Assessment of the Nova StatSensor whole blood point-of-care creatinine analyser for the measurement of kidney function in screening for chronic kidney disease

Abstract

Point-of-care testing for creatinine using a fingerprick sample and resultant estimated glomerular filtration rate has potential for screening for chronic kidney disease in community settings. This study assessed the applicability of the Nova StatSensor creatinine analyzer for this purpose. Fingerprick samples from 100 patients (63 renal, 37 healthy volunteers; range 46–962 mmol/L) were assayed using two StatSensor analyzers. Lithium heparin venous plasma samples collected simultaneously were assayed in duplicate using the isotope dilution mass spectrometryaligned Roche Creatinine Plus enzymatic assay on a Hitachi Modular P unit. Method comparison statistics and the ability of the StatSensor to correctly categorise estimated glomerular filtration rate above or below 60 mL/min were calculated pre- and post-alignment with the laboratory method. Isotope dilution mass spectrometry alignment of the StatSensor will identify most patients with estimated glomerular filtration rate -60 mL/min, but there will be many falsely low estimated glomerular filtration rate results that require laboratory validation. Creatinine results need improvement