Brief Article
Copyright ©2012 Baishideng Publishing Group Co., Limited. All rights reserved.
World J Radiol. Jul 28, 2012; 4(7): 328-334
Published online Jul 28, 2012. doi: 10.4329/wjr.v4.i7.328
Evaluation of a handheld creatinine measurement device for real-time determination of serum creatinine in radiology departments
Stefan Haneder, Alexandra Gutfleisch, Claudia Meier, Joachim Brade, Dieter Hannak, Stefan O Schoenberg, Christoph R Becker, Henrik J Michaely
Stefan Haneder, Alexandra Gutfleisch, Claudia Meier, Stefan O Schoenberg, Henrik J Michaely, Institute of Clinical Radiology and Nuclear Medicine, University Medical Centre Mannheim, University of Heidelberg, 68167 Mannheim, Germany
Joachim Brade, Institute for Clinical Statistics, University Medical Centre Mannheim, University of Heidelberg, 68167 Mannheim, Germany
Dieter Hannak, Institute of Clinical Chemistry, University Medical Centre Mannheim, University of Heidelberg, 68167 Mannheim, Germany
Christoph R Becker, Institute of Clinical Radiology, Hospital Munich-Grosshadern, University of Munich, 81377 Munich, Germany
Author contributions: Haneder S, Gutfleisch A, Schoenberg SO, Becker CR and Michaely HJ participated in the study; and all authors contributed to supportive work.
Correspondence to: Stefan Haneder, MD, Institute of Clinical Radiology and Nuclear Medicine, University Medical Centre Mannheim, Heidelberg University, Thoedor-Kutzer-Ufer 1-3, 68167 Mannheim, Germany. stefan.haneder@umm.de
Telephone: +49-621-3832067 Fax: +49-621-3831910
Received: May 14, 2012
Revised: July 5, 2012
Accepted: July 12, 2012
Published online: July 28, 2012
Abstract

AIM: To assess the feasibility/accuracy of a commercial handheld device in the context of increased demand for point-of-care serum creatinine (SCr) determination.

METHODS: In this institutional review board-approved, prospective study, 401 patients referred for contrast-enhanced computed tomography were included at two centres. Capillary (c)SCr was determined using two devices A+B and venous (v)SCr was determined in the centre’s laboratory. Method comparison statistics for both centres and for vSCr<>1.2 mg/dL, receiver operating characteristic analysis, negative predictive values (NPV), sensitivity and specificity were calculated pre-/post-curve offset correction with vSCr.

RESULTS: Pearson’s coefficients for cSCr vs vSCr were: centre 1-A:0.93/B:0.92; centre 2-A:0.85/B:0.82 (all P < 0.0001). Overall correlation was better for vSCr > 1.2 mg/dL. The area under the receiver operating characteristic curves showed a high accuracy for cSCr, but the device underestimated SCr, which was confirmed by Bland-Altman plot. Addition of the offset correction factor to the original data from centre 1 resulted in an improvement in sensitivity for detecting patients at risk (> 1.2 mg/dL), whilst maintaining acceptable specificity and improving NPV.

CONCLUSION: This study showed the feasibility of SCr determination using the evaluated handheld device in a routine clinical setting. The device showed high sensitivity and high NPV, but may significantly underestimate SCr without offset correction to local laboratories.

Keywords: Contrast-medium-induced nephropathy; Nephrogenic systemic fibrosis; Point of care testing; Serum creatinine determination; StatSensor