MO382: Validation of a Handheld Point-Of-Care Creatinine/EGFR Meter for Evaluating Renal Function

Abstract

Abstract BACKGROUND AND AIMS Measurement of glomerular filtration rate (GFR) is a cumbersome, time consuming, and expensive process, thus estimated GFR (eGFR) has become a commonly accepted surrogate or screening tool for individuals suspected to have kidney disease. Until recently this required testing through phlebotomy and a large laboratory analyzer. Nova Biomedical (Waltham, MA, USA) has developed a point-of-care (POC) handheld device, the NovaMax Cr/eGFR System that is able to measure creatinine (Cr) and calculate an eGFR using a fingerstick (1.2 µL) of whole blood. METHOD A group of 517 subjects (48% male) were recruited for study at three different Clinical Research Organizations (CRO's). The patient population was from both healthy cohorts and those known to have CKD. Creatinine and eGFR was tested on all subjects using a finger stick sample with the NovaMax System and compared with venous blood on a Siemens RXL (Siemens Medical Solutions, Malvern, PA, USA). The CKD-EPI formula was used to calculate eGFR. RESULTS The average age was 61.1 years (range 18–91). The range of Cr in the groups were as follows: NovaMax 0.57—>7 mg/dL (7 is the maximum reading), and for the Siemens 0.36–16.79 mg/dL. The range of eGFR was <7–127 mL/min/1.73 m2 on the NovaMax, and 4.3–137 mL/min/1.73 m2 on the Siemens. See Table 1 for sensitivity and specificity results. CONCLUSION The NovaMax Cr/eGFR System is an acceptable alternative for eGFR measurement in patients with a wide range of renal function. Its ability to measure renal function in a variety of settings make it a very useful device for several patient populations: screening patients at risk for CKD or AKI, telenephrology, population screening in low- and middle-income countries, following patients post kidney transplant, and evaluating patients prior to and after contrast imaging studies, among other indications.