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 to 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. Do not use reagents over the expiration
date. Do not freeze; frozen Latex or Diluent could change the functionality of the
test.
Reagent deterioration: Presence of particles (R1, R2) and turbidity (R1).
ADDITIONAL EQUIPMENT
- Spintech 240 autoanalizer
- 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.
INTERFERENCES
Glucose (2 g/L), hemoglobine (10 g/L) and creatinine (3 g/L), do not interfere. Urea
( 1 g/L) and bilirrubin ( 10 mg/dL), interfere. Other substances may interfere6.
