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

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

Abstract

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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Albuminuria / complications
  • Albuminuria / diagnosis*
  • Albuminuria / urine*
  • Creatinine / urine*
  • Humans
  • Kidney Failure, Chronic / complications*
  • Kidney Failure, Chronic / urine*
  • Reagent Kits, Diagnostic*
  • Reproducibility of Results
  • Sensitivity and Specificity
  • Time Factors

Substances

  • Reagent Kits, Diagnostic
  • Creatinine