Evaluation of the Nova StatSensor® XpressTM Creatinine Point-Of-Care Handheld Analyzer
MetadataShow full item record
AbstractCreatinine is a parameter that is required to monitor renal function and is important to follow in patients under treatment with potentially toxic renal drugs, such as the anti-HIV drug Tenofovir. A point of care instrument to measure creatinine would be useful for patients monitoring in resource-limited settings, where more instruments that are sophisticated are not available. The StatSensor Xpress Creatinine (Nova Biomedical Cooperation, Waltham, MA, USA) point of care analyzer was evaluated for its diagnostic performance in indicating drug therapy change. Creatinine was measured in parallel using the Nova StatSensor Xpress Creatinine analyzer and the Vitros 5,1FS (Ortho Clinical Diagnostics, Inc, Rochester, USA), which served as reference standard. The precision (i.e., repeatability and reproducibility) and accuracy of the StatSensor Xpress Creatinine analyzer were calculated using a panel of specimens with normal, low pathological and high pathological values. Two different Nova StatSensor Xpress Creatinine analyzers were used for the assessment of accuracy using repeated measurements. The coefficient of variation of the StatSensor Xpress Creatinine analyzers ranged from 2.3 to 5.9% for repeatability and from 4.2 to 9.0% for between-run reproducibility. The concordance correlation agreement was good except for high values (>600 µmol/L). The Bland-Altman analysis in high pathological specimens suggests that the Nova StatSensor Xpress Creatinine test tends to underestimate high creatinine values (i.e., >600 µmol/L). The Nova StatSensor Xpress Creatinine analyzers showed acceptable to good results in terms of repeatability, inter-device reproducibility and between-run reproducibility over time using quality control reagents. The analyzer was found sufficiently accurate for detecting pathological values in patients (age >10 year) and can be used with a moderate risk of misclassification.
PublisherPublic Library of Science
- Application of a point of care creatinine device for trend monitoring in kidney transplant patients: fit for purpose?
- Authors: van Lint CL, van der Boog PJ, Romijn FP, Schenk PW, van Dijk S, Rövekamp TJ, Kessler A, Siekmann L, Rabelink TJ, Cobbaert CM
- Issue date: 2015 Sep 1
- Chronic kidney disease prevalence in Rivas, Nicaragua: use of a field device for creatinine measurement.
- Authors: Minnings K, Kerns E, Fiore M, Fiore M, Parekh RS, DuBois J, Isbell TS, Ferguson R, Fiore L
- Issue date: 2015 Apr
- Assessment of the Nova StatSensor whole blood point-of-care creatinine analyzer for the measurement of kidney function in screening for chronic kidney disease.
- Authors: Shephard M, Peake M, Corso O, Shephard A, Mazzachi B, Spaeth B, Barbara J, Mathew T
- Issue date: 2010 Aug
- Evaluation of a handheld point-of-care analyser for measurement of creatinine in cats.
- Authors: Reeve J, Warman S, Lewis D, Watson N, Papasouliotis K
- Issue date: 2017 Feb
- Comparability of point-of-care whole-blood electrolyte and substrate testing using a Stat Profile Critical Care Xpress analyzer and standard laboratory methods.
- Authors: Flegar-Mestrić Z, Perkov S
- Issue date: 2006