Specifications - HemoCue Glucose 201 RT Manuel D'utilisation

Specifications

GB
Intended purpose/Intended use
The HemoCue Glucose 201 RT system is used for quantita-
tive determination of glucose in whole blood, supplement-
ing the clinical evidence in the diagnosis and treatment of
patients with diabetes as well as monitoring of neonatal
blood glucose levels. The system should not be used on
critically ill neonates in neonatal intensive care settings. The
HemoCue Glucose 201 RT system is for In Vitro Diagnostic
use only. The HemoCue Glucose 201 RT Analyzer is only to
be used with HemoCue Glucose 201 RT Microcuvettes. For
professional use only.
IVD Medical Device Directive
The HemoCue Glucose 201 RT complies with the IVD Medical
Device Directive 98/79/EC and carries the CE mark.
Principles of the method/procedure
Principle of the method
The chemical reaction in the cavity has two phases, hemolysis
and the glucose reaction. The glucose reaction is a modified
glucose dehydrogenase method in which a tetrazolium salt
(MTT) is used to obtain a quantification of glucose in vis-
ible light. α-D-glucose is transformed to β-D-glucose using
mutarotase. Glucose dehydrogenase acts as a catalyst for the
oxidation of β-D-glucose, to form NADH, which in the pres-
ence of diaphorase produces a colored formazan with MTT.
Principle of the procedure
The system consists of an analyzer together with microcu-
vettes. The microcuvette serves both as a pipette and as a
measuring cuvette and is for single-use only. A blood sam-
ple of approximatly 4 μL is drawn into the cavity by capil-
lary action. The measurement takes place in the analyzer in
which the transmittance is measured and the absorbance and
glucose level is calculated. The calibration of the HemoCue
Glucose 201 RT system is traceable to the YSI 2300 STAT
Plus method and ID GC-MS method. The HemoCue Glucose
201 RT is factory calibrated and needs no further calibration.
Composition
The microcuvette is made of copolyester plastic and con-
tains the following reagent: <75 μg/g cuvette MTT (methyl-
thiazolyldiphenyl tetrazolium), <130 μg/g cuvette saponin,
<40 μg/g cuvette sodium fluoride, <525 μg/g cuvette enzyme
mix: mutarotase (bacterial), glucose dehydrogenase (bacte-
rial), diaphorase (bacterial), NAD (nicotinamide-adenine-
dinucleotide), and non-reactive ingredients.
Warning and precaution
In accordance with "Good Laboratory Practices", interven-
tion levels and normal values should be established by each
laboratory when instituting a new method. The specimen
collection should be done according to instruction for use
to reduce the risk of incorrect results. In cases of severe
hypotension and peripheral circulatory failure, glucose
measurement from capillary samples may be misleading. In
such circumstances it is recommended that the glucose level
should be measured using venous or arterial whole blood.
The measurement needs to be started no later than 40 sec-
onds after filling the microcuvette. If a second sample is to
be taken, fill a new microcuvette from a new drop of blood.
This should not be done until the measurement of the first
sample is completed. Do not remeasure the microcuvette.
If the results exceeds the measuring range of the system
"HHH" will be displayed.
Always handle blood specimens with care as they may
be infectious. Consult local environmental authorities for
proper disposal.
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