HEALTHSENS NEPHROPOC® is an in vitro diagnostic medical device (IVD MD) designed for the quantification of creatinine levels in peripheral blood and the estimation of the glomerular filtration rate (eGFR). Keeping informed on the peripheral blood creatinine concentration is being in control of the kidney disease, considered the third most prevalent disease in the world (it affects 10% of the world’s population), with creatinine being the main biomarker for renal function assessment and considered as one of the three critical biomarkers to be frequently evaluated alongside glucose and cholesterol. Our technology provides a robust, portable, affordable and simple tool that enables highly reliable early diagnosis and monitoring of kidney disease. It is a medical device Point-of-Care Testing device (POCT, also called mini-lab or pocket laboratories).
HEALTHSENS NEPHROPOC® is a POCT system based on the use of an electrochemical transducer and enzymatic reactions, which is fully portable and automatic. It is a miniaturized electroanalytical system, in which screen-printed electrodes have replaced conventional cells.
All these features make this device exclusive for patients.
HEALTHSENS NEPHROPOC® involves the use of economic, simple and portable equipment, combined with a novel and efficient test strip. The main analytical advantage of HEALTHSENS NEPHROPOC® is that the analytical results achieved in whole blood coincide with those achieved by clinical methods based on the Jaffé reaction (which are carried out in serum).
The reliability of our method has been verified and validated by comparing it to the isotopic dilution mass spectrometry (IDMS) reference method and to the two methods most commonly used in clinical settings (Crep2® Cobas and Cobas® 8000 c 7012, based on Jaffe’s reaction).
With this study we have demonstrated that the results of the HEALTHSENS NEPHROPOC® method correlate well with the reference methods used in clinical laboratories around the globe, making it the cheapest and most reliable POCT technology on the market for early diagnosis and follow-up of renal disease.
El 10% of the world’s population is affected by Chronic Kidney Disease.
986.246 deaths directly related to Chronic Kidney Disease in 2013.
134% increase in deaths due to Chronic Kidney Disease.
96% of people with kidney damage or decreased kidney function are not aware of suffering Chronic Kidney Disease.