Results From 16 Years of Quality Surveillance of Urine Albumin to Creatinine Ratio Testing for a National Indigenous Point-of-Care Testing Program.

CONTEXT.­: The burden of chronic kidney disease in Indigenous Australians is 7.3 times higher than that of non-Indigenous Australians. If chronic kidney disease is detected early and managed, deterioration in kidney function can be reduced. Urine albumin to creatinine ratio is a key marker of early renal damage. OBJECTIVE.­: To report on 16 years of analytic quality of urine albumin to creatinine ratio testing on Siemens DCA devices enrolled in the national Quality Assurance for Aboriginal and Torres Strait Islander Medical Services point-of-care testing program. DESIGN.­: Quality Assurance for Aboriginal and Torres Strait Islander Medical Services participants are required to test 2 quality assurance samples each month across two 6-monthly testing cycles per year. Participants also test 2 quality control samples monthly. RESULTS.­: The percentage of urine albumin, creatinine, and albumin to creatinine ratio results for quality assurance point-of-care testing that were within assigned allowable limits of performance averaged 96.9%, 95.9%, and 97.5%, respectively. The percentage acceptable quality control results for urine albumin and creatinine averaged 93.5% and 86.8%. The median imprecision for urine albumin, creatinine, and albumin to creatinine ratio quality assurance testing averaged 5.5%, 4.1%, and 3.3%, respectively, and the median within-site imprecision for quality control testing averaged 5.4%, 4.3%, and 5.7%, respectively, for the low sample and 4.0%, 4.1%, and 4.5%, respectively, for the high sample. CONCLUSIONS.­: For 16 years the DCA system has proven to be reliable and robust and operators at Aboriginal medical services have demonstrated they are able to conduct point-of-care testing for urine albumin to creatinine ratio that consistently meets analytic performance standards.

Results from 15years of quality surveillance for a National Indigenous Point-of-Care Testing Program for diabetes.

INTRODUCTION: Diabetes is a major health problem for Australia's Aboriginal and Torres Strait Islander peoples. Point-of-care testing for haemoglobin A1c (HbA1c) has been the cornerstone of a long-standing program (QAAMS) to manage glycaemic control in Indigenous people with diabetes and recently, to diagnose diabetes. METHODS: The QAAMS quality management framework includes monthly testing of quality control (QC) and external quality assurance (EQA) samples. Key performance indicators of quality include imprecision (coefficient of variation [CV%]) and percentage acceptable results. This paper reports on the past 15years of quality testing in QAAMS and examines the performance of HbA1c POC testing at the 6.5% cut-off recommended for diagnosis. RESULTS: The total number of HbA1c EQA results submitted from 2002 to 2016 was 29,093. The median imprecision for EQA testing by QAAMS device operators averaged 2.81% (SD 0.50; range 2.2 to 3.9%) from 2002 to 2016 and 2.44% (SD 0.22; range 2.2 to 2.9%) from 2009 to 2016. No significant difference was observed between the median imprecision achieved in QAAMS and by Australasian laboratories from 2002 to 2016 (p=0.05; two-tailed paired t-test) and from 2009 to 2016 (p=0.17; two-tailed paired t-test). For QC testing from 2009 to 2016, imprecision averaged 2.5% and 3.0% for the two levels of QC tested. Percentage acceptable results averaged 90% for QA testing from 2002 to 2016 and 96% for QC testing from 2009 to 2016. The DCA Vantage was able to measure a patient and an EQA sample with an HbA1c value close to 6.5% both accurately and precisely. CONCLUSION: HbA1c POC testing in QAAMS has remained analytically sound, matched the quality achieved by Australasian laboratories and met profession-derived analytical goals for 15years.