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Evaluation of the Bayer Multistix PRO 10LS Point-of-Care Urine Test

Croal, Bernard L. MB, ChB, MSc, MRCP, MRCPath*†; Finlay, David*; Davidson, Elaine PhD*; Mutch, William J. MSc*; Stephen, Duncan PhD*; Rothnie, Ian MSc*; Dickie, Arthur PhD*; Newall, Ronald PhD

Peer-Reviewed Articles

Urine strip tests for use at the point-of-care and centralized laboratory locations are commonplace and provide clinical information on kidney function, urinary tract infections, glucose handling, and liver function. The Multistix PRO 10LS is a new strip incorporating an extra protein pad with increased specificity for urinary albumin and a pad for urinary creatinine estimation, thus allowing calculation of the urinary protein-to-creatinine ratio. In this study, freshly voided urine samples were obtained from a total of 881 patients attending a variety of outpatient clinics. Protein, creatinine, and their ratio were estimated using the Multistix PRO 10LS strip, followed by analysis within a few hours using the central laboratory methods for protein, albumin, and creatinine. More than 90% of laboratory protein and creatinine measurements agreed to within one band of the Multistix PRO 10LS estimations. Diagnostic performance for the detection of clinically relevant proteinuria (defined by urinary albumin ≥80 mg/L) demonstrated a sensitivity of 96.5% and a specificity of 94.9%. An abnormal protein-to-creatinine ratio as detected by the Multistix PRO 10LS strip agreed with the central laboratory method in 94.6% of samples. The Multistix PRO 10LS urine strip test provides useful urinalysis information, including improved renal protein handling data in the form of the protein-to-creatinine ratio. Availability of this at the point of care thus will potentially augment immediate clinical decision making while the patient is physically at the outpatient clinic.

From the *Clinical Biochemistry Department, Grampian University Hospitals Trust; †The Health Services Research Unit, University of Aberdeen; and ‡Bayer Diagnostics, United Kingdom.

Address correspondence and reprint requests to Dr. Bernard Lewis Croal, Department of Clinical Biochemistry, Polwarth Building, Medical School, Foresterhill, Aberdeen, UK AB25 22N (e-mail: b.croal@arh.grampian.scot.nhs.uk).

The Health Services Research Unit is funded by the Chief Scientist Office of the Scottish Office Department of Health; however, the opinions expressed in this communication are those of the authors.

© 2003 Lippincott Williams & Wilkins, Inc.