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Biosystems Reagent Albumin Microalbuminuria

INTENDED USE

Reagents for the measurement of albumin concentration in human urine. The obtained values are useful as an aid in the diagnosis and monitoring of renal disorders.

This reagent is for use in the BioSystems BA analyzers or in other analyzer with similar performance characteristics.

CLINICAL SIGNIFICANCE

Urinary albumin concentration values provide a good indicator of changes in glomerular permeability, as occur in a number of renal disease1.

Diabetic nephropathy is characterized by an early hyperfiltration stage resulting in small increases
in urinary albumin excretion.

That is why the measurement of urinary albumin is considered a clinically important indicator of deteriorating renal function in diabetic subjects.

Urinary albumin excretion is also monitored in hypertensive patients to identify the development
of significant nephropathy.

Clinical diagnosis should not be made on the findings of a single test result, but should integrate
both clinical and laboratory data.

Biosystems Reagent Albumin Microalbuminuria

PRINCIPLE OF THE METHOD

Albumin in the urine sample causes agglutination of the latex particle coated with antibody.

The agglutination of the particles is proportional to the albumin concentration and can be measured by
turbidimetry2-5

Biosystems Reagent Albumin Microalbuminuria

COMPOSITION

A. Reagent: Borate buffer 0.1 mol/L, sodium azide 0.95 g/L, pH 10.0.
B. Reagent: Suspension of latex particles coated with anti-human albumin antibodies, sodium
azide 0.95 g/L (Note 1).

STORAGE AND STABILITY

Store at 2-8ºC.
Components are stable once opened until the expiry date marked in the label if they are stored
well closed and care is taken to prevent contamination during their use.

On board stability: Reagents open and kept in the refrigerated compartment of the analyzer are
stable 2 months.
Indications of deterioration: Absorbance of the blank over the limit indicated in “Test Parameters”.

Biosystems Reagent Albumin Microalbuminuria

ADDITIONAL MATERIALS REQUIRED (NOT PROVIDED)

S. Albumin Standard: 1 x 1 mL (BioSystems cod. 31130). Human albumin. Albumin
concentration is given on the label.

The concentration value is traceable to the ERM DA-470
reference standard (Institute for Reference Materials and Measurements, IRMM).

Human serum used in the preparation of the standard has been tested and found to be
negative for the presence of antibodies anti-HIV and anti-HCV, as well as for HBs antigen.

However, the standard should be handled cautiously as potentially infectious.

Reconstitute with 1.00 mL of distilled water. Stable for 30 days at 2-8ºC. For longer periods, keep
frozen in aliquots to avoid repeated freeze-thaw cycles

Biosystems Reagent Albumin Microalbuminuria

REAGENT PREPARATION

Reagent is provided ready to use.

SAMPLES

Urine collected by standard procedures. Urine should be centrifuged before analysis. Albumin in
urine is stable for 7 days at 2-8ºC.

CALIBRATION

A reagent blank should be done every day and a calibration at least every 2 months, after reagent
lot change or as required by quality control procedures.

QUALITY CONTROL

It is recommended to use the Control Urine (cod. 18036 and cod. 18037) and the Biochemistry
Control Urine (cod. 18054 and cod. 18066) to verify the accuracy of the measurement procedure.

Each laboratory should establish its own internal Quality Control scheme and procedures for
corrective action if control results are not within the acceptable limits.

Biosystems Reagent Albumin Microalbuminuria

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