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SYNCHRON® Microalbumin (MA)

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Although albumin is the most common plasma protein, only minuscule amounts of albumin are normally excreted in the urine, usually no more than 30 mg/day. Microalbuminuria is used to describe albumin concentrations in the urine that are greater than normal but not detectable with common urine dipstick assays. Synonyms include slight albuminuria, paucialbuminuria, and incipient diabetic nephropathy.

Methodology

The SYNCHRON Microalbumin Reagent is used for the quantitative determination of albumin in human urine by a turbidimetric method. The SYNCHRON system automatically proportions the appropriate sample and reagent volumes into the cuvette at 37°C.

In the reaction, urine albumin combines with specific antibody to form insoluble antigen-antibody complexes. The system monitors the change in absorbance at 380 nm. This change in absorbance is proportional to the concentration of albumin in the sample and is used by the SYNCHRON system to calculate urine albumin concentration based upon a multi-point, non-linear calibration curve. (On the SYNCHRON LX Systems, the curve is stored and a single calibration point is made to adjust the curve.)

Reaction Scheme

More Information

Symptoms Associated with the Microalbuminuria Phase of Type 1 Diabetes

Clinical Significance

Diabetes is the leading cause of end-stage renal disease, characterized by hypertension and a markedly decreased glomerular filtration rate with creatinine levels exceeding 10 mg/dL (884 mmmol/L). Microalbuminuria has been found to predict the occurrence of clinical nephropathy in Type I diabetes and, to a lesser extent, in Type II diabetes. Albuminuria may be an early indicator of treatable diabetic kidney disease. Many studies have indicated that normalization of blood glucose and blood pressure can delay the progression from microalbuminuria to clinical nephropathy. Abnormal albumin excretion is related both to the duration of diabetes and the degree of glycemic control as reflected in the levels of HbA1c.

Comparison of Five Different Urine Collections

Microalbuminuria has predictive value for development of overt diabetic nephropathy and mortality from renal or cardiovascular disease. In Type I diabetics with microalbuminuria, albumin excretion rate (AER) and blood pressure increase approximately 20% and 5% per year, respectively, and glomerular filtration rate (GFR) starts to decline. For patients with overt proteinuria, AER and blood pressure increase 50-100% and 8% per year, and GFR falls by 12 mL/min/year.1 With overt nephropathy, there is acceleration that had already begun during the period of microalbuminuria or incipient nephropathy. Miroalbuminuria results may also be dependent on the type of urine collection. The optimal collection would have minimal inter-individual and intra-individual variability and the highest diagnostic sensitivity and specificity. It is suggested that at least three urine collections are necessary because of high intra-individual variation.

Correlations*

Ordering Information

Name	Description	Part Type	Part Number
SYNCHRON DxC, CX Microalbumin Reagent	100 tests per cartridge, 60 day onboard stability	Reagent	475100
SYNCHRON CX Microalbumin Calibrator	100 tests per cartridge	Calibrator	475057
SYNCHRON DxC, LXi Microalbumin Calibrator	100 tests per cartridge	Calibrator	475089

References

1. Mogensen CE, Cohen JJ, Harrington JT, et al. Microalbuminuria as a predictor of clinical diabetic nephropathy. Kidney Int 1987;31:673-89.

2. Mogensen CE. Natural history of renal functional abnormalities in human diabetes mellitus: from normoalbuminuria to incipient and overt nephropathy. In: Brenner BM, Stein JH, ed. The Kidney in Diabetes Mellitus. New York:Churchill Livingstone, 1989:19-49.

3. Cembrowski GS. Testing for microalbuminuria: promises and pitfalls. Lab Medicine 1990;21:491-6.

4. American Diabetes Association, Diabetic Nephropathy. Diabetes care 1997;20[Suppl 1]:524-7.

5. National Committee for Clinical Laboratory Standards. Evaluation of Precision Performance of Clinical Chemistry Devices, Approved Guideline, Volume 19, No. 2, NCCLS Publication EP5-A. Villanova, PA (1999).

*The precision and correlation studies were obtained during limited evaluation and are not intended to represent performance specifications for this reagent.

**Manual ORDAC

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