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Clinical Chemistry 45: 414-417, 1999;
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(Clinical Chemistry. 1999;45:414-417.)
© 1999 American Association for Clinical Chemistry, Inc.

Technical Briefs

Validation of a Point-of-Care Assay for the Urinary Albumin:Creatinine Ratio

Marie P. Parsons1, David J. Newman1,3, Ronald G. Newall2 and Christopher P. Price1,a

1 St. Bartholomew's and the Royal London School of Medicine and Dentistry, Turner Street, London E1 2AD, UK;
2 Bayer plc, Diagnostics Division, Bayer House, Strawberry Hill, Newbury, Berks RG14 1JA, UK;
3 SW Thames Institute for Renal Research, St. Helier NHS Trust, Wrythe Lane, Carshalton, Surrey SM5 1AA, UK;
a address correspondence to this author at: Department of Clinical Biochemistry, St. Bartholomew's and the Royal London School of Medicine and Dentistry, Turner Street, London E1 2AD, UK

Microalbuminuria is a risk factor for the development of overt nephropathy in type 1 and type 2 diabetic patients (1)(2). Importantly, improvement of glycemic control and early intervention with antihypertensive drugs can retard the development of microalbuminuria and possibly its progression towards overt nephropathy (3)(4). Microalbuminuria is defined as an increased excretion of albumin above the reference range for healthy nondiabetic subjects, but which is undetectable by the Albustix dipstick test (5). It has also been defined as a urinary albumin excretion rate between 20 and 200 µg/min in an overnight or 24-h sample on at least two of three occasions within a period of 6 months (6). This is equivalent to 30–300 mg/24 h or 3–30 g/mol creatinine.

Although there are no clinical data to define the analytical requirements for the detection and monitoring of microalbuminuria, it has been suggested that a method should have an interassay precision of <12% over the concentration range 5–200 mg/L and be sensitive enough to reliably detect changes of 10 mg/L in the concentration range 5–35 mg/L (5). The method must also be reproducible over long periods because patients may be screened only two or three times throughout the year.

Albumin may be measured in urine by radial immunodiffusion methods, which include a rapid, gold sol labeled variant of the technique capable of semiquantitative measurement (7), and by direct immunoturbidimetric and nephelometric methods that enable automation and rapid turnaround of results. The latter methods are prone to a "hook effect" at high antigen concentrations (8). Latex-enhanced methods, in addition to providing improved sensitivity, also allow the use of an inhibition format, thereby avoiding a hook effect (9).

The DCA 2000TM desktop microalbumin system . . . [Full Text of this Article]


Acknowledgments


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References




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