Denise L Uettwiller-Geiger1, Ravi Vijayendran2, John A Kellum3, Robert L Fitzgerald4. 1. John T. Mather Memorial Hospital, Port Jefferson, NY, United States. Electronic address: dgeiger@matherhospital.org. 2. Astute Medical, Inc., San Diego, CA, United States. 3. Center for Critical Care Nephrology, Department of Critical Care Medicine, University of Pittsburgh, Pittsburgh, PA, United States. 4. 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.
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.
Authors: Michael Joannidis; Lui G Forni; Michael Haase; Jay Koyner; Jing Shi; Kianoush Kashani; Lakhmir S Chawla; John A Kellum Journal: Crit Care Med Date: 2019-10 Impact factor: 7.598