Self-test medical device
HEALTHSENS NEPHROPOC® is a medical device for in vitro diagnosis (IVD-MD), designed for the quantification of peripheral blood creatinine concentration and the estimation of the glomerular filtration rate (eGFR). In this way, it is possible to have a comprehensive control over kidney disease, which is considered the third impact disease across the world (affecting on average 10% of the population). HEALTHSENS NEPHROPOC® allows the early detection and monitoring of kidney disease or other multisystemic pathologies.
Creatinine is, because of that, the most important biomarker for the tracking of kidney disease, and it is one of the role model biomarkers that should be controlled frequently, apart from glucose and cholesterol.
HEALTHSENS NEPHROPOC® technology is robust, portable, low cost and easy to use, that shows a great reliability for the early diagnosis and monitoring of kidney disease.
It enables the patient to be more independent in the management of his/her disease, always providing safety
HEALTHSENS NEPHROPOC® is a self-test medical device based on an electrochemical transducer on which different enzymatic reactions are carried out, fully portable and combined with artificial intelligence.
This device has been designed to be used directly by the patients themselves.
HEALTHSENS NEPHROPOC® uses low-cost, simple and portable equipment, combined with a novel and efficient test strip. Its analytical characteristics are reflected in the excellent results obtained when measuring whole blood, showing an excellent accuracy when comparing with other methods commonly used in clinical practice.
The accuracy of our method has been validated by comparing it with the reference method, based on isotopic dilution mass spectrometry (IDMS), and the most common methodology in clinical practice for the quantification of creatinine (Cobas® 8000 c 7012, based on Jaffé reaction).
Throughout this study, we have been able to demonstrate that HEALTHSENS NEPHROPOC® device shows an excellent correlation with the reference methods commonly used in clinical laboratories around the world, making it the cheapest and most reliable self-test technology for the diagnosis and monitoring of kidney disease.
Furthermore, possible interfering substances that can affect the measurement have been evaluated, verifying that there are not potential interferences in therapeutical concentrations for acetaminophen, ascorbic acid, bilirubin, creatine, dopamine, glucose, heparin, levodopa or sarcosine.
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.