Store 2 - 8ºC.
PRINCIPLE OF THE METHOD
Microalbumin-turbilatex is a quantitative turbidimetric test for the
measurement of microalbumin (µALB) in human urine.
Latex particles coated with specific antibodies anti-human albumin are
agglutinated when mixed with samples containing µALB. The agglutination
causes an absorbance change, dependent upon the µALB contents of the
patient sample that can be quantified by comparison from a calibrator of
known µALB concentration.
CLINICAL SIGNIFICANCE
Microalbuminuria is at present defined as an excretion rate for albumin
between 20 and 200 mg/L, which is already above normal values but still
below the values seen in patients with "conventional" proteinuria.
Microalbuminuria is a marker of an increased risk of diabetic nephropathy as
well as cardiovascular disease in patients with insulin-dependent diabetes
mellitus as well as with non-insulin-dependent diabetes mellitus. More
recently, microalbuminuria has been found to be associated with
cardiovascular disease also in the non-diabetic population. In fact,
microalbuminuria may show to be a risk factor of cardiovascular disease
among otherwise apparently healthy people.
CALIBRATION
Use Microalbumin Calibrator Reference 1107072.
The sensitivity of the assay and the target value of the calibrator have been
standardized against the International Reference Material ERM-DA
470K/IFCC. Recalibrate when control results are out of specified tolerances,
when using different lot of reagent and when the instrument is adjusted.
PREPARATION
Ready for use.
STORAGE AND STABILITY
All the components of the kit are stable until the expiration date on the label
when stored tightly closed at 2-8ºC and contaminations are prevented during
their use. Reagents should not be left inside the analyzer after use, they must
be stored refrigerated at 2-8ºC. Latex may sediment. Mix reagents gently
before use. Do not use reagents over the expiration date.
Reagent deterioration: Presence of particles (R1, R2) and turbidity (R1).
Do not freeze; frozen Latex or Diluent could change the functionality of the
test.
ADDITIONAL EQUIPMENT
- SPINLAB 180 autoanalyzer
- Laboratory equipment.
SAMPLES
24 hours or random/ first morning urine specimen. It is recommended to
adjust the pH at 7.0 with NaOH/HCl 1 mol/L. Stable 7 days at 2-8ºC when
sodium azide 1 g/L is added to prevent contamination.
Urine should be centrifuged before testing.
QUALITY CONTROL
Control Sera are recommended to monitor the performance of manual and
automated assay procedures. It should be used the SPINREACT
Microalbumin Control Ref: 1107073.
REFERENCE VALUES
Normal values up to 30 mg/24 hrs urine specimen and 20 mg/L in a first
morning urine specimen.
Each laboratory should establish its own reference range.
