Isotope dilution mass spectrometry alignment of the StatSensor will identify most patients with estimated glomerular filtration rate <60 mL/min, but there will be many falsely low estimated glomerular filtration rate results that require laboratory validation. Creatinine results need improvement.

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This unique POC model for supporting diabetes management is the first of its type to be developed for indigenous communities and has considerable potential to be adopted worldwide.

Background: From 2005 to 2007 the Australian Government funded a multicentre, clustered randomized controlled trial to determine the clinical effectiveness, cost-effectiveness, satisfaction and safety of point of care testing (PoCT) in general practice (GP). PoC tests measured (and devices used) in the trial were haemoglobin A1c and urine albumin:creatinine ratio (DCA 2000), lipids (Cholestech LDX) and international normalized ratio (CoaguChek S). Methods: An internal quality control (QC) program was developed as part of a quality management framework for the trial. PoCT device operators were provided with a colour-coded QC Result Sheet and QC Action Sheet for on-site recording and interpreting of their results. Within-practice imprecision for QC testing was calculated and compared with the analytical goals for imprecision set prior to the trial. Results: The average participation rate for QC testing was 91% or greater. Median within-practice imprecision met the analytical goals for all PoC tests, except for high-density lipoprotein-cholesterol (HDL-C) where observed performance was outside the minimum goal for one level and one lot number of QC. Most practices achieved the imprecision goals for all analytes, with the principal exception of HDL-C. Conclusions: Results from QC testing indicate that PoCT in the GP trial met the analytical goals set for the trial, with the exception of HDL-C.

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