NDLI: Analytical characteristics of a biomarker-based risk assessment test for acute kidney injury (AKI).

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Uettwiller-Geiger, Denise L. Vijayendran, Ravi Kellum, John A. Fitzgerald, Robert L.
Description	Author Affiliation: Uettwiller-Geiger DL ( John T. Mather Memorial Hospital, Port Jefferson, NY, United States. Electronic address: dgeiger@matherhospital.org.); Vijayendran R ( Astute Medical, Inc., San Diego, CA, United States.); Kellum JA ( Center for Critical Care Nephrology, Department of Critical Care Medicine, University of Pittsburgh, Pittsburgh, PA, United States.); Fitzgerald RL ( Department of Pathology, Center for Advanced Laboratory Medicine, University of California-San Diego Health Systems, San Diego, CA, United States.)
Abstract	BACKGROUND: Acute kidney injury (AKI) is associated with increased mortality, morbidity, hospital length of stay, and costs. A quantitative urine test is available to assess the risk of developing AKI by measuring the concentrations of two protein biomarkers, TIMP-2 and IGFBP-7. The NephroCheck Test combines these concentrations into an AKIRisk Score. The purpose of this study is to characterize the analytical performance characteristics of the AKIRisk Score. METHODS: Linearity and analytical sensitivity were evaluated by following Clinical Laboratory Standards Institute (CLSI) EP06-A and EP17-A, respectively. Precision was evaluated by testing clinical samples and examining the repeatability of test results. Potential interference was evaluated for endogenous and exogenous substances. Sample stability was examined at room temperature and at 2-8°C, as well as the effect of sample centrifugation temperature on test results. RESULTS: The AKIRisk Score exhibits approximately 10% coefficient of variation (CV) at the recommended cutoff value of 0.3 and the limit of quantitation (LoQ) was 0.002. Only albumin, bilirubin (conjugated), and methylene blue interfered with test results, at concentrations exceeding 1250 mg/L, 72 mg/L, and 0.49 mg/L, respectively. AKIRisk Score results were stable for 6h at room temperature, 24h refrigerated, and not impacted by sample centrifugation temperature. CONCLUSIONS: Our studies demonstrate that the AKIRisk Score has robust analytical performance, good precision, minimal analytical interference, acceptable sensitivity, and excellent sample stability.
File Format	HTM / HTML
ISSN	00098981
Journal	Clinica Chimica Acta
Volume Number	455
e-ISSN	18733492
Language	English
Publisher	Elsevier
Publisher Date	2016-04-01
Publisher Place	Netherlands
Access Restriction	One Nation One Subscription (ONOS)
Content Type	Text
Resource Type	Article
Subject	Biochemistry (medical) Clinical Biochemistry Biochemistry

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