Validation of the Nova Point-of-Care Testing StatStrip p-Ketone Test in a Laboratory and Clinical Setting

摘要

Each year in Belgium, 2000 patients are newly diagnosed with type 1 diabetes mellitus (DM) and 23,500 patients with type 2 DM.1 Diabetic ketoacidosis (DKA) is a severe acute complication of DM, with a prevalence around 30% in type 1 DM and 6% in type 2 DM.2 Guidelines advocate whole-blood measurement of beta-hydroxybutyrate ((5HB) for the management of DKA, making point-of-care testing (POCT) devices for glucose and ketones an important and lifesaving tool.3'4 At the request of our emergency department (ED), the POCT hospital meter StatStrip (Nova Biomedical, Waltham, Mass) was installed on trial. AIM The aim of this study was to determine performance, possible interferences, and correlation to a reference method of the POCT hospital meter StatStrip for measurement of whole-blood betaHB. MATERIALS AND METHODS The performance reliability was tested on 8 StatStrip devices by means of assayed quality controls (QCs) in 2 concentrations, according to the Clinical and Laboratory Standards Institute-EP15 A3 protocol. For the correlation with our reference spectro-photometric method (Ranbut Assay, Randox on Spectramax), 17 healthy volunteers fasted for 14,16, or 20 hours. (3HB values were obtained right before and after breaking their fast through a fingerprick with the StatStrip ketones meter.