CLINICAL SIGNIFICATION
Microalbuminuria is the excretion of albumin in the urine at a rate above the normal range of values but without manifest clinical nephropathy. It is defined as the excretion of 30 to 300 mg of albumin in 24 hours (20-200 ug/min) in 2 of 3 urine samples taken during a period of few weeks.
Microalbumin (MAlb) determination is important when monitoring diabetic patients since it allows the early detection of subjects at risk for progressive renal failure, thus allowing the application of proper therapeutic measures. Presently, microalbuminuria has been recognized as a risk factor independent of cardiovascular disease in patients with and without diabetes.

PRINCIPLE
The albumin reacts with the specific antibody forming insoluble immunocomplexes. The turbidity caused by these immunocomplexes is proportional to the concentration of albumin in the sample and can be measured spectrophotometrically.

REAGENTS INCLUDED
Reagent A: buffered physiological solution, pH 7.6
Reagent B: anti-albumin (human) monospecific antibodies.

STABILITY AND STORAGE INSTRUCTIONS
Reagents included: stable refrigerated (2-10ºC) until the expiration date specified in the box. Do not freeze.

PERFORMANCE
a) Reproducibility: evaluated through a modification in the CLSI EP5-A protocol. For that purpose, a control sample and samples with different levels of microalbuminuria were processed. The intra-run and total accuracy was calculated from the obtained data.



b) Detection limit: concentration: 0.7 mg/l of MAlb. It is the minimum amount of analyte that can be detected as a sample different from zero.
c) Prozone effect: no prozone effect is seen up to 2700 mg/l of MAlb.


PROCEDURE





Since the reaction is non linear, it is necessary to calibrate the method by means of a calibration curve.
For that purpose, the Microalbúmina Calibrador Turbitest AA kit must be used.
Microalbúmina Control 2 niveles Turbitest AA must be used as control for the analytic system. This kit is composed by two human albumin vials of 2 ml each. One of them has a concentration level between 20 and 60 mg/l (low level). The other one ranges between 80 and 160 mg/l (high level). The value is presented in the corresponding label of each lot.


PRESENTATION

MicroalbúminaTurbitest AA
Code: 1513266
Size: 60 ml (1 x 50 ml A + 1 x 10 ml B)

Microalbúmina Calibrador Turbitest AA
Code: 1913266
Size: 1 x 2 ml

Microalbúmina Control 2 niveles Turbitest AA
Code: 1933266
Size: 2 x 2 ml (1 x 2 ml Level 1 + 1 x 2 ml Level 2)