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Clin Chim Acta. 2009 Jan;399(1-2):54-8. doi: 10.1016/j.cca.2008.09.006. Epub 2008 Sep 14.

Diagnostic accuracy of the urinary albumin: creatinine ratio determined by the CLINITEK Microalbumin and DCA 2000+ for the rule-out of albuminuria in chronic kidney disease.

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Department of Clinical Biochemistry, Salford Royal NHS Foundation Trust, Hope Hospital, Stott Lane, Salford, M6 8HD, UK.


An increased urinary albumin excretion (albuminuria) is an established test for the early detection of renal disease and is also recognized as a risk factor for cardiovascular disease and mortality in a number of clinical settings. There is an established body of data which shows that a random urinary albumin:creatinine ratio (ACR) based on a random urine sample correlates well with 24-hour urinary albumin excretion measurement. However, there is little data to show whether specific point-of-care testing devices can be used to rule-in or rule-out increased urinary albumin excretion in comparison to a 24-hour urinary albumin excretion measurement. This study evaluated the ability to rule-in or rule-out albuminuria in a cohort of patients attending a renal outpatient clinic, using the urinary ACR determined by the CLINITEK Microalbumin (Siemens Healthcare Diagnostics Inc., Deerfield, US) a semi-quantitative strip test, and by the DCA 2000+ (Siemens Healthcare Diagnostics Inc.) a quantitative cassette based test using 3 random urine samples collected within a 24-hour period compared to 24-hour urinary albumin measurement. The CLINITEK system was shown to be a reliable test for ruling out increased urinary albumin excretion with negative likelihood ratios less than 0.05 above the 24-hour urinary albumin excretion rate of 30 mg/24 h (threshold for microalbuminuria), and less than 0.01 above the albumin excretion rate of 100 mg/24 h. The DCA 2000+ system demonstrated similar performance as a rule-out test, with likelihood ratios of less than 0.02 at 24-hour albumin excretion rates above 30 mg/24 h. Both the CLINITEK and DCA 2000+ systems could be used to rule-out increased urinary albumin excretion at the albumin excretion cut-off rate of 30 mg/24 h in this cohort of patients.

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