFR with the iohexol concentrations obtained from (U)HPLC measurements.
If you are interested in experiencing the DNPx functionalities, contact us to set up a 2-week demo trial to utilize the software online.
Nephrolyx is the leading provider of GFR measurement in clinical routine. The company builds on 12 years of research in the field of kidney function diagnostics at Charité Universitätsmedizin Berlin.
Nephrolyx’s mission is to optimize patient outcomes by providing physicians and researchers with access to GFR measurement. Addressing challenges in kidney diagnostics, the company thoroughly works to enhance patient treatment in both hospital and ambulatory settings.
Moreover, Nephrolyx is dedicated to fostering innovation in the field, supporting the development of new medications and assisting pharma and biotech companies in kidney research and clinical trials. The company aims to enable precision medicine in healthcare worldwide.
