HemoCue Albumin 201 Manuel D'utilisation page 49

Specifications
GB
General
The HemoCue Albumin 201 System is intended to be
used for the determination of low levels albumin in
urine. The system consists of a specially designed ana-
lyzer and specially designed microcuvettes containing
dried reagent. The cuvettes serve as pipette, reaction
vessel and as a measuring cuvette. No dilution is re-
quired. The result of the albumin measurement is shown
on the display when the reaction has been completed.
The system is factory calibrated against a turbidimetric
method with a calibrator traceable to CRM 470 (Certified
Reference Material).
Intended purpose
The quantitative, rapid turbidimetric immunoassay of
albumin in human urine using a specially designed
analyzer, the HemoCue Albumin 201 Analyzer. The
system is designed for the quantitative determination of
low levels albumin in urine for the purpose of screening
for, diagnosis, monitoring and to support the clinical
evidence in the treatment of microalbuminuria.
The HemoCue Urine Albumin Microcuvettes are for
in vitro Diagnostic use only. The HemoCue Albumin 201
Analyzer is only to be used with HemoCue Urine Albumin
Microcuvettes. For professional use only.
Theory
A specific rabbit anti-human albumin antibody (polyclo-
nal) forms an agglutinate with the human albumin in
the sample. The agglutination is enhanced by polymers.
The turbidity of the agglutinates, once formed, is meas-
ured photometrically at 610 nm.
Reagents
11 % w/w rabbit anti-human albumin antibody (poly-
clonal), 35 % w/w PEG, 18 % w/w Tris /HCl-buffer,
2 % w/w polymer and 33 % w/w non-reactive ingredients.
Specimen collection and preparation
Collect the first voided morning urine. Morning urine
after rest is recommended since muscle activity influ-
ences the albumin excretion rate. Spot samples during
the day may be used, but higher results can be expected.
To determine the urine albumin excretion rate, a timed
collection should be performed. The urine collected
before sleep should be discarded and the time noted.
All the urine from this point until morning is collected.
Note the time for the last collected portion. Measure the
total volume 2 . Note: The system is intended to be used
with fresh specimen. Use of frozen specimen should be
avoided as this may affect results.
Storage and environmental requirements
HemoCue Urine Albumin Microcuvettes
Store the HemoCue Urine Albumin Microcuvettes in
their package in a refrigerator, at 2–8°C (35–46°F).
The individually packaged cuvettes can be stored at
room temperature for up to 3 days. Do not store the
cuvettes in the freezer. Use the HemoCue Urine Albumin
Microcuvettes prior to their expiry date. The expiry date
is printed on each container as well as on each individual
package.
HemoCue Albumin 201 Analyzer
The analyzer can be stored and transported in tem-
peratures between 0–50ºC (32–122°F). The operating
temperature is 15–30ºC (59– 86°F). The analyzer should
be allowed to equilibrate at room temperature prior to
use. The instrument should not be used in extremes of
humidity (>80 % relative moisture over 30°C (86°F)).
Quality Control
The HemoCue Albumin 201 Analyzer has a internal elec-
tronic self test of the optronic unit of the analyzer.
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