HemoCue Albumin 201, Operating Manual

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General
The HemoCue Albumin 201 system is intended to be
used for the determination of low levels of albumin in
urine, microalbuminuria. The system consists of a special-
ly designed analyzer, HemoCue Albumin 201 Analyzer,
and specially designed microcuvettes, HemoCue Urine
Albumin Microcuvettes, containing dried reagent. The
cuvettes serve as pipette, reaction vessel and as a mea-
suring cuvette. No dilution is required. The result of the
albumin measurement is shown on the display when the
reaction has been completed. The system is factory cali-
brated against a turbidimetric method with traceability
to CRM 470 (Certified Reference Material) and needs no
further calibration.
Intended purpose
The quantitative, rapid, turbidimetric immunoassay
of albumin in human urine using a specially designed
system, the HemoCue Albumin 201 system. The system is
designed to be used for the quantitative determination
of low levels of albumin in urine at the point-of-care for
the purpose of screening for, diagnosing, monitoring and
to supplement the clinical evidence in the treatment of
microalbuminuria. The system is designed for testing
using spot samples or timed collections. A quantitative
result is obtained within 90 seconds. 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.
Theory
A specific rabbit anti-human albumin antibody (poly-
clonal) forms an agglutinate with the human albumin in
the sample. The agglutination is enhanced by polymers.
The turbidity of the agglutinates, once formed, is mea-
sured 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.
Note: The system is intended to be used with fresh speci-
men. 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 35 – 46 °F, (2– 8 °C).
The individually packaged cuvettes can be stored at
room temperature for up to 3 days. Do not store the
cuvettes in the freezer. Unused HemoCue Urine Albumin
Microcuvettes should be kept in the original package but
once a individual package is opened, the cuvette must be
used immediately or discarded.
HemoCue Albumin 201 Analyzer
The analyzer can be stored and transported in tempera-
tures between 32–122°F (0 –50 ºC). The operating tem-
perature is 59 – 86°F, (15-30ºC). The analyzer should be
allowed to equilibrate at room temperature prior to use.
The analyzer should not be used in extremes of humidity
(>80 % relative moisture up to 86°F (30°C)).
Quality Control
• The system can be verified by measuring a commercially
available urine albumin control. Note that local, state,
or other accreditating agencies may require additional
Specifications
US