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The Programme aims to assess the performance of organisations utilising Point of Care (POCT) Creatinine devices to assess kidney function.
Creatinine is a well-established biochemical marker for renal function and is widely used to calculate estimated Glomerular Filtration Rate (eGFR). Whole blood Creatinine meters are increasingly used in Point of Care (POCT) settings such as Radiology as a screen for possible renal dysfunction. This screen is used for the prevention of contrast-induced-nephropathy where administration of nephro-toxic contrast media is required.
1.1 Point-of-care creatinine devices ABL800 FLEX, i STAT Alinity and StatSensor, which calculate estimated glomerular filtration rate (eGFR), are recommended to assess kidney function to guide decisions on whether to use intravenous contrast during an outpatient CT scan in adults. They should only be used when current practice is that a recent eGFR result must be available before a person has a CT scan with intravenous contrast and if all the following apply:
1.2 Take age, sex and ethnicity into account when assessing risk of acute kidney injury using a questionnaire-based tool.
The programme aim is to cover the clinically relevant ranges, encompassing the cut off for eGFR of 30ml/min/1.73m2. However, the analytical measuring range will also be assessed where appropriate. The programme is suitable for all POCT applications.
Three liquid Lysed whole blood samples are distributed bimonthly, with a minimum of 18 samples distributed over the year covering a wide clinically relevant range. The samples consist of endogenous lysed whole blood samples along with a panel of linearly related samples produced from lysed whole blood spiked with Creatinine. They are distributed on a number of occasions over that period which allows for the assessment of the organisation’s and method’s performance, including linearity, bias, within and between batch imprecision.
|POCT Creatinine Programme|
|Analyte||Approx. Range Covered|
|Creatinine||50 - 700||µmol/l|
|e-GFR||<15 - >90||mls/min/1.73m2|