Agreement between laboratory results and on-site pathology testing using Bayer DCA2000+ and Cholestech LDX point-of-care methods in remote Australian Aboriginal communities.

BACKGROUND Indigenous Australians experience high risk of diabetes and cardiovascular disease. On-site pathology data can help identify those at risk. We sought to evaluate point-of-care (POC) analysers in remote Australian communities. METHODS Results obtained from population screening (n=76-118) on the DCA2000+ and Cholestech LDX analysers were compared to laboratory measures. Results were compared using parametric and non-parametric statistical analyses, including the use of conventional cut-off values for pathology markers. RESULTS Agreements (95% CI) between the two methods for categorising results according to the selected cut-off values ranged from 88% (77-94%) for HDL-C to 99% (92-100%) for glucose, and Kappa coefficients ranged from 0.668 for total cholesterol to 0.945 for glucose. Differences in median values were not clinically meaningful but were statistically significant (P<0.05) for urinary albumin (18.8 [inter-quartile range: 7.5-41.7] vs. 18.0 [5.5-43.2] mg/L), creatinine (12.1 [7.9-17.1] vs. 12.4 [8.1-17.0] mmol/L) and albumin:creatinine ratio (ACR; 1.66 [0.70-3.53] vs. 1.27 [0.46-3.03] mg/mmol), HDL cholesterol (HDL-C; 1.05 [0.95-1.25] vs. 1.00 [0.81-1.20] mmol/L), triglycerides (1.65 [1.12-2.19] vs. 1.49 [1.07-2.36] mmol/L) and glucose (5.2 [4.5-6.0] vs. 5.2 [4.7-5.8] mmol/L), respectively, for POC and laboratory methods. Median HbA1c (5.6% [5.3-6.0%] vs. 5.5% [5.3-6.1%]) and total cholesterol (4.4 [3.8-5.0] vs. 4.4 [3.8-5.1] mmol/L) did not differ significantly. Bland-Altman analyses showed statistically significant (but not clinically meaningful) variation in the measurement difference across analyte concentration for all measures except ACR and total cholesterol. CONCLUSION POC instruments provided a reliable alternative to conventional laboratory methods for screening for chronic disease risk factors in locations remote from urban centres.

[1]  J. Mathews,et al.  Apparent dietary intake in remote aboriginal communities. , 1994, Australian journal of public health.

[2]  J. Gill,et al.  Results of an innovative education, training and quality assurance program for point-of-care HbA1c testing using the Bayer DCA 2000 in Australian Aboriginal Community Controlled Health Services. , 2003, The Clinical biochemist. Reviews.

[3]  F. Kronenberg,et al.  Effect of sample storage on the measurement of lipoprotein[a], apolipoproteins B and A-IV, total and high density lipoprotein cholesterol and triglycerides. , 1994, Journal of lipid research.

[4]  G. Maguire,et al.  Point‐of‐care testing of HbA1c and blood glucose in a remote Aboriginal Australian community , 2005, The Medical journal of Australia.

[5]  D. Nathan,et al.  Immediate feedback of HbA1c levels improves glycemic control in type 1 and insulin-treated type 2 diabetic patients. , 1999, Diabetes care.

[6]  M. Shephard,et al.  An innovative Australian point-of-care model for urine albumin: creatinine ratio testing that supports diabetes management in indigenous medical services and has international application , 2005, Annals of clinical biochemistry.

[7]  H. Lebovitz,et al.  Utility of Untimed Urinary Albumin Measurements in Assessing Albuminuria in Black NIDDM Subjects , 1997, Diabetes Care.

[8]  J. Shield,et al.  Are Frozen Urine Samples Acceptable for Estimating Albumin Excretion in Research? , 1995, Diabetic medicine : a journal of the British Diabetic Association.

[9]  C. Jackson,et al.  MICROALBUMINURIA AS PREDICTOR OF VASCULAR DISEASE IN NON-DIABETIC SUBJECTS Islington Diabetes Survey , 1988, The Lancet.

[10]  M. Shephard,et al.  Albuminuria in a remote South Australian Aboriginal community: results of a community-based screening program for renal disease. , 2003, Rural and remote health.

[11]  M. Daniel,et al.  Diabetes incidence in an Australian aboriginal population. An 8-year follow-up study. , 1999, Diabetes care.

[12]  P. Raskin,et al.  Report of the expert committee on the diagnosis and classification of diabetes mellitus. , 1999, Diabetes care.

[13]  A. Beckett,et al.  AKUFO AND IBARAPA. , 1965, Lancet.

[14]  P. Trinder,et al.  Determination of blood glucose using 4-amino phenazone as oxygen acceptor. , 1969, Journal of clinical pathology.

[15]  R. Deitch.  Commentary from Westminster , 1984, The Lancet.

[16]  A. Neil,et al.  A Prospective Population-Based Study of Microalbuminuria as a Predictor of Mortality in NIDDM , 1993, Diabetes Care.

[17]  K. O'dea.  Westernization and non-insulin-dependent diabetes in Australian Aborigines. , 1991, Ethnicity & disease.

[18]  R. Little,et al.  Rapid HbA1c Testing in a Community Setting , 1996, Diabetes Care.

[19]  M. Shephard,et al.  Is the Bayer DCA 2000 Acceptable as a Screening Instrument for the Early Detection of Renal Disease? , 1999, Annals of clinical biochemistry.

[20]  D. Altman,et al.  STATISTICAL METHODS FOR ASSESSING AGREEMENT BETWEEN TWO METHODS OF CLINICAL MEASUREMENT , 1986, The Lancet.

[21]  P. Barter,et al.  High density lipoproteins and coronary heart disease. , 1996, Atherosclerosis.