Assessment of a point-of-care device for measuring creatinine in a community screening program for chronic kidney disease
Main Article Content
Abstract
ABSTRACT
Background: Chronic kidney disease (CKD) is a major contemporary global health problem. Creatinine measurement for the calculation of estimated glomerular filtration rate is an important component of assessing CKD risk. A point-of-care test for creatinine using capillary sampling is required as part of a screening assessment.
Objectives: Evaluate the analytical performance of a modified point-of-care testing method for whole blood creatinine (Nova Biomedical StatSensor whole blood creatinine analyser) relative to a laboratory method.
Design and methods: Conduct a patient comparison study between the point-of-care testing and laboratory methods in a rural community setting. Calculate measures of imprecision and assess the ability of the POCT method to determine staging of CKD compared to the laboratory.
Results: Between-device imprecision averaged 8.8%. The StatSensor devices showed a positive bias of approximately 14% for whole blood creatinine measurement compared to the laboratory method, leading to more than 40% of community patients being staged differently for CKD risk with approximately 25% more abnormal results.
Conclusions: The StatSensor whole blood creatinine point-of-care device remains analytically unsound for use as a screening device for CKD.
Article Details
The Medical Research Archives grants authors the right to publish and reproduce the unrevised contribution in whole or in part at any time and in any form for any scholarly non-commercial purpose with the condition that all publications of the contribution include a full citation to the journal as published by the Medical Research Archives.
References
[2] Jha V, Garcia-Garcia G, Iseli K, Li Z, Naiker S, Plattner B et al. (2013). Chronic kidney disease; global dimension and perspectives. Lancet, 382: 260-272.
[3] Jha V, Wang A-M, Wang H. (2012). The impact of CKD identification in larger countries: the burden of illness. Nephrol Dialysis Transplant, 27: 32-38.
[4] Levey A, Coresh J. (2012). Chronic kidney disease. Lancet, 379: 165-180.
[5] Ayodele O, Alebiousi C. (2010). Burden of chronic kidney disease; an international perspective. Adv Chronic Kid Dis, 17: 215-224.
[6] Couser W, Remuzzi G, Mendis S, Tonelli M. (2011). The contribution of chronic disease to the global burden of major non-communicable diseases. Kidney Int, 80: 1258-1270.
[7] Chronic kidney disease (CKD) management in general practice (2nd edition). Kidney Health Australia, Melbourne 2012. Available at www.kidney.org.au [last accessed 1 September 2014].
[8] Mathew T, Corso O, Ludlow M, Boyle A, Cass A, Chadban S, et al. (2010). Screening for chronic kidney disease in Australia: a pilot study in the community and workplace. Kidney Int, 77 (Supp 116): S9-S16.
[9] Shephard A, Shephard M, Halls H, Corso O, Mathew T. (2011). Innovative use of point-of-care testing for chronic kidney disease screening. Point of Care, 10: 98-101.
[10] Polkinghorne K. (2014). Estimated glomerular filtration rate versus albuminuria in the assessment of kidney function: What’s more important? Clin Biochem Revs, 35: 67-73.
[11] Shephard M. (2011). Point-of-care testing and creatinine measurement. Clin Biochem Revs, 32: 109-114.
[12] Peake M, Whiting M. (2006). Measurement of serum creatinine – current status and future goals. Clin Biochem Revs, 27:173-84.
[13] Shephard MD, Peake MJ, Corso O, Shephard AK, Mazzachi BC, Spaeth BA et al. (2010). Assessment of the NovaStatSensor whole blood point-of-care creatinine analyser for the measurement of kidney function in screening for chronic kidney disease. Clin Chem Lab Med, 48: 1113-1119.
[14] Australian Bureau of Statistics (2011). Information Paper: Census of Population and Housing -- Products and Services, 2011 (cat. no. 2011.0.55.001). Available at www.abs.gov.au [last accessed 8 September 2014].
[15] Matsushita K, Mahmoodi BK, Woodward M, Emberson JR, Jafar TH, Jee SH et al. (2012). Comparison of risk prediction using the CKD-EPI equation and the MDRD study equation for estimated glomerular filtration rate. JAMA, 37 (18) 1941-1951.