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.
PRECAUTIONS
Components from human origin have been tested and found to be negative
for the presence of HBsAg, HCV, and antibody to HIV (1/2). However, handle
cautiously as potentially infectious.
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
- MINDRAY BS-120 / BS-200E 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.
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.
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.
NOTES
Clinical diagnosis should not be made on findings of a single test result, but
should integrate both clinical and laboratory data.
